Chiropractic Care for Chronic Neck Pain: A Pilot Randomized Controlled Trial Evaluating Feasibility, Clinical Outcomes, and EEG/Gait Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Recrutiment feasibility
研究概览
简要总结
This pilot randomized controlled trial will evaluate the feasibility and preliminary clinical effects of multimodal chiropractic care for adults with chronic neck pain. Forty participants will be randomized to receive either multimodal chiropractic care plus enhanced usual care or enhanced usual care alone. Feasibility outcomes include recruitment, retention, adherence, and safety. Clinical outcomes include pain intensity, neck-related disability, physical and psychological function, and quality of life. Exploratory electroencephalography (EEG) and gait assessments will examine potential neurophysiological and biomechanical biomarkers associated with treatment response.
详细描述
Chronic neck pain is highly prevalent and contributes substantially to disability, healthcare utilization, and reduced quality of life. Non-pharmacologic approaches such as chiropractic care are commonly used, yet mechanistic and feasibility data to inform larger trials remain limited. This two-arm pilot randomized controlled study will enroll 40 adults with chronic neck pain and allocate them 1:1 to multimodal chiropractic care plus enhanced usual care or enhanced usual care alone. The chiropractic intervention includes spinal manipulation or mobilization, soft tissue therapies, therapeutic exercise, and patient education delivered over 10 sessions across 16 weeks. Primary objectives focus on feasibility metrics including recruitment, retention, adherence, and safety. Secondary objectives evaluate changes in pain, disability, function, and quality of life. Exploratory aims assess resting-state and task-based EEG and gait biomarkers to investigate potential neurophysiological mechanisms associated with clinical improvement. Results will inform the design and implementation of a future fully powered randomized clinical trial.
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
- None
盲法说明
Statisticians until data are cleaned and locked
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
- •Adults aged 18-65 years Diagnosis of CNP (e.g., nociceptive, neuropathic, or nociplastic origin) occurring ≥5 days per week for ≥3 consecutive months.
- •Average neck pain intensity ≥3 on a 0-10 Numerical Rating Scale (NRS) during the past week (0 = no pain at all; 10 = worst neck pain imaginable).
- •Neck Disability Index (NDI) score ≥5 [37] 10-item instrument with scores ranging from 0 (no disability) to 50 (complete disability).
- •Willingness to complete all study procedures. Willingness to be randomized to either of the two intervention groups. Fluent in English.
排除标准
- •Currently receiving chiropractic care or have received chiropractic care within the past 12 months.
- •Participation in ≥1 session per week of mind-body or rehabilitation therapies (e.g., physical therapy, yoga, tai chi, Qigong) within the past 12 months.
- •Any disability precluding exercise participation. Pregnancy. Pregnancy status will be assessed by self-report only. No pregnancy testing will be conducted for the purposes of this study.
- •Prior cervical spine surgery or any spinal surgery within the past year. Active disability or accident-related compensation claim. Signs or symptoms of major systemic illness or unstable medical conditions (e.g., Parkinson's disease, cancer).
- •Psychiatric conditions requiring immediate treatment or likely to impair protocol compliance.
- •CNP attributable to on-neuromusculoskeletal source. Inflammatory arthritis. History of stroke, carotid dissection, or vertebral artery dissection. Presence of a neurological disorder. Suspected or confirmed pathological hypermobility. Receipt of interventional pain management to the cervical spine within 4 weeks prior to enrollment or planned during the study period.
- •Available diagnostic imaging demonstrating contraindications to study treatments (e.g., cervical myelopathy, substantial disc derangement).
- •Clinical screening findings indicating a need for diagnostic imaging. High risk for adverse events (AEs) related to any study treatment. Inadequate transportation to attend scheduled study visits. Contraindications to standard, non-invasive scalp EEG procedures (e.g., open scalp wounds, active skin infections, or unhealed surgical sites at electrode placement locations; recent craniotomy or skull defect that would interfere with safe electrode placement, Implanted neurostimulation devices; known seizure disorders or epilepsy; medical conditions for which EEG activation procedures are contraindicated (stroke, hyperventilation).
研究组 & 干预措施
Multimodal chiropractic care
10 visits over 16 weeks including spinal manipulation/mobilization, soft tissue therapy, exercise, and education.
Participants receive 10 visits of multimodal chiropractic care over 16 weeks in addition to enhanced usual care. Care may include spinal manipulation or mobilization, soft tissue therapy, therapeutic exercise, and education delivered by licensed chiropractors.
干预措施: Multimodal chiroprctic care (Procedure)
Multimodal chiropractic care
10 visits over 16 weeks including spinal manipulation/mobilization, soft tissue therapy, exercise, and education.
Participants receive 10 visits of multimodal chiropractic care over 16 weeks in addition to enhanced usual care. Care may include spinal manipulation or mobilization, soft tissue therapy, therapeutic exercise, and education delivered by licensed chiropractors.
干预措施: Enahnced usual care (Behavioral)
Enhanced usual care
Educational materials, usual medical care, biweekly check-in calls.
Participants continue their usual medical care and receive educational materials for neck pain self-management and biweekly check-in calls from study staff.
干预措施: Enahnced usual care (Behavioral)
结局指标
主要结局
Recrutiment feasibility
时间窗: 12 months
Number of particpants enrolled within the recruitment period
Retention/completion rate
时间窗: 16 and 24 weeks
Proportion of participants completing assessments
Intervention Adherence
时间窗: 16 weeks
Percentage attending ≥ 70% chiropractic sessions
次要结局
- Clinical outcomes(baseline, 16 and 24 weeks)
- Biomarkers / mechanistic(baseline and 16 weeks)
研究者
Peter M. Wayne, Ph.D.
Director, Osher Center for Integrative Health
Brigham and Women's Hospital