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

NCT06158321 | Unknown

• 1 other identifier: HongKongPU_Jeremy
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain; Insomnia

Keywords

Chronic low back pain; Insomnia; rTMS; RCT

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Pain intensity

  Two and six weeks

• Back-related disability

  Two and six weeks

• Insomnia severity

  Two and six weeks

• Sleep quality

  Two and six weeks

• Subjetcive sleep parameters

  Two weeks

Study Arms (3)

M1 or DLPFC sham stimulation

SHAM COMPARATOR

Participants will receive M1 or DLPFC sham stimulations.

Device: M1 or DLPFC sham stimulation

M1 rTMS

EXPERIMENTAL

Participants will receive high-frequency rTMS over M1.

Device: M1 rTMS

DLPFC rTMS

EXPERIMENTAL

Participants will receive low-frequency rTMS over DLPFC.

Device: DLPFC rTMS

Interventions

M1 or DLPFC sham stimulation DEVICE

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 or DLPFC sham stimulation

M1 rTMS DEVICE

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

Also known as: Participants will receive high-frequency rTMS over M1.

M1 rTMS

DLPFC rTMS DEVICE

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

DLPFC rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group assignment will be concealed through opaque and sealed envelopes, which will be administered by a research assistant who is not involved in the study. The envelopes will be opened after the participant consented to participate in the trial. Assessors, participants, and therapists will be blind to the allocation of rTMS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm pilot randomized controlled trial (RCT)

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: December 6, 2023
• Study Start: December 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share