Clinical trial NCT06447129: Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears
Official title: Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disease
Meniscus Tear
Knee Pain Swelling
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized-controlled trial aims to investigate the effect of NMES as an add-on to an exercise program in patients with degenerative meniscus tears.

Detailed description: To investigate the efficacy of NMES as an add-on to an exercise program, voluntary patients with degenerative meniscus tears, aged between 40 and 65 years, will be randomly divided into two groups: Group 1 (NMES with Exercise) and Group 2 (Exercise). Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline and at the end of the 8-week intervention. The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale. Health-related quality of life will be assessed with the Short Form-12 (SF-12).

Eligibility criteria: Inclusion Criteria:

* Being aged between 40 and 65 years
* Having the degenerative meniscus tear in at least one knee
* Having body mass index in the range of 18-30 kg/m2
* Feeling the pain that lasts for at least 2 months
* Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results
* Having the ability to read and write Turkish

Exclusion Criteria:

* Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear
* Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks
* Have received steroid injections in the last 6 months
* Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis
* Presence of any systemic disorder that may affect assessment parameters
* Failure to cooperate with assessments

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At the end of 8-week intervention
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline
measure: Visual Analogue Scale (VAS)
timeFrame: At the end of 8-week intervention
measure: Active Range of Motion
timeFrame: Baseline
measure: Active Range of Motion
timeFrame: At the end of 8-week intervention
measure: Muscle Strength
timeFrame: Baseline
measure: Muscle Strength
timeFrame: At the end of the 8-week intervention
measure: Lysholm Score
timeFrame: Baseline
measure: Lysholm Score
timeFrame: At the end of the 8-week intervention
measure: Short Form-12 (SF-12)
timeFrame: Baseline
measure: Short Form-12 (SF-12)
timeFrame: At the end of the 8-week intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
References: