Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001284752
Ethics application status
Approved
Date submitted
21/09/2022
Date registered
30/09/2022
Date last updated
16/10/2023
Date data sharing statement initially provided
30/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Individualised exercise rehabilitation for persistent low back pain
Scientific title
Feasibility of individualised vs standardised exercise rehabilitation for patients with persistent low back pain
Secondary ID [1] 308015 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent (also known as chronic) low back pain 327690 0
Condition category
Condition code
Musculoskeletal 324772 324772 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 324773 324773 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12-week individualised exercise rehabilitation program for persistent low back pain. The literature indicates that patients with persistent low back pain describe a preference for individualised exercise programs. In the first session (~1 hr) a registered physiotherapist will collaboratively develop physical activity goals with each participant. Based on these goals, an individualised exercise rehabilitation program will be developed with participants based on their preferences, symptoms, abilities and assessment findings. The aspects of the program to be individualised include: session frequency and duration and the aerobic, strengthening and specific muscle activation exercises. To inform the aerobic and strengthening exercises the physiotherapist will firstly determine each participant’s baseline exercise tolerance. Participants will be asked to rate their perceived exertion of their current exercise regime and describe how it affects their pain (if currently exercising). Based on this information and considering participants exercise goals, the physiotherapist will use a tool specifically designed for this intervention to determine whether to increase or decrease the duration, frequency or intensity of their exercise regime. Participant preferences regarding type of aerobic (e.g. walking, cycling) and strengthening (e.g. weight training, Barre) activities will also be incorporated. To inform the selection of specific muscle activation exercises, the physiotherapist will assess participant’s abdominal and back muscles using ultrasound imaging, pressure biofeedback and observation and palpation. Based on these assessment findings, the most appropriate exercises will be chosen based on the protocols of previous studies (e.g. Costa et al 2009). Participants will complete between two and seven 5–60-minute exercise sessions per week depending on their goals, abilities, symptoms and preferences. Exercise sessions will be conducted independently (i.e. not during physiotherapy appointments). Participants may use equipment if they have access to it and would like to use it. No equipment will be required or provided to participants. The exercise regime will be documented and provided to each participant to refer to. The physiotherapist will also educate on ways to help participants’ pain based on pain neuroscience education literature. This will cover content such as how the nervous system acts as an alarm system and the benefits of graded exercise.
To monitor progress, participants will meet with the physiotherapist (~30 min appointments) once weekly during the first month, once fortnightly during the second month and on one occasion only in the final month. In these sessions, the exercise rehabilitation program will be reviewed and may be progressed/modified to meet participants individual needs and exercise goals. Exercise goals will be monitored using the Goal Attainment Light scale. Participants will be asked to rate the perceived exertion of their exercise sessions and the impact on their symptoms. The program may then be progressed or modified in these sessions by adjusting the duration, frequency and/or intensity of exercise sessions. Participants will be required to document completion of their exercise sessions in a provided booklet (designed specifically for this study) to monitor compliance with the regime during these appointments. The first several appointments will be conducted face to face and participants will have the option to transition to telehealth. Face-to-face appointments will be conducted at the University of South Australia.
Intervention code [1] 324468 0
Rehabilitation
Intervention code [2] 324524 0
Treatment: Other
Comparator / control treatment
Identical to the intervention, however, participants will be unable to choose the types of aerobic and strengthening physical activity they participate in. They will be provided with walking (for aerobic exercise) and the strengthening exercises will be chosen from a modified program previously published in the literature (e.g. including squats and modified press ups). These exercises will not require any equipment. Like the intervention group, participants will also collaboratively determine physical activity goals with the physiotherapist. Other factors including the specific muscle activation exercises, session duration and frequency will continue to be individualised according to participants symptoms, abilities, goals and current exercise regime as described for the intervention group. Therefore participants will complete between two and seven 5–60-minute exercise sessions per week depending on their goals, abilities, symptoms and preferences.
Control group
Active

Outcomes
Primary outcome [1] 332597 0
Feasibility measure (retention): Proportion of enrolled participants who complete the re-assessment of baseline measures at the end of the 12 week intervention as determined by audit of study database
Timepoint [1] 332597 0
After all participants have completed re-assessment of baseline measures taken at the 12 weeks post-exercise program commencement.
Primary outcome [2] 332598 0
Feasibility measure (recruitment): number of eligible participants who are recruited as determined by audit of study database
Timepoint [2] 332598 0
12 weeks post-exercise program commencement
Primary outcome [3] 332599 0
Feasibility measure (exercise compliance): proportion of prescribed exercise sessions completed as determined by audit of participant exercise logs
Timepoint [3] 332599 0
12 weeks post-exercise program commencement
Secondary outcome [1] 414006 0
Lateral abdominal muscle thickness assessed using real-time ultrasound imaging
Timepoint [1] 414006 0
baseline and 12 weeks post-exercise program commencement
Secondary outcome [2] 414007 0
Pain assessed using the Pain Numeric Rating Scale
Timepoint [2] 414007 0
Baseline, 12 weeks post-exercise program commencement and 3 months post completion of exercise program
Secondary outcome [3] 414008 0
Disability assessed using the Roland Morris Disability Questionnaire
Timepoint [3] 414008 0
Baseline, 12 weeks post-exercise program commencement and 3 months post completion of exercise program
Secondary outcome [4] 414009 0
Physical activity assessed using the International Physical Activity Questionnaire (short form)
Timepoint [4] 414009 0
Baseline, 12 weeks post-exercise program commencement and 3 months post completion of exercise program
Secondary outcome [5] 414010 0
Lumbar instability assessed the using the Lumbar Instability Questionnaire
Timepoint [5] 414010 0
Baseline, 12 weeks post-exercise program commencement and 3 months post completion of exercise program
Secondary outcome [6] 414011 0
Function assessed the using the Pain Specific Functional Scale
Timepoint [6] 414011 0
Baseline, 12 weeks post-exercise program commencement and 3 months post completion of exercise program
Secondary outcome [7] 414012 0
Satisfaction with the program assessed using 5 point Likert Scale to rate agreement with the following statements: I enjoyed participating in the program, I communicated effectively with the physiotherapist, I was satisfied with the intervention, the study has helped me to become more physically active, I managed to effectively fit physical activity into my life, I feel the intervention has positively impacted my back pain, I would recommend the study to other people with back pain, I feel ready to continue with regular physical activity without the supervision of a physiotherapist, I will continue with regular physical activity. Open-ended questions on what participants enjoyed, disliked and how the intervention could be improved will provide opportunities for further feedback
Timepoint [7] 414012 0
12 weeks post-exercise program commencement
Secondary outcome [8] 414241 0
Lumbar multifidus muscle thickness assessed using real-time ultrasound imaging
Timepoint [8] 414241 0
Baseline and 12 weeks post-exercise program commencement
Secondary outcome [9] 414242 0
Lateral abdominal muscle activation as measured by pressure biofeedback
Timepoint [9] 414242 0
Baseline and 12 weeks post-exercise program commencement
Secondary outcome [10] 414243 0
Lateral abdominal muscle activation as measured by the Clinical Rating Scale to Assess Quality of Muscle Contraction and Interaction between Deep and Superficial Muscles
Timepoint [10] 414243 0
Baseline and 12 weeks post-exercise program commencement
Secondary outcome [11] 417705 0
Trunk muscle endurance assessed using the trunk flexor muscle, lateral muscle and extensor muscle endurance tests
Timepoint [11] 417705 0
Baseline and 12 weeks post-exercise program commencement

Eligibility
Key inclusion criteria
Aged 18 years or over, Have had low back pain for 3 months or more (constant or recurring), Can read and write fluent English to allow communication with physiotherapist and complete questionnaires, Classified as moderate or high risk for chronicity as scored in the Start Back Tool (identified as appropriate for a physiotherapy and therefore exercise intervention), Have the time to participate in a physical activity intervention and attend the study site for measurements to be taken, Have not previously completed a similar exercise rehabilitation program for their back pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nerve root compromise (two of strength, reflex or sensation affected for the same lower limb nerve root), Suspected or confirmed serious pathology (e.g. infection, Cauda equina syndrome, cancer, fracture), Current pregnancy, given birth within the last year. Conditions that precludes from participating in exercise, conditions or disabilities that precludes from consent completing study questionnaires or exercise regimes. Higher risk when participating in exercise as indicated from the physical activity readiness questionnaire. Abdominal or back skin conditions that would prevent ultrasound imaging Taking medications or supplements designed to affect muscle size

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)
Central randomisation by computer after eligibility confirmed via phone questionnaire.
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)
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
Statistical methods / analysis
Sample size calculations based on feasibility (exercise compliance) as the primary outcome. Assumptions included the study will be feasible if: Participants complete on average at least 85% of scheduled exercise sessions. Not feasible if: Participants complete on average less than 65% of their scheduled exercise sessions.
To meet the 80% power requirement for these assumptions, 34 people are required in the intervention arm of the study (and therefore another 34 required for the control arm, making a total of 68 participants). This number was derived from the sample size table found in Lewis et al 2021. To allow for potential attrition, it is aimed to recruit 85 participants.

Analysis of data: Demographic data regarding age, gender, height, weight and type of preferred exercise (for the experimental group) will be analysed using descriptive statistics.
Muscle activation data: The average activation and resting thickness in mm for each muscle will be calculated for each group. Muscle activation will be calculated as contracting – resting thickness / resting thickness x100. Observation and palpation findings will be scored according to the Clinical Rating Scale to Assess Quality of Muscle Contraction and Interaction between Deep and Superficial Muscles. Readings on pressure biofeedback dial, ultrasound data and observation/palpation data will collectively be considered according to the protocol of Richardson et al 1999 (Therapeutic Exercise for Spinal Segmental Stabilisation: Scientific Basis and Clinical Approach) to determine participants’ ability to achieve core muscle activation. From this, the number of participants who did/not achieve correct muscle activation for each test at the initial, end and follow up assessments will be recorded.
Questionnaires: Questionnaires will be scored according to their respective instructions.
Survey: Survey questions will be scored using the Likert scale with items reaching >70% consensus for agreement or disagreement classified as having met consensus. As >70% is an arbitrary cut off for consensus, items that fall within 10% below this may be considered if clear justification can be provided (Diamond 2014). All questions containing items with scores below this will be reported on, but defined as not meeting consensus. Open ended “why” questions: Will be analysed using thematic/content analysis.
Feasibility: Analysis of attrition (aiming for less than 20%), recruitment rates (aiming to recruit at least 75% of eligible participants assessed through participant enquiries), exercise compliance (auditing participants exercise booklets to determine if participants completed 85% of scheduled exercise sessions).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
17/10/2022
Actual
19/12/2022
Date of last participant enrolment
Anticipated
Actual
9/06/2023
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
85
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312276 0
University
Name [1] 312276 0
University of South Australia
Country [1] 312276 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 313822 0
None
Name [1] 313822 0
Address [1] 313822 0
Country [1] 313822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311649 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 311649 0
Ethics committee country [1] 311649 0
Australia
Date submitted for ethics approval [1] 311649 0
12/09/2022
Approval date [1] 311649 0
16/10/2022
Ethics approval number [1] 311649 0

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

Contacts
Principal investigator
Name 121850 0
Miss Caitlin Prentice
Address 121850 0
C/O Allied Health and Human Performance,
Level 8 Centenary Building, City East Campus
The University of South Australia
108 North Terrace
Adelaide
South Australia 5001
Country 121850 0
Australia
Phone 121850 0
+61 8 830 21053
Fax 121850 0
Email 121850 0
[email protected]
Contact person for public queries
Name 121851 0
Caitlin Prentice
Address 121851 0
C/O Allied Health and Human Performance,
Level 8 Centenary Building, City East Campus
The University of South Australia
108 North Terrace
Adelaide
South Australia 5001
Country 121851 0
Australia
Phone 121851 0
+61 8 830 21053
Fax 121851 0
Email 121851 0
[email protected]
Contact person for scientific queries
Name 121852 0
Caitlin Prentice
Address 121852 0
C/O Allied Health and Human Performance,
Level 8 Centenary Building, City East Campus
The University of South Australia
108 North Terrace
Adelaide
South Australia 5001
Country 121852 0
Australia
Phone 121852 0
+61 8 830 21053
Fax 121852 0
Email 121852 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.