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Completed

NCT Number: NCT01920360

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

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Therms Antonio Carlos

Poços de Caldas, Minas Gerais, 37701-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SULPHUROUS WATERS IMMERSION BATHS

Other

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

NOT SULPHUROUS WATERS IMMERSION BATHS

Other

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

Control Group

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Study of the Effects of Immersion Baths in Sulphurous Water in Patients With Knee Osteoarthritis: Randomized Controlled Clinical Trial.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2013
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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