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

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Insomnia
• Interventions: Device: M1 rTMS; Device: M1 or DLPFC sham stimulation; Device: DLPFC rTMS

• Registration Number: NCT06158321
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Study Start: 2024-12-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M1 rTMS	M1 rTMS	Participants will receive high-frequency rTMS over M1.
M1 or DLPFC sham stimulation	M1 or DLPFC sham stimulation	Participants will receive M1 or DLPFC sham stimulations.
DLPFC rTMS	DLPFC rTMS	Participants will receive low-frequency rTMS over DLPFC.

Primary Outcome Measures

Name	Time	Method
Eligibility rate	Two weeks	The percentage of eligible participants
Adherence to the intervention	Two weeks	The percentage of sessions attended by each participant
Accepatbility	Two weeks	To assess the acceptability of our pilot trial and treatment process, a semi-structured interview will be conducted.
Attrition rate	Two weeks	The percentage of recruited participants who did not attend the intervention or follow-up reassessment
Adverse events	Two weeks	They will be monitored and documented after each treatment session
Recruitment rate	Two weeks	The percentage of eligible individuals who provide informed consent for participation

Secondary Outcome Measures

Name	Time	Method
Back-related disability	Two and six weeks	The Roland Morris Disability Questionnaire consists of 24 items, with a total score of 24 and a higher score indicating greater functional limitation.
Subjetcive sleep parameters	Two weeks	Participants will subjectively report the time of falling asleep and waking up, sleep onset latency, and quantity and duration of nighttime awakenings. Several variables will be derived from the sleep diaries, including sleep efficiency, sleep onset latency, total sleep time, and wake after sleep onset.
Pain intensity	Two and six weeks	11-point Numerical Pain Rating Scale, with 0 = no pain and 10 = worst pain. imaginable
Sleep quality	Two and six weeks	The Pittsburgh Sleep Quality Index consists of 19 individual items, with a total score of 21 and a higher score indicating poorer sleep quality.
Objetcive sleep parameters	Two weeks	Actigraphy will be employed to collect objective sleep parameters. The software automatically generates relevant sleep parameters involving sleep efficiency, sleep onset latency, total sleep time, wake after sleep onset.
Quantitative Sensory Testing (QST)	Two weeks	QST will include static pain threshold (thermal, pressure, or pinprick stimulus) and dynamic pain assessments (temporal or spatial summation of pain and conditioned pain modulation).
Electroencephalography (EEG)	Two weeks	EEG recordings will be conducted during the resting state. Power spectral density (PSD) will be computed by a Fast Fourier Transformation and quantify the amount of oscillatory activity in five frequency bands: delta (0.5-4.0Hz), theta (4.0-8.0 Hz), alpha (8.0-13.0 Hz), beta (14.0-30.0 Hz), and gamma (30.0-10.00Hz).
Insomnia severity	Two and six weeks	The Insomnia Severity Index consists of seven items, with a total score of 28 and a higher score indicating severer insomnia.
Pain catastrophizing	Two and six weeks	The Pain Catastrophizing Scale (PCS) consists of 13 items with a five-point Likert scale scoring from zero (not at all) to four (always). High total scores indicate more catastrophic thoughts.