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Completed

NCT Number: NCT05754697

IASTM Versus PRT in Patients With Chronic PF

The goal of this clinical trial] is to compare between the effect of instrument assisted soft tissue mobilization and positional release technique in patients with chronic plantar fasciitis

The main question[s] it aims to answer are:

1. Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on pain pressure threshold in patients with chronic plantar fasciitis? 2. Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on foot function level in patients with chronic plantar fasciitis?

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Key information

Conditions

Chronic Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Clinic

Port Said, Egypt

About this study

Design of the study:

Pretest - posttest randomized controlled trial.

Subjects selection:

Sixty patients their age range from 30-50 years of both genders with chronic plantar fasciitis will participate in this study according to sample size calculation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinically diagnosed cases of plantar fasciitis not less than 3 months.
  • Heel pain felt maximally over plantar aspect of heel.
  • Pain in the heel on the first step in the morning.
  • Their age ranging from 30-50 years.
  • Body mass index range from (18.5 to 24.9 kg/m2).

Exclusion criteria

  • Subjects can't tolerate close physical contact.
  • Athletes.
  • Subjects with skin infections.
  • Subjects with recent fracture with incomplete bony union.
  • Subjects with acute inflammatory or infectious process.
  • Subjects with hematoma.
  • Subjects with osteoporosis.
  • Subjects with foot deformity.
  • Subjects that take medications that may increase blood clotting.
  • Surgery to the ankle or foot.

Treatment and study plan

Instrument assisted soft tissue mobilization in addition to traditional treatment

Other

The treatment protocol will be two sessions will be given per week for 4 weeks.

Positional release technique in addition to traditional treatment

Other

The treatment protocol will be two sessions will be given per week for 4 weeks.

traditional treatment

Other

The treatment protocol will be two sessions will be given per week for 4 weeks.

Primary outcomes

  1. Pressure Algometer (Change in pain pressure threshold)

    Time frame: Pre-intervention and immediately after intervention

    Change in pain pressure threshold as assessed using pressure algometer on medial plantar process, with the unit of measurement in kg/cm².

    Change in pain pressure threshold as assessed using pressure algometer on gastrocnemius muscle, with the unit of measurement in kg/cm².

    Change in pain pressure threshold as assessed using pressure algometer on soleus muscle, with the unit of measurement in kg/cm².

    Change in pain pressure threshold as assessed using pressure algometer over the posteromedial aspect of the calcaneus , with the unit of measurement in kg/cm².

Secondary outcomes

  1. The Arabic Version of Foot and Ankle Ability Measure

    Time frame: Pre-intervention and immediately after intervention

    The foot and ankle ability measure is a reliable, responsive, and valid measure of physical function for individuals with a broad range of musculoskeletal disorders of the lower leg, foot, and ankle.

    This self-report outcome instrument is available in English, German, French and Persian. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.

    Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Instrument Assisted Soft Tissue Mobilization Versus Positional Release Technique in Patients With Chronic Plantar Fasciitis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2023
Registry last updated
Sep 28, 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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