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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06131762
Other study ID # REC/RCR & AHS/23/0432
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date February 20, 2024

Study information

Verified date December 2023
Source Riphah International University
Contact Malia younas, Ms DPT
Phone 03258292286
Email maliayounas62@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date February 20, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Active release technique
This include active release technique for 4 weeks
Positional release technique
This include positional release technique for 4 weeks

Locations

Country Name City State
Pakistan Jawad club, Alfatah sports complex Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gait parameters gait parameters will be measured by 4-meter walking test pre and 4 weeks post intervention
Primary Foot Function Foot function will be assessed by Foot Function Index (FFI), pre and 4 weeks post intervention
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