Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis

Sponsor

King Saud University (Other)

Overall Status

Completed

CT.gov ID

NCT04589871

Collaborator

(none)

Enrollment

Location

Arms

6.5

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patellofemoral Osteoarthritis	Other: Taping technique Other: A supervised exercise protocol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two-arm parallel groups randomized control trialTwo-arm parallel groups randomized control trial

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Taping Technique in Addition to the Supervised Exercises Protocol on Pain and Functional Status in Individuals With Patello-femoral Arthritis

Actual Study Start Date :

Jun 5, 2019

Actual Primary Completion Date :

Oct 13, 2019

Actual Study Completion Date :

Dec 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Group A received a taping technique in addition to the supervised exercises protocol	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. Other: A supervised exercise protocol Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;
Active Comparator: Group B Group B received supervised exercises protocol only	Other: A supervised exercise protocol Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;

Arm

Intervention/Treatment

Experimental: Group A

Group A received a taping technique in addition to the supervised exercises protocol

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.

Other: A supervised exercise protocol

Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;

Active Comparator: Group B

Group B received supervised exercises protocol only

Other: A supervised exercise protocol

Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;

Outcome Measures

Primary Outcome Measures

Pain Intensity [4-weeks]
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.
Functional status [4-weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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