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Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Balneotherapy with thermal water
Balneotherapy with tap water
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Balneotherapy, Thermal water, Osteoarthritis, Musculoskeletal disease

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Balneotherapy with thermal water

    Balneotherapy with tap water

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    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).
    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.
    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
    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.
    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.

    Secondary Outcome Measures

    Change of quality of life as assessed by 36-Item Short Form Survey (SF-36) questionnaire
    Quality of life assessed using 36-Item Short Form Survey (SF-36) questionnaire. The 36-Item Short Form Survey (SF-36) is a self-reported measure of health. It comprises 36 questions which cover eight domains of health: 1) Limitations in physical activities because of health problems; 2) Limitations in social activities because of physical or emotional problems; 3) Limitations in usual role activities because of physical health problems; 4) Bodily pain; 5) General mental health (psychological distress and well-being); 6) Limitations in usual role activities because of emotional problems; 7) Vitality (energy and fatigue); 8) General health perceptions. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
    Change of lower limbs strength as assessed by 30-seconds Chair Stand Test (30-s CST)
    Lower limbs strength assessed using 30-seconds Chair Stand Test (30-s CST), a performance based test. The 30-s CST is administered using a folding chair without arms, with seat height of 43.2 cm. The chair, with rubber tips on the legs, is placed against a wall to prevent it from moving. The 30-s CST involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre-determined number of repetitions. That way, it is possible to assess a wide variety of ability levels with scores ranging from 0 for those who can not complete 1 stand to as many times as possible in 30 seconds.

    Full Information

    First Posted
    April 13, 2022
    Last Updated
    April 22, 2022
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05352477
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    October 31, 2022 (Anticipated)
    Study Completion Date
    February 28, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Balneotherapy, Thermal water, Osteoarthritis, Musculoskeletal disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Balneotherapy with thermal water
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Balneotherapy with tap water
    Arm Type
    Placebo Comparator
    Arm 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
    Intervention Type
    Other
    Intervention Name(s)
    Balneotherapy with thermal water
    Other Intervention Name(s)
    Acquabios thermal water of Minerbio (BO), Italy
    Intervention Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    Balneotherapy with tap water
    Other Intervention Name(s)
    Tap water supplied by Minerbio water network
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Change of knee pain as assessed by Visual Analogue Scale
    Description
    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).
    Time Frame
    At baseline (T0), after 1 weeks (T1), after 2 weeks (T2),and after 3 months (T3) from the beginning of the study
    Title
    Change of knee joint stiffness as assessed by Western Ontario and McMaster Universities.(WOMAC) osteoarthritis index
    Description
    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.
    Time Frame
    At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
    Title
    Change of knee range of motion change as assessed by the use of a universal goniometer
    Description
    Knee range of motion change measured by the use of a universal goniometer
    Time Frame
    At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
    Title
    Change of walking quality as assessed by the 6-meters Walking Test.
    Description
    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.
    Time Frame
    At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
    Title
    Change of walking quality as assessed by Western Ontario and McMaster Universities (WOMAC) osteoarthritis score.
    Description
    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.
    Time Frame
    At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
    Secondary Outcome Measure Information:
    Title
    Change of quality of life as assessed by 36-Item Short Form Survey (SF-36) questionnaire
    Description
    Quality of life assessed using 36-Item Short Form Survey (SF-36) questionnaire. The 36-Item Short Form Survey (SF-36) is a self-reported measure of health. It comprises 36 questions which cover eight domains of health: 1) Limitations in physical activities because of health problems; 2) Limitations in social activities because of physical or emotional problems; 3) Limitations in usual role activities because of physical health problems; 4) Bodily pain; 5) General mental health (psychological distress and well-being); 6) Limitations in usual role activities because of emotional problems; 7) Vitality (energy and fatigue); 8) General health perceptions. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
    Time Frame
    At baseline (T0) and after 3 months (T3) from the beginning of the study
    Title
    Change of lower limbs strength as assessed by 30-seconds Chair Stand Test (30-s CST)
    Description
    Lower limbs strength assessed using 30-seconds Chair Stand Test (30-s CST), a performance based test. The 30-s CST is administered using a folding chair without arms, with seat height of 43.2 cm. The chair, with rubber tips on the legs, is placed against a wall to prevent it from moving. The 30-s CST involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre-determined number of repetitions. That way, it is possible to assess a wide variety of ability levels with scores ranging from 0 for those who can not complete 1 stand to as many times as possible in 30 seconds.
    Time Frame
    At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mario Fontana, MD
    Phone
    +393335738728
    Email
    mario.fontana@uniroma1.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carmela Protano, MD
    Phone
    +393284823511
    Email
    carmela.protano@uniroma1.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mario Fontana, MD
    Organizational Affiliation
    University of Roma La Sapienza
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20334632
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23295957
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32200439
    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.
    Results Reference
    background
    PubMed Identifier
    33740137
    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.
    Results Reference
    background

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    Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis

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