Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000435088
Ethics application status
Approved
Date submitted
8/05/2010
Date registered
28/05/2010
Date last updated
28/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Mckenzie and Back School’s techniques in patients with chronic low back pain: A randomized controlled trial
Scientific title
The Effect of Mckenzie and Back School’s techniques on the lumbar flexion range of motion, quality of life and pain intensity in patients with chronic low back pain: A randomized controlled trial
Secondary ID [1] 251705 0
not applicable
Universal Trial Number (UTN)
U1111-1114-9515
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 257312 0
Condition category
Condition code
Musculoskeletal 257456 257456 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
McKenzie Group

Physical therapists were instructed to follow exclusively the treatment principles described in McKenzie's textbooks and not to use other treatment modalities. After testing the participants' pain response to a comprehensive physical examination, therapists will classify each patient into one of the three McKenzie syndromes (derangement, dysfunction, or postural) and an individualized treatment programme matching this classification will be then provided.

Patients will receive an individualised treatment for 30 minutes a day, once a week over four weeks.
Intervention code [1] 256435 0
Treatment: Other
Comparator / control treatment
Back school classes

Patients will receive interactive group classes (the sizes of the gropus will not exceed 4 patients) aimed to improve posture, avoid bed rest and increase activity. These classes will be administered by a trained physiotherapist.

Patients will receive an individualised back school class (30minutes duration) , once a week over four weeks.
Control group
Active

Outcomes
Primary outcome [1] 258377 0
Pain intensity Measured by the Pain Numerical Rating Scale
Timepoint [1] 258377 0
baseline, 4 weeks, 3 months and 6 months
Primary outcome [2] 258378 0
Disability measured by the Roland-Morris disability questionnaire
Timepoint [2] 258378 0
baseline, 4 weeks, 3 months and 6 months
Secondary outcome [1] 264111 0
Quality of life measured by the World Health Organization Quality of Life Questionnaire (WHOQOL-Brief)
Timepoint [1] 264111 0
baseline, 4 weeks, 3 months and 6 months
Secondary outcome [2] 264112 0
Lumbar range of motion (flexion only) measured by fleximeter
Timepoint [2] 264112 0
baseline and 4 weeks

Eligibility
Key inclusion criteria
Low back pain longer than 3 months
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy, contra-indications to exercise, serious spinal pathology

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation schedule generated by computer (Excel for Windows)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
148
Accrual to date
Final
Recruitment outside Australia
Country [1] 2618 0
Brazil
State/province [1] 2618 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 256925 0
Self funded/Unfunded
Name [1] 256925 0
Country [1] 256925 0
Brazil
Primary sponsor type
Individual
Name
Leonardo Costa
Address
Masters in Physical Therapy Program - Universidade Cidade de Sao Paulo (UNICID) Brazil
Rua Cesario Galeno 448 Tatuape Sao Paulo CEP 03071-000
Country
Brazil
Secondary sponsor category [1] 256192 0
University
Name [1] 256192 0
UNICID University City of Sao Paulo
Address [1] 256192 0
Rua Cesario Galeno 448 Tatuape Sao Paulo 03071-000
Country [1] 256192 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258931 0
Comite de etica em pesquisa (CEP) UNICID
Ethics committee address [1] 258931 0
Rua Cesario Galeno 448 Tatuape Sao Paulo 03071-000
Ethics committee country [1] 258931 0
Brazil
Date submitted for ethics approval [1] 258931 0
Approval date [1] 258931 0
09/02/2010
Ethics approval number [1] 258931 0
13469394

Summary
Brief summary
The primary purpose of the study is to compare the effectiveness of two physiotherapy interventions (Mckenzie exercises and Back School) in patients with chronic non-specific low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31135 0
Address 31135 0
Country 31135 0
Phone 31135 0
Fax 31135 0
Email 31135 0
Contact person for public queries
Name 14382 0
Alessandra Narciso Garcia
Address 14382 0
Av Dr Assis Ribeiro 2950, Engenheiro Goulart, Sao Paulo CEP 03717-001
Country 14382 0
Brazil
Phone 14382 0
+55 11 72828289
Fax 14382 0
Email 14382 0
alessandrag_narciso@yahoo.com.br
Contact person for scientific queries
Name 5310 0
Leonardo Costa
Address 5310 0
Rua da Contagem 55 apartment 81 Vila da Saude, Sao Paulo CEP 04146-100
Country 5310 0
Brazil
Phone 5310 0
+551181831550
Fax 5310 0
Email 5310 0
lcosta@edu.unicid.br

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.