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Evaluation Study of the Effects of Sulphurous Water in the Treatment of Knee Osteoarthritis.

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ClinicalTrials.gov Identifier: NCT01920360
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Marcelo Branco, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
KNEE OSTEOARTHRITIS Other: SULPHUROUS WATERS IMMERSION BATHS Other: NOT SULPHUROUS WATERS IMMERSION BATHS Other: CONTROL GROUP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Effects of Immersion Baths in Sulphurous Water in Patients With Knee Osteoarthritis: Randomized Controlled Clinical Trial.
Study Start Date : February 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: SULPHUROUS WATERS IMMERSION BATHS
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.
Other Names:
  • Balneotherapy
  • Termalism

Experimental: NOT SULPHUROUS WATERS IMMERSION BATHS
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.
Other: NOT SULPHUROUS WATERS IMMERSION BATHS
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.
Other Names:
  • Balneotherapy
  • Termalism

Experimental: 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.
Other: CONTROL GROUP
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.




Primary Outcome Measures :
  1. 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).


  2. 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).


  3. 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).



Secondary Outcome Measures :
  1. Intake of pain medication [ Time Frame: 10 weeks ]
    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.



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920360


Locations
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Brazil
Therms Antonio Carlos
Poços de Caldas, Minas Gerais, Brazil, 37701-000
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Marcelo Branco Federal University of São Paulo - UNIFESP

Publications of Results:
Other Publications:
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Responsible Party: Marcelo Branco, physiotherapist, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01920360     History of Changes
Other Study ID Numbers: 65463
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Marcelo Branco, Federal University of São Paulo:
KNEE OSTEOARTHRITIS
BALNEOTHERAPY
SULPHUROUS WATERS
WOMAC
LEQUESNE
HEALTH ASSESSMENT QUESTIONNAIRE
SHORT FORM - 36
VAS

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases