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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04589871
Other study ID # RRC-2019-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2019
Est. completion date December 19, 2019

Study information

Verified date October 2020
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 19, 2019
Est. primary completion date October 13, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Taping technique
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.
A supervised exercise protocol
Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;

Locations

Country Name City State
Saudi Arabia Rehabilitation Research Chair Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity 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. 4-weeks
Primary Functional status 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. 4-weeks
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