Clinical trial NCT01920360: 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
Overall status: COMPLETED
Phase: NA
Conditions: KNEE OSTEOARTHRITIS
Keywords: KNEE OSTEOARTHRITIS
BALNEOTHERAPY
SULPHUROUS WATERS
WOMAC
LEQUESNE
HEALTH ASSESSMENT QUESTIONNAIRE
SHORT FORM - 36
VAS
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain
timeFrame: 10 weeks
measure: Life Quality
timeFrame: 10 weeks
measure: Physical Function
timeFrame: 10 weeks
Secondary outcomes:
measure: Intake of pain medication
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Poços de Caldas
country: Brazil
facility: Therms Antonio Carlos
state: Minas Gerais
Study officials:
affiliation: Federal University of São Paulo UNIFESP
name: Marcelo Branco
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.