Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000262606
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Cumberland Low Back Pain Trial
Scientific title
The effect of motor control exercise versus placebo in patients with chronic low back pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific chronic low back pain 349 0
Condition category
Condition code
Alternative and Complementary Medicine 406 406 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to one of 2 groups. Both groups will attend 12 x 1/2 hour sessions of treatment over an 8 week period.
Group 1 will receive a motor control exercise program designed to restore control of the trunk muscles.
Intervention code [1] 267 0
Treatment: Other
Comparator / control treatment
Group 2 will receive a placebo treatment of 20 mins of detuned shortwave diathermy and 5 mins of detuned ultrasound.
Control group
Placebo

Outcomes
Primary outcome [1] 464 0
Average pain intensity over last week (0-10 scale)
Timepoint [1] 464 0
Measured at 2 months
Primary outcome [2] 465 0
Global perceived effect (Global Perceived Effect Scale)
Timepoint [2] 465 0
Measured at 2 months
Primary outcome [3] 466 0
Patient-generated measure of disability (Patient-Specific Functional Scale)
Timepoint [3] 466 0
Measured at 2 months
Primary outcome [4] 467 0
Recurrence
Timepoint [4] 467 0
At 12 months
Secondary outcome [1] 1005 0
(i)Average pain intensity over last week (0-10 scale)
Timepoint [1] 1005 0
Secondary outcome [2] 1006 0
(ii) Global perceived effect (Global Perceived Effect Scale)
Timepoint [2] 1006 0
Measured at baseline, 6 months and 12 months.
Secondary outcome [3] 1007 0
(iii)Patient- generated measure of disability (Patient-Specific Functional Scale)
Timepoint [3] 1007 0
Measured at baseline, 6 months and 12 months.
Secondary outcome [4] 1008 0
(iv) Condition-specific measure of disability (Roland Morris Disability Questionnaire)
Timepoint [4] 1008 0
Measured at baseline, 6 months and 12 months.

Eligibility
Key inclusion criteria
(i)Non-specific low back pain +/- leg pain of at least 3 months duration (ii)Currently seeking care for low back pain (iii) English speaker (iv)Clinical assessment indicates that the subject is suitable for motor control exercise.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i)Suspected or confirmed serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder).(ii)Suspected or confirmed pregnancy(iii)Are unable to speak English(iv)Nerve root compromise (2 of strength, reflex or sensation affected for same nerve root)(v)Spinal surgery in the past 12 months.(vi)Scheduled for major surgery during treatment or follow-up period (vii)Any of the contraindications to exercise listed on page 42 of the ACSM guidelines (ACSM's Guidelines for Exercise Testing and Prescription, 1995).(viii)Any contraindication to pulsed ultrasound or pulsed shortwave.

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)
The allocation sequence will be generated using random number function in Excel, blocking will also be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 455 0
University
Name [1] 455 0
University of Sydney
Country [1] 455 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 371 0
None
Name [1] 371 0
nil
Address [1] 371 0
Country [1] 371 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35484 0
Address 35484 0
Country 35484 0
Phone 35484 0
Fax 35484 0
Email 35484 0
Contact person for public queries
Name 9456 0
Leonardo Oliveira Pena Costa
Address 9456 0
C/- School of Physiotherapy
Faculty of Health Sciences
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 9456 0
Australia
Phone 9456 0
+61 2 93519682
Fax 9456 0
Email 9456 0
[email protected]
Contact person for scientific queries
Name 384 0
Leonardo Oliveira Pena Costa
Address 384 0
C/- School of Physiotherapy
Faculty of Health Sciences
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 384 0
Australia
Phone 384 0
+61 2 93519682
Fax 384 0
Email 384 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.