Evaluation Study of the Effects of Sulphurous Water in the Treatment of Knee Osteoarthritis.
Study of the Effects of Immersion Baths in Sulphurous Water in Patients With Knee Osteoarthritis: Randomized Controlled Clinical Trial.
1 other identifier
interventional
140
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Feb 2011
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 12, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 13, 2015
August 1, 2015
2.5 years
August 1, 2013
August 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
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).
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).
10 weeks
Secondary Outcomes (1)
Intake of pain medication
10 weeks
Study Arms (3)
SULPHUROUS WATERS IMMERSION BATHS
EXPERIMENTALThe 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
EXPERIMENTALThe 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
EXPERIMENTALThis 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.
Interventions
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 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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Therms Antonio Carlos
Poços de Caldas, Minas Gerais, 37701-000, Brazil
Related Publications (2)
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.
PMID: 17943920BACKGROUNDYurtkuran 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.
PMID: 16832639RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo Branco
Federal University of São Paulo UNIFESP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physiotherapist
Study Record Dates
First Submitted
August 1, 2013
First Posted
August 12, 2013
Study Start
February 1, 2011
Primary Completion
August 1, 2013
Study Completion
December 1, 2013
Last Updated
August 13, 2015
Record last verified: 2015-08