Knee OsteoarthritisNCT05352477
Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis
A study testing Balneotherapy with thermal water and Balneotherapy with tap water in people with Knee Osteoarthritis, run by University of Roma La Sapienza.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Balneotherapy with thermal water and Balneotherapy with tap water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Double-blind Randomized Controlled Clinical Trial for Evaluating the Effects of Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis
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
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Balneotherapy with thermal water, Balneotherapy with tap water
- Keywords
- Balneotherapy, Thermal water, Osteoarthritis, Musculoskeletal disease
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balneotherapy with thermal waterOther
Also called Acquabios thermal water of Minerbio (BO), Italy
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 waterOther
Also called Tap water supplied by Minerbio water network
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Balneotherapy with tap water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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)
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.
Measured: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Fontana, University of Roma La Sapienza
- Investigators
- Mario Fontana, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352477
- Sponsor's protocol ID
- Acquabios1
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20334632Chan 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.
PubMed 23295957Cheleschi 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.
PubMed 32200439D'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.
PubMed 33740137
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Controlled Clinical Trial for Evaluating the Effects of Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05352477
- Acronym / sponsor ID
- Acquabios1
- Conditions
- Knee Osteoarthritis
- Keywords
- Balneotherapy, Thermal water, Osteoarthritis, Musculoskeletal disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balneotherapy with thermal water | Experimental | Other: Balneotherapy with thermal waterDaily 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 tap water | Placebo comparator | Other: Balneotherapy with tap waterDaily 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 |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balneotherapy with thermal waterAlso: Acquabios thermal water of Minerbio (BO), ItalyBath 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) | Other | Balneotherapy with thermal water |
| Balneotherapy with tap waterAlso: Tap water supplied by Minerbio water networkBath 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 | Balneotherapy with tap water |
Primary outcome
Change of knee pain as assessed by Visual Analogue Scale
Time frame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2),and after 3 months (T3) from the beginning of the study
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
Time frame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
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
Time frame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
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.
Time frame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
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.
Time frame: 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 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.
2 secondary outcomes
Change of quality of life as assessed by 36-Item Short Form Survey (SF-36) questionnaire
Time frame: 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)
Time frame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 20334632Schulz 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.
- Background: PubMed 23295957Chan 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.
- Background: PubMed 32200439Cheleschi 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.
- Background: PubMed 33740137D'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Fontana, MD principal investigator
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A study testing Balneotherapy with thermal water and Balneotherapy with tap water in people with Knee Osteoarthritis, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Fontana, MD (+393335738728, mario.fontana@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of knee pain as assessed by Visual Analogue Scale (time frame: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2),and after 3 months (T3) from the beginning of the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05352477, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.