Home » Trials » SLCTR/2022/022
Investigating the effect of an exercise program in improving pain and disability of people with knee osteoarthritis
-
SLCTR Registration Number
SLCTR/2022/022
Date of Registration
The date of last modification
Oct 21, 2024
Trial Status
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
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
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
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 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
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
20
Date of first publication
Link to results
Brief summary of results
