High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Otago
- Enrollment
- 164
- Locations
- 2
- Primary Endpoint
- Pain intensity
Study Overview
Brief Summary
This study looks at the non-invasive brain stimulation technique in people with chronic low back pain to see:
- How effective non-invasive brain stimulation is at improving pain intensity in people with chronic low back pain?
- How safe non-invasive brain stimulation is and what side effects there may be?
- What study participants think of the study procedures and of the non-invasive brain stimulation as a treatment technique for chronic low back pain.
Participants will be assigned to receive either active brain stimulation group or sham stimulation group randomly.
Participants will be required to attend a total of twelve treatment sessions (approximately 1-hour each, three sessions per week, for four consecutive weeks).
Assessments will be done at baseline (in the week 0), immediately post-completion of the intervention (in the week 5), and at the follow-up of one-month (in the week 8), three-months (in the week 16) and six-months (in the week 28) post-completion of intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The statistician analysing the data will also be blinded to the group allocation.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 to 75 years on the day of screening
- •Pain in the lower back (region between 12th rib and gluteal fold) with or without accompanying leg pain that occurs for at least half the days in the last six months
- •An average pain intensity of ≥4 on the 11-point NPRS (0=No pain to 10=Pain as bad as you can imagine) in the week prior to enrolment
- •A disability score of ≥5 on Roland-Morris Disability Questionnaire (RMDQ).
Exclusion Criteria
- •Known or suspected serious spinal pathology (fracture; lumbar canal stenosis, malignant, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder)
- •Suspected or confirmed pregnancy or less than six months post-partum
- •Inflammatory disorders
- •Auto-immune conditions
- •Recent soft tissue injuries of the back in the last 3 months
- •Recent steroid injections to the back in the past 3 months
- •Recent spinal surgery in the past 12 months or scheduled/waiting for any major surgical procedures during the treatment or follow-up period or underwent rhizotomy or any neurosurgical procedures
- •History of neurological conditions, or psychiatric disorders (except depression and anxiety disorders)
- •History of cancer, or currently receiving/scheduled for receiving therapy for cancer
- •Cognitive impairments (dementia, Alzheimer's disease; indicated by a total score of 24 or below on Mini-Mental State Examination)
- •Alcohol or substance abuse
- •History of epilepsy or seizures
- •Presence of any electronic implants (e.g., pacemaker), metal implant in the body (particularly head and neck), or spinal cord stimulator.
Arms & Interventions
High definition transcranial infraslow gray noise stimulation (HD-tIGNS)
For the active stimulation group, the HD-tIGNS will be delivered for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between. The gray noise (50%) will be superimposed on the infraslow (0.1Hz) sinusoidal waveform (50%), with the maximum current strength of 2.0 mA per electrode and the maximum total current injected being 4.0mA.
Intervention: High-definition transcranial infraslow grey noise stimulation (Device)
Sham stimulation
For the sham stimulation group, to create an identical skin sensation to the active stimulation, we will use the Actisham protocol (with FC2 as the itchy electrode) created by the Neuroelectrics. The current will be applied for a 5s ramp up and 5s ramp down at the beginning of each stimulation session, without any current for the remainder of the stimulation period. The sham session will last as long as the HD-tIGNS session to blind the procedure appropriately.
Intervention: Sham Comparator (Device)
Outcomes
Primary Outcomes
Pain intensity
Time Frame: The primary endpoint for efficacy assessment of HD-tIGNS will be change in the average pain intensity over the past week from baseline to one-week post completion of treatment.
Average pain intensity over the past week measured on a numeric pain rating scale (NPRS) of 0 to 10 (0=No pain to 10=Pain as bad as you can imagine) from the Brief Pain Inventory short form
Secondary Outcomes
- Pain intensity(Change in the average pain intensity over the past week from baseline to one-month, three-months and six-months post completion of treatment.)
- Pain interference(Change in the pain interference from baseline to one-week, one-month, three-months and six-months post completion of treatment.)
- Pain unpleasantness(Change in the pain unpleasantness from baseline to one-week, one-month, three-months and six-months post completion of treatment.)
- Pain Bothersomeness(Change in the pain bothersomeness from baseline to one-week, one-month, three-months and six-months post completion of treatment.)
- Patient global impression of change(Recorded at one-week, one-month, three-months, and six-months post completion of treatment.)
- Movement Evoked Pain: Repeated spinal bending(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Movement Evoked Pain: Back Performance scale(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Mechanical temporal summation(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Pressure Pain Threshold(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Function(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Health Related Quality of Life(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Well-Being(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Depression(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Catastrophizing(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Attention to pain(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Positive and Negative Affect(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Self-efficacy(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Intolerance to Uncertainity scale short form(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Tampa scale of Kinesiophobia(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.)
- Rescue analgesics / Concomitant treatment(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. QAQ will also be collected during intervention period, either at start of sessions (S1, S4, S7, S10) or after completion of the session (S12).)
- Electroencephalography(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. EEG will also be collected during intervention phase either at start of the sessions (S1,S4,S7,S10) or after completion of sessions (S1 and S12).)
- Emotional Stroop Task(Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. Stroop testing will be also be done during the intervention phase either at start of sessions (S4, S7, S10) or after completion of session (S12).)