Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001298202
Ethics application status
Approved
Date submitted
24/07/2018
Date registered
1/08/2018
Date last updated
3/12/2020
Date data sharing statement initially provided
23/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Allied health professional treatments for chronic nonspecific low back pain
Scientific title
Allied health professional treatments for chronic nonspecific low back pain
Secondary ID [1] 288569 0
None
Universal Trial Number (UTN)
U1111-1205-3767
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic nonspecific low back pain 305522 0
Condition category
Condition code
Musculoskeletal 304764 304764 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be fitted with full length prefabricated foot orthoses to wear in their usual shoes for 52 weeks. Participants will be encouraged at baseline to wear the orthoses as often as possible. Additionally, participants will also receive education about their low back pain in the form of the The Back Book. Participants will be instructed to read this booklet at home.

These interventions will be administered to participants once at the beginning of the trial by a qualified podiatrist. Participants will receive these interventions in a clinical setting.

Participants in this group will be given a diary so that they can record how many hours per day, over 12 weeks, they wear the prefabricated orthotic device. Intervention adhere after 12 weeks will not be monitored. At the 12 week follow-up, participants will be asked if they have read The Back Book.
Intervention code [1] 299639 0
Treatment: Devices
Comparator / control treatment
Participants will receive education about their low back pain in the form of the The Back Book. Participants will be instructed to read this booklet at home. At the 12 week follow-up, participants will be asked if they have read The Back Book.
Control group
Placebo

Outcomes
Primary outcome [1] 303988 0
Pain as assessed by a numeric pain rating scale.
Timepoint [1] 303988 0
Baseline, 12 weeks (primary time-point), 26 weeks, and 52 weeks after intervention commencement.
Primary outcome [2] 303989 0
Function as assessed by the Oswestry Disability Index.
Timepoint [2] 303989 0
Baseline, 12 weeks (primary time-point), 26 weeks and 52 weeks after intervention commencement.
Secondary outcome [1] 340658 0
Physical activity level as assessed by the International Physical Activity Questionnaire (short-7).
Timepoint [1] 340658 0
Baseline, 12 weeks, 26 weeks, and 52 weeks after intervention commencement.
Secondary outcome [2] 340659 0
Transversus abdominis muscle thickness as assessed by ultrasound.
Timepoint [2] 340659 0
Baseline and 12 weeks after intervention commencement.
Secondary outcome [3] 340660 0
Gluteus medius muscle activity as assessed by electromyography.
Timepoint [3] 340660 0
Baseline and 12 weeks after intervention commencement.
Secondary outcome [4] 349134 0
Number of hours foot orthotic worn as assessed by a self-reported diary provided at baseline.
Timepoint [4] 349134 0
12 weeks after intervention commencement.
Secondary outcome [5] 349135 0
Self reported adverse events associated with the intervention/s. Examples of known possible adverse events include: pain, discomfort, irritation, blister formation, and redness.
Timepoint [5] 349135 0
At any point from after intervention commencement to the end of the trial period (52 weeks).

Eligibility
Key inclusion criteria
Participants must have a history of chronic nonspecific low back pain (CNLBP) of three months or greater as confirmed by a general practitioner. The CNLBP will need to be located between the ribs and buttock creases to be eligible. Additionally, participants are required to be proficient in English and report a score of 3 or greater for their CNLBP on the Numeric Pain Rating Scale to ensure a minimally clinically important change for this score can be measured.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have non-mechanical low back pain (LBP) (e.g. spinal stenosis, spondylolisthesis, recent fractures, spinal surgery, tumours), specific LBP (e.g. herniated disc) acute or subacute LBP of any type, previous lower back surgery, neurological deficit, inflammatory joint disease, are pregnant or have previous (within the last 12 months) or current use of foot orthotic devices.

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)
Sequentially numbered, sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block random allocation with mixed block lengths of four and six participants randomisation.
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
The sample size for this trial was calculated to find minimal clinically important change of 2 (s=2.5) on the NPRS with 80% power, a 5% Type I error rate and non-adherence rate of 20%. NPRS was chosen for the calculation instead of the Oswestry disability index (ODI) because it had the smaller effect size and thus would require the larger sample size. The calculation adjusted for non-adherence required a total sample size of 30 per group, therefore a total of 60 participants will be recruited.

Statistical analysis will be conducted using the latest version of appropriate statistical software (SPSS or STATA). Analyses involving primary outcomes will be conducted on an intention-to-treat principle using all randomised participants. Missing data will be replaced using multiple imputation. Normality will be assessed using the Shapiro Wilks test. For the primary outcomes of pain and function (NPS and ODI), data will be compared using analysis of covariance (ANCOVA) to investigate the change from baseline to each of the follow-up points. The baseline measure will be the only covariate used in each analysis.

The IPAQ-7 will be used to determine changes in physical activity from baseline for participants using analysis of covariance at each time point (12, 26 and 52 weeks). The correlation between IPAQ score and change in primary outcomes will be investigated and where appropriate (significant correlations identified) a regression analysis performed.

For the secondary outcomes of GMed activity and TrA thickness, ANCOVA will be used to investigate change from baseline following the 12 week intervention for each variable. The baseline measure will be the only covariate used in each analysis.

Where appropriate, Cohen's d will used to calculate effect sizes for both primary and secondary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/08/2018
Actual
11/09/2018
Date of last participant enrolment
Anticipated
15/12/2021
Actual
Date of last data collection
Anticipated
15/12/2022
Actual
Sample size
Target
60
Accrual to date
41
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298014 0
University
Name [1] 298014 0
University of Newcastle
Country [1] 298014 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 297086 0
None
Name [1] 297086 0
Address [1] 297086 0
Country [1] 297086 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299050 0
The University of Newcastle Human Research Ethics Committee [EC00144]
Ethics committee address [1] 299050 0
University Drive, Callaghan, 2308, NSW
Ethics committee country [1] 299050 0
Australia
Date submitted for ethics approval [1] 299050 0
20/10/2017
Approval date [1] 299050 0
29/06/2018
Ethics approval number [1] 299050 0

Summary
Brief summary
Chronic nonspecific low back pain (CNLBP) has a significant impact on the health and well-being of individuals. The number of people with this condition is growing and the physical, mental, and financial costs are continuing to increase.

People with CNLBP are more likely to experience changes to the way muscles in the hip and lower back area function. Foot orthoses have been shown to reduce pain and improve function in people with CNLBP. Additionally, foot orthotic devices have also been shown to alter the timing and intensity of muscle contractions in hip and lower back areas. This may be significant in the treatment of CNLBP as this condition is associated with dysfunction of muscles in these areas.

The primary outcome measures will be change in pain and function from baseline to 12 (primary time point), 26, and 52 weeks. Secondary outcome measures include: gluteus medius muscle activity and transversus abdominis muscle thickness from baseline to 12 weeks, and physical activity over 12, 26, and 52 weeks. Number of hours per day and week that the prefabricated orthoses are worn over 12 weeks, as well as, adverse events over 52 weeks will be self-reported by participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63650 0
A/Prof Vivienne Chuter
Address 63650 0
10 Chittaway Road
University of Newcastle
Ourimbah, NSW 2258
Country 63650 0
Australia
Phone 63650 0
+ 61 2 4349 4424
Fax 63650 0
Email 63650 0
[email protected]
Contact person for public queries
Name 63651 0
Mr Sean Sadler
Address 63651 0
10 Chittaway Road
University of Newcastle
Ourimbah, NSW 2258
Country 63651 0
Australia
Phone 63651 0
+61 2 4349 4655
Fax 63651 0
Email 63651 0
[email protected]
Contact person for scientific queries
Name 63652 0
A/Prof Vivienne Chuter
Address 63652 0
10 Chittaway Road
University of Newcastle
Ourimbah, NSW 2258
Country 63652 0
Australia
Phone 63652 0
+ 61 2 4349 4424
Fax 63652 0
Email 63652 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not necessary


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3330Study protocol1. Sadler S, Spink M, Cassidy S, Chuter V: Prefabricated foot orthoses compared to a placebo intervention for the treatment of chronic nonspecific low back pain: a study protocol for a randomised controlled trial. Journal of foot and ankle research 2018, 11:56.   



Results publications and other study-related documents

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