Knee OsteoarthritisNCT06010394
Control of Edema in the Knee in Patients With Knee Osteoarthritis
A study testing conventional physiotherapy, exercises for the knee area and payment oriented massage in people with Knee Osteoarthritis and Edema, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effectiveness of exercise and classical massage in the control of knee edema in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Knee Osteoarthritis, Edema, Edema Leg
- What is being tested?
- conventional physiotherapy, exercises for the knee area and payment oriented massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 6 Dec 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 30-65
- Patients with a diagnosis of osteoarthritis in stage 2 and stage 3 according to Kellgren-Lawrence criteria(1) and also with measurable edema
Who cannot join
- Inability to continue treatment regularly
- situations that prevent you from doing the exercise
- inflammation that interferes with massage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Exercise and Classical Massage in the Control of Edema in the Knee in Patients With Knee Osteoarthritis.
The aim of this study was to compare the effectiveness of exercise and classical massage in the control of knee edema in patients with knee osteoarthritis.
Read the detailed description
This study will be a prospective randomized controlled study. It is planned to include 75 patients with knee osteoarthritis in this study. It was categorized as osteoarthritis(OA) stages according to Kellgren-Lawrence criteria. Patients were randomly divided into three groups. the investigators first group is the control group (KG) and this group will receive classical physical therapy with ultrasound and subcutaneous electrical nerve stimulation. Exercise therapy will be applied to the second group in addition to the classical physical therapy applied to the KG. The third group will be given classical massage in addition to the classical physical therapy applied to the KG. The treatments to be applied to the patients will be 3 sessions per week and it is planned to continue for 4 weeks. Knee edema, pain severity, functional status and daily life activities will be measured at the beginning and in the 4th week of the patients. The data obtained will be analyzed statistically.
- Conditions
- Knee Osteoarthritis, Edema, Edema Leg
- Being tested
- conventional physiotherapy, exercises for the knee area, payment oriented massage
- Keywords
- massage
- Medical subject headings
- Osteoarthritis, Knee, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physiotherapyOther
ultrasound electrotherapy cold applications
exercises for the knee areaOther
range of motion exercises strengthening exercises exercises to reduce edema
payment oriented massageOther
10 / 15-minute massage treatments to reduce payment
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | commensal physiotherapy will be applied Receives: Other: conventional physiotherapy |
| exercise group | Experimental | exercises will be given Receives: Other: conventional physiotherapy; Other: exercises for the knee area |
| massage group | Experimental | massage will be done Receives: Other: conventional physiotherapy; Other: payment oriented massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score
It is used to detect symptoms and restrictions in current work that individuals do in daily life. The test is collected under 2 main headings, consisting of 6 questions about the effect of symptoms and 8 sub-activities that question the status of the activity. The answer to each question in the test is scored between 0-5. The scores that the person gets from each question are added together and these scores are divided by 70 and multiplied by 100. High score means low quality of life.
Measured: 4 weeks
Western Ontario and McMaster Universities Osteoarthritis Index
Pain, joint stiffness and functional status; Evaluated with the Arthritis Index of Western Ontario and McMaster Universities. The scale is a disease-specific, multidimensional, self-administered health status tool used in hip or knee osteoarthritis27. It consists of 24 questions on pain, stiffness and physical disability and is approximately 10 min. can be completed in Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions under three sub-headings. Pain consists of 5 questions, stiffness 2 questions and function 17 questions. Each sub-parameter is scored between 0-4 points. Accordingly, it is classified as pain (0-20), stiffness (0-8) and function (0-68). A high score indicates poor health, a low score indicates good health.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Sep 2023
- Primary completion15 Oct 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- classical physical therapy, exercise therapy, classical massage
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Enver Deniz YILDIRIM, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010394
- Sponsor's protocol ID
- Uskudar50
- Status last verified
- Dec 2023
- First submitted
- 18 Aug 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maricar N, Callaghan MJ, Parkes MJ, Felson DT, O'Neill TW. Clinical assessment of effusion in knee osteoarthritis-A systematic review. Semin Arthritis Rheum. 2016 Apr;45(5):556-63. doi: 10.1016/j.semarthrit.2015.10.004. Epub 2015 Oct 22.
PubMed 26581486Hofmann S, Kramer J, Vakil-Adli A, Aigner N, Breitenseher M. Painful bone marrow edema of the knee: differential diagnosis and therapeutic concepts. Orthop Clin North Am. 2004 Jul;35(3):321-33, ix. doi: 10.1016/j.ocl.2004.04.005.
PubMed 15271540Molfetta L, Florian A, Saviola G, Frediani B. Bone Marrow Edema: pathogenetic features. Clin Ter. 2022 Sep-Oct;173(5):434-439. doi: 10.7417/CT.2022.2459.
PubMed 36155729Kan HS, Chan PK, Chiu KY, Yan CH, Yeung SS, Ng YL, Shiu KW, Ho T. Non-surgical treatment of knee osteoarthritis. Hong Kong Med J. 2019 Apr;25(2):127-133. doi: 10.12809/hkmj187600. Epub 2019 Mar 28.
PubMed 30919810
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Exercise and Classical Massage in the Control of Edema in the Knee in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06010394
- Acronym / sponsor ID
- Uskudar50
- Conditions
- Knee Osteoarthritis, Edema, Edema Leg
- Keywords
- massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 24 Aug 2023 (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.
The aim of this study was to compare the effectiveness of exercise and classical massage in the control of knee edema in patients with knee osteoarthritis.
Detailed description
This study will be a prospective randomized controlled study. It is planned to include 75 patients with knee osteoarthritis in this study. It was categorized as osteoarthritis(OA) stages according to Kellgren-Lawrence criteria. Patients were randomly divided into three groups. the investigators first group is the control group (KG) and this group will receive classical physical therapy with ultrasound and subcutaneous electrical nerve stimulation. Exercise therapy will be applied to the second group in addition to the classical physical therapy applied to the KG. The third group will be given classical massage in addition to the classical physical therapy applied to the KG. The treatments to be applied to the patients will be 3 sessions per week and it is planned to continue for 4 weeks. Knee edema, pain severity, functional status and daily life activities will be measured at the beginning and in the 4th week of the patients. The data obtained will be analyzed statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- classical physical therapy, exercise therapy, classical massage
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: conventional physiotherapycommensal physiotherapy will be applied |
| exercise group | Experimental | Other: conventional physiotherapy, Other: exercises for the knee areaexercises will be given |
| massage group | Experimental | Other: conventional physiotherapy, Other: payment oriented massagemassage will be done |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being between the ages of 30-65
- Patients with a diagnosis of osteoarthritis in stage 2 and stage 3 according to Kellgren-Lawrence criteria(1) and also with measurable edema
Key exclusion criteria (3 listed)
- Inability to continue treatment regularly
- situations that prevent you from doing the exercise
- inflammation that interferes with massage.
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 |
|---|---|---|
| conventional physiotherapyultrasound electrotherapy cold applications | Other | control group, exercise group, massage group |
| exercises for the knee arearange of motion exercises strengthening exercises exercises to reduce edema | Other | exercise group |
| payment oriented massage10 / 15-minute massage treatments to reduce payment | Other | massage group |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score
Time frame: 4 weeks
It is used to detect symptoms and restrictions in current work that individuals do in daily life. The test is collected under 2 main headings, consisting of 6 questions about the effect of symptoms and 8 sub-activities that question the status of the activity. The answer to each question in the test is scored between 0-5. The scores that the person gets from each question are added together and these scores are divided by 70 and multiplied by 100. High score means low quality of life.
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 4 weeks
Pain, joint stiffness and functional status; Evaluated with the Arthritis Index of Western Ontario and McMaster Universities. The scale is a disease-specific, multidimensional, self-administered health status tool used in hip or knee osteoarthritis27. It consists of 24 questions on pain, stiffness and physical disability and is approximately 10 min. can be completed in Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions under three sub-headings. Pain consists of 5 questions, stiffness 2 questions and function 17 questions. Each sub-parameter is scored between 0-4 points. Accordingly, it is classified as pain (0-20), stiffness (0-8) and function (0-68). A high score indicates poor health, a low score indicates good health.
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 7 Dec 2023.
- Background: PubMed 26581486Maricar N, Callaghan MJ, Parkes MJ, Felson DT, O'Neill TW. Clinical assessment of effusion in knee osteoarthritis-A systematic review. Semin Arthritis Rheum. 2016 Apr;45(5):556-63. doi: 10.1016/j.semarthrit.2015.10.004. Epub 2015 Oct 22.
- Background: PubMed 15271540Hofmann S, Kramer J, Vakil-Adli A, Aigner N, Breitenseher M. Painful bone marrow edema of the knee: differential diagnosis and therapeutic concepts. Orthop Clin North Am. 2004 Jul;35(3):321-33, ix. doi: 10.1016/j.ocl.2004.04.005.
- Background: PubMed 36155729Molfetta L, Florian A, Saviola G, Frediani B. Bone Marrow Edema: pathogenetic features. Clin Ter. 2022 Sep-Oct;173(5):434-439. doi: 10.7417/CT.2022.2459.
- Background: PubMed 30919810Kan HS, Chan PK, Chiu KY, Yan CH, Yeung SS, Ng YL, Shiu KW, Ho T. Non-surgical treatment of knee osteoarthritis. Hong Kong Med J. 2019 Apr;25(2):127-133. doi: 10.12809/hkmj187600. Epub 2019 Mar 28.
- 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.
Enver Deniz YILDIRIM study chair
Uskudar 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 conventional physiotherapy, exercises for the knee area and payment oriented massage in people with Knee Osteoarthritis and Edema, run by Uskudar 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 2 inclusion and 3 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 7 Dec 2023. 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 (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT06010394, which also lists 4 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 7 Dec 2023.