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

NCT ID: NCT06158321

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-08-31

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.

Conditions

Chronic Pain; Insomnia

Keywords

Chronic low back pain; Insomnia; rTMS; RCT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

M1 or DLPFC sham stimulation

Participants will receive M1 or DLPFC sham stimulations.

Group Type: SHAM_COMPARATOR

M1 or DLPFC sham stimulation

Intervention Type: DEVICE

Participants receiving M1 or DLPFC sham stimulations will complete the same procedures as those in the active groups. The sham coil, with the same stimulation parameters, will provide auditory and sensory effects similar to the active coil without delivering active stimulation.

M1 rTMS

Participants will receive high-frequency rTMS over M1.

Group Type: EXPERIMENTAL

M1 rTMS

Intervention Type: DEVICE

The stimulation parameter of the active M1-rTMS is a 10 Hz stimulation frequency with a total of 1500 stimulation pulses.

DLPFC rTMS

Participants will receive low-frequency rTMS over DLPFC.

Group Type: EXPERIMENTAL

DLPFC rTMS

Intervention Type: DEVICE

The stimulation parameter of the active DLPFC-rTMS is a 1 Hz stimulation frequency with a total of 1500 stimulation pulses.

Interventions

M1 or DLPFC sham stimulation

Participants receiving M1 or DLPFC sham stimulations will complete the same procedures as those in the active groups. The sham coil, with the same stimulation parameters, will provide auditory and sensory effects similar to the active coil without delivering active stimulation.

Intervention Type: DEVICE

M1 rTMS

The stimulation parameter of the active M1-rTMS is a 10 Hz stimulation frequency with a total of 1500 stimulation pulses.

Intervention Type: DEVICE

DLPFC rTMS

The stimulation parameter of the active DLPFC-rTMS is a 1 Hz stimulation frequency with a total of 1500 stimulation pulses.

Intervention Type: DEVICE

Other Intervention Names

Participants will receive high-frequency rTMS over M1.

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HongKongPU_Jeremy

Identifier Type: -

Identifier Source: org_study_id