None listed
Conditions
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.
Interventions
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 (ba
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.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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).
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.
Outcome results
None listed