The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Eligibility rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
结局指标
主要结局
Eligibility rate
时间窗: Two weeks
The percentage of eligible participants
Adherence to the intervention
时间窗: Two weeks
The percentage of sessions attended by each participant
Accepatbility
时间窗: Two weeks
To assess the acceptability of our pilot trial and treatment process, a semi-structured interview will be conducted.
Attrition rate
时间窗: Two weeks
The percentage of recruited participants who did not attend the intervention or follow-up reassessment
Adverse events
时间窗: Two weeks
They will be monitored and documented after each treatment session
Recruitment rate
时间窗: Two weeks
The percentage of eligible individuals who provide informed consent for participation
次要结局
- Back-related disability(Two and six weeks)
- Subjetcive sleep parameters(Two weeks)
- Pain intensity(Two and six weeks)
- Sleep quality(Two and six weeks)
- Objetcive sleep parameters(Two weeks)
- Quantitative Sensory Testing (QST)(Two weeks)
- Electroencephalography (EEG)(Two weeks)
- Insomnia severity(Two and six weeks)
- Pain catastrophizing(Two and six weeks)