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Trial registered on ANZCTR


Registration number
ACTRN12608000524392
Ethics application status
Approved
Date submitted
16/09/2008
Date registered
15/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise prescription for people with non-specific chronic low back pain
Scientific title
Effects of preferred-exercise prescription compared to usual exercise prescription on function, pain and quality of life for people with non-specific low back pain: a randomized controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific Chronic Low Back Pain 3704 0
Condition category
Condition code
Musculoskeletal 3856 3856 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 3863 3863 0 0
Physiotherapy
Musculoskeletal 3869 3869 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be a randomised controlled trial with the intervention strengthening and conditioning programs (progressive resisted exercises for upper and lower limb, abdomen and trunk), per usual clinician practice, being informed by a participant preferences questionnaire. The questionnaire is a one-off assessment and takes less than 5 minutes to complete. The population group are those with non-specific chronic low back pain. There will be two 1 hour sessions per week for 6 weeks.

A 2.5 hour qualitative focus group study of exercise instructor feedback about the exercise preferences instrument will be embedded in the research design. Two 2.5 hour qualitative focus group studies will also be conducted for participants in the intervention and the control groups. It will obtain feedback about participants’ experiences of the two types of exercise programs. The focus groups will be conducted after completion of the randomised controlled trial. The qualitative research is not a measure of outcome but of experience.
Intervention code [1] 3405 0
Treatment: Other
Intervention code [2] 3476 0
Rehabilitation
Comparator / control treatment
The control goup will be strengthening and conditioning exercise programs without the use of, and input from, an exercise preferences questionnaire
Control group
Active

Outcomes
Primary outcome [1] 4772 0
Function (Oswestry Disabilioty Index)
Timepoint [1] 4772 0
6, 12, 26, 52 weeks
Secondary outcome [1] 8062 0
Pain (Tagged Numeric Pain Scale)
Timepoint [1] 8062 0
6, 12, 26, 52 weeks

Eligibility
Key inclusion criteria
Participants will be adults aged 18 years or older with a history of pain in the area from the lower thoracic spine extending to the gluteal folds +/- radiation to the lower extremities. Participants have had a LBP episode of at least 8 weeks prior to entering the exercise program and an exercise program for back pain is planned.
Participants must be able to speak, read and write English
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They will be excluded if they are pregnant or have any of the following: cardiovascular disease, diabetes, inflammatory disease, tumour, fracture, spinal nerve root compression, spinal cord irritation or cauda equine signs or osteoporosis.

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)
Clinics and clinicians
Melbourne metropolitan primary health care clinics that provide exercise programs for rehabilitation of musculoskeletal conditions. The contact details used will be those publicly available in the telephone directory or online at professional association websites. The clinics will be approached by telephone or email/mail advertisement seeking expressions of interest in research participation. This advertisement will contain a summary of the research project and will ask interested clinics to contact the researcher for more information. After receipt of signed Clinic Consent an in-service/ information session will be scheduled to inform clinicians of the research background and aims. They will be given an Explanatory Statement to read and keep and a Consent Form to sign and return to the researcher if they wish to participate.
Patients
The opportunity for patients seeking back pain therapy to participate will be offered to every eligible consecutive patient in order of contact until adequate numbers of participants are achieved. Clinic reception staff, who are not aware of the research protocol or aims, will ask or advise all consecutive new patients who have non-specific chronic low back pain (NSCLBP) and are attending the clinic for exercise prescription. If patients are interested, the reception staff will give them the Explanatory Statement to read and keep and a Consent Form that they will sign and return to the receptionist. Following patient completion of the Consent Form the participants will then complete the set of outcome measures and questionnaires contained in consecutively numbered folders, put these in the accompanying envelopes and return them sealed to the receptionist. All completed forms, except the exercise preferences questionnaire, will be put into an envelope and returned to the researcher. The completed exercise preferences questionnaire will be put in a sealed envelope, marked EQ, addressed to the researcher and forwarded to the treating clinician. The envelope will only be opened by the clinicians allocated to the questionnaire group and those clinicians allocated to the control group will put this sealed envelope into a sealed box with a slit in the top for collection by the researcher. Reception staff and patients will not know to which exercise prescription group (with or without an exercise preference questionnaire) participants have been allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clinicians who have consented to participate will be randomly allocated, by computer-generated codes in sealed opaque envelopes, to one of two groups with stratification to allow equal representation of qualifications. These codes will be generated by an independent Monash staff member who is not part of the research project (Code: exercise questionnaire group (EQ); no exercise questionnaire group(NQ)). Group EQ will open the EQ envelope, keep the completed exercise preferences questionnaire and use it to inform their exercise prescription.
Group NQ clinicians will not open the EQ envelope and therefore will not receive the completed exercise preferences questionnaire. They will put the sealed EQ envelope in the sealed labeled box, via a slit in the top, for collection by the researcher. These clinicians will prescribe the exercise program as is their usual practice.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The two groups of clinicians have already agreed in their consent forms not to disclose their group allocation. They will be reminded not communicate to which group they have been allocated or any details or findings of the questionnaire.
To maintain patient blinding, the plain language statement and consent procedures will inform participants that they have an equal chance of receiving one of two valid exercise prescription methods. A blinded examiner will perform all outcome assessments. Participants will also be asked to refrain from discussing their treatment with the outcome assessor. Intention To Treat (ITT) analysis will be conducted, last data point moved forward.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3882 0
Self funded/Unfunded
Name [1] 3882 0
Country [1] 3882 0
Primary sponsor type
University
Name
Monash University
Address
School of Primary Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University - Peninsula Campus
PO Box 527 Frankston, Victoria, 3199
Country
Australia
Secondary sponsor category [1] 3486 0
Government body
Name [1] 3486 0
National Health & Medical Research Council (NHMRC)
Address [1] 3486 0
GPO Box 1421
Canberra, ACT 2601
Country [1] 3486 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5927 0
Standing Committee on Ethics in Research Involving Humans
Ethics committee address [1] 5927 0
Australia
Building 3E, Room 111, Clayton Campus, Wellington Road, Monash University, Vic 3800,
Ethics committee country [1] 5927 0
Australia
Date submitted for ethics approval [1] 5927 0
Approval date [1] 5927 0
08/09/2008
Ethics approval number [1] 5927 0
CF08/2015 - 2008000990

Summary
Brief summary
Research hypotheses:
People with chronic low back pain are likely to prefer and participate in exercise programs that are designed with consideration of their preferences, circumstances and past experiences.

Research Aims:
1. The primary aim of this study is to test the effect of a mechanism for systematically recruiting information about patient exercise program preferences using a questionnaire developed from previous focus group research on exercise adherence and health outcomes compared to designing an exercise program without the assistance of the questionnaire

2. The secondary aims are to obtain feedback from clinicians who have utilized the instrument to assist with instrument refinement.

Research Questions:
1. Does participant-informed exercise design improve program engagement and adherence?

2. Does participant informed exercise design improve health outcomes of exercise programs for chronic low back pain and other musculoskeletal conditions?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28933 0
Address 28933 0
Country 28933 0
Phone 28933 0
Fax 28933 0
Email 28933 0
Contact person for public queries
Name 12090 0
Susan Slade
Address 12090 0
School of Primary Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University - Peninsula Campus
PO Box 527 Frankston, Victoria, 3199
Country 12090 0
Australia
Phone 12090 0
0418 598 595
Fax 12090 0
Email 12090 0
[email protected]
Contact person for scientific queries
Name 3018 0
Professor Jenny Keating
Address 3018 0
School of Primary Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University - Peninsula Campus
PO Box 527 Frankston, Victoria, 3199
Country 3018 0
Australia
Phone 3018 0
61 3 9904 4816
Fax 3018 0
Email 3018 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
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