Myofascial Pain Syndrome and Plantar Fasciitis Treatment

NCT06023836 | Completed

• 1 other identifier: 07/04/2023; 2011-KAEK-50;89
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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, 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

Conditions

Plantar Fascitis; Myofascial Pain Syndrome

Keywords

plantar fasciitis; ESWT; dry needling

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

group 1: ESWT treatment

ACTIVE COMPARATOR

Participants in this group will only receive ESWT treatment

Device: ESWT

Dry needling

ACTIVE COMPARATOR

Participants in this group will only receive Dry needling treatment

Procedure: Dry needling

Interventions

ESWT DEVICE

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

group 1: ESWT treatment

Dry needling PROCEDURE

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.

Dry needling

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Resarch Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Fasciitis, Plantar

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Fasciitis; Foot Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Burak Tayyip Dede

  İstanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

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

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 5, 2023
• Study Start: May 1, 2023
• Primary Completion: August 28, 2023
• Study Completion: September 8, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Locations

TU (1)