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

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, 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

Condition or disease	Intervention/treatment	Phase
Plantar Fascitis; Myofascial Pain Syndrome	Device: ESWT; Procedure: Dry needling	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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.
• 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
• Actual Primary Completion Date: August 28, 2023
• Actual Study Completion Date: September 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 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
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 :

1. 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

2. 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

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Istanbul Training and Resarch Hospital

Istanbul, Turkey

Sponsors and Collaborators

Istanbul Training and Research Hospital

Investigators

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

More Information

• Responsible Party: Burak Tayyip Dede, Medical Doctor, Istanbul Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT06023836
• Other Study ID Numbers: 07/04/2023; 2011-KAEK-50;89
• First Posted: September 5, 2023
• Last Update Posted: October 3, 2023
• Last Verified: September 2023

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

Keywords provided by Burak Tayyip Dede, Istanbul Training and Research Hospital:

plantar fasciitis; ESWT; dry needling

Additional relevant MeSH terms:

Fasciitis; Myofascial Pain Syndromes; Fasciitis, Plantar; Fibromyalgia; Syndrome; Somatoform Disorders; Disease; Pathologic Processes; Mental Disorders; Musculoskeletal Diseases; Muscular Diseases; Foot Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases