ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Low back pain

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

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]

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]

2 weeks, 1 month, 6 months

Secondary outcome [1]

Visual analogue scale (Pain)

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

4380

Recruitment postcode(s) [2]

4370

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Cynan Lewis

Address [1]

PO Box 630
Stanthorpe

Queensland 4380

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

St Lucia
Queensland 4067

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Stanthorpe Health Services

Address [1]

8 McGregor Tce
Stanthorpe
Queensland 4380

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Alexandra Newcombe

Address [1]

57 Locke St
Warwick
Queensland 4370

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Medical Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Physiotherapists sometimes use passive positioning of the body (positioning of the patient’s body by the physiotherapist without the patient helping) to treat for pain and loss of movement.  When using such a passive positioning technique, Strain-Counterstrain, digitally tender points are used for assessment and treatment (Jones, Kusunose et al. 1995).  This technique has not been researched and so there is little support for its continued use.  The aim of this study is to examine the effect of passive body positioning treatment for low back pain in a clinical population. Subjects are to be randomly assigned to either a treatment group or a control group.  The treatment group are to receive passive-positioning treatment (Strain-Counterstrain) in addition to exercise instruction while the control group is to receive only exercise instruction.  Interventions are to be provided twice in a week for two weeks.  Treatment and control interventions are to be provided within half an hour on each occasion.  To find digitally tender points and assess these  during treatment interventions,  it will be necessary for the experimenter to press gently with thumb or forefinger at sites in the lower back, loin, buttock, abdominal, anterior pelvic and pubic areas (Jones, Kusunose et al. 1995) (Kusunose and Wendorff 1990).  Subjects may be required to lie on their back or stomach for up to 15 minutes at a time.  In this study there is little or no risk of injury if subjects have met the selection criteria for entry into the study.  Subjects in the treatment group may experience some temporary discomfort at digitally tender point sites that are pressed during assessment and intervention.  Approximately a third of clients have been found to experience a muscle-ache type of discomfort in the day following passive body positioning.  Subjects may experience a reduction in low back pain as a result of participating in this study.  The study may provide evidence for the effectiveness of passive positioning treatment for low back pain.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Cynan Lewis

Address

PO Box 630
Stanthorpe
Queensland 4380

Country

Australia

Phone

+61 7 46815250

Fax

Cynan_Lewis@health.qld.gov.au

Contact person for scientific queries

Name

Cynan Lewis

Address

PO Box 630
Stanthorpe
Queensland 4380

Country

Australia

Phone

+61 7 46815250

Fax

Cynan_Lewis@health.qld.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Strain-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.	2011	https://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.

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Documents added manually

Documents added automatically