Myofascial Pain Syndrome and Plantar Fasciitis Treatment

Sponsor

Istanbul Training and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06023836

Collaborator

(none)

Enrollment

Location

Arms

4.3

Anticipated Duration (Months)

15.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with plantar fasciitis between the ages of 25-65 years who presented to the Physical Medicine and Rehabilitation clinic with the complaint of heel pain and met the inclusion and exclusion criteria will be included in the study. Demographic data (age, gender, body mass index, symptom duration) will be recorded at the beginning of the study. Then, Foot Functional Index (FFI) and Visual Analog Scale (VAS) scales will be recorded. Participants will be randomly divided into two groups. Group 1 will receive dry needling and Group 2 will receive extracorporeal shock wave therapy (ESWT). Patients in the 1st group will undergo 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles at one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles. Patients in the 2nd group will receive 3 sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 brand ESWT device) with a frequency of 12-15 Hz, 2-3 bars and 2500 pulses once a week. ESWT will be applied to the 5 most sensitive points of the plantar fascia with equal shares of 2500 pulses.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fascitis Myofascial Pain Syndrome	Device: ESWT Procedure: Dry needling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling.Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Myofascial Pain Syndrome in Plantar Fasciitis; Comparison of Dry Needling and Extracorporeal Shockwave Therapy (ESWT) Effects on Pain and Function

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 28, 2023

Anticipated Study Completion Date :

Sep 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group 1: ESWT treatment Participants in this group will only receive ESWT treatment	Device: ESWT Patients in the group will receive 3 sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 brand ESWT device) with a frequency of 12-15 Hz, 2-3 bars and 2500 pulses once a week. ESWT will be applied to the 5 most sensitive points of the plantar fascia with equal shares of 2500 pulses.
Active Comparator: Dry needling Participants in this group will only receive Dry needling treatment	Procedure: Dry needling Dry needling with Seirin branded 0.6*50 mm acupuncture needles will be performed for 3 sessions with one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles of the patients in the group.

Arm

Intervention/Treatment

Active Comparator: group 1: ESWT treatment

Participants in this group will only receive ESWT treatment

Device: ESWT

Patients in the group will receive 3 sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 brand ESWT device) with a frequency of 12-15 Hz, 2-3 bars and 2500 pulses once a week. ESWT will be applied to the 5 most sensitive points of the plantar fascia with equal shares of 2500 pulses.

Active Comparator: Dry needling

Participants in this group will only receive Dry needling treatment

Procedure: Dry needling

Dry needling with Seirin branded 0.6*50 mm acupuncture needles will be performed for 3 sessions with one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles of the patients in the group.

Outcome Measures

Primary Outcome Measures

Pain was evaluated with a Visual analog scale (VAS) score. [5 months]
VAS score ranges from 0 to 10. Comparison of the effects of ESWT and dry needling on pain in the management of plantar fasciitis
Function was evaluated with (Foot Functional Index) FFI score. [5 months]
Comparison of the effects of ESWT and dry needling on function in the management of plantar fasciitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged 25-65 years with heel pain for more than 6 weeks
tenderness on palpation in the medial calcaneal region
aggravation of symptoms while standing and in the first hours of the morning
who agreed not to receive anti-inflammatory treatment during the study period
fascia thickness >4mm measured by ultrasound.

Exclusion Criteria:

Patients diagnosed with rheumatologic diseases
Those diagnosed with Diabetes Mellitus (DM), those with chronic liver and kidney failure
Anti-inflammatory-analgesic treatment within the last 1 month
Diagnosed with inflammatory rheumatic disease
Those with a history of foot surgery
Those with mid or hindfoot deformity
Previous history of central or peripheral nerve damage, lower extremity neuropathy
Those diagnosed with Diabetes Mellitus
Those with cognitive impairment
Unassisted mobilization
Those with bleeding disorders
Pregnant women