- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05165134
Hallux Valgus Conservative Treatment (RCT)
December 20, 2021 updated by: Mohammed Moustafa, University of Jazan
Influence of Short-Term Conservative Treatment Using Kinesiotape on Hallux Valgus Angle
Studying the effect of kinesiotape on hallux valgus angle and pain in hallux valgus patients.
Study Overview
Detailed Description
30 patients (male and female) suffering from bilateral Halux valgus. Divided randomly into 2 groups
- st group receive kinesiotape bilaterally for correction : Hallux valgus angle (HVA) was measured using Xray and pain was measured using VAS before applying tape and after 8 weeks of tape application.
- nd group receive placebo tape bilaterally and had the same measurements.
2 groups were on a group of exercises
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
-
-
Jazan
-
Gizan, Jazan, Saudi Arabia, 45142
- Jazan University
-
-
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
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- mobile hallux valgus
Exclusion Criteria:
- using orthotics
- knee malalignment
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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental kinesiotape group A
Kinesiotape group
|
Elastic tape used for mechanical correction of the deformity in study group and placebo in control group
|
|
Placebo Comparator: Placebo kinesiotape group B
Control group
|
Elastic tape used for mechanical correction of the deformity in study group and placebo in control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hallux valgus angle (HVA )
Time Frame: 8 weeks
|
Hallux valgus angle measured by x ray
|
8 weeks
|
|
Pain on metatarsophalangeal joint measured by visual analogue scale (VAS)
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed M Ahmed, assistant professor of physical therapy
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)
August 24, 2020
Primary Completion (Actual)
January 29, 2021
Study Completion (Actual)
November 15, 2021
Study Registration Dates
First Submitted
December 5, 2021
First Submitted That Met QC Criteria
December 20, 2021
First Posted (Actual)
December 21, 2021
Study Record Updates
Last Update Posted (Actual)
December 21, 2021
Last Update Submitted That Met QC Criteria
December 20, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ju
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All will be accessible on request
IPD Sharing Time Frame
March 2022
IPD Sharing Access Criteria
Thru e mail
IPD Sharing Supporting Information Type
- Study Protocol
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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