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Trial registered on ANZCTR
Registration number
ACTRN12624000807550
Ethics application status
Approved
Date submitted
14/06/2024
Date registered
29/06/2024
Date last updated
29/06/2024
Date data sharing statement initially provided
29/06/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Movement Treatment Following Rhizolysis
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Scientific title
Does a movement-based self-management program improve outcomes for people with chronic low back pain following their lumbar facet procedures? A pilot randomised controlled trial
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Secondary ID [1]
312275
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic back pain
333995
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Facet joint rhizolysis
334176
0
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Condition category
Condition code
Public Health
330665
330665
0
0
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Health service research
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Public Health
330666
330666
0
0
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Health promotion/education
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Physical Medicine / Rehabilitation
330843
330843
0
0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants who are randomly allocated to the Movement is Medicine (MiM) intervention treatment will be booked to attend one of four groups of the 6-week treatment program (n~8 participants per group). The maximum total sample size is n=32 for this intervention. The four groups will run consecutively over a period of 8 months, with approximately 2 weeks' break between each group. The treatment participation will commence from 2 weeks and up to 12 weeks post-rhizolysis. The intervention will comprise 6 x 3hr small-group sessions (held once weekly), conducted face-to-face in a group room at Flinders Medical Centre Pain Unit clinic.
The intervention will include pain science education regarding movement and graded exercise, activity pacing, managing flare-ups, and guided demonstrations around breathing/relaxation, and low-intensity exercise (e.g. stretching, muscle relaxation, yoga), with exercise-based homework in-between sessions.
In the first and last sessions, participants will complete several simple tests of functional ability (including standing and walking speed, and functional reach), closely supervised by the physiotherapist facilitator, taking 5 minutes maximum. Participants in the intervention treatment receive a treatment manual with all study materials, space to record individualised treatment plans, and weekly homework tasks and progress review.
Two facilitators will be present at each intervention session to ensure participants remain engaged. Each facilitator will lead different sections of the session to maximize individual participant interaction. The primary facilitator is a registered physiotherapist, while the co-facilitator is a registered nurse. Facilitators record session attendance, and participants who do not attend are contacted by phone to determine the reason for their absence.
At commencement and completion of the treatment group, group facilitators will send courtesy letters to participants’ referring GP, as well as an email to the Pain Unit doctor who referred them to the research project, as a duty of care, and to provide continuity of care (done with participants’ explicit consent).
Immediately following completion of the intervention (MiM) program, participants will be made aware that they will be contacted again in three months for a check-in and follow-up.
Intervention participants are reimbursed up to $120 (depending on their session attendance).
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Intervention code [1]
328741
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Treatment: Other
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Intervention code [2]
328881
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Rehabilitation
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Comparator / control treatment
Participants who are randomly allocated to the control condition will only participate in 'treatment as usual', i.e., having their rhizolysis procedure and attending their usual healthcare appointments and treatments both in the Pain Management Unit (differing by patient, but mostly involving medical reviews) and elsewhere. The maximum total sample size is n=32 for the control condition.
Control participants are informed that they are able to ask their Pain Unit doctor to refer them to the Movement is Medicine program (run within normal Pain Unit clinical practice, and not as research) after their study completion is finished, if they are still interested in taking part.
Control participants are reimbursed $50.
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Control group
Active
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Outcomes
Primary outcome [1]
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Physical function (completed by the intervention group only)
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Assessment method [1]
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Functional assessment tests (including Sit to Stand; Functional Reach; Timed Up and Go)
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Timepoint [1]
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During the first Movement is Medicine treatment session (session 1); and during the last Movement is Medicine treatment session (session 6)
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Primary outcome [2]
338423
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Fear of movement
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Assessment method [2]
338423
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The Tampa Scale of Kinesiophobia (TSK)
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Timepoint [2]
338423
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This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
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Primary outcome [3]
338424
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Lower back pain
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Assessment method [3]
338424
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Oswestry Lower Back Pain Disability Questionnaire
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Timepoint [3]
338424
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This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
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Secondary outcome [1]
435874
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Pain Severity
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Assessment method [1]
435874
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The Brief Pain Inventory (BPI)
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Timepoint [1]
435874
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This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
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Secondary outcome [2]
435875
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Pain Interference
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Assessment method [2]
435875
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The Brief Pain Inventory (BPI)
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Timepoint [2]
435875
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This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
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Secondary outcome [3]
435876
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Pain self-efficacy
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Assessment method [3]
435876
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Pain Self-Efficacy Questionnaire (PSEQ)
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Timepoint [3]
435876
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This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
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Secondary outcome [4]
436394
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Pain catastrophising
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Assessment method [4]
436394
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The Pain Catastrophising Scale (PCS)
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Timepoint [4]
436394
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This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
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Secondary outcome [5]
436420
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recruitment rates (and reasons)
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Assessment method [5]
436420
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The proportion of participants recruited at each study milestone, calculated separately for treatment and control groups, recorded contemporaneously from participant contact into an Excel spreadsheet.
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Timepoint [5]
436420
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Assessed at the conclusion of the study period
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Secondary outcome [6]
436421
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Group attendance rates (intervention group only)
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Assessment method [6]
436421
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Recorded contemporaneously into an Excel spreadsheet
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Timepoint [6]
436421
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Assessed at the conclusion of the study period
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Secondary outcome [7]
436422
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Homework/therapy adherence (intervention group only)
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Assessment method [7]
436422
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Recorded contemporaneously as a yes/no response into an Excel spreadsheet by group facilitators
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Timepoint [7]
436422
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Assessed at the conclusion of the study period
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Secondary outcome [8]
436423
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Participant satisfaction (intervention participants only)
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Assessment method [8]
436423
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A paper-based feedback/satisfaction measure developed in-house, partially adapted from the Credibility Expectancy Questionnaire
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Timepoint [8]
436423
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During participants' last Movement is Medicine session
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Secondary outcome [9]
436424
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Patient pain management goals
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Assessment method [9]
436424
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At baseline, participants will respond to the open-ended question “if the treatments/services you receive at the Pain Unit were successful, what would this enable you to do that you can’t do now?”. At subsequent timepoints, they will rate the degree that they have achieved this goal on a 0-10 scale (and why/why not).”
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Timepoint [9]
436424
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Baseline, treatment end and 3-month follow-up (similarly-timed timepoints for control participants)
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Secondary outcome [10]
436425
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Subsequent rhizolysis procedures
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Assessment method [10]
436425
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The date of any rhizolysis procedures performed at the Pain Unit subsequent to their procedure at baseline over the following 12-month period will be recorded.
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Timepoint [10]
436425
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12 months following participants' baseline rhizolysis procedure
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Secondary outcome [11]
436630
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Depression
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Assessment method [11]
436630
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The Depression Anxiety and Stress Scale (DASS)
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Timepoint [11]
436630
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This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
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Secondary outcome [12]
436631
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Anxiety
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Assessment method [12]
436631
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the Depression Anxiety and Stress Scale (DASS)
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Timepoint [12]
436631
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This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
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Secondary outcome [13]
436632
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Stress
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Assessment method [13]
436632
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The Depression Anxiety and Stress Scale (DASS)
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Timepoint [13]
436632
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This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
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Secondary outcome [14]
436633
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Drop-out rates (and reasons)
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Assessment method [14]
436633
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The proportion of participants recruited at each study milestone, calculated separately for treatment and control groups, recorded contemporaneously from participant contact into an Excel spreadsheet.
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Timepoint [14]
436633
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Assessed at the conclusion of the study period
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Eligibility
Key inclusion criteria
Existing Flinders Medical Centre Pain Management Unit patients who are booked to receive their first lumbar rhizolysis procedure at the Pain Unit.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Have already had a lumbar rhizolysis procedure
Previously completed/are currently undergoing Flinders Pain Management Unit Allied Health group programs
Severe mobility issues
Issues with dizziness/balance
Actively suicidal
Unstable mental health
Requiring an interpreter
Significant cognitive impairment
Significant visual or auditory difficulties (which would be a major impediment to group participation)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
17/06/2024
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Date of last participant enrolment
Anticipated
17/03/2025
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Actual
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Date of last data collection
Anticipated
24/03/2026
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Actual
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Sample size
Target
64
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Accrual to date
2
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
26647
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
42687
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
316662
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Charities/Societies/Foundations
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Name [1]
316662
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The Hospital Research Foundation (given to the SAHLN Enquiry grant round)
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Address [1]
316662
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Country [1]
316662
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Australia
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Funding source category [2]
316743
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Charities/Societies/Foundations
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Name [2]
316743
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The Flinders Foundation (given to the SALHN enquiry grant round)
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Address [2]
316743
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Country [2]
316743
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Australia
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Primary sponsor type
Government body
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Name
Southern Adelaide Local Health Network
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Address
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Country
Australia
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Secondary sponsor category [1]
318874
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Hospital
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Name [1]
318874
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The Flinders Medical Centre (Pain Management Unit. C/O Dr Amelia Searle)
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Address [1]
318874
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Country [1]
318874
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315442
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
315442
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https://www.sahealth.sa.gov.au/wps/wcm/connect/Public%2BContent/SA%2BHealth%2BInternet/About%2Bus/Our%2BLocal%2BHealth%2BNetworks/Southern%2BAdelaide%2BLocal%2BHealth%2BNetwork/Research/For%2BResearchers/Southern%2BAdelaide%2BClinical%2BHuman%2BResearch%2BEthics%2BCommittee
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Ethics committee country [1]
315442
0
Australia
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Date submitted for ethics approval [1]
315442
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19/01/2024
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Approval date [1]
315442
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04/04/2024
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Ethics approval number [1]
315442
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Summary
Brief summary
The aim of this study is determine the effectiveness and feasibility of implementing the Movement is Medicine (MiM) small-group program after patients undergo facet joint rhizolysis for their chronic back pain. Participants randomly allocated to the intervention condition attend one of four 6-week (18 hours total) Movement is Medicine small-group interventions following their rhizolysis procedure, with around 8 participants per group, and led by two trained facilitators. Sessions include pain science, relaxation/breathing, and guided demonstrations of various low-intensity exercise options, with all of these techniques suggested as homework between sessions. Control participants simply attend their usual healthcare appointments following their rhizolysis procedure. Outcome measures include functional assessments, as well as self-reported symptoms of pain intensity/interference, lower back pain disability, fear of movement, depression, anxiety and stress, pain self-efficacy, and pain catastrophising, completed immediately before and after the intervention, and three months later (and similar timepoints for controls). If the intervention improves self-management, functional outcomes and quality of life, these patients may "live well despite the pain" and be less reliant on repeated and costly hospital-based care, and findings may provide grounds for offering the intervention to our procedural patients more broadly.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
134710
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Dr Amelia Searle
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Address
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C/O Flinders Medical Centre PMU, Flinders Drive, Bedford Park SA 5042
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Country
134710
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Australia
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Phone
134710
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+61 882044016
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Fax
134710
0
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Email
134710
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[email protected]
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Contact person for public queries
Name
134711
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Dr. Porhan Kang
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Address
134711
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C/O Flinders Medical Centre PMU, Flinders Drive, Bedford Park SA 5042
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Country
134711
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Australia
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Phone
134711
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+61 882045499
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Fax
134711
0
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Email
134711
0
[email protected]
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Contact person for scientific queries
Name
134712
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Dr Amelia Searle
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Address
134712
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C/O Flinders Medical Centre PMU, Flinders Drive, Bedford Park SA 5042
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Country
134712
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Australia
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Phone
134712
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+61 882044016
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Fax
134712
0
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Email
134712
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23892
Study protocol
[email protected]
23893
Informed consent form
[email protected]
23894
Ethical approval
[email protected]
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.
Download to PDF