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Completed

NCT Number: NCT06023836

Myofascial Pain Syndrome and Plantar Fasciitis Treatment

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

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Key information

Conditions

Plantar Fascitis Fasciitis Fasciitis, Plantar Foot Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndrome Myofascial Pain Syndromes

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Training and Resarch Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2023
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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