Status:
UNKNOWN
rTMS in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
Chronic Pain
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
NA
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 rando...
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 distu...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06158321
Start Date
December 1 2024
End Date
August 31 2025
Last Update
December 6 2023
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