rTMS in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia
Unknown statusNot applicableNCT06158321
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Interventions
- Device: M1 or DLPFC sham stimulation
- Device: M1 rTMS
- Device: DLPFC rTMS
- Sponsor
- The Hong Kong Polytechnic University
- Start date
- 2024-12-01
- Primary completion
- 2025-06-30
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06158321