Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000792628p
Ethics application status
Not yet submitted
Date submitted
12/07/2023
Date registered
24/07/2023
Date last updated
24/07/2023
Date data sharing statement initially provided
24/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Moves Like Jagger - Acceptability of an in-person 12-week movement program (Motum) in addressing functional outcomes in people with chronic non-specific low back pain
Scientific title
Moves Like Jagger - Acceptability of an in-person 12-week movement program (Motum) in addressing functional outcomes in people with chronic non-specific low back pain; a mixed method pilot study
Secondary ID [1] 310113 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Specific Low Back Pain (NSLBP) 330683 0
Condition category
Condition code
Physical Medicine / Rehabilitation 327500 327500 0 0
Physiotherapy
Musculoskeletal 327547 327547 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design: single group pre-post intervention (N=20) with a sub-sample of qualitative interviews (N=5)

Intervention: The Motum movement program aims to sequentially address mobility, motor control and strength abilities through a 12-week progressive, ground-based program. Concepts are first taught in prone and supine, then four-point kneel, tall kneel and half kneel before continuing to standing postures (e.g. squat and lunge positions). The movements are performed individually focussing on body awareness, technique and control and then strung together as movement flows, to emphasise co-ordination, stability and motor control. Participants will complete one hour of in person class at the clinic for 12 consecutive weeks.

Location: Physio Smart Clinic, 296 Payneham Rd, Payneham, SA, 5070
Who: X2 physiotherapists who have experience in delivering the program (2 years)
Mode: In person classes
Number of times: 12 x 1hr classes (1 per week)
Level of intensity: low-moderate intensity when assessed using Borg RPE
Exercise examples: ROM of the spine/spinal waves, bending/extending of trunk and core, modified/ variations of squats, hops, planks, tibial rotation, shin boxes, kick throughs

Adherence will be monitored by an attendance sheet and participants will be invited to complete the post-intervention questionnaires regardless of number of sessions attended to best capture the acceptability (reasons for non-attendance etc.)

Interviews:
Semi-structured interviews using a questionnaire consisting of the following questions:
• What are your overall thoughts on the program Motum program?
• What part(s) of the program did you like/think went well? Why?
• What part(s) of the program didn’t you like/ think went not well? Why?
• What impact has participating in the program had on you? Positive +/- negative
• Have you had any issues affecting your ability to engage with the program? If yes, what and why?
• Would you suggest any changes to the program? If yes, what and why?

Approximate duration of interviews is expected to be 20minutes, they will be audio-recorded via zoom. Interviews will be conducted by a member of the research team (expected to be Alice Farmer)
Intervention code [1] 326511 0
Rehabilitation
Intervention code [2] 326512 0
Lifestyle
Intervention code [3] 326513 0
Treatment: Other
Comparator / control treatment
None, pre-post study design all participants will receive the intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335363 0
Acceptability of the Motum program as an intervention for those with NSLBP symptoms, measured using the Theoretical Framework of Acceptability Questionnaire (TFAQ)
Timepoint [1] 335363 0
Post intervention delivery (after the delivery of the 12 week program is complete)
Primary outcome [2] 335364 0
Acceptability of the Motum program as an intervention for those with NSLBP symptoms, using the Credibility and Expectancy Questionnaire (CEQ)
Timepoint [2] 335364 0
Pre-intervention delivery (at baseline). Once the participant has read the participant information sheet, expressed interest and been screened for eligibility and successfully entered into the trial they will be sent the pre-intervention questionnaires to complete online at a time of their convenience prior to the commencement of the first class
Secondary outcome [1] 424110 0
Possible clinical outcomes of the Motum program on pain/function of those with NSLBP symptoms using the Oswestry Disability Index (ODI). These will be assess as composite secondary outcomes captured together by the ODI rather than separate outcomes.
Timepoint [1] 424110 0
Pre-intervention (at baseline, prior to commencing first class) and post-intervention (after the delivery of the 12 week program is complete).
Secondary outcome [2] 424111 0
Possible clinical outcomes of the Motum program on the fear of movement of those with NSLBP symptoms using the Tampa Scale of Kinesiophobia (TSK)
Timepoint [2] 424111 0
Pre-intervention (at baseline, prior to commencing first class) and post-intervention (after the delivery of the 12 week program is complete).
Secondary outcome [3] 424112 0
Possible clinical outcomes of the Motum program on the amount of active/sedentary time being spent by those with NSLBP symptoms using Simple Physical Activity Questionnaire (SIMPAQ). This will be assessed as a composite outcome
Timepoint [3] 424112 0
Pre-intervention (at baseline, prior to commencing first class) and post-intervention (after the delivery of the 12 week program is complete).
Secondary outcome [4] 424113 0
Possible clinical outcomes of the Motum program on self efficacy of those with NSLBP symptoms using the Perceive Self Efficacy Questionnaire (PSEQ)
Timepoint [4] 424113 0
Pre-intervention (at baseline, prior to commencing first class) and post-intervention (after the delivery of the 12 week program is complete).
Secondary outcome [5] 424116 0
Possible clinical outcomes of the Motum program on dynamic balance of those with NSLBP symptoms using the Y Balance Test (YBT).
Timepoint [5] 424116 0
Pre-intervention (at baseline, prior to commencing first class) and post-intervention (after the delivery of the 12 week program is complete).

Eligibility
Key inclusion criteria
Inclusion criteria: Able to speak, read and write in English. Able to commit to attending classes at the clinic one a week for 12 weeks. Living with chronic non-specific low back pain (>3 months)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: Pregnancy, recent surgery (previous three months) , inability to get up/down from the floor unassisted as they all impact ability to safely participate in the program. Specific low back pain (confirmed radiculopathy). Red flags indicating possible other pathologies (e.g severe night pain, fever, unexplained weight loss, metastases, etc.). Previous participation in the Motum program as it impairs their ability to judge acceptability.

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)
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
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As the aim of this research is to determine the acceptability of the Motum intervention rather than the efficacy it does not need to be powered. The number of participants (n=20) was decided by the available resources and the constraints (e.g time) of the clinic/researchers.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/08/2023
Actual
Date of last participant enrolment
Anticipated
11/09/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314275 0
University
Name [1] 314275 0
University of South Australia
Country [1] 314275 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
UniSA City East Campus
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 316214 0
Individual
Name [1] 316214 0
Dr. Jacinta Brinsley
Address [1] 316214 0
UniSA City East Campus
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country [1] 316214 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313393 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 313393 0
Ethics committee country [1] 313393 0
Australia
Date submitted for ethics approval [1] 313393 0
25/07/2023
Approval date [1] 313393 0
Ethics approval number [1] 313393 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127990 0
Miss Alice Farmer
Address 127990 0
University of South Australia
City East Campus
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country 127990 0
Australia
Phone 127990 0
+61 468954467
Fax 127990 0
Email 127990 0
[email protected]
Contact person for public queries
Name 127991 0
Alice Farmer
Address 127991 0
University of South Australia
City East Campus
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country 127991 0
Australia
Phone 127991 0
+61 468954467
Fax 127991 0
Email 127991 0
[email protected]
Contact person for scientific queries
Name 127992 0
Alice Farmer
Address 127992 0
University of South Australia
City East Campus
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country 127992 0
Australia
Phone 127992 0
+61 468954467
Fax 127992 0
Email 127992 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
For confidentiality no identifiable/individual data will be included in the report. Only aggregated group data will be analysed and reported in the results.


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
No additional documents have been identified.