Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001179820
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
2/09/2021
Date last updated
6/10/2022
Date data sharing statement initially provided
2/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two exercise interventions for people with chronic lower back pain
Scientific title
Feasibility outcomes for comparing exercise cues for individuals with chronic lower back pain
Secondary ID [1] 304281 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic lower back pain 322011 0
Condition category
Condition code
Musculoskeletal 319732 319732 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 319733 319733 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A physiotherapist with 15 years’ experience will deliver 60-minute exercise classes once a week, over 12 weeks, at the University of South Australia, East Campus. The maximum 3 people face-to-face groups will receive some weekly individual tailoring (progression/regression) by the physiotherapist relative to participant capacity. Checklists will record weekly attendance and exercise modifications. Exercises will address mobility (eg. pelvic tilts/clocks, book openings), stability (eg. bridging, plank) and whole-body integration (eg. rolling side to side, variations of getting on/off the floor). The intervention group will combine 60 minutes of standardised floor exercises with the addition of specific cues throughout the session. Intensity will be low to moderate, with participants able to talk comfortably throughout the session.
Intervention code [1] 320619 0
Rehabilitation
Comparator / control treatment
The control group receives the same standardised floor exercises, length of session, location and class size as the intervention group, focusing on completion of the exercises. Specific cues in the intervention group will be omitted for the control group. Intensity will be low to moderate, with participants able to talk comfortably throughout the session.
Control group
Active

Outcomes
Primary outcome [1] 327599 0
Feasibility measure - attendance checklist audit to determine if 80% of participants attended all sessions.
Timepoint [1] 327599 0
end of intervention
Primary outcome [2] 327600 0
Feasibility measure - recruiting at least 70% of eligible participants assessed through auditing participants enquiries and enrolment logs.
Timepoint [2] 327600 0
end of intervention
Primary outcome [3] 327601 0
Feasibility measure - Satisfaction with the program will be gleaned from participants of both arms, by a research team member conducting 60 minute, individual semi-structured interviews,
Timepoint [3] 327601 0
An individual semi-structured interview will be undertaken up to 6 weeks post completion of intervention.
Secondary outcome [1] 395861 0
Pain related disability assessed using Patient Reported Outcomes Measurement Information System-29
Timepoint [1] 395861 0
Baseline and up to 6 weeks post completion of intervention
Secondary outcome [2] 395862 0
Neuropathic pain assessed using painDETECT Questionnaire
Timepoint [2] 395862 0
Baseline and up to 6 weeks post completion of intervention
Secondary outcome [3] 395863 0
Dysfunctional breathing symptoms using Nijmegen Questionnaire
Timepoint [3] 395863 0
Baseline and up to 6 weeks post completion of intervention
Secondary outcome [4] 395864 0
Diaphragm excursion assessed using diagnostic ultrasound
Timepoint [4] 395864 0
Baseline and up to 6 weeks post completion of intervention
Secondary outcome [5] 395865 0
Inspiratory pressure assessed using handheld micro RPM device
Timepoint [5] 395865 0
Baseline and up to 6 weeks post completion of intervention
Secondary outcome [6] 395866 0
Self efficacy assessed using the Pain self-efficacy questionnaire
Timepoint [6] 395866 0
Baseline and up to 6 weeks post completion of intervention
Secondary outcome [7] 395867 0
Psychological state assessed using State trait and anxiety inventory
Timepoint [7] 395867 0
Baseline and up to 6 weeks post completion of intervention
Secondary outcome [8] 395868 0
Kinesiophobia assessed using Tampa Scale of Kinesiophobia
Timepoint [8] 395868 0
Baseline and up to 6 weeks post completion of intervention
Secondary outcome [9] 395869 0
Participant current function relative to goals assessed using Patient Specific Functional Scale
Timepoint [9] 395869 0
Baseline and up to 6 weeks post completion of intervention
Secondary outcome [10] 398865 0
Acceptability of the program of 80% satisfaction reported by 80% of participants on a 10cm Likehart scale questions - “How satisfied were you with the group program?”.
Timepoint [10] 398865 0
Up to 6 weeks post completion of intervention
Secondary outcome [11] 404426 0
Metalyzer 3B portable gas analysis unit for breathing gas analysis and related timing and volumes
Timepoint [11] 404426 0
Baseline and up to 6 weeks post completion of intervention

Eligibility
Key inclusion criteria
Chronic lower back pain (longer than 3 month history)
Converse and understand English
Capable of participating in a weekly low-impact exercise session
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer related pain
Neuropathy or neurological signs (tingling, numbness)
Chronic conditions that are associated with breathing issues (for example interstitial lung disease, heart failure, asthma, chronic obstructive pulmonary disorder)
Headaches
Surgery within three months

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)
Allocation will be computer generated and administered via phone to the physiotherapist conducting the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). A person independent to the intervention/assessment will generate the groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The mixed-methods feasibility trial will recruit approximately 48 participants. The small sample size will require baseline characteristics and feasibility outcomes to undergo descriptive analysis. Calculations of feasibility outcome measures and exploratory analysis, using inferential statistics of remaining outcome measures, will inform future sample size requirements.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2022
Actual
10/01/2022
Date of last participant enrolment
Anticipated
8/09/2023
Actual
Date of last data collection
Anticipated
15/12/2023
Actual
Sample size
Target
48
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 34112 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 308657 0
University
Name [1] 308657 0
University of South Australia
Country [1] 308657 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 309536 0
None
Name [1] 309536 0
Address [1] 309536 0
Country [1] 309536 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308584 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 308584 0
GPO Box 2471
Adelaide SA 5001
Ethics committee country [1] 308584 0
Australia
Date submitted for ethics approval [1] 308584 0
10/03/2021
Approval date [1] 308584 0
30/03/2021
Ethics approval number [1] 308584 0
203542

Summary
Brief summary
The feasibility pilot trial will recruit and randomly allocate approximately 48 adults with lower back pain to an exercise program with or without breathing cues. The 12 x 1-hour exercise sessions will be weekly for 12 weeks at University of South Australia East Campus. Some individual tailoring (progression/regression) for individual capacity will be undertaken and recorded by the physiotherapist. The intervention and control groups will experience the same standardised floor exercises, length of session, location and class numbers. The aim is to determine if the addition of specific cues to a 12-week exercise program alters participant tolerance and compliance, including dropout rate and satisfaction. The aim is not to establish evidence reliant on sample size, rather determining which measures demonstrate most relevance for future research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111226 0
Ms Joanne Bouckley
Address 111226 0
University of South Australia
GPO Box 2471
Adelaide, 5001, South Australia
Country 111226 0
Australia
Phone 111226 0
+61 402511599
Fax 111226 0
Email 111226 0
[email protected]
Contact person for public queries
Name 111227 0
Ms Louise Massie
Address 111227 0
Internal post code CEA-08
University of South Australia
GPO Box 2471
Adelaide, 5001, South Australia
Country 111227 0
Australia
Phone 111227 0
+61 883022097
Fax 111227 0
Email 111227 0
[email protected]
Contact person for scientific queries
Name 111228 0
Ms Joanne Bouckley
Address 111228 0
University of South Australia
GPO Box 2471
Adelaide, 5001, South Australia
Country 111228 0
Australia
Phone 111228 0
+61 402511599
Fax 111228 0
Email 111228 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


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.