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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06158321
• Other study ID #: HongKongPU_Jeremy
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Insomnia
• Low Back Pain
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• M1 rTMS
The stimulation parameter of the active M1-rTMS is a 10 Hz stimulation frequency with a total of 1500 stimulation pulses.
• DLPFC rTMS
The stimulation parameter of the active DLPFC-rTMS is a 1 Hz stimulation frequency with a total of 1500 stimulation pulses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eligibility rate	The percentage of eligible participants	Two weeks
Primary	Recruitment rate	The percentage of eligible individuals who provide informed consent for participation	Two weeks
Primary	Attrition rate	The percentage of recruited participants who did not attend the intervention or follow-up reassessment	Two weeks
Primary	Adherence to the intervention	The percentage of sessions attended by each participant	Two weeks
Primary	Adverse events	They will be monitored and documented after each treatment session	Two weeks
Primary	Accepatbility	To assess the acceptability of our pilot trial and treatment process, a semi-structured interview will be conducted.	Two weeks
Secondary	Pain intensity	11-point Numerical Pain Rating Scale, with 0 = no pain and 10 = worst pain. imaginable	Two and six weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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