Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis
NCT ID: NCT05352477
Last Updated: 2022-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
88 participants
INTERVENTIONAL
2022-06-01
2023-02-28
Brief Summary
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Detailed Description
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The evaluated outcomes will be the reduction of pain and muscle-joint stiffness, the improvement of the joint range, the improvement of the quality of life, strength in the lower limbs and tolerance to physical exercise, the quality of walking and function in specific daily activities compared to the control group. Appropriated and validated tests will be used to evaluate the achievement of these outcomes.
The evaluation will be carried out on all patients enrolled in the study at the beginning, after the first week of treatment, after the second week of treatment and at the end of the study period (90 days after the first day of treatment). All eligible patients will be evaluated at the time of selection for weight, height, blood pressure, heart rate. These parameters will be evaluated and recorded on a specific form both during the enrollment and during all the visits planned for the follow-up. Each visit will last approximately 30 minutes.
The adverse reactions known for the balneotherapy with thermal water are the temporary reduction or increase of blood pression, thermal crisis and thermal reaction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Balneotherapy with thermal water
Daily balneotherapy with Acquabios thermal water at 33°C for 20 minutes each, for a total of 12 applications carried out over a period of 2 weeks
Balneotherapy with thermal water
Bath with Acquabios thermal water at 33°C, 20 minutes daily for a total of 12 days, 6 days a week (from Monday to Saturday, Sundays excluded)
Balneotherapy with tap water
Daily balneotherapy with tap water at 33°C for 20 minutes each, for a total of 12 applications carried out over a period of 2 weeks
Balneotherapy with tap water
Bath with tap water at 33°C, 20 minutes daily for a total of 12 days, 6 days a week (from Monday to Saturday, Sundays excluded)
Interventions
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Balneotherapy with thermal water
Bath with Acquabios thermal water at 33°C, 20 minutes daily for a total of 12 days, 6 days a week (from Monday to Saturday, Sundays excluded)
Balneotherapy with tap water
Bath with tap water at 33°C, 20 minutes daily for a total of 12 days, 6 days a week (from Monday to Saturday, Sundays excluded)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of pain characteristic of osteoarthritis of the right knee joint for at least 3 months
* Absence of severe disability
* Consent to treatment and participation in the study
Exclusion Criteria
* Not eligilble for thermal balneotherapy treatments
* Previous arthroprotesis
* Previous balneotherapy treatments in last six months
* One or more steroid treatments in last two months
* One or more chondroprotective treatments, including infiltration with hyaluronic acid and similar in last six months
* One or more physiotherapy treatments in last two months, with the exception of exercises carried out individually at home
* Treatment with non-steroidal anti-inflammatory drugs in the last week
* One or more surgery on the lower limbs
* One or more trauma to the knee joint in the last 12 months
* Knee joint instability and / or intra-articular effusion before or during study participation
* Presence of palpable Baker's cyst
* Severe psychiatric or neurological conditions
* Being affected by severe chronic diseases: cardiovascular, respiratory, hepatic, cerebral, renal, juvenile diabetes, complicated diabetes mellitus, phlebopathies, systemic blood diseases, neoplasms
* Ongoing rheumatic diseases
* Being pregnant or breastfeeding
* Being suffering from severe acute pathologies
45 Years
70 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Mario Fontana
Prof
Principal Investigators
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Mario Fontana, MD
Role: PRINCIPAL_INVESTIGATOR
University of Roma La Sapienza
Central Contacts
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References
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Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010 Mar 24;11:32. doi: 10.1186/1745-6215-11-32.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
Cheleschi S, Gallo I, Tenti S. A comprehensive analysis to understand the mechanism of action of balneotherapy: why, how, and where they can be used? Evidence from in vitro studies performed on human and animal samples. Int J Biometeorol. 2020 Jul;64(7):1247-1261. doi: 10.1007/s00484-020-01890-4. Epub 2020 Mar 21.
D'Angelo D, Coclite D, Napoletano A, Fauci AJ, Latina R, Gianola S, Castellini G, Salomone K, Gambalunga F, Sperati F, Iacorossi L, Iannone P. The efficacy of balneotherapy, mud therapy and spa therapy in patients with osteoarthritis: an overview of reviews. Int J Biometeorol. 2021 Jul;65(7):1255-1271. doi: 10.1007/s00484-021-02102-3. Epub 2021 Mar 19.
Other Identifiers
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Acquabios1
Identifier Type: -
Identifier Source: org_study_id
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