Knee PainNCT04925726
Rehabilitation After Arthroscopic Partial Meniscectomy
A study testing Land based exercise and Water based exercise in people with Knee Pain, run by Hilal Yeşil at 1 site in Turkey (Türkiye).
Trial summary
Water-Based vs. Land-Based Rehabilitation After Arthroscopic Partial Meniscectomy in Middle-Aged Active Patients with a Degenerative Meniscal Tear: A Randomized, Controlled Study Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Knee Pain
- What is being tested?
- Land based exercise and Water based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2018to 10 Oct 2019
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
Water-Based vs. Land-Based Rehabilitation After Arthroscopic Partial Meniscectomy in Middle-Aged Active Patients with a Degenerative Meniscal Tear: A Randomized, Controlled Study
Read the detailed description
In this study, we aimed to determine and compare the benefits of water-based exercise (WBE) and land-based exercise (LBE) on pain, functionality, and quality of life after arthroscopic partial meniscectomy (APM). Middle-aged (35-50), active 30 patients having APM for a degenerative meniscal tear randomized into LBE (n=15) and WBE (n=15) groups. The pain level (visual analogue scale [VAS]), isokinetic muscle strength, quality of life (Short Form-36 [SF-36]), and function level (single-leg hop test and Lysholm questionnaire) were evaluated prior to treatment and at follow-up visits at the fourth and eighth week after surgery. The exercise sessions were conducted 3 times a week for 4 weeks in both groups.
- Conditions
- Knee Pain
- Being tested
- Land based exercise, Water based exercise
- Keywords
- Rehabilitation, Exercise, Aquatherapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Land based exerciseOther
The patients who had land based exercise
Water based exerciseOther
The patients who had water based exercise
| Study group | Role | What they receive |
|---|---|---|
| Land based exercise | Active comparator | Land based exercise Receives: Other: Land based exercise |
| Water based exercise | Active comparator | Water based exercise Receives: Other: Water based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 8 weeks
Secondary outcomes (4)
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 .
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start10 Jul 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hilal Yeşil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Yeşil, Afyonkarahisar Health Sciences University
- Investigators
- Murat Yesil, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925726
- Sponsor's protocol ID
- MYHY
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yesil M, Ozcan O, Dundar U, Toktas H, Yesil H. Aquatic vs. land-based exercise after arthroscopic partial meniscectomy in middle-aged active patients with a degenerative meniscal tear: A randomized, controlled study. J Orthop Sci. 2023 Mar;28(2):391-397. doi: 10.1016/j.jos.2021.11.011. Epub 2021 Dec 16.
PubMed 34924251
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04925726
- Acronym / sponsor ID
- MYHY
- Conditions
- Knee Pain
- Keywords
- Rehabilitation, Exercise, Aquatherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hilal YeşilUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 14 Jun 2021 (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.
Water-Based vs. Land-Based Rehabilitation After Arthroscopic Partial Meniscectomy in Middle-Aged Active Patients with a Degenerative Meniscal Tear: A Randomized, Controlled Study
Detailed description
In this study, we aimed to determine and compare the benefits of water-based exercise (WBE) and land-based exercise (LBE) on pain, functionality, and quality of life after arthroscopic partial meniscectomy (APM). Middle-aged (35-50), active 30 patients having APM for a degenerative meniscal tear randomized into LBE (n=15) and WBE (n=15) groups. The pain level (visual analogue scale [VAS]), isokinetic muscle strength, quality of life (Short Form-36 [SF-36]), and function level (single-leg hop test and Lysholm questionnaire) were evaluated prior to treatment and at follow-up visits at the fourth and eighth week after surgery. The exercise sessions were conducted 3 times a week for 4 weeks in both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Land based exercise | Active comparator | Other: Land based exerciseLand based exercise |
| Water based exercise | Active comparator | Other: Water based exerciseWater based exercise |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Land based exerciseThe patients who had land based exercise | Other | Land based exercise |
| Water based exerciseThe patients who had water based exercise | Other | Water based exercise |
Primary outcome
Change from baseline VAS (visual analog scale) at 4th and 8th week
Time frame: up to 8 weeks
The patients were asked to make an assesment of their pain level between 0 and 10 scale
4 secondary outcomes
Change from baseline isokinetic muscle strength at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline quality of life (short form 36) at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline Single-leg hop test at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline Lysholm questionnaire at 4th and 8th week
Time frame: up to 8 weeks
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 14 Jun 2021.
- Derived from this study: PubMed 34924251Yesil M, Ozcan O, Dundar U, Toktas H, Yesil H. Aquatic vs. land-based exercise after arthroscopic partial meniscectomy in middle-aged active patients with a degenerative meniscal tear: A randomized, controlled study. J Orthop Sci. 2023 Mar;28(2):391-397. doi: 10.1016/j.jos.2021.11.011. Epub 2021 Dec 16.
Related trials for Knee Pain
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
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.
Murat Yesil, MD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Land based exercise and Water based exercise in people with Knee Pain, run by Hilal Yeşil 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?
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 14 Jun 2021. 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?
Change from baseline VAS (visual analog scale) at 4th and 8th week (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925726, which also lists 1 linked publication.
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 14 Jun 2021; AzTrials last refreshed its copy on 31 Oct 2026.