Knee OsteoarthritisNCT06424782
Therapeutic Effect of the Natural Mineral Water of the Well B-308 OKK in Győr (Gyirmót) on Knee Osteoarthrosis
A study testing medicinal water in people with Knee Osteoarthritis, run by University of Pecs at 1 site in Hungary.
Trial summary
The main purpose of the study is to investigate the therapeutic effect of the thermal water of Győr (Gyirmót) well No. B-308 OKK on patients with knee arthrosis, and to compare its therapeutic effect with tap water (placebo) group. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- medicinal water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2024to Sep 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthrosis that has existed for at least 3 months
- Age between 50 and 80 years
- Willingness to participate in 3-week outpatient rehabilitation treatment
- Pain in the knee joint lasting at least 3 months and at least 5 days a week
- At least mild pain during selection (1 point on the Likert scale)
- Does not have a serious disability
Who cannot join
- Any kind of physiotherapy treatment in the last 2 months (except home gymnastics)
- Any previous knee joint surgery
- Any trauma to the knee or hip joint in the 1 year prior to the examination
- Knee arthroscopy performed within 3 months prior to the examination
- Intra-articular corticosteroid treatment of the affected knee in the last 3 months
- Palpable Baker's cyst
Show all 16Show fewer
- Any hip joint or spine surgery within a year before the examination
- Intra-articular hyaluronic injection within 2 months before the examination
- Appearance of lumbar radiculopathy
- Presence of serious internal medicine disease, urogenital or other diseases
- Uncooperative or psychoneurotic patients
- Lumbago, sciatica; and any other surgery or previous fracture in the hip joint
- Subluxation, luxation, algodystrophy, fibromyalgia, gout
- Balneotherapy in the last 6 months
- Systemic corticosteroid treatment in 1 month before the examination
- Starting the treatment of osteoarthritis SYSADOA (symptomatic slow-acting drugs for osteoarthritis) in 3 months before the examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Therapeutic Effect of the Natural Mineral Water of the Well B-308 OKK in Győr (Gyirmót) Among People With Knee Arthrosis (Randomized, Controlled, Double-blind, Follow-up Study)
The main purpose of the study is to investigate the therapeutic effect of the thermal water of Győr (Gyirmót) well No. B-308 OKK on patients with knee arthrosis, and to compare its therapeutic effect with tap water (placebo) group.
Read the detailed description
After being informed about the study and the potential risks, all patients giving written informed consent will undergo a continuous screening period, until the number of 25-25 patients is reached, to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to medicinal water or placebo group.
- Conditions
- Knee Osteoarthritis
- Being tested
- medicinal water
- Keywords
- medicinal water, healing water, balneotherapy, WOMAC
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medicinal waterOther
Medicinal water treatment in bath tub once daily.
| Study group | Role | What they receive |
|---|---|---|
| Medicinal water treatment | Experimental | Participants receive medicinal water treatment in bath tub once daily (30 min) on weekdays for 3 weeks. Receives: Other: medicinal water |
| Tap water (placebo) treatment | Placebo comparator | Participants receive placebo water treatment in bath tub once daily (30 min) on weekdays for 3 weeks. Receives: Other: medicinal water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline in range of motion of the knee measured with goniometer at week 3 and 12
Goniometer is a range of motion measuring device. Its measuring range is 180 degrees. Change = (Week 3 degree - Baseline degree), Change = (Week 12 degree - Baseline degree)
Measured: Baseline and week 3 and 12
30-second Chair Stand Test
The test counts the number of times the patient comes to a full standing position in 30 seconds. Change = (Week 3 number - Baseline number), Change = (Week 12 number - Baseline number)
Measured: Baseline and week 3 and 12
Timed Up and Go (TUG)
It is a simple test that measures how quickly you can stand up, walk 3 meters, turn around, walk back, and sit down. It is done to assess mobility in older adults or predict their risk of falls. Many healthy adults less than 80 years old can complete the TUG test in 10 seconds or less. Change = (Week 3 seconds - Baseline seconds), Change = (Week 12 seconds - Baseline seconds)
Measured: Baseline and week 3 and 12
Change from baseline in pain on the 10-point Visual Analogue Scale (VAS) at week 3 and 12
The visual analogue scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Change = (Week 3 point - Baseline point), Change = (Week 12 point - Baseline point)
Measured: Baseline and week 3 and 12
Change from baseline in functional status with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) index at week 3 and 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. Change = (Week 3 score - Baseline score), Change = (Week 12 score - Baseline score)
Measured: Baseline and week 3 and 12
Change from baseline in quality of life with the Short Form 36 Health Survey Questionnaire (SF-36) at week 3 and 12
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). Scores ranges from 0 to 100. Higher scores indicate higher quality of life. Change = (Week 3 score - Baseline score), Change = (Week 12 score - Baseline score)
Measured: Baseline and week 3 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study startSep 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Collaborators
- Gyirmót Sport & Wellness Hotel
- Responsible party
- Sponsor
- Investigators
- Adrienn Hanzel, Ph.D., Principal investigator, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424782
- Sponsor's protocol ID
- B-308 OKK
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The outcome measures as individual participant data can be shared. Outcome measures are the followings: range of motion, 30-second Chair Stand Test, Timed Up and Go (TUG), VAS scale, WOMAC index, SF-36 questionnaire
Publications
Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742.
PubMed 14644851Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.
PubMed 23595142Kulisch A, Benko A, Bergmann A, Gyarmati N, Horvath H, Kranicz A, Mando ZS, Matan A, Nemeth A, Szakal E, Szanto D, Szekeres L, Bender T. Evaluation of the effect of Lake Heviz thermal mineral water in patients with osteoarthritis of the knee: a randomized, controlled, single-blind, follow-up study. Eur J Phys Rehabil Med. 2014 Aug;50(4):373-81. Epub 2014 Mar 5.
PubMed 24594851Gyarmati N, Kulisch A, Nemeth A, Bergmann A, Horvath J, Mando Z, Matan A, Szakal E, Sasne Peter T, Szanto D, Bender T. Evaluation of the Effect of Heviz Mud in Patients with Hand Osteoarthritis: A Randomized, Controlled, Single-Blind Follow-Up Study. Isr Med Assoc J. 2017 Mar;19(3):177-182.
PubMed 28457097Ayan C, Carvalho P, Varela S, Cancela JM. Effects of Water-Based Exercise Training on the Cognitive Function and Quality of Life of Healthy Adult Women. J Phys Act Health. 2017 Nov 1;14(11):899-904. doi: 10.1123/jpah.2017-0036. Epub 2017 Sep 25.
PubMed 28682652Bender T, Balint G, Prohaszka Z, Geher P, Tefner IK. Evidence-based hydro- and balneotherapy in Hungary--a systematic review and meta-analysis. Int J Biometeorol. 2014 Apr;58(3):311-23. doi: 10.1007/s00484-013-0667-6. Epub 2013 May 16.
PubMed 23677421Karagulle M, Kardes S, Karagulle MZ. Long-term efficacy of spa therapy in patients with rheumatoid arthritis. Rheumatol Int. 2018 Mar;38(3):353-362. doi: 10.1007/s00296-017-3926-8. Epub 2018 Jan 11.
PubMed 29327104Peter I, Jagicza A, Ajtay Z, Boncz I, Kiss I, Szendi K, Kustan P, Nemeth B. Balneotherapy in Psoriasis Rehabilitation. In Vivo. 2017 Nov-Dec;31(6):1163-1168. doi: 10.21873/invivo.11184.
PubMed 29102940Gutenbrunner C, Bender T, Cantista P, Karagulle Z. A proposal for a worldwide definition of health resort medicine, balneology, medical hydrology and climatology. Int J Biometeorol. 2010 Sep;54(5):495-507. doi: 10.1007/s00484-010-0321-5. Epub 2010 Jun 9.
PubMed 20532921McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
PubMed 24462672
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Therapeutic Effect of the Natural Mineral Water of the Well B-308 OKK in Győr (Gyirmót) Among People With Knee Arthrosis (Randomized, Controlled, Double-blind, Follow-up Study)
- ClinicalTrials.gov ID
- NCT06424782
- Acronym / sponsor ID
- B-308 OKK
- Conditions
- Knee Osteoarthritis
- Keywords
- medicinal water, healing water, balneotherapy, WOMAC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Collaborators
- Gyirmót Sport & Wellness Hotel
- Study start
- Sep 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 May 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.
The main purpose of the study is to investigate the therapeutic effect of the thermal water of Győr (Gyirmót) well No. B-308 OKK on patients with knee arthrosis, and to compare its therapeutic effect with tap water (placebo) group.
Detailed description
After being informed about the study and the potential risks, all patients giving written informed consent will undergo a continuous screening period, until the number of 25-25 patients is reached, to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to medicinal water or placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicinal water treatment | Experimental | Other: medicinal waterParticipants receive medicinal water treatment in bath tub once daily (30 min) on weekdays for 3 weeks. |
| Tap water (placebo) treatment | Placebo comparator | Other: medicinal waterParticipants receive placebo water treatment in bath tub once daily (30 min) on weekdays for 3 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Knee osteoarthrosis that has existed for at least 3 months
- Age between 50 and 80 years
- Willingness to participate in 3-week outpatient rehabilitation treatment
- Pain in the knee joint lasting at least 3 months and at least 5 days a week
- At least mild pain during selection (1 point on the Likert scale)
Key exclusion criteria (16 listed)
- Any kind of physiotherapy treatment in the last 2 months (except home gymnastics)
- Any previous knee joint surgery
- Any trauma to the knee or hip joint in the 1 year prior to the examination
- Knee arthroscopy performed within 3 months prior to the examination
- Intra-articular corticosteroid treatment of the affected knee in the last 3 months
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 |
|---|---|---|
| medicinal waterMedicinal water treatment in bath tub once daily. | Other | Medicinal water treatment, Tap water (placebo) treatment |
Primary outcome
Change from the baseline in range of motion of the knee measured with goniometer at week 3 and 12
Time frame: Baseline and week 3 and 12
Goniometer is a range of motion measuring device. Its measuring range is 180 degrees. Change = (Week 3 degree - Baseline degree), Change = (Week 12 degree - Baseline degree)
30-second Chair Stand Test
Time frame: Baseline and week 3 and 12
The test counts the number of times the patient comes to a full standing position in 30 seconds. Change = (Week 3 number - Baseline number), Change = (Week 12 number - Baseline number)
Timed Up and Go (TUG)
Time frame: Baseline and week 3 and 12
It is a simple test that measures how quickly you can stand up, walk 3 meters, turn around, walk back, and sit down. It is done to assess mobility in older adults or predict their risk of falls. Many healthy adults less than 80 years old can complete the TUG test in 10 seconds or less. Change = (Week 3 seconds - Baseline seconds), Change = (Week 12 seconds - Baseline seconds)
Change from baseline in pain on the 10-point Visual Analogue Scale (VAS) at week 3 and 12
Time frame: Baseline and week 3 and 12
The visual analogue scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Change = (Week 3 point - Baseline point), Change = (Week 12 point - Baseline point)
Change from baseline in functional status with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) index at week 3 and 12
Time frame: Baseline and week 3 and 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. Change = (Week 3 score - Baseline score), Change = (Week 12 score - Baseline score)
Change from baseline in quality of life with the Short Form 36 Health Survey Questionnaire (SF-36) at week 3 and 12
Time frame: Baseline and week 3 and 12
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). Scores ranges from 0 to 100. Higher scores indicate higher quality of life. Change = (Week 3 score - Baseline score), Change = (Week 12 score - Baseline score)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 14644851Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742.
- Background: PubMed 23595142Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.
- Background: PubMed 24594851Kulisch A, Benko A, Bergmann A, Gyarmati N, Horvath H, Kranicz A, Mando ZS, Matan A, Nemeth A, Szakal E, Szanto D, Szekeres L, Bender T. Evaluation of the effect of Lake Heviz thermal mineral water in patients with osteoarthritis of the knee: a randomized, controlled, single-blind, follow-up study. Eur J Phys Rehabil Med. 2014 Aug;50(4):373-81. Epub 2014 Mar 5.
- Background: PubMed 28457097Gyarmati N, Kulisch A, Nemeth A, Bergmann A, Horvath J, Mando Z, Matan A, Szakal E, Sasne Peter T, Szanto D, Bender T. Evaluation of the Effect of Heviz Mud in Patients with Hand Osteoarthritis: A Randomized, Controlled, Single-Blind Follow-Up Study. Isr Med Assoc J. 2017 Mar;19(3):177-182.
- Background: PubMed 28682652Ayan C, Carvalho P, Varela S, Cancela JM. Effects of Water-Based Exercise Training on the Cognitive Function and Quality of Life of Healthy Adult Women. J Phys Act Health. 2017 Nov 1;14(11):899-904. doi: 10.1123/jpah.2017-0036. Epub 2017 Sep 25.
- Background: PubMed 23677421Bender T, Balint G, Prohaszka Z, Geher P, Tefner IK. Evidence-based hydro- and balneotherapy in Hungary--a systematic review and meta-analysis. Int J Biometeorol. 2014 Apr;58(3):311-23. doi: 10.1007/s00484-013-0667-6. Epub 2013 May 16.
- Background: PubMed 29327104Karagulle M, Kardes S, Karagulle MZ. Long-term efficacy of spa therapy in patients with rheumatoid arthritis. Rheumatol Int. 2018 Mar;38(3):353-362. doi: 10.1007/s00296-017-3926-8. Epub 2018 Jan 11.
- Background: PubMed 29102940Peter I, Jagicza A, Ajtay Z, Boncz I, Kiss I, Szendi K, Kustan P, Nemeth B. Balneotherapy in Psoriasis Rehabilitation. In Vivo. 2017 Nov-Dec;31(6):1163-1168. doi: 10.21873/invivo.11184.
- Background: PubMed 20532921Gutenbrunner C, Bender T, Cantista P, Karagulle Z. A proposal for a worldwide definition of health resort medicine, balneology, medical hydrology and climatology. Int J Biometeorol. 2010 Sep;54(5):495-507. doi: 10.1007/s00484-010-0321-5. Epub 2010 Jun 9.
- Background: PubMed 24462672McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
- Individual participant dataSharing planned: Yes. The outcome measures as individual participant data can be shared. Outcome measures are the followings: range of motion, 30-second Chair Stand Test, Timed Up and Go (TUG), VAS scale, WOMAC index, SF-36 questionnaire
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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.
Adrienn Hanzel, Ph.D. principal investigator
University of Pecs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medicinal water in people with Knee Osteoarthritis, run by University of Pecs at 1 site in Hungary.
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 16 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: status not confirmed, as of the sponsor's last update on 22 May 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 Hungary. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katalin Szendi, M.D., Ph.D. (+36702654095, szkata82@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline in range of motion of the knee measured with goniometer at week 3 and 12 (time frame: Baseline and week 3 and 12). The study lists 6 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 NCT06424782, which also lists 10 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 22 May 2024.