Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000084280
Ethics application status
Approved
Date submitted
17/01/2009
Date registered
6/02/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to investigate the effect of body positioning treatment on lower back pain.
Scientific title
A randomised, controlled clinical trial of the effects of passive body positioning treatment for low back pain
Secondary ID [1] 252988 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 4211 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4427 4427 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This group is to receive both the passive positioning intervention and the prescription of home exercises intervention. The passive positioning intervention is to be provided twice a week for two consecutive weeks. Following each passive positioning treatment intervention, supervision of prescribed home exercises is to be undertaken. Additionally, participants are to be instructed to perform the home exercises independently twice per day in a pain-free range.

For the passive-positioning treatment intervention, a digitally tender point (DTP) is to be treated by passively positioning the participant (that is, the participant does not assist the investigator in positioning the participants body) such that there is a two-thirds reduction in tenderness at the DTP (Jones, Kusunose et al. 1995). Kusunose (Kusunose 1993). Participants are to be asked to consider that their initial DTP tenderness is ‘10’ on a verbal analogue scale where ‘0’ is no tenderness. Appropriate passive positioning is to be assumed to have been reached when the participant rates tenderness at ‘3’ or less on the scale with intermittent probing at the DTP. In addition to reported tenderness with intermittent probing, perceived tissue tension is to be used to guide the experimenter to the appropriate passive position. The participant is to be passively maintained at this point by the experimenter for 90 seconds before being slowly and passively returned to a neutral position (Kusunose 1993) (Jones, Kusunose et al. 1995). A DTP is to be considered successfully treated if a reduction of greater than 70% tenderness is achieved (Kusunose 1993). Experimentally, this is to be determined by asking the participant to again rate their tenderness at the DTP, following passive positioning, with reference to the verbal analogue scale. If tenderness is rated at ‘3’ or less then the DTP is to be considered successfully treated.

For the home exercise prescription intervention, exercises are to include:
1) Side-lying abdominal bracing (activation of deep abdominal stabilisers).
2) Supine (on back) alternate knee to chest holds.
3) Supine lumbar rotation (keeping knees together while rolling them side to side).
Intervention code [1] 3926 0
Rehabilitation
Intervention code [2] 4000 0
Other interventions
Comparator / control treatment
The control group is to receive only the prescription of home exercises intervention.
Home exercises are to be supervised by the investigator twice a week for two consecutive weeks for this group. Additionally, participants are to be instructed to perform home exercises independently twice per day in a pain free range.

Home exercises are to be the same as those performed by the passive positioning intervention group. That is, they are to comprise three exercises:
1) Side-lying abdominal bracing (activation of deep abdominal stabilisers).
2) Supine (on back) alternate knee to chest holds.
3) Supine lumbar rotation (keeping knees together while rolling them side to side).
Control group
Active

Outcomes
Primary outcome [1] 5309 0
The 'Modified Oswestry Low Back Pain Disability Questionnaire' (Fritz and Irrgang, 2001) is to be used to generate the 'Oswestry Disability Index' - an index for dysfunction and disability due to low back pain.
Timepoint [1] 5309 0
2 weeks, 1 month, 6 months
Secondary outcome [1] 8929 0
Visual analogue scale (Pain)
Timepoint [1] 8929 0
2 weeks, 1 month, 6 months

Eligibility
Key inclusion criteria
(1) Currently suffering from acute (symptoms for less than 3 months) low back pain (International Association for the Study of Pain definition: either initial episode or acute exacerbation).
or surgery in the spine.

(2) Willing to sign an informed consent form
(3) Able to lie supine and prone.
(4) Possessing four or more digitally tender points at prescribed sites in the low back and buttock
regions and/or the anterior pelvic and abdominal regions.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) History of spinal fractures
(2) Diagnosed with an inflammatory disorder
(3) Diagnosed with fibromyalgia
(4) Suffering from signs of lumbar radiculopathy
(5) Of Aboriginal or Torres Strait Islander ancestry

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)
Participants are to contact the physiotherapy departments of one of two public hospitals for treatment of their low back pain. After initial assessment and confirmation that they meet inclusion criteria, they are to be invited to participate in the study. After reading participant information forms and signing informed consent forms they are to select an envelope in which their group allocation is concealed. Assignment to either the treatment or control group is to remain concealed from the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Envelopes containing indication of group assignment are to be shuffled and the participant is to be able to select any envelope from a packet of 50.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
89
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1383 0
4380
Recruitment postcode(s) [2] 1384 0
4370

Funding & Sponsors
Funding source category [1] 4393 0
Self funded/Unfunded
Name [1] 4393 0
Cynan Lewis
Country [1] 4393 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
Queensland 4067
Country
Australia
Secondary sponsor category [1] 3952 0
Hospital
Name [1] 3952 0
Stanthorpe Health Services
Address [1] 3952 0
8 McGregor Tce
Stanthorpe
Queensland 4380
Country [1] 3952 0
Australia
Other collaborator category [1] 533 0
Individual
Name [1] 533 0
Alexandra Newcombe
Address [1] 533 0
57 Locke St
Warwick
Queensland 4370
Country [1] 533 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6441 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 6441 0
Ethics committee country [1] 6441 0
Australia
Date submitted for ethics approval [1] 6441 0
Approval date [1] 6441 0
Ethics approval number [1] 6441 0

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

Contacts
Principal investigator
Name 35099 0
Address 35099 0
Country 35099 0
Phone 35099 0
Fax 35099 0
Email 35099 0
Contact person for public queries
Name 12446 0
Cynan Lewis
Address 12446 0
PO Box 630
Stanthorpe
Queensland 4380
Country 12446 0
Australia
Phone 12446 0
+61 7 46815250
Fax 12446 0
Email 12446 0
[email protected]
Contact person for scientific queries
Name 3374 0
Cynan Lewis
Address 3374 0
PO Box 630
Stanthorpe
Queensland 4380
Country 3374 0
Australia
Phone 3374 0
+61 7 46815250
Fax 3374 0
Email 3374 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
SourceTitleYear of PublicationDOI
EmbaseStrain-Counterstrain therapy combined with exercise is not more effective than exercise alone on pain and disability in people with acute low back pain: a randomised trial.2011https://dx.doi.org/10.1016/S1836-9553%2811%2970019-4
N.B. These documents automatically identified may not have been verified by the study sponsor.