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

The Hong Kong Polytechnic University45 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Pain Insomnia

Interventions

M1 or DLPFC sham stimulationDEVICE

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 rTMSDEVICE

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

DLPFC rTMSDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Eligibility rate

The percentage of eligible participants

Time frame: Two weeks

Recruitment rate

The percentage of eligible individuals who provide informed consent for participation

Time frame: Two weeks

Attrition rate

The percentage of recruited participants who did not attend the intervention or follow-up reassessment

Time frame: Two weeks

Adherence to the intervention

The percentage of sessions attended by each participant

Time frame: Two weeks

Adverse events

They will be monitored and documented after each treatment session

Time frame: Two weeks

Accepatbility

To assess the acceptability of our pilot trial and treatment process, a semi-structured interview will be conducted.

Time frame: Two weeks

Secondary Outcomes

Pain intensity

11-point Numerical Pain Rating Scale, with 0 = no pain and 10 = worst pain. imaginable

Time frame: Two and six weeks

Back-related disability

The Roland Morris Disability Questionnaire consists of 24 items, with a total score of 24 and a higher score indicating greater functional limitation.

Time frame: Two and six weeks

Data from ClinicalTrials.gov

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