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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Pain, Insomnia

Intervention / Treatment
-----------------
* Device: M1 or DLPFC sham stimulation
* Device: M1 rTMS
* Device: DLPFC rTMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants aged between18 and 65 years; willing to participate in the study and randomization; having stable pharmacological or nonpharmacological treatments for pain or sleep at least one month prior to study participation; having CLBP (defined as pain between 12 ribs and gluteal crease with or without leg pain that has persisted for at least three months) 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 specific causes of CLBP (e.g., spondylosis, spondyloarthropathy, or vertebral fracture); pregnancy or nursing; previous spinal surgery; inflammatory or autoimmune diseases; other sleep disorders (e.g., sleep apnea or restless leg); presence of severe psychopathologies, neurological, or physical disease directly related to the onset of insomnia (e.g., depression, substance abuse, or alcohol abuse); severe dependence on hypnotic drugs; concurrent receipt of new treatments outside the scope of the study; contraindications to use rTMS (e.g., severe head trauma, intracranial hypertension, implanted ferromagnetic devices, history of epilepsy).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three-arm pilot randomized controlled trial (RCT)
Masking: Quadruple


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic low back pain, Insomnia, rTMS, RCT