Efficacy of Dry Needling in Plantar Fasciitis

• Sponsor: Universidad Complutense de Madrid (Other)
• Overall Status: Completed
• CT.gov ID: NCT02467465
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The plantar fasciitis (PF) is the most common cause of pain on the underside of the heel. About 10% to 20% of the population suffer once during their lifetime. PF concept began to describe at the end of XX century through the discovery of new clinical and histopathological signs of the plantar fascia. The difficulty of diagnosis, understanding and treatment of PF require us to develop new treatment avenues to improve the approach and the understanding of it. Dry needling (DN) as a treatment of myofascial pain syndrome (MPS) and myofascial trigger points (MTP) of muscle associated with the pathology, it may be a good treatment strategy, as demonstrated in the treatment of MPS in other body regions such as the neck, shoulder or the lumbar spine.

Condition or Disease	Intervention/Treatment	Phase
Fasciitis, Plantar	Other: Physical therapy modalities; Device: Invasive Physical therapy modalities	N/A

Detailed Description

Hypothesis:

Add dry needling to a physiotherapy intervention, increases the efficacy of treatment for plantar fasciosis.

Objectives:

General:

Test the efficacy of DN in addition to physiotherapy treatment includes: manual therapy and home exercises; directed to normalize muscle tone and inhibit MTP of the gastrocnemius and soleus muscles, in a group of patients who have been diagnosed with PF.

The variables to measure the efficacy are:

Pain assessment in the affected heel, by visual analog scale (VAS). Ultrasonographic assessment of the thickness of the plantar fascia affected, in longitudinal view, compared with the contralateral.

Goniometric assessment of joint range of ankle dorsiflexion, compared with the contralateral.

Specific:

Analyze the efficacy of the combination of DN treatment with manual therapy and home exercise, in patients who have been diagnosed with PF through monitoring and comparison between groups.

Methodology:

Type of study: clinical trial.

Sample:

It has been used sample size calculator GRANMO version 7.12, and accepting an alpha risk of 0.05 and a beta risk of 0.2, 15 subjects were required in the first group and 15 in the second to detect a difference equal to or greater than 0.6 units. It is assumed that the common standard deviation is 0.57. It has been estimated loss rate of 0%.

population: patients with a confirmed diagnosis of PF, who agree to participate in the study after signing the informed consent and carry out the selection criteria.

Sample:

It has been used sample size calculator GRANMO version 7.12, and accepting an alpha risk of 0.05 and a beta risk of 0.2, 15 subjects were required in the first group and 15 in the second to detect a difference equal to or greater than 0.6 units. It is assumed that the common standard deviation is 0.57. It has been estimated loss rate of 0%.

Selection criteria:

Ultrasonographic study in which a proximal thickened affected plantar fascia is observed greater than or equal to 4 mm.

Pain fell to the first steps in the morning. Pain with palpation at the insertion of the medial calcaneal tubercle, above 5, in a 10-point VAS.

Pathology time evolution of greater than or equal to 4 weeks. Age of patients over 18 years. Acceptance by the patient to participate in the study, having signed the informed consent.

Absence of neoplastic disease. Absence of neurological, sensory, orthopedic and / or surgical alterations. The patient is already doing treatment of physical medicine and rehabilitation. Be subjected to antiplatelet drug therapy. Fear of needles (needle phobia). Difficulty for the patient to understand the instructions to be followed during the study.

Methods of collecting information:

Personal data for each patient and relevant to the study, collected in a protocolized questionnaire, as well as an Excel sheet. All this in a personal history, encoded according to a table of alphanumeric equivalents, allowing subsequent statistical analysis with SPSS19.0 program.

Statistical method:

Initially, a descriptive statistical analysis will be conducted: qualitative variables were summarized by frequency distribution and quantitative by its average and standard deviation. Also it summarizes the information graphically using box plots, bar charts and pie charts.

Furthermore an inferential analysis using parametric or non-parametric techniques, particularly for the main objective analysis of variance was used in two groups (assuming a normal distribution for the variable response) U test or Mann-Whitney will be made in the case lack of normal. To study the response variables in each test group the Student t test or unimuestral averages Wilcoxon signed ranks for related samples was used.

For the analysis of qualitative variables the test of Chi-square test and the association between quantitative variables will be analyzed using the Pearson correlation coefficients and Spearman.

To test these significant differences in values of p <0.05 was assumed. Statistical analysis was performed using the statistical software SPSS v19.0

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Dry Needling in Plantar Fasciitis
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical therapy modalities Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises.	Other: Physical therapy modalities; Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
Experimental: Invasive Physical therapy modalities Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles.	Other: Physical therapy modalities; Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.; Device: Invasive Physical therapy modalities; Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.

Outcome Measures

Primary Outcome Measures

1. Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View. [1 day.]

   Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.

2. Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View. [1 month]

   Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.

3. Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View. [3 month]

   Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.

4. Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View. [6 month]

   Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.

Secondary Outcome Measures

1. Pain Assessment in the Affected Heel, by Visual Analog Scale. [1 day.]

   First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.

2. Pain Assessment in the Affected Heel, by Visual Analog Scale. [1 month]

   First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.

3. Pain Assessment in the Affected Heel, by Visual Analog Scale. [3 month]

   First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.

4. Pain Assessment in the Affected Heel, by Visual Analog Scale. [6 month]

   First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.

5. Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale. [1 day]

   Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.

6. Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale. [1 month]

   Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.

7. Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale. [3 month]

   Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.

8. Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale. [6 month]

   Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.

9. Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended. [1 day]

   Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.

10. Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended. [1 month]

    Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values.Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.

11. Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened. [3 month]

    Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.

12. Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended. [6 month]

    Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.

13. Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed. [1 day]

    Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.

14. Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed. [1 month]

    Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.

15. Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed. [3 month]

    Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.

16. Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed. [6 month]

    Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ultrasonographic study in which a proximal thickened affected plantar fascia is observed -greater than or equal to 4 mm.

• Pain fell to the first steps in the morning.

• Pain with palpation at the insertion of the medial calcaneal tubercle, above 5, in a 10-point VAS.

• Pathology time evolution of greater than or equal to 4 weeks.

• Age of patients over 18 years.

• Acceptance by the patient to participate in the study, having signed the informed consent.

Exclusion Criteria:

• Presence of neoplastic disease.

• Presence of neurological, sensory, orthopedic and / or surgical alterations.

• The patient is already doing treatment of physical medicine and rehabilitation.

• Be subjected to antiplatelet drug therapy.

• Fear of needles (needle phobia).

• Difficulty for the patient to understand the instructions to be followed during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clínica Universitaria de Podología de la Universidad Complutense de Madrid	Madrid		Spain	28040

Sponsors and Collaborators

• Universidad Complutense de Madrid

Investigators

• Principal Investigator: Suárez Miguel, Physician, Principal Investigator

Study Documents (Full-Text)

• Statistical Analysis Plan - Apr 23, 2014
• Study Protocol - Apr 23, 2014
• Informed Consent Form - Jul 23, 2014

More Information

Publications

None provided.

• Responsible Party: Miguel Suárez Varela, Physiotherapy degree, Universidad Complutense de Madrid
• ClinicalTrials.gov Identifier: NCT02467465
• Other Study ID Numbers: Univ. Complutense de Madrid
• First Posted: Jun 10, 2015
• Last Update Posted: Sep 9, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Miguel Suárez Varela, Physiotherapy degree, Universidad Complutense de Madrid: Fasciosis plantar; physiotherapy; fascitis plantar; dry needling
• Additional relevant MeSH terms: Fasciitis; Fasciitis, Plantar

Study Results

Participant Flow

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities	Total
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.67 (11)	49.47 (12.44)	51.57 (11.73)
Sex: Female, Male (Count of Participants)
Female	6 40%	4 26.7%	10 33.3%
Male	9 60%	11 73.3%	20 66.7%
Region of Enrollment (participants) [Number]
Spain	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Description	Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Time Frame	1 day.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [millimeters]	5.3	4.7

2. Primary Outcome

Title	Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Description	Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [millimeters]	5.0	4.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.175
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Description	Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [millimeters]	4.6	4.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.250
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Primary Outcome

Title	Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Description	Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [millimeters]	4.4	3.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.466
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Pain Assessment in the Affected Heel, by Visual Analog Scale.
Description	First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Time Frame	1 day.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
Measure Participants	15	15
Median (Inter-Quartile Range) [units on a scale]	8	7

6. Secondary Outcome

Title	Pain Assessment in the Affected Heel, by Visual Analog Scale.
Description	First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [units on a scale]	3	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.737
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Pain Assessment in the Affected Heel, by Visual Analog Scale.
Description	First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [units on a scale]	2	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.275
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	Pain Assessment in the Affected Heel, by Visual Analog Scale.
Description	First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [units on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.066
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

Title	Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Description	Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [units on a scale]	7	7

10. Secondary Outcome

Title	Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Description	Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [units on a scale]	4	4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.849
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

11. Secondary Outcome

Title	Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Description	Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [units on a scale]	0	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.425
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

12. Secondary Outcome

Title	Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Description	Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [units on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.487
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

13. Secondary Outcome

Title	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Description	Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [degrees]	95	99

14. Secondary Outcome

Title	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Description	Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values.Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [degrees]	101	104

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.651
	Comments
	Method	t-test, 1 sided
	Comments

15. Secondary Outcome

Title	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened.
Description	Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [degrees]	100	104

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.387
	Comments
	Method	t-test, 1 sided
	Comments

16. Secondary Outcome

Title	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Description	Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [degrees]	104	108

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.755
	Comments
	Method	t-test, 1 sided
	Comments

17. Secondary Outcome

Title	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Description	Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [degrees]	104	109

18. Secondary Outcome

Title	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Description	Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [degrees]	108	110

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.032
	Comments
	Method	t-test, 1 sided
	Comments

19. Secondary Outcome

Title	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Description	Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [degrees]	109	110

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.058
	Comments
	Method	t-test, 1 sided
	Comments

20. Secondary Outcome

Title	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Description	Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Therapy Modalities	Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
Measure Participants	15	15
Median (Inter-Quartile Range) [degrees]	110	110

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Therapy Modalities, Invasive Physical Therapy Modalities
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.279
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	6 months.
Arm/Group Title	Physical Therapy Modalities		Invasive Physical Therapy Modalities
Arm/Group Description	Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.		Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
All Cause Mortality
	Physical Therapy Modalities		Invasive Physical Therapy Modalities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Physical Therapy Modalities		Invasive Physical Therapy Modalities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Physical Therapy Modalities		Invasive Physical Therapy Modalities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.