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

NCT ID: NCT01920360

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-12-31

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.

Conditions

KNEE OSTEOARTHRITIS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SULPHUROUS WATERS IMMERSION BATHS

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

NOT SULPHUROUS WATERS IMMERSION BATHS

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

CONTROL GROUP

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Balneotherapy; Termalism; Balneotherapy; Termalism

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Branco

physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo Branco

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo UNIFESP

Locations

Therms Antonio Carlos

Poços de Caldas, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 17943920 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16832639 (View on PubMed)

Other Identifiers

65463

Identifier Type: -

Identifier Source: org_study_id