Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000142336
Ethics application status
Approved
Date submitted
23/01/2017
Date registered
25/01/2017
Date last updated
12/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the outcomes of two physiotherapy treatment approaches for persistent low back pain.
Scientific title
Comparison of the effects of two physiotherapy treatment approaches on pain intensity and activity limitation for persistent low back pain. A pilot randomised controlled trial.
Secondary ID [1] 290899 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent low back pain 301620 0
Condition category
Condition code
Musculoskeletal 301327 301327 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 301328 301328 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapy treatment A. Participants will receive 1 x 45-minute physiotherapy assessment plus 12 x 30-minute physiotherapy treatment sessions over a 6-month period. All participants will be treated by qualified and registered physiotherapists at one of four private physiotherapy clinics throughout Melbourne, Australia. To protect trial blinding, the nature of the physiotherapy treatment is being withheld from the registry but has been provided privately to ANZCTR staff and will be made publically available at the conclusion of the trial. Treatment fidelity will be monitored by the submission of the physiotherapist's treatment notes to the researchers for every patient.
Intervention code [1] 296846 0
Rehabilitation
Intervention code [2] 296847 0
Treatment: Other
Comparator / control treatment
Physiotherapy treatment B. Participants will receive 1 x 45-minute physiotherapy assessment plus 12 x 30-minute physiotherapy treatment sessions over a 6-month period. All participants will be treated by qualified and registered physiotherapists at one of four private physiotherapy clinics throughout Melbourne, Australia. To protect trial blinding, the nature of the physiotherapy treatment is being withheld from the registry but has been provided privately to ANZCTR staff and will be made publically available at the conclusion of the trial. Treatment fidelity will be monitored by the submission of the physiotherapist's treatment notes to the researchers for every patient.
Control group
Active

Outcomes
Primary outcome [1] 300733 0
Activity limitation: measured with the Oswestry Low Back Pain Disability Index.
Timepoint [1] 300733 0
Measured at baseline, and at 12, 26 and 52 weeks post randomisation
Primary outcome [2] 300734 0
Back pain intensity: measured with a 0-10 Numerical Rating Scale
Timepoint [2] 300734 0
Measured at baseline, and at 12, 26 and 52 weeks post randomisation
Primary outcome [3] 300735 0
Leg pain intensity: measured with a 0-10 Numerical Rating Scale
Timepoint [3] 300735 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [1] 330738 0
Global rating of change: measured on a 7-point Global Rating of Change Scale ranging from “vastly worsened” to “completely recovered”
Timepoint [1] 330738 0
Measured at 12, 26 and 52 weeks post-randomisation
Secondary outcome [2] 330739 0
Treatment satisfaction: measured on a 5-point scale from “very dissatisfied” to “completely satisfied”
Timepoint [2] 330739 0
Measured at 12, 26 and 52 weeks post-randomisation
Secondary outcome [3] 330740 0
Health related quality of life: measured using two tools, 1) EuroQol-5D, and 2) The Assessment of Quality of Life (AQoL-8D). These will also be the "effectiveness" measures for the cost-effectiveness analysis, with the Euro-Qol-5D being the primary measure and the AQoL-8D being the secondary / sensitivity measure).
Timepoint [3] 330740 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [4] 330741 0
Psychosocial distress: measured with the Orebro Musculoskeletal Pain Questionnaire
Timepoint [4] 330741 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [5] 330742 0
Pain self-efficacy: measured using the Pain Self-efficacy Questionnaire
Timepoint [5] 330742 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [6] 330743 0
Depression, anxiety and stress: measured using the Depression Anxiety & Stress Scales (DASS-21). This is a composite questionnaire that allows collation of sub-scales relating to depression, anxiety and stress from the one questionnaire.
Timepoint [6] 330743 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [7] 330744 0
Pain catastrophising: measured with the Pain Catastrophising Scale
Timepoint [7] 330744 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [8] 330745 0
Fear of movement / activity: measured using the Tampa Scale of Kinesiophobia
Timepoint [8] 330745 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [9] 330746 0
Credibility of treatment: measured using a modified treatment credibility / expectations questionnaire.
1) At this point, how logical does the treatment offered to you seem? (0-10 scale)
2) At this point, how successful do you think this treatment will be in helping you with your back problem? (0-10 scale)
3) How confident would you be in recommending this treatment to a friend who experiences similar problems? (0-10 scale)
4) By the end of your treatment, how much improvement in your back condition do you think will occur? (0-100%)
Timepoint [9] 330746 0
Measured after the initial physiotherapy assessment session, and at 12, 26 and 52 weeks post randomisation.
Secondary outcome [10] 330747 0
Central sensitisation: measured with the Central Sensitization Inventory
Timepoint [10] 330747 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [11] 330748 0
Neuropathic pain: measured with the Neuropathic Pain Questionnaire (original full-length English version)
Timepoint [11] 330748 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [12] 330749 0
Adherence will be measured in three ways:
1) .Number of physiotherapy sessions attended.
2) Patient self-report of adherence at each follow-up: "On a scale of 0-10, how adherent have you been to following the advice and exercises recommended by your physiotherapist" (from “not at all” to “fully”)
3) Therapist rating of patient adherence after each session attended: "On a scale of 0-10, how adherent has the patient been to following your advice and exercises since the last session" (from “not at all” to “fully”)

Timepoint [12] 330749 0
1) and 3) assessed after every treatment session and recorded in the physiotherapists treatment notes
2) Assessed on participant questionnaires at 12, 26 and 52 weeks post randomisation
Secondary outcome [13] 330750 0
Work absence: number of work days missed due to low back condition in the last 30 days, measured via a question on follow-up questionnaires ("in the last 30 days, how many days did low back pain or leg pain (sciatica) prevent you from going to work or school"?) These data will also form part of the "cost" data for the cost-effectiveness analysis.
Timepoint [13] 330750 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [14] 330751 0
Medication use: measured via a participant diary over the last 24-hours. These data will also form part of the "cost" data for the cost-effectiveness analysis.
Timepoint [14] 330751 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [15] 330752 0
Healthcare utilisation: recorded via a participant diary where each participant will record the nature and dosage (number of sessions attended, number of injections received etc) of all healthcare received. This will include medical consultations, other healthcare consultations (eg. physiotherapy, chiropractic, massage), medical interventions (eg. injections or surgery) and radiological imaging procedures. These data will also form part of the "cost" data for the cost-effectiveness analysis.
Timepoint [15] 330752 0
Measured at baseline, and at 12, 26 and 52 weeks post-randomisation
Secondary outcome [16] 330753 0
Adverse events: measured via two methods developed for this trial:
1) Participant self-report on follow-up questionnaires (open question: "Have you noticed any adverse, harmful or unpleasant effects that you think may have been due to the
treatment program that you undertook in this trial? If so, please explain".)
2) Treating physiotherapist reporting at each treatment session recorded on clinical notes ("Please record any adverse events reported by the participant since the last treatment session, or during today's treatment session").
Timepoint [16] 330753 0
1) measured at 12, 26 and 52 weeks post randomisation
2) measured at each physiotherapy treatment session
Secondary outcome [17] 330754 0
Baseline clinical assessment information: Obtained via the Subjective Complaints Questionnaire, and the Pain Drawing
Timepoint [17] 330754 0
Assessed at baseline only
Secondary outcome [18] 330755 0
Baseline prognosis: measured using the StartBack screening tool
Timepoint [18] 330755 0
Measured at baseline only
Secondary outcome [19] 331004 0
Success of blinding: Participants will be asked if they know what the two physiotherapy approaches being compared in the trial are, and if so, which approach they received.
Timepoint [19] 331004 0
At 12, 26 and 52 weeks post-randomisation

Eligibility
Key inclusion criteria
i) A primary complaint of either low back pain or back-related leg pain
ii) Duration of current episode of at least 6 months
iii) Aged between 18 and 65 years
iv) Sufficient fluency in English to complete outcome questionnaires
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Red flag pathologies (active cancer, signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging, risk of spinal fracture, signs of potential infection, foot drop that may cause tripping, spondyloarthropathy)
ii) A compensation claim for low back pain
iii) Pregnancy or childbirth within the last 6 months
iv) Spinal injections within the last 6 weeks
v) Any history of lumbar spine surgery, including for insertion of spinal cord stimulators
vi) A pain score of less than 2/10 on a numerical rating scale, or an activity limitation score < 20% (measure with the Oswestry)
vii) Already received physiotherapy treatment for low back pain at one of the involved treatment centres within the last 2 years
viii) A presentation that makes the participant unsuitable for single-discipline physiotherapy treatment (ie. the patient is likely to require complex medical and / or psychological care beyond what physiotherapy can offer):
a. Dependent on >20mg per day of Morphine equivalent Opioid medication over the last month
b. Likely post-traumatic stress disorder, determined by a score of 43 or more on the PTSD Checklist (civilian version: PCL-C)
c. Extremely severe depression, determined by a score of 14 or more on the depression section of the Depression and Anxiety Scales (DASS-21)

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)
Concealed allocation via use of a central allocation service (email access).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted block randomisation sequence (random block sizes), with stratification for treatment location (4 locations), will be prepared by a researcher who will have no contact with any volunteers or participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This will be a pilot trial, with the available funding allowing treatment of 40 participants.

Statistical analysis
Analyses will be conducted on an intention to treat basis, with missing data accounted for using maximum likelihood estimation within repeated measures linear mixed models. A sensitivity analysis will be undertaken using multiple imputation for missing data. Alpha will be set at 0.05 using a two-tailed hypothesis. Between-group treatment effects for continuous data will be derived from the group x time interaction of the linear mixed models. The models will adjust for the baseline score of the outcome of interest, and the stratification variable (treatment location). Ordinal data (relating to some secondary outcome measures) will be analysed using the Mann Whitney U test.

Cost-effectiveness analysis
A within-trial cost-effectiveness analysis will be undertaken from the healthcare perspective, with costs associated with work absence considered separately. Health benefits will be calculated using the EuroQol-5D (primary measure) and the AQoL-8D (secondary / sensitivity measure).. Cost data will be calculated from participant questionnaires (see outcome assessment relating to healthcare utilisation, number of work days missed, and medication consumption).

Differences in incremental health outcomes and incremental costs between the groups will be calculated using linear mixed models. The incremental cost effectiveness ratio (ICER) will then be derived, to indicate the cost to gain one additional quality adjusted life year. Uncertainty will be evaluated using bootstrapping, plotting on a cost-effectiveness plane and a cost-effectiveness acceptability curve

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
6/02/2017
Actual
6/02/2017
Date of last participant enrolment
Anticipated
30/06/2017
Actual
12/10/2017
Date of last data collection
Anticipated
12/10/2018
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15115 0
3046 - Glenroy
Recruitment postcode(s) [2] 15117 0
3021 - St Albans
Recruitment postcode(s) [3] 15118 0
3083 - Bundoora
Recruitment postcode(s) [4] 15144 0
3153 - Bayswater

Funding & Sponsors
Funding source category [1] 295368 0
University
Name [1] 295368 0
La Trobe University
Country [1] 295368 0
Australia
Funding source category [2] 295392 0
Commercial sector/Industry
Name [2] 295392 0
Advance Healthcare
Country [2] 295392 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive
Melbourne, Australia VIC 3086
Country
Australia
Secondary sponsor category [1] 294191 0
None
Name [1] 294191 0
Address [1] 294191 0
Country [1] 294191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296704 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 296704 0
Kingsbury Drive
Melbourne, VIC 3086
Ethics committee country [1] 296704 0
Australia
Date submitted for ethics approval [1] 296704 0
26/09/2016
Approval date [1] 296704 0
04/11/2016
Ethics approval number [1] 296704 0
HEC16-102

Summary
Brief summary
Low back pain that persists for longer than 6 months is an expensive and troublesome problem for individuals and society. In this randomised controlled trial, volunteers with persistent low back or leg pain (> 6 months duration) will all receive 1 x 45-minute physiotherapy assessment plus 12 x 30-minute physiotherapy treatment sessions (over a 6-month period) and complete outcome questionnaires over a 12-month period.

The trial compares two different physiotherapy treatment approaches. Participants will not know what the two treatment approaches are, and they will not know the study hypothesis. Treating physiotherapists will not know what treatment participants in the other group are receiving, Information about the two treatment approaches has therefore been withheld from the registry to maintain blinding, but full details have been uploaded to the registry and will be released at the conclusion of the trial.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 71674 0
Dr Andrew Hahne
Address 71674 0
Discipline of Physiotherapy
School of Allied Health
La Trobe University
Kingsbury Drive
Melbourne VIC 3086
Country 71674 0
Australia
Phone 71674 0
+61 3 9479 3392
Fax 71674 0
Email 71674 0
[email protected]
Contact person for public queries
Name 71675 0
Dr Andrew Hahne
Address 71675 0
Discipline of Physiotherapy
School of Allied Health
La Trobe University
Kingsbury Drive
Melbourne VIC 3086
Country 71675 0
Australia
Phone 71675 0
+61 3 9479 3392
Fax 71675 0
Email 71675 0
[email protected]
Contact person for scientific queries
Name 71676 0
Dr Andrew Hahne
Address 71676 0
Discipline of Physiotherapy
School of Allied Health
La Trobe University
Kingsbury Drive
Melbourne VIC 3086
Country 71676 0
Australia
Phone 71676 0
+61 3 9479 3392
Fax 71676 0
Email 71676 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4040Plain language summaryNo Manuscript in preparation - not yet published

Documents added automatically
No additional documents have been identified.