IASTM Versus PRT in Patients With Chronic PF

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05754697
• Collaborator: (none)
• Enrollment: 60
• Arms: 3
• Anticipated Duration (Months): 3.5

Study Details

Study Description

Brief Summary

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?

Condition or Disease	Intervention/Treatment	Phase
Chronic Plantar Fasciitis	Other: Instrument assisted soft tissue mobilization in addition to traditional treatment; Other: Positional release technique in addition to traditional treatment; Other: Traditional treatment	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Instrument Assisted Soft Tissue Mobilization Versus Positional Release Technique in Patients With Chronic Plantar Fasciitis
• Anticipated Study Start Date: Mar 15, 2023
• Anticipated Primary Completion Date: Jun 15, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Pressure Algometer (Change in pain pressure threshold) [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 Outcome Measures

1. The Arabic Version of Foot and Ankle Ability Measure [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Doaa Ibrahim, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Doaa Said Mohamed Ibrahim, Assistant Lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT05754697
• Other Study ID Numbers: P.T.REC/012/003841
• First Posted: Mar 6, 2023
• Last Update Posted: Mar 6, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Doaa Said Mohamed Ibrahim, Assistant Lecturer, Cairo University: Positional release technique; Instrument assisted soft tissue mobilization
• Additional relevant MeSH terms: Fasciitis; Fasciitis, Plantar

Study Results

No Results Posted as of Mar 6, 2023