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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05754697
Other study ID # P.T.REC/012/003841
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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