- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04589871
Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis
October 18, 2020 updated by: AMIR IQBAL, King Saud University
Efficacy of Taping Technique in Addition to the Supervised Exercises Protocol on Pain and Functional Status in Individuals With Patello-femoral Arthritis
Osteoarthritis (OA) is claimed to be a global burden and a key health issue that affects the large weight-bearing joints of the lower extremity such as the knee and hip joints.
The study was aimed to find out the efficacy of the tapping technique in addition to the supervised exercise protocol on pain intensity and functional status of an individual with patella-femoral arthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was based on a controlled pretest-posttest experimental group design.
After initial screening, forty individuals (mean age 55years, ranged 40-60years) with patello-femoral arthritis randomly (n=20each) assigned into two group A and B. Group A received taping technique in addition to the supervised exercises protocol while group B received supervised exercises protocol only.
Both the groups received their specified treatment 5 consecutive days in a week for 4weeks.
Data collected for the variables (VAS and WOMAC) at day1 pre-intervention (baseline) and at day 28th post-intervention.
The t-test used for within and between group analysis with keeping the p<0.05.
Study Type
Interventional
Enrollment (Actual)
40
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
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Riyadh, Saudi Arabia, 11433
- Rehabilitation Research Chair
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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
40 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The individuals with unilateral patella-femoral osteoarthritis
- Aged between 40-60years;
- Pain more than 3cm on VAS;
- Crepitus on movement,
- Showing osteophytes on standing skyline view of radiograph (Kallgren/Lawrence grade ≥2),
- found positive for the special tests (coordination test for the muscle vastus medialis, apprehension test for patellar, Clarke's test, and Waldron's test with phase I and II)
Exclusion Criteria:
- The individuals with involvement of tibio-femoral joint;
- Presence of patella alta/baja;
- History of rheumatoid arthritis/traumatic knee, knee surgeries within six months
- On steroid injection, neurological deficit, fragile skin around the knee, allergic to tape;
- Poor cooperation
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Group A received a taping technique in addition to the supervised exercises protocol
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Fixmull stretch and Leukotape (rigid tape) were used in taping to guide the patellar trajectory orientation while performing the movement.
Individuals were asked to lay down in supine position with knee in a slightly bent position.
Fixomull stretch was used as an adhesive pre-wrap to protect the skin and provide some of the checking force.
The main check strap was provided by stripes of rigid tape (Leukotape).
The knee cap was taped, started on the outer aspect of the knee cap and pulled inwards.
Finished at the back of the inside of the knee.
Two further pieces of tape (Fixomull Stretch and Leukotape) applied distal to the patella unloaded the infrapatellar fat pad.
Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;
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Active Comparator: Group B
Group B received supervised exercises protocol only
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Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity
Time Frame: 4-weeks
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Knee pain assessed by Visual Analog Scale (VAS).
It is a 10-cm horizontal line marked with 0 (no pain) and 10 (worst pain) on its either end.
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4-weeks
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Functional status
Time Frame: 4-weeks
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Functional status of knee assessed by functional subscale of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
It has eight test-questions.
The test questions are scored on a scale of 0 - 4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-32 for Physical Function.
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4-weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: AMIR IQBAL, MPT-Ortho, Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
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)
June 5, 2019
Primary Completion (Actual)
October 13, 2019
Study Completion (Actual)
December 19, 2019
Study Registration Dates
First Submitted
October 11, 2020
First Submitted That Met QC Criteria
October 11, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
October 20, 2020
Last Update Submitted That Met QC Criteria
October 18, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRC-2019-16
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
product manufactured in and exported from the U.S.
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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