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Myofascial Pain Syndrome and Plantar Fasciitis Treatment

Primary Purpose

Plantar Fascitis, Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ESWT
Dry needling
Sponsored by
Istanbul Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring plantar fasciitis, ESWT, dry needling

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istanbul Training and Resarch Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group 1: ESWT treatment

Dry needling

Arm Description

Participants in this group will only receive ESWT treatment

Participants in this group will only receive Dry needling treatment

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
August 26, 2023
Last Updated
September 30, 2023
Sponsor
Istanbul Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06023836
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
August 28, 2023 (Actual)
Study Completion Date
September 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis, Myofascial Pain Syndrome
Keywords
plantar fasciitis, ESWT, dry needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1: ESWT treatment
Arm Type
Active Comparator
Arm Description
Participants in this group will only receive ESWT treatment
Arm Title
Dry needling
Arm Type
Active Comparator
Arm Description
Participants in this group will only receive Dry needling treatment
Intervention Type
Device
Intervention Name(s)
ESWT
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain was evaluated with a Visual analog scale (VAS) score.
Description
VAS score ranges from 0 to 10. Comparison of the effects of ESWT and dry needling on pain in the management of plantar fasciitis
Time Frame
5 months
Title
Function was evaluated with (Foot Functional Index) FFI score.
Description
Comparison of the effects of ESWT and dry needling on function in the management of plantar fasciitis
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burak Tayyip Dede
Organizational Affiliation
İstanbul Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Training and Resarch Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Myofascial Pain Syndrome and Plantar Fasciitis Treatment

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