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Hallux Valgus Conservative Treatment (RCT)

Primary Purpose

Hallux Valgus

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Kinesiotape
Sponsored by
University of Jazan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • mobile hallux valgus

Exclusion Criteria:

  • using orthotics
  • knee malalignment

Sites / Locations

  • Jazan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental kinesiotape group A

Placebo kinesiotape group B

Arm Description

Kinesiotape group

Control group

Outcomes

Primary Outcome Measures

Hallux valgus angle (HVA )
Hallux valgus angle measured by x ray
Pain on metatarsophalangeal joint measured by visual analogue scale (VAS)

Secondary Outcome Measures

Full Information

First Posted
December 5, 2021
Last Updated
December 20, 2021
Sponsor
University of Jazan
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1. Study Identification

Unique Protocol Identification Number
NCT05165134
Brief Title
Hallux Valgus Conservative Treatment
Acronym
RCT
Official Title
Influence of Short-Term Conservative Treatment Using Kinesiotape on Hallux Valgus Angle
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jazan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Studying the effect of kinesiotape on hallux valgus angle and pain in hallux valgus patients.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pretest and posttest Control group randomized control trial
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental kinesiotape group A
Arm Type
Experimental
Arm Description
Kinesiotape group
Arm Title
Placebo kinesiotape group B
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Kinesiotape
Intervention Description
Elastic tape used for mechanical correction of the deformity in study group and placebo in control group
Primary Outcome Measure Information:
Title
Hallux valgus angle (HVA )
Description
Hallux valgus angle measured by x ray
Time Frame
8 weeks
Title
Pain on metatarsophalangeal joint measured by visual analogue scale (VAS)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mobile hallux valgus Exclusion Criteria: using orthotics knee malalignment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Ahmed
Organizational Affiliation
Assistant Professor of physical therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jazan University
City
Gizan
State/Province
Jazan
ZIP/Postal Code
45142
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All will be accessible on request
IPD Sharing Time Frame
March 2022
IPD Sharing Access Criteria
Thru e mail

Learn more about this trial

Hallux Valgus Conservative Treatment

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