- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06131762
Effects of Active and PRT on Pain, Function and Temporospatial Gait Parameters in Runners With Plantar Fascitis
December 26, 2023 updated by: Riphah International University
Comparative Effects of Active and Positional Release Technique on Pain, Function and Temporospatial Gait Parameters in Runners With Plantar Fasciitis
The study is randomized and single -blinded.
Ethical approval is taken from ethical committee of Riphah International university Lahore.Participants who will meet criteria will be requested to give verbal consent and to sign written consent form.
After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization.
Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks.
Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A single blinded randomized clinical trial will be conducted on 26 subjects diagnosed for planter fasciitis from Jawad Club Faisalabad and Alfatah Sports Club, Faisalabad by looking for symptoms and tenderness at heel as mentioned in inclusion criteria and will confirmed by windlass test.
Participants who will meet criteria will be requested to give verbal consent and to sign written consent form.
After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization.
Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks.
Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks.
Pain will be measured by Numerical Pain Rating Scale (NPRS), Foot and ankle disability will be assessed by Foot Function Index (FFI), while gait parameters i.e. walking speed will be measured by 4-meter walking test, and step and stride length will be evaluated by measuring tape by taking foot prints before and after the 4 weeks of treatment period.
Data will be analyzed through statistical package for the social sciences (SPSS) version 22.
Study Type
Interventional
Enrollment (Estimated)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Malia younas, Ms DPT
- Phone Number: 03258292286
- Email: maliayounas62@gmail.com
Study Locations
-
-
Punjab
-
Faisalābad, Punjab, Pakistan, 38000
- Recruiting
- Jawad club, Alfatah sports complex
-
Contact:
- Hamza Azeem, BBA
- Phone Number: 03247664872
- Email: hamza.azeem2018@gmail.com
-
Contact:
- Athar Azeem, Dpt
- Phone Number: 03350079772
- Email: atharazzem420@gmail.com
-
Principal Investigator:
- Athar Azeem, dpt
-
Sub-Investigator:
- Malia younas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male runners age between 18-30 years
- Duration of running at least 6 months
- Positive windlass test
- Patients with unilateral or bilateral plantar fasciitis
Exclusion Criteria:
- Recent accidental foot or ankle injury
- Previous lower-body surgical intervention within 6 months
- Recent fractures in the lower limb (femur, tibia, fibula or foot bones) within 6 months
- Diagnosed musculoskeletal disorders (rheumatoid arthritis, calcaneal spurs)
- Diagnosed neuropathy, local and systemic neurologic disorders (including sciatica, tarsal tunnel syndrome, nerve entrapment of abductor digiti minimi and posterior tibial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active release technique
ART performed from long sitting position, the therapist started by shortening the muscle or fascia of affected limb then apply very specific pressure with hand as we stretch tissue is lengthened.
Active movement is done whenever possible according to the instructions given by therapist.
ART for 8-10 minutes will be given.
|
This include active release technique for 4 weeks
|
Experimental: Positional release technique
Positional release technique where participant lie supine with the affected limb out of the plinth and then by application of brief mechanical pressure on tender point with one fingertip in order to determine tenderness.
The foot should then be positioned, most probably into pure plantarflexion and gentle fine-tuned by rotation, until the score in the tender point has reduce by at least 70%.
This position is held for 90 seconds with 3 repetitions i.e. total of 270 seconds was given.
|
This include positional release technique for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait parameters
Time Frame: pre and 4 weeks post intervention
|
gait parameters will be measured by 4-meter walking test
|
pre and 4 weeks post intervention
|
Foot Function
Time Frame: pre and 4 weeks post intervention
|
Foot function will be assessed by Foot Function Index (FFI),
|
pre and 4 weeks post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Athar Azeem, Dpt, Investigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Brachman A, Sobota G, Marszalek W, Pawlowski M, Juras G, Bacik B. Plantar pressure distribution and spatiotemporal gait parameters after the radial shock wave therapy in patients with chronic plantar fasciitis. J Biomech. 2020 May 22;105:109773. doi: 10.1016/j.jbiomech.2020.109773. Epub 2020 Apr 3.
- Waclawski ER, Beach J, Milne A, Yacyshyn E, Dryden DM. Systematic review: plantar fasciitis and prolonged weight bearing. Occup Med (Lond). 2015 Mar;65(2):97-106. doi: 10.1093/occmed/kqu177. Epub 2015 Feb 17.
- Tong KB, Furia J. Economic burden of plantar fasciitis treatment in the United States. Am J Orthop (Belle Mead NJ). 2010 May;39(5):227-31.
- Thong-On S, Bovonsunthonchai S, Vachalathiti R, Intiravoranont W, Suwannarat S, Smith R. Effects of Strengthening and Stretching Exercises on the Temporospatial Gait Parameters in Patients With Plantar Fasciitis: A Randomized Controlled Trial. Ann Rehabil Med. 2019 Dec;43(6):662-676. doi: 10.5535/arm.2019.43.6.662. Epub 2019 Dec 31.
- Fabrikant JM, Park TS. Plantar fasciitis (fasciosis) treatment outcome study: plantar fascia thickness measured by ultrasound and correlated with patient self-reported improvement. Foot (Edinb). 2011 Jun;21(2):79-83. doi: 10.1016/j.foot.2011.01.015. Epub 2011 Mar 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2023
Primary Completion (Estimated)
February 20, 2024
Study Completion (Estimated)
February 20, 2024
Study Registration Dates
First Submitted
November 9, 2023
First Submitted That Met QC Criteria
November 9, 2023
First Posted (Actual)
November 14, 2023
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 26, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0432
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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