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Clinical Trials/CTRI/2025/11/096968
CTRI/2025/11/096968RecruitingNot Applicable

Music Therapy for early rehabilitation of persons with total knee arthroplasty: A Single-Blinded Randomized Controlled Trial

NO1 site in 1 country114 target enrollmentStarted: November 18, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
114
Locations
1
Primary Endpoint
Pain : VAS

Study Overview

Brief Summary

Persons who have undergone total knee arthroplasty (TKA) in the orthopedic department, CMC Vellore, will be assessed for eligibility by the Principal Investigator and included in the study after obtaining written consent. An initial assessment will be performed by the physical therapist (Outcome assessor) who will be blinded to the group allocation. The assessment will include measurement of pain using Visual Analogue Scale (VAS), knee flexion and extension range using a universal goniometer and an accelerometer, muscle power using Modified Oxford scale for manual muscle testing and hand-held dynamometer, knee function will be assessed using Knee injury and Osteoarthritis Outcome Score (KOOS) .Following this, the patients will be randomized using sequentially numbered, opaque, sealed envelope (SNOSE) to two groups. The ambulatory status shall be assessed after 3 days of surgery when patients are able to walk independently by using the 2 minute and 10 meter walk test . The interventional group will receive music therapy in addition to two weeks of conventional physiotherapy (PT). The control group will receive only two weeks of standard PT. During music therapy, patients will listen to music of their choice through earphones in one ear, while the other ear remains unobstructed to hear commands from the physical therapist conducting the conventional PT. Conventional PT will include exercises of the TKA protocol (Appendix I – TKA protocol), which will include isometric exercises, multiangled isometrics, dynamic knee strengthening exercises, and progressive gait training. This will be progressed until suture removal (12th post-op day). At the end of two weeks, the outcomes will be re-assessed by the physical therapist (blinded outcome assessor). The data will be analyzed to find out if the addition of music therapy to a two–week conventional PT helped in reducing pain and improving the joint range of motion and muscle strength when compared to the control group. In addition, ,hospital related anxiety and patient experience will also be analysed.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
50.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients admitted for total knee arthroplasty 2.Age group from 50 to 80 years 3.Both genders.

Exclusion Criteria

  • Patients undergoing revision knee arthroplasty.
  • Patients presenting with deformities in other joint due ankylosing spondylitis, rheumatoid arthritis.
  • Patients having hearing difficulty.

Outcomes

Primary Outcomes

Pain : VAS

Time Frame: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

Knee range :Universal goniometer and

Time Frame: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

accelerometer

Time Frame: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

Quadriceps strength:Modified Oxford scale and Hand-

Time Frame: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

held dynamometer

Time Frame: Pain:Day 1 and Day 12 | Knee range: Day 1 and Day 12 | Quadriceps strength:Day 1 and Day 12

Secondary Outcomes

  • Knee function :KOOS scale

Investigators

Sponsor
NO
Sponsor Class
Other [nil]
Responsible Party
Principal Investigator
Principal Investigator

Ashruto Dey

Christian Medical College Vellore

Study Sites (1)

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