A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain

• Sponsor: Universidad de Zaragoza (Other)
• Overall Status: Completed
• CT.gov ID: NCT03236779
• Collaborator: Universidad San Jorge (Other), Ministry of Health, Kuwait (Other)
• Enrollment: 102
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.2
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

This is a clinical trial that will be done in the state of Kuwait, at the physical rehabilitation medicine hospital. the participants will be recruited from all over Kuwait, there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of health.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fascitis; Myofacial Pain Syndromes; Trigger Point Pain, Myofascial	Other: dry needling	N/A

Detailed Description

Physical therapy approaches continue evolving. During the last years, minimally invasive techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining promising results for tendon pathology. PNE technique is a minimally invasive treatment that consists of an application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. This allows for phagocytosis and the subsequent regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to manage MTrP, but there are no studies supporting that they have an additional beneficial effect over DN.

From a biological point of view, it seems reasonable to ascertain that a patient will obtain benefits thanks to the mechanical effects provided by the needle and that patients may benefit more if the electrolysis effect is added to the mechanical stimuli provided by the needle. Therefore, the aim of this randomized controlled study is to compare the effectiveness of DN versus PNE for the level of pain in patients suffering from PHP.

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study is a prospective, two parallel-groups (participant) randomized controlled trial with blinded outcome assessment at baseline, and at 4, 8, 12, 26 and 52 weeks. The study flow chart shown in Figure 1 conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for nonpharmacological studiesThis study is a prospective, two parallel-groups (participant) randomized controlled trial with blinded outcome assessment at baseline, and at 4, 8, 12, 26 and 52 weeks. The study flow chart shown in Figure 1 conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for nonpharmacological studies
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Participants who fulfill the inclusion criteria will receive the standardized oral and written information, and, once they consent to participate in the trial, will be randomized in a block system by blocks of 10 patients. Allocation to the groups will be achieved using a computer program (Randomizer, https://www.randomizer.org/) generated a random patient file numbers sequence by a third person not involved in the study from the file section in Kuwait. This person will be responsible for guarding the envelope with the information of the randomization. The envelopes will be closed until the moment of the intervention to maintain the blinding. This professional also will ask the patients for informed consent. The consent form is recruited upon the ethical medical committee at the ministry of health in the state of Kuwait.
• Primary Purpose: Treatment
• Official Title: A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain: A Randomized Clinical Trial
• Actual Study Start Date: Jan 14, 2018
• Actual Primary Completion Date: Oct 10, 2019
• Actual Study Completion Date: Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dry needling (DN) arm Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.	Other: dry needling; The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.; Other Names: Percutaneous needle electrolysis
Active Comparator: Percutaneous needle electrolysis (PNE) arm The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.	Other: dry needling; The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.; Other Names: Percutaneous needle electrolysis

Outcome Measures

Primary Outcome Measures

1. Foot Health Status Questioner (FHSQ) PAIN [Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks]

   Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain

Secondary Outcome Measures

1. VAS Maximum [1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)]

   Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable

2. The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) [Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"]

   The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Clinical diagnosis of PHP in accordance with the Clinical Guidelines linked to the International Classification of Function, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association

• Age greater than 21 years according to the Kuwaiti law.

• History of plantar heel pain for greater than one month.

• Walking 50 meters without any support

• Having MTPs on initial physical examination on plantar and calf muscles

• Accepting to be treated by a male physiotherapist.

• Capacity to understand the study and the informed consent, as well as having signed the document.

Exclusion Criteria:

• • Needle phobia

• Allergy from needles or hypersensitivity to metals

• Presence of coagulopathy or use of anticoagulants

• Presence of peripheral arterial vascular disease

• Pregnancy

• Dermatological disease with the dry needling area

• The presence of a chronic medical condition that might preclude participation in the study such as malignancy, systemic inflammatory disorders (e.g. psoriatic arthritis, ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy, mononeuropathy.

• Treatment of plantar heel pain with needling or acupuncture during last 4 weeks.

• A history of injection therapy in the heel in the previous three months.

• Previous history of foot surgery or fracture.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physical Medicine and rehabilitation Kuwait	Kuwait		Kuwait

Sponsors and Collaborators

• Universidad de Zaragoza
• Universidad San Jorge
• Ministry of Health, Kuwait

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Jan 23, 2021
• Study Protocol and Statistical Analysis Plan - Jan 23, 2021

More Information

Publications

None provided.

• Responsible Party: ZAID AL BOLOUSHI, PhD student, Universidad de Zaragoza
• ClinicalTrials.gov Identifier: NCT03236779
• Other Study ID Numbers: ALBOLOUSHI
• First Posted: Aug 2, 2017
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fasciitis; Fasciitis, Plantar; Myofascial Pain Syndromes; Facial Neuralgia; Facial Pain

Study Results

Participant Flow

Arm/Group Title	Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm
Arm/Group Description	Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Period Title: Overall Study
STARTED	51	51
COMPLETED	38	30
NOT COMPLETED	13	21

Baseline Characteristics

Arm/Group Title	Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm	Total
Arm/Group Description	Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	Total of all reporting groups
Overall Participants	51	51	102
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	51 100%	51 100%	102 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.5 (8.9)	48.1 (8.8)	48.8 (8.8)
Sex: Female, Male (Count of Participants)
Female	36 70.6%	36 70.6%	72 70.6%
Male	15 29.4%	15 29.4%	30 29.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	51 100%	51 100%	102 100%
Region of Enrollment (Count of Participants)
Kuwait	51 100%	51 100%	102 100%

Outcome Measures

1. Primary Outcome

Title	Foot Health Status Questioner (FHSQ) PAIN
Description	Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
Time Frame	Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm
Arm/Group Description	Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Measure Participants	51	51
baseline	38.8 (18.8)	40.4 (21.9)
4 weeks	73.4 (27.7)	71.9 (25.7)
8 weeks	70.1 (28.4)	67.4 (26.8)
12 weeks	66.8 (24.8)	63.6 (26.8)
26 weeks	68.8 (25.3)	67.1 (27.1)
52 weeks	68.4 (25.1)	73.1 (29.0)

2. Secondary Outcome

Title	VAS Maximum
Description	Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable
Time Frame	1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VAS DN	VAS PNE
Arm/Group Description	the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain	the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain
Measure Participants	51	51
baseline 1st session	7.6 (2.0)	7.5 (2.3)
2nd session	6.2 (2.3)	5.5 (2.9)
3rd session	5.4 (2.6)	5.3 (3.1)
4th session	4.9 (2.9)	4.5 (3.0)

3. Secondary Outcome

Title	The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
Description	The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.
Time Frame	Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm
Arm/Group Description	Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Measure Participants	51	51
baseline	0.63 (0.23)	0.67 (0.22)
4 weeks	0.78 (0.22)	0.76 (0.24)
8 weeks	0.72 (0.23)	0.74 (0.23)
12 weeks	0.64 (0.30)	0.70 (0.27)
26 weeks	0.65 (0.29)	0.73 (0.27)
52 weeks	0.66 (0.27)	0.77 (0.25)

4. Primary Outcome

Title	Foot Health Status Questioner (FHSQ) PAIN
Description	Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
Time Frame	Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dry Needling (DN) Arm	Percutaneous Needle Electrolysis (PNE) Arm
Arm/Group Description	Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.	The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Measure Participants	51	51
baseline	38.8 (18.8)	40.4 (21.9)
4 weeks	73.4 (27.7)	71.9 (25.7)
8 weeks	70.1 (28.4)	67.4 (26.8)
12 weeks	66.8 (24.8)	63.6 (26.8)
26 weeks	68.8 (25.3)	67.1 (27.1)
52 weeks	68.4 (25.1)	73.1 (29.0)

Adverse Events

Time Frame	1 year follow up
Adverse Event Reporting Description	Unable to tolerate pain of the treatment
Arm/Group Title	Dry Needling		Percutaneous Needle Electrolysis
Arm/Group Description	Once the clinician located the MTrP, the needle was inserted over the same and a rapid needle entry was performed. The chosen technique for manipulating the needle was the technique described by Hong, which consists of a rapid needle entry and exit (fast in/fast out), in order to obtain a local twitch response, lasting 5 seconds employing a rhythmic movement at approximately 1Hz/sec (5 entries).		The electrotherapy equipment used (Physio Invasiva, PRIM Fisioterapia, Spain) produced a continuous galvanic current through the cathode while the patient held a hand-held anode.18 Once the needle reached the relevant treatment area, this was needled in exactly the same manner as in the dry needling group, with the only difference being that the needle was transmitting an electrical current with an intensity of 1.5 mA (intensity was adapted to patient´s characteristics according to their pain tolerance).
All Cause Mortality
	Dry Needling		Percutaneous Needle Electrolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Serious Adverse Events
	Dry Needling		Percutaneous Needle Electrolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Dry Needling		Percutaneous Needle Electrolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/51 (17.6%)		14/51 (27.5%)
Musculoskeletal and connective tissue disorders
unable to tolerate pain	9/51 (17.6%)	9	14/51 (27.5%)	14

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.