Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000674538p
Ethics application status
Submitted, not yet approved
Date submitted
10/05/2024
Date registered
27/05/2024
Date last updated
27/05/2024
Date data sharing statement initially provided
27/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Mind, Heart, and Spine (MHS) Study: the effect of biofeedback for treating pain and mental health in adults with spinal-related disorders.
Scientific title
The effect of heart rate variability biofeedback on pain and mental health in adults with spinal-related disorders: A single-case experimental design study
Secondary ID [1] 312113 0
N/A
Universal Trial Number (UTN)
U1111-1307-7713
Trial acronym
The Mind, Heart, and Spine (MHS) Study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Spinal-related disorders 333753 0
Condition category
Condition code
Musculoskeletal 330436 330436 0 0
Other muscular and skeletal disorders
Anaesthesiology 330503 330503 0 0
Pain management
Mental Health 330504 330504 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall goal of HRV-F is to learn resonance frequency breathing, that is, slow relaxed diaphragmatic breathing around 4-7 breaths per minute that has a regulating effect on the ANS, so that respiratory sinus arrhythmia and baroreflex gain are maximised. This training is conducted by trained researchers/clinicians and involves training participants in slow breathing and supplying visual/auditory feedback of HRV activity related to their breathing.

There are two intervention study periods (back-to-back), each for 6 weeks duration. In the first treatment period, participants will undergo heart rate variability biofeedback (HRV-F) treatment.

The intervention sessions include:
(1) Six weekly training sessions:
1a. Four in-person training sessions at the laboratory space: These sessions will include: (i) introduction to HRV-F and slow breathing techniques; (ii) determine participant’s resonance frequency breathing; (iii) HRV-F supervised practice; (iv) education about autonomic balance and health and transfer of HRV-F skills to everyday life and stressful contexts; (v) education about psychological self-management strategies such as self-monitoring of mood, anxiety, breath/heart rate, pain/fatigue and sleep; and (vi) visualisation and mindfulness strategies to enhance self-regulation of HRV and breathing. Each session will run for up to 180 minutes. These sessions will be conducted using a ProComp2 device (Thought technology, Canada; non-invasive biofeedback device). ProComp 2 device is a safe and non-invasive device providing real time biofeedback. ProComp 2 device will record heart rate using a finger sensor and respiration using a belt placed around the participants’ abdominal area. Participants will receive feedback about their heart rate and respiration on the monitor and instructed to modify their respiration (part of the training) in order to improve their respiration technique, signal coherence and heart rate variability.

1b. Two telephone conference sessions (one-on-one call): This will involve discussions with the participant about progress and troubleshoot any issues that may have arisen. It is also an opportunity to review any material that was discussed in the face-to-face training. Each session will run for up to 30 minutes.

(2) Daily homework
2a. Home-based training: Home sessions will involve participants practising HRV-F for twice daily (20 minutes each session) using a smartphone/tablet application, Elite HRV, with a provided Polar H10 heart rate monitor (Polar Electro, Kempele, Finland). Adherence to home training will be monitored via the Elite HRV team dashboard platform which allows the research team to access the length of participant’s sessions and calculates HRV values.

In the second treatment period, participants will continue their unsupervised HRV-F home practice only. These sessions are the same as the home practice performed in the intervention period (2 x 20-minute unsupervised HRV-F home practice daily). Adherence to unsupervised sessions will be monitored via the Elite HRV team dashboard platform which allows the research team to access the length of participant’s sessions and calculates HRV values.
Intervention code [1] 328554 0
Treatment: Devices
Comparator / control treatment
The study utilising a ABC n-of-1 study design with multiple baseline, therefore participant will be their own control.

In the control period, participants will be asked to continue with their usual standard care, including conservative management such as medication and therapy, and no restrictions will be placed upon the individual’s lifestyle or activities. This period varies from a minimum of 2-weeks and a maximum of 4-weeks, ensuring sufficient duration to obtain a minimum of 5 observations of the primary outcomes for maximum rigour. Three different baseline lengths (2, 3, or 4 weeks) are used to meet single case study design standards in three different study blocks (I, II and II), respectively.
Control group
Active

Outcomes
Primary outcome [1] 338185 0
Pain intensity (one location)
Timepoint [1] 338185 0
Every 24 hours (daily diary) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Primary outcome [2] 338186 0
Pain interference related to day-to-day activities.
Timepoint [2] 338186 0
Every 24 hours (daily diary) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Primary outcome [3] 338187 0
Subjective Units of Distress Scale
Timepoint [3] 338187 0
Every 24 hours (daily diary) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [1] 434856 0
Overall health status (sub-set of EQ-5D)
Timepoint [1] 434856 0
Every week for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [2] 434857 0
Adverse events
Timepoint [2] 434857 0
Every week for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [3] 434858 0
Perception of change
Timepoint [3] 434858 0
Every week for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [4] 434859 0
Satisfaction scale
Timepoint [4] 434859 0
Every week for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [5] 434930 0
Oxygen saturation level (daily average)
Timepoint [5] 434930 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [6] 434931 0
Body temperature (daily average)
Timepoint [6] 434931 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [7] 434932 0
Respiration rate (daily average)
Timepoint [7] 434932 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [8] 434933 0
Heart rate (daily average)
Timepoint [8] 434933 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [9] 434934 0
Heart rate (for 5 mins)
Timepoint [9] 434934 0
Every day for 5 mins (after awakening) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [10] 434935 0
HRV measure - root mean square of successive differences (RMSSD)
Timepoint [10] 434935 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [11] 434936 0
HRV measure - Low frequency
Timepoint [11] 434936 0
Every day for 5 mins (after awakening) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [12] 434937 0
HRV measure - High frequency
Timepoint [12] 434937 0
Every day for 5 mins (after awakening) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [13] 434938 0
HRV measure - Low and High frequency ratio (LF/HF)
Timepoint [13] 434938 0
Every day for 5 mins (after awakening) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [14] 434939 0
HRV measure - root mean square of successive differences
Timepoint [14] 434939 0
Every day for 5 mins (after awakening) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [15] 434940 0
HRV measure - standard deviation of all normal RR intervals (SDNN)
Timepoint [15] 434940 0
Every day for 5 mins (after awakening) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [16] 434941 0
HRV measure - total power
Timepoint [16] 434941 0
Every day for 5 mins (after awakening) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [17] 434942 0
Sleep parameter - sleep length
Timepoint [17] 434942 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [18] 434943 0
Sleep parameter - light sleep duration
Timepoint [18] 434943 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [19] 434944 0
Sleep parameter - deep sleep duration
Timepoint [19] 434944 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [20] 434945 0
Sleep parameter - rapid eye movement (REM) duration
Timepoint [20] 434945 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [21] 434946 0
Sleep parameter - awake time
Timepoint [21] 434946 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [22] 434947 0
Sleep parameter - sleep latency
Timepoint [22] 434947 0
Daily average monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [23] 434948 0
Physical activity duration
Timepoint [23] 434948 0
Daily monitoring for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [24] 435236 0
PRIMARY OUTCOME: Pain interference related to overall mood.
Timepoint [24] 435236 0
Every 24 hours (daily diary) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).
Secondary outcome [25] 435237 0
PRIMARY OUTCOME: Pain interference related to good night's sleep.
Timepoint [25] 435237 0
Every 24 hours (daily diary) for 14 weeks (in block I), 15 weeks (in block II) and 16 weeks (in block III).

Eligibility
Key inclusion criteria
Participants will be included if:
(i) aged 18-80 years;
(ii) English speaking;
(iii) sustained a spinal-related disorder (such as degenerative disc disease, disc herniations/prolapse, scoliosis, arthritis of the spine (ankylosing spondylitis, spondylolisthesis), with or without spinal root and nerve dysfunction;
(iv) experiencing chronic pain (>3 months, more than 4 (out of 10) on a numeric rating scale average weekly pain intensity).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A participant will be excluded if:
(i) there is evidence of traumatic or non-traumatic spinal cord injury and other inflammatory/degenerative diseases of the spinal cord (such as, multiple sclerosis) or affecting the spinal cord (e.g., spinal stenosis).
(ii) there is evidence of severe cognitive impairment, due to moderate to severe traumatic brain injury or dementia
(iii) evidence of psychiatric disorder, e.g. bipolar disorder or psychoses or chronic depression disorder, determined by medical history or psychiatric interview
(iv) they have serious medical condition or other source of pain that may exclude them from participation.

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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
A series of N-of-1 study using an ABC study design, nested within a multiple baselines approach.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcomes, graphical representation and calculation of a mean and trend line will be used to analyse changes over time and between periods. Level- and slope-change analyses will be used to further analyse change between periods. Secondary analyses will be performed on secondary outcomes. No interim analyses will be performed in this study. Level of significance to be used will be set at 0.05 unless otherwise required. Quality of the dataset will be inspected regularly by outcome assessors for missing data. Additionally, missing, or spurious data will also be inspected by one of the senior researchers.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316471 0
Other Collaborative groups
Name [1] 316471 0
John Walsh Centre for Rehabilitation Research
Country [1] 316471 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 318647 0
None
Name [1] 318647 0
Address [1] 318647 0
Country [1] 318647 0
Other collaborator category [1] 283028 0
University
Name [1] 283028 0
The University of Sydney
Address [1] 283028 0
Country [1] 283028 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315259 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315259 0
https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx
Ethics committee country [1] 315259 0
Australia
Date submitted for ethics approval [1] 315259 0
29/04/2024
Approval date [1] 315259 0
Ethics approval number [1] 315259 0
2024/ETH00877

Summary
Brief summary
A spinal-related disorder (SRD) refers to any condition that affects the spinal column and surrounding structure. Some common SRDs, include degenerative disc disease, disc herniations, spinal stenosis, scoliosis, arthritis of the spine, spondylolisthesis, and tumors. These disorders
typically result in chronic pain, mental health issues, severely impacting on daily life, functioning, and overall quality of life. Current treatments for chronic pain in SRD populations include anti-inflammatory, diets, physical activity, cognitive behavioral therapy, electrical stimulation, each with varying degrees of success. However, little research has been done on heart rate variability feedback and paced breathing (HRV-F), a promising low-cost, self-regulation, non-invasive intervention that could alleviate pain and improve mental health and well-being. This study will assess the effectiveness of HRV-F in improving pain and mental health in adults with SRDs. The hypothesis is that adults with SRDs who receive HRV-F intervention will experience greater improvements in pain levels and mental health compared to when they receive standard care alone.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134162 0
Dr Mohit Arora
Address 134162 0
John Walsh Centre for Rehabilitation Research, Level 12 The Kolling Institute, 10 Westbourne Street, St Leonards, NSW 2065
Country 134162 0
Australia
Phone 134162 0
+61 2 99264772
Fax 134162 0
Email 134162 0
mohit.arora@sydney.edu.au
Contact person for public queries
Name 134163 0
Dr Mohit Arora
Address 134163 0
John Walsh Centre for Rehabilitation Research, Level 12 The Kolling Institute, 10 Westbourne Street, St Leonards, NSW 2065
Country 134163 0
Australia
Phone 134163 0
+61 2 99264772
Fax 134163 0
Email 134163 0
mohit.arora@sydney.edu.au
Contact person for scientific queries
Name 134164 0
Professor Ashley Craig
Address 134164 0
John Walsh Centre for Rehabilitation Research, Level 12 The Kolling Institute, 10 Westbourne Street, St Leonards, NSW 2065
Country 134164 0
Australia
Phone 134164 0
+61 417290521
Fax 134164 0
Email 134164 0
a.craig@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable primary and secondary outcomes data
When will data be available (start and end dates)?
Immediately following study results publication until 5 years from study completion.
Available to whom?
Only researchers who provide a methodologically sound proposal at the discretion of principal investigator and on case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Systematic review and meta-analysis.
How or where can data be obtained?
Repository of journals where the results of the study will be published and can be accessed subject to approvals by Principal Investigator (mohit.arora@sydney.edu.au)


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.