Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000586011
Ethics application status
Approved
Date submitted
13/07/2010
Date registered
21/07/2010
Date last updated
21/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The benefits of hydrotherapy in quality of life of patients with low back pain mechanism associated with the symptoms of fibromyalgia.
Scientific title
The effect of hydrotherapy on quality of life in patients experiencing low back pain associated with fibromyalgia.
Secondary ID [1] 252198 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The low back pain 257758 0
Condition category
Condition code
Musculoskeletal 257905 257905 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 257906 257906 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An independent examiner assessed the symptoms that meet the classification criteria of the American Association of Rheumatology(ACR) fibromyalgia (FM) 1990. Then, selected patients answered a questionnaire about quality of life fibromyalgia patients(FIQ), Scale depression (Beck Scale), questionnaire and state anxiety inventory(IDATE), sleep (Sleep Inventory), and a history of adaptation to the aquatic environment. The intervention consisted of 12 sessions, two times a week, individually, lasting 45 minutes each, composed of aquatic therapeutic exercises for stretching, strengthening and relaxation, with emphasis on segments of the lumbar spine. These results suggest that hydrotherapy is an effective treatment of symptoms of anxiety, pain, decrease in tender points, depression, improves sleep and quality of life of patients with mechanical back pain not associated with the symptoms of fibromyalgia.
Administered by the physiotherapist.
Intervention code [1] 256793 0
Rehabilitation
Intervention code [2] 256813 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258799 0
In the first and last session were evaluated the intensity of low back pain and tender points by visual analog scale (VAS), which consists of a line of 10 cm in length, without number, in which there is only an indication of the extreme left "without pain "and the extreme right" unbearable pain. " The higher the score, the greater the intensity of pain.
Timepoint [1] 258799 0
at the end of 12 sessions.
Secondary outcome [1] 264826 0
Quality of Life Questionnaire (QIF), there was a decrease in three patients symptoms of depression, anxiety, stiffness, fatigue, inability to perform activities and number of days of interrupted activity, decrease in the symptom of pain in patients 1 and 2.The three patients remained with the same number of tender points .
Timepoint [1] 264826 0
at the end of 12 sessions.

Eligibility
Key inclusion criteria
All had a diagnosis of low back pain and fulfilled the criteria of the American College of Rheumatology 1990 for fibromyalgia.
Minimum age of 18 years.
Level of understanding (cognitive) to accomplish the tasks.
Signing the free and informed consent approved by the Ethics in Research of the University Center - FIEO (CEP-UNIFIEO).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We excluded patients with contraindications to the pool, such as infectious disease, the participants delivered the medical certificate for physical activity in the heated pool.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3
Accrual to date
Final
Recruitment outside Australia
Country [1] 2759 0
Brazil
State/province [1] 2759 0
SP

Funding & Sponsors
Funding source category [1] 257296 0
University
Name [1] 257296 0
Program of scientific initiation(PIBIC -Unifieo) research support.
Country [1] 257296 0
Brazil
Primary sponsor type
University
Name
Program of scientific initiation(PIBIC -Unifieo) research support.
Address
Avenida Fraz Voegeli, 300 Vila Yara-SP
Cep: 06020-190
Country
Brazil
Secondary sponsor category [1] 256522 0
Individual
Name [1] 256522 0
Rosangela Cristina de Souza
Address [1] 256522 0
Avenida Novo Osasco 1200 casa 04
Jardim Bussocaba
Osasco/SP
CEP:06056000
Country [1] 256522 0
Brazil
Other collaborator category [1] 251388 0
Individual
Name [1] 251388 0
Luciana Akemi Matsutani
Address [1] 251388 0
Avenida Fraz Voegeli, 300 Vila Yara-SP
Cep: 06020-190
Country [1] 251388 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259303 0
Committee for ethics in research UNIFIEO
Ethics committee address [1] 259303 0
Avenida Franz Voegeli,300
Vila Yara- SP.
CEP 06020-190
Ethics committee country [1] 259303 0
Brazil
Date submitted for ethics approval [1] 259303 0
Approval date [1] 259303 0
30/04/2008
Ethics approval number [1] 259303 0

Summary
Brief summary
The aim of this study was to assess the effectiveness of hydrotherapy in the improvement of clinical symptoms, pain, general health and quality of life in patients with low back pain and fulfill the classification criteria of fibromyalgia(FM).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31386 0
Address 31386 0
Country 31386 0
Phone 31386 0
Fax 31386 0
Email 31386 0
Contact person for public queries
Name 14633 0
Rosangela Cristina de Souza
Address 14633 0
Avenida Novo Osasco, 432 casa 04
JD.: Bussocaba- Osasco- SP
CEP: 06056000
Country 14633 0
Brazil
Phone 14633 0
(055)(011)-36553592 or (055) (011)-74244994
Fax 14633 0
Email 14633 0
[email protected]
Contact person for scientific queries
Name 5561 0
Rosangela Cristina de Souza
Address 5561 0
Avenida Novo Osasco, 432 casa 04
JD.: Bussocaba- Osasco- SP
CEP: 06056000
Country 5561 0
Brazil
Phone 5561 0
(055)(011)-36553592 or (055) ( 011)-74244994
Fax 5561 0
Email 5561 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.