rTMS in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: Insomnia; Chronic Pain

Treatments: Device: M1 or DLPFC sham stimulation; Device: M1 rTMS; Device: DLPFC rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06158321

HongKongPU_Jeremy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

M1 or DLPFC sham stimulation

Sham Comparator group

Description:

Participants will receive M1 or DLPFC sham stimulations.

Treatment:

Device: M1 or DLPFC sham stimulation

M1 rTMS

Experimental group

Description:

Participants will receive high-frequency rTMS over M1.

Treatment:

Device: M1 rTMS

DLPFC rTMS

Experimental group

Description:

Participants will receive low-frequency rTMS over DLPFC.

Treatment:

Device: DLPFC rTMS