Myofascial Pain Syndrome and Plantar Fasciitis Treatment

• ClinicalTrials.gov Identifier: NCT06023836
• Recruitment Status: Completed
• First Posted: September 5, 2023
• Last Update Posted: October 3, 2023
• Sponsor: Istanbul Training and Research Hospital
• Information provided by (Responsible Party): Burak Tayyip Dede, Istanbul Training and Research Hospital

Tracking Information

• First Submitted Date: August 26, 2023
• First Posted Date: September 5, 2023
• Last Update Posted Date: October 3, 2023
• Actual Study Start Date: May 1, 2023
• Actual Primary Completion Date: August 28, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 4, 2023)

• Pain was evaluated with a Visual analog scale (VAS) score. [ Time Frame: 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. [ Time Frame: 5 months ]
  Comparison of the effects of ESWT and dry needling on function in the management of plantar fasciitis

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Myofascial Pain Syndrome and Plantar Fasciitis Treatment
• Official Title: Myofascial Pain Syndrome in Plantar Fasciitis; Comparison of Dry Needling and Extracorporeal Shockwave Therapy (ESWT) Effects on Pain and Function
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Plantar Fascitis
• Myofascial Pain 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.

Study Arms

• Active Comparator: group 1: ESWT treatment
  Participants in this group will only receive ESWT treatment
  Intervention: Device: ESWT
• Active Comparator: Dry needling
  Participants in this group will only receive Dry needling treatment
  Intervention: Procedure: Dry needling

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 4, 2023): 66
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 8, 2023
• Actual Primary Completion Date: August 28, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT06023836
• Other Study ID Numbers: 07/04/2023; 2011-KAEK-50;89
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Burak Tayyip Dede, Istanbul Training and Research Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Istanbul Training and Research Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Burak Tayyip Dede; İstanbul Training and Research Hospital

• PRS Account: Istanbul Training and Research Hospital
• Verification Date: September 2023