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

Primary Purpose

KNEE OSTEOARTHRITIS

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
SULPHUROUS WATERS IMMERSION BATHS
NOT SULPHUROUS WATERS IMMERSION BATHS
CONTROL GROUP
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for KNEE OSTEOARTHRITIS focused on measuring KNEE OSTEOARTHRITIS, BALNEOTHERAPY, SULPHUROUS WATERS, WOMAC, LEQUESNE, HEALTH ASSESSMENT QUESTIONNAIRE, SHORT FORM - 36, VAS

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Therms Antonio Carlos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SULPHUROUS WATERS IMMERSION BATHS

NOT SULPHUROUS WATERS IMMERSION BATHS

CONTROL GROUP

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
August 1, 2013
Last Updated
August 10, 2015
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01920360
Brief Title
Evaluation Study of the Effects of Sulphurous Water in the Treatment of Knee Osteoarthritis.
Official Title
Study of the Effects of Immersion Baths in Sulphurous Water in Patients With Knee Osteoarthritis: Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
KNEE OSTEOARTHRITIS
Keywords
KNEE OSTEOARTHRITIS, BALNEOTHERAPY, SULPHUROUS WATERS, WOMAC, LEQUESNE, HEALTH ASSESSMENT QUESTIONNAIRE, SHORT FORM - 36, VAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SULPHUROUS WATERS IMMERSION BATHS
Arm Type
Experimental
Arm Description
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.
Arm Title
NOT SULPHUROUS WATERS IMMERSION BATHS
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL GROUP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SULPHUROUS WATERS IMMERSION BATHS
Other Intervention Name(s)
Balneotherapy, Termalism
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NOT SULPHUROUS WATERS IMMERSION BATHS
Other Intervention Name(s)
Balneotherapy, Termalism
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CONTROL GROUP
Intervention Description
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 Measure Information:
Title
Pain
Description
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).
Time Frame
10 weeks
Title
Life Quality
Description
Tools: Short Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).
Time Frame
10 weeks
Title
Physical Function
Description
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).
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Intake of pain medication
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Branco
Organizational Affiliation
Federal University of São Paulo UNIFESP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Therms Antonio Carlos
City
Poços de Caldas
State/Province
Minas Gerais
ZIP/Postal Code
37701-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
17943920
Citation
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.
Results Reference
background
PubMed Identifier
16832639
Citation
Yurtkuran 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.
Results Reference
result

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

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