Knee Pain Clinical Trial
Official title:
Water-Based vs. Land-Based Rehabilitation After Arthroscopic Partial Meniscectomy in Middle-Aged Active Patients With a Degenerative Meniscal Tear: A Randomized, Controlled Study
NCT number | NCT04925726 |
Other study ID # | MYHY |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 10, 2018 |
Est. completion date | October 10, 2019 |
Verified date | June 2021 |
Source | Afyonkarahisar Health Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Water-Based vs. Land-Based Rehabilitation After Arthroscopic Partial Meniscectomy in Middle-Aged Active Patients with a Degenerative Meniscal Tear: A Randomized, Controlled Study
Status | Completed |
Enrollment | 30 |
Est. completion date | October 10, 2019 |
Est. primary completion date | October 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 50 Years |
Eligibility | Inclusion Criteria: The inclusion criteria comprised a non-locked painful knee of more than 1 month, age between 35-50 years, a clinical history and examination compatible with degenerative meniscus, positive findings of a degenerative meniscal tear visible with magnetic resonance imaging (MRI), no response to nonoperative treatment of at least 3 months after onset of symptoms, and no evidence of advanced osteoarthritis (OA) on X-rays or MRI Exclusion Criteria: The exclusion criteria employed were advanced knee OA, systemic inflammatory disease, a concurrent tear of posterior cruciate ligament, a concurrent collateral ligament repair, other problems causing knee pain (e.g., hip and ankle pathologies), a history of cardiopulmonary disease that could limit isokinetic and functional testing, an unstable medical condition, a serious cognitive deficit, a psychiatric problem, no capacity for independent walking and standing, an open wound on the skin, or pregnancy |
Country | Name | City | State |
---|---|---|---|
Turkey | Hilal Yesil | Merkez | Afyon |
Lead Sponsor | Collaborator |
---|---|
Hilal Yesil |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline VAS (visual analog scale) at 4th and 8th week | The patients were asked to make an assesment of their pain level between 0 and 10 scale | up to 8 weeks | |
Secondary | Change from baseline isokinetic muscle strength at 4th and 8th week | Isokinetic knee extensor muscle strength of the patients was measured with an isokinetic dynamometer. The test was repeated 10 times at the velocity of 60°/second and 180°/second and peak torque (Nm) measurements were recorded . | up to 8 weeks | |
Secondary | Change from baseline quality of life (short form 36) at 4th and 8th week | The physical and mental health summary scores were the primary components used. Scoring is on a scale of 0 to 100 and a higher score reflects better health-related quality of life. | up to 8 weeks | |
Secondary | Change from baseline Single-leg hop test at 4th and 8th week | The patient stands on one foot with the big toe touching a line marked on the floor. The participant asked to hop forward as far as possible using the same leg with their arms swing freely on both sides of the body. Distance is measured from the starting point to the heel of the landing leg. | up to 8 weeks | |
Secondary | Change from baseline Lysholm questionnaire at 4th and 8th week | Eight subtitles are scored differently (limping or use of support: 5 points, locking sensation: 15 points, joint instability and pain: 25 points, swelling: 10 points, stair climbing: 10 points, and squatting: 5 points). The highest and optimal total score is 100 points | up to 8 weeks |
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