Home » Trials » SLCTR/2022/022


Investigating the effect of an exercise program in improving pain and disability of people with knee osteoarthritis

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SLCTR Registration Number

SLCTR/2022/022


Date of Registration

07 Oct 2022

The date of last modification

Dec 27, 2023



Application Summary


Scientific Title of Trial

Investigating the effect of an exercise program in improving pain and disability of people with knee osteoarthritis


Public Title of Trial

Finding the effect of a customized exercise program in improving pain and disability of people with knee arthritis compared to usual exercise program: A randomized controlled study


Disease or Health Condition(s) Studied

Knee osteoarthritis


Scientific Acronym

Knee & Core


Public Acronym

Knee & Core


Brief title

Investigating the effect of an exercise program in improving pain and disability of people with knee osteoarthritis


Universal Trial Number

U1111-1282-1887


Any other number(s) assigned to the trial and issuing authority

2022/EC/09:FoM, UoP


Trial Details


What is the research question being addressed?

Is a combined ‘lumbar strengthening program and usual osteoarthritis care’ effective in improving pain intensity, range of motion and function/ disability of the people with knee osteoarthritis compared to a usual osteoarthritis care alone?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Participants


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 1


Intervention(s) planned

  • Study setting – Clinical setting
  • Randomisation - Is done using a computer generated random number
  • Intervention - Combined lumbar strengthening program and usual osteoarthritis rehabilitation (standard care) program administered 3 times per week for a duration of 6 weeks by a student researcher
  • Both intervention and control groups will receive standard care during this period
  • Patients will be blinded to the treatment group, however the treatment provider is not blinded to the treatment group

Inclusion criteria

• Age 18 years or above 18 years • Fulfills the American College of Rheumatology clinical classification criteria for knee osteoarthritis. In this criteria the presence of knee pain along with at least three of the following six items can classify the condition as knee osteoarthritis: o Age> 50 years old o Morning stiffness < 30 minutes o Crepitus on active knee motion o Bony tenderness o Bony enlargement o No palpable warmth of synovium knee joint osteoarthritis o Less than or equal to grade 2 (as diagnosed and graded by a Rheumatologist, based on the Kellgren and Lawrence radiological classification)


Exclusion criteria

• Hip/Ankle/ Foot osteoarthritis • History of neurological, infectious, and systemic diseases, including cerebrovascular disease, spinal cord disease, spondylitis, cancer, rheumatologic disorders, which may cause long-term immobilization • Participants with structural lesions, such as spondylolisthesis (Lumbar spinous process palpation and stork test) • Vertebral bone fracture, visible significant scoliosis or kyphosis or lower limb radiculopathy (as confirmed by straight leg raise test to exclude radiculopathy from spinal origin) • Knee injection within previous three months • Participants who have prescribed exercise therapy in the past >3 months • Any history of spinal or lower extremity surgery • Pregnancy



Primary outcome(s)

1.

Measures relate to knee joint Change in the measure and % of the change in, i. Pain intensity: (visual analogue scale (VAS)) ii. Active range of motion (AROM): flexion, extension iii. Disability/function: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

[

Pre-intervention, after 6 weeks post-intervention, after 6 months follow up

]
2.

Measures relate to lumbar spine Change in the measure and % of the change in, i. Pain intensity: (VAS) ii. AROM: flexion, extension, side-flexion, rotation iii. Disability: Oswestry Disability Index (ODI)

[

Pre-intervention, after 6 weeks post-intervention, after 6 months follow up

]

Secondary outcome(s)

1.

None

[]

Target number/sample size

20 (10 in each group)


Countries of recruitment

Sri Lanka


Anticipated start date

2023-02-01


Anticipated end date

2023-12-01


Date of first enrollment

2023-01-02


Date of study completion

2023-09-30


Recruitment status

Complete: follow up complete


Funding source

None


Regulatory approvals

Not relevant



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-06-09


Approval number

2022/EC/09


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Peradeniya.
Institutional Address:Ethics Review Committee of the Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
Telephone:081-2389106
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Piyumi Amarasinghe
Physiotherapist
Physiotherapist, Department of Physical Medicine, District General Hospital, Embilipitiya
0472230994
0761770212
0472230141
dghembilipitiya@gmail.com

Contact Person for Public Queries

Ishanka Weerasekara
1. Applied Research Fellow 2. Adjunct Associate Lecturer
1. Holmesglen Institute, VIC, Australia 2. Faculty of Health and Medicine, The University of Newcastle, NSW, Australia; AND Faculty of Health and Medical Sciences, The University of Adelaide, SA, Australia
+614244208114
0761770212

ishankaweerasekarauop@gmail.com


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion

2023-09-30


Final sample size


Date of first publication


Link to results


Brief summary of results