Myofascial Pain Syndrome and Plantar Fasciitis Treatment

Myofascial Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06023836
• Other study ID #: 07/04/2023; 2011-KAEK-50;89
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 8, 2023

Study information

• Verified date: September 2023
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, Patients in this group received three sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 trademarked ESWT device) at an energy density of 2 bars and a frequency of 2,000 shocks/min at 12 Hz for three weeks, each session once a week. Each of the five most sensitive and painful points was given 400 pulses in the supine position

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 8, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Plantar Fascitis
• Somatoform Disorders
• Syndrome

Intervention

Device:
• ESWT
Patients in this group received three sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 trademarked ESWT device) at an energy density of 2 bars and a frequency of 2,000 shocks/min at 12 Hz for three weeks, each session once a week. Each of the five most sensitive and painful points was given 400 pulses in the supine position

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.

Locations

Country	Name	City	State
Turkey	Istanbul Training and Resarch Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain was evaluated with a Visual analog scale (VAS) score.	VAS score ranges from 0 to 10.; Comparison of the effects of ESWT and dry needling on pain in the management of plantar fasciitis	5 months
Primary	Function was evaluated with (Foot Functional Index) FFI score.	Comparison of the effects of ESWT and dry needling on function in the management of plantar fasciitis	5 months