Clinical trial NCT06158321: rTMS in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia
Official title: The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Insomnia
Keywords: Chronic low back pain
Insomnia
rTMS
RCT
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm pilot randomized controlled trial (RCT)
Primary purpose: TREATMENT

Brief summary: This pilot randomized controlled trial (RCT) aims to investigate the feasibility and efficiency of delivering different rTMS protocols in individuals with CLBP and insomnia. Participants will be randomly assigned to either the primary motor cortex (M1) rTMS, the dorsolateral prefrontal cortex (DLPFC) rTMS, or sham stimulation.

Detailed description: Sleep disturbance exacerbates pain perception, disability, and poor prognosis in individuals with chronic low back pain (CLBP). A recent systematic review demonstrated that improvements in sleep disturbance were associated with corresponding improvements in pain intensity, recovery, and disability in individuals with CLBP. These findings indicate that achieving restorative sleep is likely to mitigate chronic pain symptoms. The application of rTMS at a specific frequency over a focal brain area has been proposed as a promising treatment for chronic pain and insomnia independently. To date, no studies have compared the effectiveness of different rTMS protocols in treating comorbid CLBP and insomnia. Given the above, the current study aims to investigate the feasibility and acceptability of delivering different rTMS protocols in individuals with CLBP and insomnia and explore the relative therapeutic efficacy of these protocols on pain and sleep parameters at immediate post-treatment and one-month follow-up.

Eligibility criteria: Inclusion Criteria:

1. participants aged between18 and 65 years;
2. willing to participate in the study and randomization;
3. having stable pharmacological or nonpharmacological treatments for pain or sleep at least one month prior to study participation;
4. having CLBP (defined as pain between 12 ribs and gluteal crease with or without leg pain that has persisted for at least three months)
5. diagnosing insomnia using the Brief Insomnia Questionnaire (BIQ) based on the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)

Exclusion Criteria

1. specific causes of CLBP (e.g., spondylosis, spondyloarthropathy, or vertebral fracture);
2. pregnancy or nursing;
3. previous spinal surgery;
4. inflammatory or autoimmune diseases;
5. other sleep disorders (e.g., sleep apnea or restless leg);
6. presence of severe psychopathologies, neurological, or physical disease directly related to the onset of insomnia (e.g., depression, substance abuse, or alcohol abuse);
7. severe dependence on hypnotic drugs;
8. concurrent receipt of new treatments outside the scope of the study;
9. contraindications to use rTMS (e.g., severe head trauma, intracranial hypertension, implanted ferromagnetic devices, history of epilepsy).

Primary outcomes:
measure: Eligibility rate
timeFrame: Two weeks
measure: Recruitment rate
timeFrame: Two weeks
measure: Attrition rate
timeFrame: Two weeks
measure: Adherence to the intervention
timeFrame: Two weeks
measure: Adverse events
timeFrame: Two weeks
measure: Accepatbility
timeFrame: Two weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: Two and six weeks
measure: Back-related disability
timeFrame: Two and six weeks
measure: Insomnia severity
timeFrame: Two and six weeks
measure: Sleep quality
timeFrame: Two and six weeks
measure: Subjetcive sleep parameters
timeFrame: Two weeks
measure: Objetcive sleep parameters
timeFrame: Two weeks
measure: Quantitative Sensory Testing (QST)
timeFrame: Two weeks
measure: Electroencephalography (EEG)
timeFrame: Two weeks
measure: Pain catastrophizing
timeFrame: Two and six weeks
Other outcomes:
Locations:
Study officials:
References: