IASTM Versus PRT in Patients With Chronic PF

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

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?

Study Overview

• Status: Completed
• Conditions: Chronic Plantar Fasciitis
• Intervention / Treatment: Other: Instrument assisted soft tissue mobilization in addition to traditional treatment; Other: Positional release technique in addition to traditional treatment; Other: Traditional treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Port Said, Egypt
    • Private Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects can't tolerate close physical contact.
2. Athletes.
3. Subjects with skin infections.
4. Subjects with recent fracture with incomplete bony union.
5. Subjects with acute inflammatory or infectious process.
6. Subjects with hematoma.
7. Subjects with osteoporosis.
8. Subjects with foot deformity.
9. Subjects that take medications that may increase blood clotting.
10. Surgery to the ankle or foot.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: instrument assisted soft tissue mobilization in addition to traditional treatment; study group	Other: Instrument assisted soft tissue mobilization in addition to traditional treatment; The treatment protocol will be two sessions will be given per week for 4 weeks.
Experimental: positional release technique in addition to traditional treatment; study group	Other: Positional release technique in addition to traditional treatment; The treatment protocol will be two sessions will be given per week for 4 weeks.
Active Comparator: traditional treatment; control group	Other: Traditional treatment; The treatment protocol will be two sessions will be given per week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Algometer (Change in pain pressure threshold)	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.	Pre-intervention and immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Arabic Version of Foot and Ankle Ability Measure	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.	Pre-intervention and immediately after intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Doaa Ibrahim, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Instrument assisted soft tissue mobilization; Positional release technique
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: P.T.REC/012/003841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No