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Trial registered on ANZCTR


Registration number
ACTRN12619001133123
Ethics application status
Approved
Date submitted
30/07/2019
Date registered
13/08/2019
Date last updated
14/03/2022
Date data sharing statement initially provided
13/08/2019
Date results information initially provided
13/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the relationship between movement, pain, and function in 12 individuals with persistent, disabling low back pain.
Scientific title
Does changing movement matter? Understanding the relationship between changes in movement, pain, activity limitation and psychological factors in persistent low back pain. A replicated single-case series experimental design study.
Secondary ID [1] 297972 0
PG17-004
Universal Trial Number (UTN)
Trial acronym
MVMTLBP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 313851 0
Condition category
Condition code
Musculoskeletal 312249 312249 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 312250 312250 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Functional Therapy (CFT): All participants receive CFT. CFT is best briefly described as an integrated, personalised, behavioural approach to the identification and management of modifiable multidimensional factors underlying a person’s pain and activity limitation. It has foundations in behavioural psychology and neuroscience within physiotherapy practice. CFT comprehensively operationalises and integrates a self-management program, targeting psychological (cognitive and emotional factors), physical (e.g. movement and avoidance) and lifestyle factors (e.g. sleep and stress). The intervention is provided by specially trained physiotherapists with at least 100 hours of experience in this approach. It will be delivered face-to-face in a clinical setting and will address these targets using a tailored behavioural self-management plan depending on which factors are dominant for each individual.
The CFT intervention treatment components consist of:
(1) Cognitive: Education focused on the reconceptualization of pain within a biopsychosocial context related to the person’s story and valued daily life goals. Negative pain beliefs related to radiological imaging are specifically addressed in this process if appropriate and the role of an unhealthy lifestyle on pain and activity limitation are explained.
(2) Functional training: Pain controllability is enhanced through normalization of postures and movements, discouraging pain behaviours, while safely performing feared and/or painful movements and activities in a graduated manner. These newly learned movement behaviours are then incorporated into daily tasks with respect to levels of pain control. The movements and behaviours targeted will be tailored to the specific task the individual with back pain nominates they have most limitations with (based on their answers in the Patient Specific Functional Scale which will be corroborated during the first assessment session). Examples of common movements or behaviours include bending, sitting, lifting, standing and walking.
(3) Lifestyle training: Addressing physical activity levels, ensuring its performance is in a relaxed, confident, and mindful manner while developing skills to enhance stress coping and sleep hygiene.

The treatment dosage for all participants is up to 10 sessions in total over the 12-week intervention. The initial session is 1hr with follow-ups of 30–45 min. Participants are seen weekly for 2-3 sessions and progressed to one session every 2–3 weeks based on clinical course.

Participants are requested to practice the strategies at home (the patient is encouraged to practice the strategies whenever they perform the movement/postural task throughout the day, this is usually on a daily basis however does depend on the patient) and to become increasingly aware of both physical and psychosocial dimensions to their pain, both during and after the intervention period. Adherence to the at-home practice will not formally be monitored.

A 5-week baseline control phase includes the collection of movement, pain, activity limitation and psychological factor data on five occasions (weekly). No intervention will be provided during this phase.
Intervention code [1] 315145 0
Treatment: Other
Intervention code [2] 315146 0
Rehabilitation
Intervention code [3] 315147 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320896 0
Movement:
2 Inertial Measurement Units (IMUs) with tri-axis gyroscopes, accelerometers, and magnetometers. These devices will measure lumbar kinematics during common and nominated tasks that individuals with LBP report as difficult or avoided.
Timepoint [1] 320896 0
On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Primary outcome [2] 320897 0
Activity Limitation
Patient Specific Functional Scale (3-items)
Timepoint [2] 320897 0
As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Primary outcome [3] 320898 0
Pain Intensity

Instrument: Tri-numerical Pain Rating Scale (0-10) (mean of current, average over last week, worst over last week on a 0-10 numerical pain rating scale)
Timepoint [3] 320898 0
As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [1] 373284 0
Kinesiophobia:
2-item (short form) Tampa Scale of Kinesiophobia


Timepoint [1] 373284 0
As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [2] 373285 0
Pain self-efficacy:
2-item Pain Self-efficacy Questionnaire
Timepoint [2] 373285 0
As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [3] 373286 0
Pain catastrophising:
2-item Pain catastrophising questionnaire
Timepoint [3] 373286 0
As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [4] 373287 0
Body Perception:
2 best performing items from Fremantle Back Awareness Questionnaire
Timepoint [4] 373287 0
As per Movement. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [5] 373288 0
Pain controllability
Instrument: 3 brief questions adapted from Jensen and Karoly (1991) J of Consult and Clin Psych
Timepoint [5] 373288 0
Timepoints: As per Movement. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [6] 373289 0
Back pain beliefs:
2-item Back Pain Attitudes Questionnaire
Timepoint [6] 373289 0
As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [7] 373290 0
Pain Interference:
Instrument: Brief Question Adapted from Dionne et al (2008) Spine
Timepoint [7] 373290 0
Timepoints: As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [8] 373291 0
Pain Bothersomeness:
Instrument: Brief Question Adapted from Dunn and Croft (2005) Spine
Timepoint [8] 373291 0
Timepoints: As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [9] 373292 0
Trust:
Instrument: Brief Question: “How much do you trust your back”
Timepoint [9] 373292 0
Timepoints: As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [10] 373293 0
Control over movement:
Instrument: Brief Questions: “How much do you have control over the movement/position of your back” and “controlling the movement/position of my back gives me control over my pain“
Timepoint [10] 373293 0
Timepoints: As per movement assessment. On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [11] 373771 0
*This is a primary outcome*
Movement (lumbar muscle activity).
Two wearable surface electromyography units will measure lumbar (paraspinal) muscle activity) during common and nominated tasks that individuals with LBP report as difficult or avoided.
Timepoint [11] 373771 0
*This is a primary outcome*
On 20 occasions over the 22-week study period (weekly during the 5-week baseline phase, on 10 occasions during the 12-week intervention phase, and weekly during the 5-week follow-up phase. Additionally, on one occasion at the nine-month long-term follow-up timepoint.
Secondary outcome [12] 373772 0
*This is a primary outcome*
Activity Limitation:
Roland Morris Disability Questionnaire (23-item)
Timepoint [12] 373772 0
*This is a primary outcome*
Twice during the baseline phase (week 1 and 5) and once at the end of the intervention phase (week 17)
Secondary outcome [13] 373773 0
Kinesiophobia:
Full Tampa Scale of Kinesiophobia
Timepoint [13] 373773 0
Twice during the baseline phase (week 1 and 5) and once at the end of the intervention phase (week 17)
Secondary outcome [14] 373774 0
Pain self-efficacy:
Full Pain self-efficacy questionnaire
Timepoint [14] 373774 0
Twice during the baseline phase (week 1 and 5) and once at the end of the intervention phase (week 17)
Secondary outcome [15] 373775 0
Pain catastrophising:
Full Pain catastrophising scale
Timepoint [15] 373775 0
Twice during the baseline phase (week 1 and 5) and once at the end of the intervention phase (week 17)
Secondary outcome [16] 373776 0
Body Perception:
Full Fremantle Back Awareness Questionnaire
Timepoint [16] 373776 0
Twice during the baseline phase (week 1 and 5) and once at the end of the intervention phase (week 17)
Secondary outcome [17] 373777 0
Back pain beliefs:
Full Back Pain Attitudes Questionnaire
Timepoint [17] 373777 0
Twice during the baseline phase (week 1 and 5) and once at the end of the intervention phase (week 17)

Eligibility
Key inclusion criteria
Primary complaint is persistent disabling low back pain; dominant activity limitations being any of bending (such as picking up objects from the floor, bending while gardening), sustained sitting or standing postures (such as driving, watching television or standing) and/or sit-to-stand (such as rising from chair/bed or getting out of a car) as these were the most commonly reported in a sample of 39 patients with non-specific persistent disabling low back pain (unpublished data); Body Mass Index less than or equal to 30kg/m2 (to limit validity concerns about surface-based measures in overweight and obese individuals).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-disabling low back pain (mean baseline patient specific functional scale score <3/10 for two consecutive weeks), and a planned leave of absence greater than two consecutive weeks throughout the 22-week study period (due to the intensive and frequent measurements required for analysis).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Participants will act as their own control. This will be achieved by collecting 5 consecutive weeks of measures to form a baseline before the intervention phase.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In addition to conventional interpretation of single-case data using visual inspection of graphed data for each variable and potential associations within and across phases, Simulation Modeling Analysis (SMA Version 8.3.3, Borckardt 2008, Am Psychol) will be used to estimate and statistically compare cross-lag correlations between serial measures of movement and measures pain, activity limitation and psychological factors.
Transcribed audio data from interviews exploring the participants' perceptions and beliefs of the relationship between movement and low back pain will be analysed using an inductive analytic approach described by Thorne et al (2004) Int J Qual Methods. It involves five steps: 1) open coding, 2) intra-subject analysis: salient coding, 3) inter-subject analysis: search for patterns between participants, 4) identification of emerging themes and 5) interpretive description of findings.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/02/2018
Date of last participant enrolment
Anticipated
Actual
18/07/2019
Date of last data collection
Anticipated
8/09/2019
Actual
12/10/2019
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302496 0
Charities/Societies/Foundations
Name [1] 302496 0
Physiotherapy Research Foundation
Country [1] 302496 0
Australia
Primary sponsor type
Individual
Name
Kevin Wernli
Address
School of Physiotherapy and Exercise Science, Kent Street, Bentley Western Australia. GPO Box U1987, Perth WA 6845
Country
Australia
Secondary sponsor category [1] 303476 0
None
Name [1] 303476 0
Address [1] 303476 0
Country [1] 303476 0
Other collaborator category [1] 280884 0
Commercial sector/Industry
Name [1] 280884 0
Body Logic Physiotherapy
Address [1] 280884 0
Body Logic Physiotherapy
215 Nicholson Road
Shenton Park, 6008
Western Australia

*Body Logic Physiotherapy has agreed to allow the chief researcher, Kevin Wernli, to use the clinic facilities to collect data free of charge.
Country [1] 280884 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303152 0
Curtin University’s Human Research Ethics Committee
Ethics committee address [1] 303152 0
Office of Research and Development, GPO Bx U1987, Perth Western Australia 6845
Ethics committee country [1] 303152 0
Australia
Date submitted for ethics approval [1] 303152 0
Approval date [1] 303152 0
05/10/2017
Ethics approval number [1] 303152 0
HRE2017-0706

Summary
Brief summary
Low back pain is the leading cause of disability worldwide. Most current treatments are only moderately effective at improving this condition and optimal ways to target factors linked to persistent low back pain are poorly understood. Despite the widespread belief of a relationship between movement, posture and low back pain, evidence of this relationship, and the influence of psychological factors on this relationship is sparse. This study aims to investigate this in 12 people with persistent, disabling low back pain using wearable motion sensors over a 22-week study period (5-week baseline, 12-week intervention, and 5-week follow-up). This will lead to a greater understanding of the factors related to an improvement in low back pain, leading to the generation of hypotheses and the refinement of approaches in the management of this burdensome condition.
Trial website
Trial related presentations / publications
Public notes
Recruitment materials:
30 second recruitment video:
https://www.facebook.com/KWernliPhysio/videos/141207989891670/

3-minute detailed recruitment video:
https://www.facebook.com/KWernliPhysio/videos/141215916557544/

Contacts
Principal investigator
Name 92658 0
Mr Kevin Wernli
Address 92658 0
School of Physiotherapy and Exercise Science
Curtin University, Kent Street, Bentley, 6102
Western Australia
Country 92658 0
Australia
Phone 92658 0
+61892664644
Fax 92658 0
Email 92658 0
kevin.wernli@postgrad.curtin.edu.au
Contact person for public queries
Name 92659 0
Kevin Wernli
Address 92659 0
School of Physiotherapy and Exercise Science
Curtin University, Kent Street, Bentley, 6102
Western Australia
Country 92659 0
Australia
Phone 92659 0
+61892664644
Fax 92659 0
Email 92659 0
kevin.wernli@postgrad.curtin.edu.au
Contact person for scientific queries
Name 92660 0
Kevin Wernli
Address 92660 0
School of Physiotherapy and Exercise Science
Curtin University, Kent Street, Bentley, 6102
Western Australia
Country 92660 0
Australia
Phone 92660 0
+61892664644
Fax 92660 0
Email 92660 0
kevin.wernli@postgrad.curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data underlying published results only.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Case-by-case basis at the discretion of the research team
Available for what types of analyses?
For any scientific purpose that meets the research team’s approval
How or where can data be obtained?
Access subject to approvals by the research team. There will be a requirement to sign a data access agreement.

The research team can be contacted via:
Kevin Wernli
School of Physiotherapy and Exercise Science
Curtin University, Kent Street, Bentley, 6102
Western Australia, Australia.

Email: kevin.wernli@postgrad.curtin.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFrom protection to non-protection: A mixed methods study investigating movement, posture and recovery from disabling low back pain.2022https://dx.doi.org/10.1002/ejp.2022
N.B. These documents automatically identified may not have been verified by the study sponsor.