Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis

NCT05352477 | Unknown DMC

• 1 other identifier: Acquabios1
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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

Conditions

Knee Osteoarthritis

Keywords

Balneotherapy; Thermal water; Osteoarthritis; Musculoskeletal disease

Outcome Measures

Primary Outcomes (5)

• Change of knee pain as assessed by Visual Analogue Scale

  Knee pain change measured by the use of Visual Analogue Scale (VAS). VAS scale consists of a straight line segment (100 mm) at the ends of which there are the indications "no pain" (0 mm) and "the strongest pain imaginable" (100 mm). The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (best, 0) to the right (worst, 100).

  At baseline (T0), after 1 weeks (T1), after 2 weeks (T2),and after 3 months (T3) from the beginning of the study

• Change of knee joint stiffness as assessed by Western Ontario and McMaster Universities.(WOMAC) osteoarthritis index

  Knee joint stiffness change assessed by Western Ontario and McMaster Universities.(WOMAC) osteoarthritis index, a self-administered questionnaire. WOMAC questionnaire consists of 24 items divided into 3 subscales characterizing the patient's state of health: pain, joint stiffness and functionality. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.

  At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study

• Change of knee range of motion change as assessed by the use of a universal goniometer

  Knee range of motion change measured by the use of a universal goniometer

  At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study

• Change of walking quality as assessed by the 6-meters Walking Test.

  Walking quality assessed by the 6-meters Walking Test, that evaluates the functional ability of walking by measuring the time required to walk 6 meters at a brisk pace. Each participants will be timed from the moment their foot cross the start line to the moment their foot cross the stop line placed at 6 meters from starting line.

  At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study

• Change of walking quality as assessed by Western Ontario and McMaster Universities (WOMAC) osteoarthritis score.

  Change of walking quality assessed by Western Ontario and McMaster Universities (WOMAC) osteoarthritis score. WOMAC questionnaire consists of 24 items divided into 3 subscales characterizing the patient's state of health: pain, joint stiffness and functionality. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.

  At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study

Secondary Outcomes (2)

• Change of quality of life as assessed by 36-Item Short Form Survey (SF-36) questionnaire

  At baseline (T0) and after 3 months (T3) from the beginning of the study

• Change of lower limbs strength as assessed by 30-seconds Chair Stand Test (30-s CST)

  At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study

Study Arms (2)

Balneotherapy with thermal water

EXPERIMENTAL

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

Other: Balneotherapy with thermal water

Balneotherapy with tap water

PLACEBO COMPARATOR

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

Other: Balneotherapy with tap water

Interventions

Balneotherapy with thermal water OTHER

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)

Also known as: Acquabios thermal water of Minerbio (BO), Italy

Balneotherapy with thermal water

Balneotherapy with tap water OTHER

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)

Also known as: Tap water supplied by Minerbio water network

Balneotherapy with tap water

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (4)

• 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.

  PMID: 20334632 BACKGROUND

• 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.

  PMID: 23295957 BACKGROUND

• 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.

  PMID: 32200439 BACKGROUND

• 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.

  PMID: 33740137 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Musculoskeletal Diseases

Interventions

Balneology

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mario Fontana, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Fontana, MD

CONTACT

+393335738728; mario.fontana@uniroma1.it

Carmela Protano, MD

CONTACT

+393284823511; carmela.protano@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 28, 2022
• Study Start: June 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: February 28, 2023
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share