High-Definition Transcranial Infraslow Pink Noise Stimulation for Chronic Low Back Pain: A Pilot, Safety, and Feasibility Randomised Placebo-Controlled Trial
Authors List
Adhia, D.B., University of Otago, New Zealand
Mani, R., University of Otago, New Zealand
Turner, P., University of Otago, New Zealand
O'Leary, F., University of Otago, New Zealand
Hall, M., University of Otago, New Zealand
Reynolds, J.N.J., University of Otago, New Zealand
Vanneste, S., Trinity College Dublin, Ireland
De Ridder, D., University of Otago, New Zealand
Introduction
In people with chronic low back pain (CLBP), neuroimaging studies demonstrate altered electrical activities in cortical areas responsible for pain modulation, emotional, and sensory components of pain experience [i.e., pregenual and dorsal anterior cingulate cortex (pgACC, dACC), and somatosensory cortex (SSC) respectively].1 Treatments targeting to change electrical activities of these key brain regions may produce clinical benefits.2
Aims
To determine feasibility, safety, and acceptability of a novel neuromodulation technique, high-definition transcranial infraslow pink noise stimulation (HD-tIPNS), in people with CLBP, and explore its effects on pain and disability.
Methods
A pilot triple-blinded (participant, treating therapist, and outcome assessor) randomized placebo-controlled trial. Participants with CLBP (n=40) received 20 sessions of either HD-tIPNS (targeting pgACC, dACC, SSC) or Sham stimulation. Feasibility and safety measures were collected, and acceptability of intervention was assessed post-intervention. Brief pain inventory and Roland-Morris Disability Questionnaires were administered at baseline, immediately post-intervention, and at one-week, one-month, and three-months post-intervention. Data were analysed descriptively.
Results
Feasibility data includes recruitment rate (28%), randomization (100%), dropouts (8%) and treatment adherence (91%). No serious adverse events were reported. Participants reported moderate to high levels of acceptability (Mean±SD:2.57.2±2.5) and treatment satisfaction (Mean±SD:6.3±2.5). A higher proportion of participants in HD-tIPNS group demonstrated a clinically meaningful reduction in pain severity (70%), interference (65%), and disability (65%), when compared to sham stimulation group at three-months post-intervention.
Conclusion
HD-tIPNS is a safe and an acceptable approach for treating CLBP. A fully powered trial is feasible and warranted to test effectiveness of HD-tIPNS in people with CLBP.
References
1. De Ridder, D., Vanneste, S., Smith, M., & Adhia, D. (2022). Pain and the triple network model. Frontiers in neurology, 13, 272.
2. Adhia, D. B., Mani, R., Reynolds, J. N., Vanneste, S., & De Ridder, D. (2022). High-definition transcranial infraslow pink noise stimulation for chronic low back pain: protocol for a pilot, safety and feasibility randomised placebo-controlled trial. BMJ open, 12(6), e056842.
Adhia, D.B., University of Otago, New Zealand
Mani, R., University of Otago, New Zealand
Turner, P., University of Otago, New Zealand
O'Leary, F., University of Otago, New Zealand
Hall, M., University of Otago, New Zealand
Reynolds, J.N.J., University of Otago, New Zealand
Vanneste, S., Trinity College Dublin, Ireland
De Ridder, D., University of Otago, New Zealand
Introduction
In people with chronic low back pain (CLBP), neuroimaging studies demonstrate altered electrical activities in cortical areas responsible for pain modulation, emotional, and sensory components of pain experience [i.e., pregenual and dorsal anterior cingulate cortex (pgACC, dACC), and somatosensory cortex (SSC) respectively].1 Treatments targeting to change electrical activities of these key brain regions may produce clinical benefits.2
Aims
To determine feasibility, safety, and acceptability of a novel neuromodulation technique, high-definition transcranial infraslow pink noise stimulation (HD-tIPNS), in people with CLBP, and explore its effects on pain and disability.
Methods
A pilot triple-blinded (participant, treating therapist, and outcome assessor) randomized placebo-controlled trial. Participants with CLBP (n=40) received 20 sessions of either HD-tIPNS (targeting pgACC, dACC, SSC) or Sham stimulation. Feasibility and safety measures were collected, and acceptability of intervention was assessed post-intervention. Brief pain inventory and Roland-Morris Disability Questionnaires were administered at baseline, immediately post-intervention, and at one-week, one-month, and three-months post-intervention. Data were analysed descriptively.
Results
Feasibility data includes recruitment rate (28%), randomization (100%), dropouts (8%) and treatment adherence (91%). No serious adverse events were reported. Participants reported moderate to high levels of acceptability (Mean±SD:2.57.2±2.5) and treatment satisfaction (Mean±SD:6.3±2.5). A higher proportion of participants in HD-tIPNS group demonstrated a clinically meaningful reduction in pain severity (70%), interference (65%), and disability (65%), when compared to sham stimulation group at three-months post-intervention.
Conclusion
HD-tIPNS is a safe and an acceptable approach for treating CLBP. A fully powered trial is feasible and warranted to test effectiveness of HD-tIPNS in people with CLBP.
References
1. De Ridder, D., Vanneste, S., Smith, M., & Adhia, D. (2022). Pain and the triple network model. Frontiers in neurology, 13, 272.
2. Adhia, D. B., Mani, R., Reynolds, J. N., Vanneste, S., & De Ridder, D. (2022). High-definition transcranial infraslow pink noise stimulation for chronic low back pain: protocol for a pilot, safety and feasibility randomised placebo-controlled trial. BMJ open, 12(6), e056842.
