KNEE OSTEOARTHRITISNCT01920360
Evaluation Study of the Effects of Sulphurous Water in the Treatment of Knee Osteoarthritis.
A study testing SULPHUROUS WATERS IMMERSION BATHS and NOT SULPHUROUS WATERS IMMERSION BATHS in people with KNEE OSTEOARTHRITIS, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The objectives are to evaluate the effects of immersion bath with sulphurous water in pain, joint mobility and quality of life in patients with knee osteoarthritis. Patients will undergo three weekly baths in sulphurous water and not sulphurous, twenty minutes each, for ten weeks. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- KNEE OSTEOARTHRITIS
- What is being tested?
- SULPHUROUS WATERS IMMERSION BATHS and NOT SULPHUROUS WATERS IMMERSION BATHS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Dec 2013
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We selected individuals of both genders, diagnosed with Osteoarthritis of the knee according to the classification criteria of the American College of Rheumatology (ACR) only grades I to III chronic pain at some knees, for a minimum period of three months.
Who cannot join
- Patients with fibromyalgia;
- Individuals with respiratory diseases;
- Rheumatic diseases autoimmune inflammatory;
- Patients with uncontrolled thyroidopathies;
- Patients with injuries or amputations of lower limbs;
- Patients with psychiatric disorders or cognitive;
Show all 12Show fewer
- Patients with a history of osteoporotic fracture;
- Patients with malignant
- Patients with infectious processes;
- Patients pregnant;
- Individuals who failed to enter the baths due to physical limitations;
- Were also excluded those who were engaged in other forms of treatment or using painkillers and anti-inflammatory drugs for other diseases. Note: were not excluded participants who were diagnosed with osteoarthritis in the spine, herniated, or degenerative disc protrusions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effects of Immersion Baths in Sulphurous Water in Patients With Knee Osteoarthritis: Randomized Controlled Clinical Trial.
The objectives are to evaluate the effects of immersion bath with sulphurous water in pain, joint mobility and quality of life in patients with knee osteoarthritis. Patients will undergo three weekly baths in sulphurous water and not sulphurous, twenty minutes each, for ten weeks.
The expected results are: reduction of pain, improved range of motion of the lower limbs with consequent increase in muscle mass improvement in postural balance, which will come due to the reduction of pain and improvement movements of the lower limbs; greater independence in performing the activities of daily living, better quality of life.
Read the detailed description
The baths were performed in individual tubs, properly disinfected, supplied with thermal water and sulphurous thermal sulphurous not at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects drank two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. Treatment consisted of 30 individual treatment sessions, three times a week, lasting twenty minutes each session, for ten weeks. The experiment was performed at the Therms Antonio Carlos, institution belonging to the Municipality of Poços de Caldas, Minas Gerais, Brazil.
- Conditions
- KNEE OSTEOARTHRITIS
- Being tested
- SULPHUROUS WATERS IMMERSION BATHS, NOT SULPHUROUS WATERS IMMERSION BATHS, CONTROL GROUP
- Keywords
- KNEE OSTEOARTHRITIS, BALNEOTHERAPY, SULPHUROUS WATERS, WOMAC, LEQUESNE, HEALTH ASSESSMENT QUESTIONNAIRE, SHORT FORM - 36, VAS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SULPHUROUS WATERS IMMERSION BATHSOther
Also called Balneotherapy, Termalism
SULPHUROUS WATERS IMMERSION BATHS: The baths will be held in individual tubs, properly disinfected, supplied with sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.
NOT SULPHUROUS WATERS IMMERSION BATHSOther
Also called Balneotherapy, Termalism
NOT SULPHUROUS WATERS IMMERSION BATHS:The baths will be held in individual tubs, properly disinfected, supplied with not sulphur thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.
CONTROL GROUPOther
CONTROL GROUP: This group did not receive any treatment, only received some verbal directions as to the care that should be taken to prevent and control the knee pain.
| Study group | Role | What they receive |
|---|---|---|
| SULPHUROUS WATERS IMMERSION BATHS | Experimental | The baths will be held in individual tubs, properly disinfected, supplied with sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. Receives: Other: SULPHUROUS WATERS IMMERSION BATHS |
| NOT SULPHUROUS WATERS IMMERSION BATHS | Experimental | The baths will be held in individual tubs, properly disinfected, supplied with not sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. Receives: Other: NOT SULPHUROUS WATERS IMMERSION BATHS |
| CONTROL GROUP | Experimental | This group did not receive any treatment, only received some verbal directions as to the care that should be taken to prevent and control the knee pain. Receives: Other: CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Tools:
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 5 questions about pain, 2 about stiffness, 17 about physical function. Each question receives a score from 0 to 100. After is done the arithmetic mean. The higher the score on each subscale, the greater deficit.
Visual Analogic Scale (VAS): horizontal line marked from 0 (no pain) to 10 (intense pain).
LEQUESNE: 11 questions about pain, discomfort and function, 6 about pain and discomfort, 1 about to walk away, and 4 on daily activities. The scores range from 0 (no impairment) to 24 (severe).
Short Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).
Measured: 10 weeks
Life Quality
Tools:
Short Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).
Measured: 10 weeks
Physical Function
Tools:
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 5 questions about pain, 2 about stiffness, 17 about physical function. Each question receives a score from 0 to 100. After is done the arithmetic mean. The higher the score on each subscale, the greater deficit.
LEQUESNE: 11 questions about pain, discomfort and function, 6 about pain and discomfort, 1 about to walk away, and 4 on daily activities. The scores range from 0 (no impairment) to 24 (severe).
Health Assessment Questionnaire (HAQ): Each question ranges from zero (no functional impairment) to three (task disabling).
Short Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).
Measured: 10 weeks
Secondary outcomes (1)
Intake of pain medication
After randomization, patients were instructed to report home about taking medication for pain in the knees, noting in a spreadsheet every time you wear some medicine to relieve pain in the knees. The result of this analysis was based on the number of times each individual ingested some medication.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startFeb 2011
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for KNEE OSTEOARTHRITISStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Branco, Federal University of São Paulo
- Investigators
- Marcelo Branco, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920360
- Sponsor's protocol ID
- 65463
- Status last verified
- Aug 2015
- First submitted
- 1 Aug 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Verhagen AP, Bierma-Zeinstra SM, Boers M, Cardoso JR, Lambeck J, de Bie RA, de Vet HC. Balneotherapy for osteoarthritis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006864. doi: 10.1002/14651858.CD006864.
PubMed 17943920Yurtkuran M, Yurtkuran M, Alp A, Nasircilar A, Bingol U, Altan L, Sarpdere G. Balneotherapy and tap water therapy in the treatment of knee osteoarthritis. Rheumatol Int. 2006 Nov;27(1):19-27. doi: 10.1007/s00296-006-0158-8. Epub 2006 Jul 11.
PubMed 16832639
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Immersion Baths in Sulphurous Water in Patients With Knee Osteoarthritis: Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01920360
- Acronym / sponsor ID
- 65463
- Conditions
- KNEE OSTEOARTHRITIS
- Keywords
- KNEE OSTEOARTHRITIS, BALNEOTHERAPY, SULPHUROUS WATERS, WOMAC, LEQUESNE, HEALTH ASSESSMENT QUESTIONNAIRE, SHORT FORM - 36, VAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Aug 2013 (estimated)
- 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 objectives are to evaluate the effects of immersion bath with sulphurous water in pain, joint mobility and quality of life in patients with knee osteoarthritis. Patients will undergo three weekly baths in sulphurous water and not sulphurous, twenty minutes each, for ten weeks.
The expected results are: reduction of pain, improved range of motion of the lower limbs with consequent increase in muscle mass improvement in postural balance, which will come due to the reduction of pain and improvement movements of the lower limbs; greater independence in performing the activities of daily living, better quality of life.
Detailed description
The baths were performed in individual tubs, properly disinfected, supplied with thermal water and sulphurous thermal sulphurous not at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects drank two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. Treatment consisted of 30 individual treatment sessions, three times a week, lasting twenty minutes each session, for ten weeks. The experiment was performed at the Therms Antonio Carlos, institution belonging to the Municipality of Poços de Caldas, Minas Gerais, Brazil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SULPHUROUS WATERS IMMERSION BATHS | Experimental | Other: SULPHUROUS WATERS IMMERSION BATHSThe baths will be held in individual tubs, properly disinfected, supplied with sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. |
| NOT SULPHUROUS WATERS IMMERSION BATHS | Experimental | Other: NOT SULPHUROUS WATERS IMMERSION BATHSThe baths will be held in individual tubs, properly disinfected, supplied with not sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. |
| CONTROL GROUP | Experimental | Other: CONTROL GROUPThis group did not receive any treatment, only received some verbal directions as to the care that should be taken to prevent and control the knee pain. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We selected individuals of both genders, diagnosed with Osteoarthritis of the knee according to the classification criteria of the American College of Rheumatology (ACR) only grades I to III chronic pain at some knees, for a minimum period of three months.
Key exclusion criteria (12 listed)
- Patients with fibromyalgia;
- Individuals with respiratory diseases;
- Rheumatic diseases autoimmune inflammatory;
- Patients with uncontrolled thyroidopathies;
- Patients with injuries or amputations of lower limbs;
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 |
|---|---|---|
| SULPHUROUS WATERS IMMERSION BATHSAlso: Balneotherapy, TermalismSULPHUROUS WATERS IMMERSION BATHS: The baths will be held in individual tubs, properly disinfected, supplied with sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. | Other | SULPHUROUS WATERS IMMERSION BATHS |
| NOT SULPHUROUS WATERS IMMERSION BATHSAlso: Balneotherapy, TermalismNOT SULPHUROUS WATERS IMMERSION BATHS:The baths will be held in individual tubs, properly disinfected, supplied with not sulphur thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. | Other | NOT SULPHUROUS WATERS IMMERSION BATHS |
| CONTROL GROUPCONTROL GROUP: This group did not receive any treatment, only received some verbal directions as to the care that should be taken to prevent and control the knee pain. | Other | CONTROL GROUP |
Primary outcome
Pain
Time frame: 10 weeks
Tools: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 5 questions about pain, 2 about stiffness, 17 about physical function. Each question receives a score from 0 to 100. After is done the arithmetic mean. The higher the score on each subscale, the greater deficit. Visual Analogic Scale (VAS): horizontal line marked from 0 (no pain) to 10 (intense pain). LEQUESNE: 11 questions about pain, discomfort and function, 6 about pain and discomfort, 1 about to walk away, and 4 on daily activities. The scores range from 0 (no impairment) to 24 (severe). Short Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).
Life Quality
Time frame: 10 weeks
Tools: Short Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).
Physical Function
Time frame: 10 weeks
Tools: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 5 questions about pain, 2 about stiffness, 17 about physical function. Each question receives a score from 0 to 100. After is done the arithmetic mean. The higher the score on each subscale, the greater deficit. LEQUESNE: 11 questions about pain, discomfort and function, 6 about pain and discomfort, 1 about to walk away, and 4 on daily activities. The scores range from 0 (no impairment) to 24 (severe). Health Assessment Questionnaire (HAQ): Each question ranges from zero (no functional impairment) to three (task disabling). Short Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).
1 secondary outcome
Intake of pain medication
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Background: PubMed 17943920Verhagen AP, Bierma-Zeinstra SM, Boers M, Cardoso JR, Lambeck J, de Bie RA, de Vet HC. Balneotherapy for osteoarthritis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006864. doi: 10.1002/14651858.CD006864.
- Results publication: PubMed 16832639Yurtkuran M, Yurtkuran M, Alp A, Nasircilar A, Bingol U, Altan L, Sarpdere G. Balneotherapy and tap water therapy in the treatment of knee osteoarthritis. Rheumatol Int. 2006 Nov;27(1):19-27. doi: 10.1007/s00296-006-0158-8. Epub 2006 Jul 11.
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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.
Marcelo Branco principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SULPHUROUS WATERS IMMERSION BATHS and NOT SULPHUROUS WATERS IMMERSION BATHS in people with KNEE OSTEOARTHRITIS, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 10 weeks). The study lists 3 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 NCT01920360, which also lists 2 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 13 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.