Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis

University of Roma La Sapienza

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Other: Balneotherapy with tap water; Other: Balneotherapy with thermal water

Study type: Interventional

Funder types: Other

Identifiers

NCT05352477

Acquabios1

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

Balneotherapy with thermal water

Experimental group

Description:

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

Treatment:

Other: Balneotherapy with thermal water

Balneotherapy with tap water

Placebo Comparator group

Description:

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

Treatment:

Other: Balneotherapy with tap water