Clinical trial NCT05352477: Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis
Official title: Double-blind Randomized Controlled Clinical Trial for Evaluating the Effects of Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Balneotherapy
Thermal water
Osteoarthritis
Musculoskeletal disease
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 88
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is the evaluation of the effect of balneotherapy with Acquabios bicarbonate-alkaline-sodium thermal water in ameliorating some signs and symptoms of knee osteoarthritis in human subjects suffering from this disease

Detailed description: This double-blind randomized controlled clinical trial is aimed to evaluate whether the balneotherapy with Acquabios thermal water is effective in improving some signs and symptoms of gonarthrosis in subjects affected by this disease.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of right knee osteoarthritis
* 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:

* Bilateral knee osteoarthrosis or left knee osteoarthritis
* 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

Primary outcomes:
measure: Change of knee pain as assessed by Visual Analogue Scale
timeFrame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2),and after 3 months (T3) from the beginning of the study
measure: Change of knee joint stiffness as assessed by Western Ontario and McMaster Universities.(WOMAC) osteoarthritis index
timeFrame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
measure: Change of knee range of motion change as assessed by the use of a universal goniometer
timeFrame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
measure: Change of walking quality as assessed by the 6-meters Walking Test.
timeFrame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
measure: Change of walking quality as assessed by Western Ontario and McMaster Universities (WOMAC) osteoarthritis score.
timeFrame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
Secondary outcomes:
measure: Change of quality of life as assessed by 36-Item Short Form Survey (SF-36) questionnaire
timeFrame: At baseline (T0) and after 3 months (T3) from the beginning of the study
measure: Change of lower limbs strength as assessed by 30-seconds Chair Stand Test (30-s CST)
timeFrame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Mario Fontana, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.