NCT04589871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

October 11, 2020

Last Update Submit

October 18, 2020

Conditions

Keywords

Patellofemoral osteoarthritisTherapeutic exercisesVASWOMACTaping

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Taping techniqueOther: A supervised exercise protocol

Group B

ACTIVE COMPARATOR

Group B received supervised exercises protocol only

Other: A supervised exercise protocol

Interventions

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.

Group A

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

Group AGroup B

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Research Chair

Riyadh, 11433, Saudi Arabia

Location

Study Officials

  • AMIR IQBAL, MPT-Ortho

    Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm parallel groups randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2020

First Posted

October 19, 2020

Study Start

June 5, 2019

Primary Completion

October 13, 2019

Study Completion

December 19, 2019

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations