IASTM Versus PRT in Patients With Chronic PF

Chronic Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05754697
• Other study ID #: P.T.REC/012/003841
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Plantar Fasciitis
• Fasciitis
• Fasciitis, Plantar

Intervention

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.
• Positional release technique in addition to traditional treatment
The treatment protocol will be two sessions will be given per week for 4 weeks.
• Traditional treatment
The treatment protocol will be two sessions will be given per week for 4 weeks.

Locations

Country	Name	City	State
Egypt	Private Clinic	Port Said

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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