Back to resultsIASTM Versus PRT in Patients With Chronic PF
Primary Purpose
Chronic Plantar Fasciitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Instrument assisted soft tissue mobilization in addition to traditional treatment
Positional release technique in addition to traditional treatment
Traditional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plantar Fasciitis focused on measuring Positional release technique, Instrument assisted soft tissue mobilization
Eligibility Criteria
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.
Sites / Locations
- Private Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
instrument assisted soft tissue mobilization in addition to traditional treatment
positional release technique in addition to traditional treatment
traditional treatment
Arm Description
study group
study group
control group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05754697
Brief Title
IASTM Versus PRT in Patients With Chronic PF
Official Title
Instrument Assisted Soft Tissue Mobilization Versus Positional Release Technique in Patients With Chronic Plantar Fasciitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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:
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?
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plantar Fasciitis
Keywords
Positional release technique, Instrument assisted soft tissue mobilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
instrument assisted soft tissue mobilization in addition to traditional treatment
Arm Type
Experimental
Arm Description
study group
Arm Title
positional release technique in addition to traditional treatment
Arm Type
Experimental
Arm Description
study group
Arm Title
traditional treatment
Arm Type
Active Comparator
Arm Description
control group
Intervention Type
Other
Intervention Name(s)
Instrument assisted soft tissue mobilization in addition to traditional treatment
Intervention Description
The treatment protocol will be two sessions will be given per week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Positional release technique in addition to traditional treatment
Intervention Description
The treatment protocol will be two sessions will be given per week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Traditional treatment
Intervention Description
The treatment protocol will be two sessions will be given per week for 4 weeks.
Primary Outcome Measure Information:
Title
Pressure Algometer (Change in pain pressure threshold)
Description
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.
Time Frame
Pre-intervention and immediately after intervention
Secondary Outcome Measure Information:
Title
The Arabic Version of Foot and Ankle Ability Measure
Description
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.
Time Frame
Pre-intervention and immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa Ibrahim
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Clinic
City
Port Said
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
IASTM Versus PRT in Patients With Chronic PF
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