Degenerative DiseaseNCT06447129
Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears
A study testing Exercise and Neuromuscular electrical stimulation in people with Degenerative Disease and Meniscus Tear, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Degenerative Disease, Meniscus Tear, Knee Pain Swelling
- What is being tested?
- Exercise and Neuromuscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 28 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Bakırkoy, 34147
About this study
Official title: Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears: A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Degenerative Disease, Meniscus Tear, Knee Pain Swelling
- Being tested
- Exercise, Neuromuscular electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
An 8-week exercise program used in conservative treatment of degenerative meniscus tears will be performed.
The patients will do exercises under the control of the physiotherapist in the clinic.
The patient will perform the exercises with the verbal and visual commands of the physiotherapist.
Neuromuscular electrical stimulationOther
The Neuromuscular Electrical Stimulation (NMES) will be applied for 20 minutes. The patient will be seated with hips and knees flexed at 90°. Electrodes will be placed on the proximal and distal ends of the vastus medialis obliquus and vastus lateralis muscles. The intensity will be increased as much as the patient can tolerate, and the patient will be asked to relax and not make voluntary muscle contractions.
| Study group | Role | What they receive |
|---|---|---|
| NMES with Exercise | Experimental | Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip, and NMES application for the quadriceps femoris muscle. Receives: Other: Exercise; Other: Neuromuscular electrical stimulation |
| Exercise | Active comparator | Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Baseline
Secondary outcomes (11)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: At the end of 8-week intervention
Visual Analogue Scale (VAS)
Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
Measured: Baseline
Visual Analogue Scale (VAS)
Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
Measured: At the end of 8-week intervention
Active Range of Motion
Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
Measured: Baseline
Active Range of Motion
Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
Measured: At the end of 8-week intervention
Muscle Strength
Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
Measured: Baseline
Muscle Strength
Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
Measured: At the end of the 8-week intervention
Lysholm Score
Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
Measured: Baseline
Lysholm Score
Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
Measured: At the end of the 8-week intervention
Short Form-12 (SF-12)
Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
Measured: Baseline
Short Form-12 (SF-12)
Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
Measured: At the end of the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start10 Jun 2024
- Primary completion30 Nov 2024
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tansu Birinci, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447129
- Sponsor's protocol ID
- 216
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06447129
- Acronym / sponsor ID
- 216
- Conditions
- Degenerative Disease, Meniscus Tear, Knee Pain Swelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES with Exercise | Experimental | Other: Exercise, Other: Neuromuscular electrical stimulationEach subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip, and NMES application for the quadriceps femoris muscle. |
| Exercise | Active comparator | Other: ExerciseEach subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAn 8-week exercise program used in conservative treatment of degenerative meniscus tears will be performed. The patients will do exercises under the control of the physiotherapist in the clinic. The patient will perform the exercises with the verbal and visual commands of the physiotherapist. | Other | Exercise, NMES with Exercise |
| Neuromuscular electrical stimulationThe Neuromuscular Electrical Stimulation (NMES) will be applied for 20 minutes. The patient will be seated with hips and knees flexed at 90°. Electrodes will be placed on the proximal and distal ends of the vastus medialis obliquus and vastus lateralis muscles. The intensity will be increased as much as the patient can tolerate, and the patient will be asked to relax and not make voluntary muscle contractions. | Other | NMES with Exercise |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline
Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
11 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At the end of 8-week intervention
Visual Analogue Scale (VAS)
Time frame: Baseline
Visual Analogue Scale (VAS)
Time frame: At the end of 8-week intervention
Active Range of Motion
Time frame: Baseline
Active Range of Motion
Time frame: At the end of 8-week intervention
Muscle Strength
Time frame: Baseline
Muscle Strength
Time frame: At the end of the 8-week intervention
Lysholm Score
Time frame: Baseline
Lysholm Score
Time frame: At the end of the 8-week intervention
Short Form-12 (SF-12)
Time frame: Baseline
Short Form-12 (SF-12)
Time frame: At the end of the 8-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Neuromuscular electrical stimulation in people with Degenerative Disease and Meniscus Tear, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.