Chronic Pain, Insomnia
Conditions
Keywords
Chronic low back pain, Insomnia, rTMS, RCT
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.
Interventions
DEVICEM1 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.
DEVICEM1 rTMS
The stimulation parameter of the active M1-rTMS is a 10 Hz stimulation frequency with a total of 1500 stimulation pulses.
DEVICEDLPFC rTMS
The stimulation parameter of the active DLPFC-rTMS is a 1 Hz stimulation frequency with a total of 1500 stimulation pulses.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Three-arm pilot randomized controlled trial (RCT)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility rate | Two weeks | The percentage of eligible participants |
| Recruitment rate | Two weeks | The percentage of eligible individuals who provide informed consent for participation |
| Attrition rate | Two weeks | The percentage of recruited participants who did not attend the intervention or follow-up reassessment |
| Adherence to the intervention | Two weeks | The percentage of sessions attended by each participant |
| Adverse events | Two weeks | They will be monitored and documented after each treatment session |
| Accepatbility | Two weeks | To assess the acceptability of our pilot trial and treatment process, a semi-structured interview will be conducted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Sensory Testing (QST) | Two weeks | 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). |
| Pain intensity | Two and six weeks | 11-point Numerical Pain Rating Scale, with 0 = no pain and 10 = worst pain. imaginable |
| Pain catastrophizing | Two and six weeks | 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. |
| Electroencephalography (EEG) | Two weeks | 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). |
| Back-related disability | Two and six weeks | The Roland Morris Disability Questionnaire consists of 24 items, with a total score of 24 and a higher score indicating greater functional limitation. |
| Insomnia severity | Two and six weeks | The Insomnia Severity Index consists of seven items, with a total score of 28 and a higher score indicating severer insomnia. |
| Sleep quality | Two and six weeks | The Pittsburgh Sleep Quality Index consists of 19 individual items, with a total score of 21 and a higher score indicating poorer sleep quality. |
| Subjetcive sleep parameters | Two weeks | 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. |
| Objetcive sleep parameters | Two weeks | 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. |
Outcome results
None listed