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

The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Insomnia
• Intervention / Treatment: Device: M1 or DLPFC sham stimulation; Device: M1 rTMS; Device: DLPFC rTMS

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: M1 or DLPFC sham stimulation; Participants will receive M1 or DLPFC sham stimulations.	Device: 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.
Experimental: M1 rTMS; Participants will receive high-frequency rTMS over M1.	Device: M1 rTMS; The stimulation parameter of the active M1-rTMS is a 10 Hz stimulation frequency with a total of 1500 stimulation pulses.; Other Names: Participants will receive high-frequency rTMS over M1.
Experimental: DLPFC rTMS; Participants will receive low-frequency rTMS over DLPFC.	Device: DLPFC rTMS; The stimulation parameter of the active DLPFC-rTMS is a 1 Hz stimulation frequency with a total of 1500 stimulation pulses.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	11-point Numerical Pain Rating Scale, with 0 = no pain and 10 = worst pain. imaginable	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.	Two and six weeks
Insomnia severity	The Insomnia Severity Index consists of seven items, with a total score of 28 and a higher score indicating severer insomnia.	Two and six weeks
Sleep quality	The Pittsburgh Sleep Quality Index consists of 19 individual items, with a total score of 21 and a higher score indicating poorer sleep quality.	Two and six weeks
Subjetcive sleep parameters	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.	Two weeks
Objetcive sleep parameters	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.	Two weeks
Quantitative Sensory Testing (QST)	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).	Two weeks
Electroencephalography (EEG)	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).	Two weeks
Pain catastrophizing	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.	Two and six weeks

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Estimated): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Insomnia; RCT; rTMS; Chronic low back pain
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: HongKongPU_Jeremy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No