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Trial registered on ANZCTR


Registration number
ACTRN12622000260729
Ethics application status
Approved
Date submitted
15/12/2021
Date registered
14/02/2022
Date last updated
17/11/2022
Date data sharing statement initially provided
14/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of health coaching on the burden of low back pain within the chiropractic setting
Scientific title
Feasibility and efficacy of health coaching for management of low back pain within the chiropractic setting
Secondary ID [1] 306053 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 324696 0
Condition category
Condition code
Musculoskeletal 322148 322148 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The health intervention of 3 months duration, includes chiropractic patient participants receiving a patient-centred physical activity plan developed with the advice of a certified health coach/accredited allied health professional. This physical activity plan will specifically suit patient needs and preferences, encouraging them to develop goals to suit and gradually increase their physical activity. Health coaching will involve an initial individual online / virtual session, which can take up to 1 hour and it will be held over Zoom or similar platform. Subsequent health coaching sessions will be 10-15 minutes duration.
Specifically, the health coaching sessions will comprise:
1. Increasing physical activity through an individually developed plan that meets patient lifestyle preferences. Guided by The World Health Organisation (WHO), physical activities will relate (but not limited to) sports, other leisure activities, work and transport activity.
2. Decreasing sedentary behaviour by encouraging an increase in incidental physical activity throughout the day. Opportunities may include (but not limited to) public transportation to work, walking to shops, carrying out a home exercise program, standing at work and spending less time sitting while at home.
3. Setting goals that are to the individual, realistic, can be monitored, and receives positive encouragement. The health coach will work with each participant to set short-term physical activity goals to be achieved fortnightly. The participants’ individual goals will be set taking into consideration the nature of their chronic low back pain.
After the first individual virtual coaching session, the health coach will contact each participant 2 week later, and each phone call will be approximately each fortnightly (5 phone calls over a 3-month period for each participant). Calls will comprise of patient progress, updating goals and assist in overcoming barriers. Within the phone call, patients will be asked about their adherence to the intervention.
Intervention code [1] 322458 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329910 0
Proportion of eligible patients who participate (recruitment) will be assessed by an audit of study database.
Timepoint [1] 329910 0
Baseline, 3 months (after intervention commencement)
Primary outcome [2] 329911 0
Effectiveness: pre and post study patient outcome measures collected, will be assessed by an audit of study database. This outcome will be assessing the completeness of data, i.e., proportion of outcome measures collected for each participant assessed by an audit of study database.
Timepoint [2] 329911 0
Baseline, 3 month (post intervention commencement)
Primary outcome [3] 329912 0
Adoption: proportion of clinics who promoted the program, will be assessed by an audit of study database. Information will be added to the study database following a telephone interview and/or email to check promotion with relevant clinic staff.
Timepoint [3] 329912 0
Baseline, 3 month (post intervention commencement)
Secondary outcome [1] 404247 0
Physical function, assessed using the Patient Specific Functional Scale
Timepoint [1] 404247 0
Baseline, 3 months post intervention commencement
Secondary outcome [2] 404248 0
Self-reported physical activity levels, assessed with Global Physical Activity Questionnaire (GPAQ)
Timepoint [2] 404248 0
Baseline, 3 months post intervention commencement
Secondary outcome [3] 404249 0
Pain intensity, assessed fortnightly with the Numerical Rating Scale (NRS).
Timepoint [3] 404249 0
Baseline, and fortnightly for up to 3 months post intervention commencement.
Secondary outcome [4] 404250 0
Disability, assessed via the Roland– Morris Disability Questionnaire (0-24)
Timepoint [4] 404250 0
Baseline, 3 months post intervention commencement
Secondary outcome [5] 404251 0
Quality of life, assessed using the Assessment of Quality of Life questionnaire (AQoL-8D)
Timepoint [5] 404251 0
Baseline, 3 month post intervention commencement.
Secondary outcome [6] 404252 0
Sleep quality, assessed with the Pittsburgh Sleep Quality Index
Timepoint [6] 404252 0
Baseline, 3 months post intervention commencement.
Secondary outcome [7] 404253 0
Beliefs about back pain, assessed with the Back Beliefs Questionnaire
Timepoint [7] 404253 0
Baselines, 3 months post intervention commencement
Secondary outcome [8] 404254 0
Attitudes regarding use of pain medications, assessed using the short-form Pain Medication Attitudes Questionnaire (PMAQ-14)
Timepoint [8] 404254 0
Baseline, 3 months post intervention commencement
Secondary outcome [9] 404255 0
Medication use. Data on the use of medications for managing low back pain, including type (i.e., paracetamol, non-steroidal anti-inflammatory drugs, opioids), dosage, and whether the medication was prescribed by a medical or health professional, will be collected by participant self report.
Timepoint [9] 404255 0
Baseline, 3 months post intervention commencement.
Secondary outcome [10] 405918 0
This is a primary outcome:
Proportion of patients who undertook health coaching, will be assessed by an audit of health coaches patient notes and study database.
Timepoint [10] 405918 0
Baseline, 3 months post intervention commencement.

Eligibility
Key inclusion criteria
Patients who are 18 years and over with chronic low back pain (persisting for over 12 weeks).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute (<6 weeks) low back pain;
Planned surgery
Currently participating in a supervised exercise program

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
There is no control group / no randiomisation.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will describe all quantitative data collected. As a feasibility study, we will employ the Wilcoxon signed rank test to evaluate the change in participants’ measures at baseline and at 3-month follow up post intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310390 0
Other
Name [1] 310390 0
The Australasian Institute of Chiropractic Education (AICE)
Country [1] 310390 0
Australia
Primary sponsor type
Individual
Name
Matthew Fernandez
Address
CQUniversity
60 Ann Street, Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 311535 0
None
Name [1] 311535 0
Not applicable
Address [1] 311535 0
Not applicable
Country [1] 311535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310039 0
CQUniversity Australia Ethics Committee
Ethics committee address [1] 310039 0
Ethics committee country [1] 310039 0
Australia
Date submitted for ethics approval [1] 310039 0
22/12/2021
Approval date [1] 310039 0
15/02/2022
Ethics approval number [1] 310039 0

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

Contacts
Principal investigator
Name 116278 0
Dr Matthew Fernandez
Address 116278 0
CQUniversity Australia, Level 20, 160 Ann St, Brisbane QLD 4000
Country 116278 0
Australia
Phone 116278 0
+61 07 3023 4279
Fax 116278 0
Email 116278 0
m.fernandez@cqu.edu.au
Contact person for public queries
Name 116279 0
Matthew Fernandez
Address 116279 0
CQUniversity Australia, Level 20, 160 Ann St, Brisbane QLD 4000
Country 116279 0
Australia
Phone 116279 0
+61 07 3023 4279
Fax 116279 0
Email 116279 0
m.fernandez@cqu.edu.au
Contact person for scientific queries
Name 116280 0
Matthew Fernandez
Address 116280 0
CQUniversity Australia, Level 20, 160 Ann St, Brisbane QLD 4000
Country 116280 0
Australia
Phone 116280 0
+61 07 3023 4279
Fax 116280 0
Email 116280 0
m.fernandez@cqu.edu.au

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.