Osteoarthritis, KneeNCT06675318
The Effect of Contralateral Isokinetic Lower Extremity Exercises in Unilateral Painful Knee Osteoarthritis
A study testing Cross training for quadriceps muscle of contralateral lower limb and Quadriceps isometric exercises, along with hot pack and TENS for painful knee in people with Osteoarthritis, Knee and Exercise, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Patients with unilateral knee pain due to knee osteoarthritis presenting to our clinic will be included in a 20-session treatment program, either on an outpatient basis or as inpatients at our clinic. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Exercise
- What is being tested?
- Cross training for quadriceps muscle of contralateral lower limb and Quadriceps isometric exercises, along with hot pack and TENS for painful knee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2022to 31 Aug 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To agree to participate in the study
- To be aged 50 years or older
- To have a clinically and radiographically confirmed diagnosis of knee osteoarthritis
- To have unilateral knee pain due to osteoarthritis (VAS <2 in the contralateral knee, VAS >2 in the painful knee)
- To have Kellgren-Lawrence Grade 1-3 in the painful knee and Kellgren-Lawrence Grade <4 in the contralateral knee
- To have dominance of the right lower extremity
Who cannot join
- A history of previous lower extremity fractures or orthopedic surgery that would interfere with isokinetic and isometric exercises in both lower extremities
- The presence of significant sensorimotor deficits due to neurological diseases
- The presence of known inflammatory rheumatic diseases
- The presence of non-curable malignant tumors with bone metastasis
- The presence of neuropsychiatric diseases or conditions that would hinder cooperation
- Having undergone interventions such as injections for pain relief within the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Ankara, 06560
About this study
Official title: The Effect of Contralateral Isokinetic Lower Extremity Exercises Added to Conventional Rehabilitation in Unilateral Painful Knee Osteoarthritis
Patients with unilateral knee pain due to knee osteoarthritis presenting to our clinic will be included in a 20-session treatment program, either on an outpatient basis or as inpatients at our clinic. The patients will be divided into 2 groups, and conventional treatments including isometric exercises, TENS (Transcutaneous Electrical Nerve Stimulation) and hot pack therapy for the painful knee will be administered to both groups. In addition to these treatments, the intervention group will receive isokinetic exercise sessions using the Cybex 770 Norm isokinetic dynamometer system (Lumex Inc., Ronkonkoma, New York) at speeds of 60°/s and 180°/s according to the device's standard protocol, targeting the contralateral lower extremity. Subsequently, examinations and measurements will be conducted to evaluate patients for reduction in pain, increase in muscle strength, improvement in functionality, and increase in thigh muscle thickness.
Read the detailed description
Osteoartritis is the most common form of arthritis, originating from the failed repair of joint damage caused by stress initiated by any joint or periarticular tissue abnormality. Its most common symptom is pain. The long-term consequences of osteoarthritis include decreased physical activity, loss of conditioning, sleep disturbances, fatigue, depression, and disability. Factors associated with increased risk of knee osteoarthritis include advanced age, female gender, overweight or obesity, knee injury, occupational factors, and varus or valgus alignment of the knee.
With the increasing aging population, degenerative joint problems have become relevant to a large portion of society. Exercise is a fundamental component in the treatment of this chronic disease, which limits functionality and reduces quality of life.
A systematic review including 32 randomized controlled trials evaluating 5362 participants showed that various types of exercise provide improvement in pain, functionality, and quality of life in knee osteoarthritis.
Musculoskeletal pains can lead to cortical reorganization in both somatosensory and motor areas, which can reduce motor activity in both the affected and unaffected contralateral extremities. For example, a decrease in motor activity in both painful and pain-free contralateral extremities has been identified during acute pain and/or in the presence of chronic pain.
If exercise is performed to increase muscle strength on one side of the body, strength may also increase on the opposite side. This effect, called the contralateral exercise phenomenon, is typically measured in homologous muscles. Although known for over a century, most studies have not been well-designed to demonstrate the exact magnitude of the strength increase effect. However, an updated meta-analysis of 16 studies indicates that the size of the contralateral exercise effect is approximately 8% of baseline strength or about half of the increase in strength on the exercised side.
However, there are few studies examining the combined effects of contralateral lower extremity isokinetic exercises on pain, muscle thickness, and functionality. Therefore, the aim of this study is to demonstrate the effect of isokinetic exercises applied to the contralateral lower extremity added to routine treatment on muscle strength, muscle thickness, and functionality in the painful knee, and to show its potential relationship. We aim to provide clinicians with a new perspective on the treatment of knee osteoarthritis.
- Conditions
- Osteoarthritis, Knee, Exercise
- Being tested
- Cross training for quadriceps muscle of contralateral lower limb, Quadriceps isometric exercises, along with hot pack and TENS for painful knee
- Keywords
- Knee osteoarthritis, Isokinetic exercise, Contralateral exercise effect, Quadriceps muscle thickness, Physical Function, Quality of life
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross training for quadriceps muscle of contralateral lower limbOther
An isokinetic exercise program consisting of 20 sessions conducted five days a week. The program begins with five repetitions at a speed of 60°/s, followed by sets of 5-15 repetitions with incremental increases of 30°/s. Rest periods of 30 seconds were included between sets.
Quadriceps isometric exercises, along with hot pack and TENS for painful kneeOther
10 repetitions of quadriceps isometric exercises in 3 sets, along with hot pack and TENS treatments for painful knee
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients with unilateral painful knee osteoarthritis who are applied to Gazi University Faculty of Medicine PM\&R will be included. 20 sessions of conventional physical therapy and rehabilitation (isometric exercises, TENS, hot pack) for the symptomatic extremity will be applied to patients In the active control group. Receives: Other: Quadriceps isometric exercises, along with hot pack and TENS for painful knee |
| Study group | Experimental | Patients with unilateral painful knee osteoarthritis who are applied to Gazi University Faculty of Medicine PM\&R will be included. 20 sessions of conventional physical therapy and rehabilitation for the symptomatic extremity combined with isokinetic strengthening exercises for the asymptomatic extremity will be applied to patients In the experimental group Receives: Other: Cross training for quadriceps muscle of contralateral lower limb; Other: Quadriceps isometric exercises, along with hot pack and TENS for painful knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
WOMAC score evaluation following the last treatment session. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, validated questionnaire designed to assess pain, stiffness, and physical function in patients with knee and hip osteoarthritis. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Patients rate their symptoms on a Likert scale, with higher scores indicating worse pain, stiffness, or functional limitations. The WOMAC is commonly used in clinical research to evaluate the efficacy of various treatments for osteoarthritis.
Measured: From enrollment day to the end of the rehabilitation program at 4 weeks.
Secondary outcomes (6)
Pain level; VAS score
The Visual Analog Scale (VAS) is a tool used to measure a patient's level of pain. It consists of a straight line with endpoints defining extreme limits such as 'no pain' and 'worst pain imaginable.' The patient marks on the line the point that they feel represents their perception of their current state. This method is simple, reliable, and widely used in both clinical and research settings to quantify pain intensity.
Measured: From enrollment day to the end of the rehabilitation program at 4 weeks
Muscle strength
To evaluate isokinetic muscle strength, the Cybex 770 Norm isokinetic dynamometer system (Lumex Inc., Ronkonkoma, New York) will be used to measure peak torque values for flexion and extension at a speed of 60°/s, peak torque values for flexion and extension at a speed of 180°/s, and total work production (endurance) at 180 degrees.
Measured: From enrollment day to the end of the rehabilitation program at 4 weeks
Physical function
To evaluate physical function, SF-36 (Short Form-36) will be used. SF-36: The SF-36 is a scale consisting of 36 items divided into 8 subscales: physical functioning, physical role, emotional role, pain, general health, energy, social functioning, and mental health. Lower scores indicate higher levels of restriction. The Turkish version has been validated for reliability and validity.
Measured: From enrollment day to the end of the rehabilitation program at 4 weeks
Lower extremity function
To evaluate physical function, TUG test will be used. Timed Up and Go Test (TUG): To assess lower extremity function, participants will be timed as they rise from a chair, walk to a marked point 3 meters away, turn around, and return to sit in the chair. The elapsed time will be recorded.
Measured: From enrollment day to the end of the rehabilitation program at 4 weeks
Ultrasonographic Measurement of Thigh muscle thickness
Participants will be evaluated in a supine position. Measurements will be taken for the Rectus Femoris (RF), Vastus Intermedius (VI), Vastus Lateralis (VL), Vastus Medialis (VM), and Vastus Medialis Obliquus (VMO) muscles. A line will be drawn from the upper pole of the patella to the anterior superior iliac spine (ASIS) along the length of the thigh. RF and VI will be measured at 50% of this line. For VL, the circumference of the thigh at 50% of the line will be measured, and then VL will be measured at 10% of the circumference. VM will be measured at 20% of the line, and then at 12.5% of the circumference at the same point. VMO will be measured 4 cm above and 3 cm medial to the upper pole of the patella.
MyLab 70 XV ultrasound device (Esaote Biomedica, Genoa, Italy) with a multifrequency linear probe will be used at the Physical Medicine and Rehabilitation Unit of Gazi University Faculty of Medicine.
Measured: From enrollment day to the end of the rehabilitation program at 4 weeks
Range of motion
Range of motion will be measured with a goniometer according to the neutral zero method.
The principle of joint measurement by the neutral zero method is to measure the movement of a joint from a defined neutral O-position. The measured angle gives the magnitude of movement.
Measured: From enrollment day to the end of the rehabilitation program at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start30 Nov 2022
- Primary completion31 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Model description
- A prospective cohort study involving two parallel groups with randomization control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine METIN IPEK, Gazi University
- Investigators
- Jale Meray, MD, Study director, Gazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675318
- Sponsor's protocol ID
- Contralateral Exercise
- Status last verified
- Sep 2024
- First submitted
- 13 Jul 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.
PubMed 33406330Hawker GA, Stewart L, French MR, Cibere J, Jordan JM, March L, Suarez-Almazor M, Gooberman-Hill R. Understanding the pain experience in hip and knee osteoarthritis--an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 Apr;16(4):415-22. doi: 10.1016/j.joca.2007.12.017. Epub 2008 Mar 4.
PubMed 18296075Flor H. Cortical reorganisation and chronic pain: implications for rehabilitation. J Rehabil Med. 2003 May;(41 Suppl):66-72. doi: 10.1080/16501960310010179.
PubMed 12817660Arguis MJ, Perez J, Martinez G, Ubre M, Gomar C. Contralateral neuropathic pain following a surgical model of unilateral nerve injury in rats. Reg Anesth Pain Med. 2008 May-Jun;33(3):211-6. doi: 10.1016/j.rapm.2007.12.003.
PubMed 18433671Cheon S, Lee JH, Jun HP, An YW, Chang E. Acute Effects of Open Kinetic Chain Exercise Versus Those of Closed Kinetic Chain Exercise on Quadriceps Muscle Thickness in Healthy Adults. Int J Environ Res Public Health. 2020 Jun 29;17(13):4669. doi: 10.3390/ijerph17134669.
PubMed 32610511van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.
PubMed 29287067
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Contralateral Isokinetic Lower Extremity Exercises Added to Conventional Rehabilitation in Unilateral Painful Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06675318
- Acronym / sponsor ID
- Contralateral Exercise
- Conditions
- Osteoarthritis, Knee, Exercise
- Keywords
- Knee osteoarthritis, Isokinetic exercise, Contralateral exercise effect, Quadriceps muscle thickness, Physical Function, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Nov 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.
Patients with unilateral knee pain due to knee osteoarthritis presenting to our clinic will be included in a 20-session treatment program, either on an outpatient basis or as inpatients at our clinic. The patients will be divided into 2 groups, and conventional treatments including isometric exercises, TENS (Transcutaneous Electrical Nerve Stimulation) and hot pack therapy for the painful knee will be administered to both groups. In addition to these treatments, the intervention group will receive isokinetic exercise sessions using the Cybex 770 Norm isokinetic dynamometer system (Lumex Inc., Ronkonkoma, New York) at speeds of 60°/s and 180°/s according to the device's standard protocol, targeting the contralateral lower extremity. Subsequently, examinations and measurements will be conducted to evaluate patients for reduction in pain, increase in muscle strength, improvement in functionality, and increase in thigh muscle thickness.
Detailed description
Osteoartritis is the most common form of arthritis, originating from the failed repair of joint damage caused by stress initiated by any joint or periarticular tissue abnormality. Its most common symptom is pain. The long-term consequences of osteoarthritis include decreased physical activity, loss of conditioning, sleep disturbances, fatigue, depression, and disability. Factors associated with increased risk of knee osteoarthritis include advanced age, female gender, overweight or obesity, knee injury, occupational factors, and varus or valgus alignment of the knee.
With the increasing aging population, degenerative joint problems have become relevant to a large portion of society. Exercise is a fundamental component in the treatment of this chronic disease, which limits functionality and reduces quality of life.
A systematic review including 32 randomized controlled trials evaluating 5362 participants showed that various types of exercise provide improvement in pain, functionality, and quality of life in knee osteoarthritis.
Musculoskeletal pains can lead to cortical reorganization in both somatosensory and motor areas, which can reduce motor activity in both the affected and unaffected contralateral extremities. For example, a decrease in motor activity in both painful and pain-free contralateral extremities has been identified during acute pain and/or in the presence of chronic pain.
If exercise is performed to increase muscle strength on one side of the body, strength may also increase on the opposite side. This effect, called the contralateral exercise phenomenon, is typically measured in homologous muscles. Although known for over a century, most studies have not been well-designed to demonstrate the exact magnitude of the strength increase effect. However, an updated meta-analysis of 16 studies indicates that the size of the contralateral exercise effect is approximately 8% of baseline strength or about half of the increase in strength on the exercised side.
However, there are few studies examining the combined effects of contralateral lower extremity isokinetic exercises on pain, muscle thickness, and functionality. Therefore, the aim of this study is to demonstrate the effect of isokinetic exercises applied to the contralateral lower extremity added to routine treatment on muscle strength, muscle thickness, and functionality in the painful knee, and to show its potential relationship. We aim to provide clinicians with a new perspective on the treatment of knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective cohort study involving two parallel groups with randomization control
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Quadriceps isometric exercises, along with hot pack and TENS for painful kneePatients with unilateral painful knee osteoarthritis who are applied to Gazi University Faculty of Medicine PM\&R will be included. 20 sessions of conventional physical therapy and rehabilitation (isometric exercises, TENS, hot pack) for the symptomatic extremity will be applied to patients In the active control group. |
| Study group | Experimental | Other: Cross training for quadriceps muscle of contralateral lower limb, Other: Quadriceps isometric exercises, along with hot pack and TENS for painful kneePatients with unilateral painful knee osteoarthritis who are applied to Gazi University Faculty of Medicine PM\&R will be included. 20 sessions of conventional physical therapy and rehabilitation for the symptomatic extremity combined with isokinetic strengthening exercises for the asymptomatic extremity will be applied to patients In the experimental group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To agree to participate in the study
- To be aged 50 years or older
- To have a clinically and radiographically confirmed diagnosis of knee osteoarthritis
- To have unilateral knee pain due to osteoarthritis (VAS <2 in the contralateral knee, VAS >2 in the painful knee)
- To have Kellgren-Lawrence Grade 1-3 in the painful knee and Kellgren-Lawrence Grade <4 in the contralateral knee
Key exclusion criteria (6 listed)
- A history of previous lower extremity fractures or orthopedic surgery that would interfere with isokinetic and isometric exercises in both lower extremities
- The presence of significant sensorimotor deficits due to neurological diseases
- The presence of known inflammatory rheumatic diseases
- The presence of non-curable malignant tumors with bone metastasis
- The presence of neuropsychiatric diseases or conditions that would hinder cooperation
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 |
|---|---|---|
| Cross training for quadriceps muscle of contralateral lower limbAn isokinetic exercise program consisting of 20 sessions conducted five days a week. The program begins with five repetitions at a speed of 60°/s, followed by sets of 5-15 repetitions with incremental increases of 30°/s. Rest periods of 30 seconds were included between sets. | Other | Study group |
| Quadriceps isometric exercises, along with hot pack and TENS for painful knee10 repetitions of quadriceps isometric exercises in 3 sets, along with hot pack and TENS treatments for painful knee | Other | Control group, Study group |
Primary outcome
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
Time frame: From enrollment day to the end of the rehabilitation program at 4 weeks.
WOMAC score evaluation following the last treatment session. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, validated questionnaire designed to assess pain, stiffness, and physical function in patients with knee and hip osteoarthritis. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Patients rate their symptoms on a Likert scale, with higher scores indicating worse pain, stiffness, or functional limitations. The WOMAC is commonly used in clinical research to evaluate the efficacy of various treatments for osteoarthritis.
6 secondary outcomes
Pain level; VAS score
Time frame: From enrollment day to the end of the rehabilitation program at 4 weeks
Muscle strength
Time frame: From enrollment day to the end of the rehabilitation program at 4 weeks
Physical function
Time frame: From enrollment day to the end of the rehabilitation program at 4 weeks
Lower extremity function
Time frame: From enrollment day to the end of the rehabilitation program at 4 weeks
Ultrasonographic Measurement of Thigh muscle thickness
Time frame: From enrollment day to the end of the rehabilitation program at 4 weeks
Range of motion
Time frame: From enrollment day to the end of the rehabilitation program at 4 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 5 Nov 2024.
- Background: PubMed 33406330Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.
- Background: PubMed 18296075Hawker GA, Stewart L, French MR, Cibere J, Jordan JM, March L, Suarez-Almazor M, Gooberman-Hill R. Understanding the pain experience in hip and knee osteoarthritis--an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 Apr;16(4):415-22. doi: 10.1016/j.joca.2007.12.017. Epub 2008 Mar 4.
- Background: PubMed 12817660Flor H. Cortical reorganisation and chronic pain: implications for rehabilitation. J Rehabil Med. 2003 May;(41 Suppl):66-72. doi: 10.1080/16501960310010179.
- Background: PubMed 18433671Arguis MJ, Perez J, Martinez G, Ubre M, Gomar C. Contralateral neuropathic pain following a surgical model of unilateral nerve injury in rats. Reg Anesth Pain Med. 2008 May-Jun;33(3):211-6. doi: 10.1016/j.rapm.2007.12.003.
- Background: PubMed 32610511Cheon S, Lee JH, Jun HP, An YW, Chang E. Acute Effects of Open Kinetic Chain Exercise Versus Those of Closed Kinetic Chain Exercise on Quadriceps Muscle Thickness in Healthy Adults. Int J Environ Res Public Health. 2020 Jun 29;17(13):4669. doi: 10.3390/ijerph17134669.
- Background: PubMed 29287067van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Jale Meray, MD study director
Gazi University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross training for quadriceps muscle of contralateral lower limb and Quadriceps isometric exercises, along with hot pack and TENS for painful knee in people with Osteoarthritis, Knee and Exercise, run by Gazi University 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 5 Nov 2024. 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?
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score (time frame: From enrollment day to the end of the rehabilitation program at 4 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 NCT06675318, which also lists 6 linked publications.
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 5 Nov 2024.