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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
Recrutiment feasibility
Number of particpants enrolled within the recruitment period
Time frame: 12 months
Retention/completion rate
Proportion of participants completing assessments
Time frame: 16 and 24 weeks
Intervention Adherence
Percentage attending ≥ 70% chiropractic sessions
Time frame: 16 weeks
Clinical outcomes
Neck pain intensity, Neck Pain Disability Index, Promis 29, Bothersomeness of Pain, Pain on Movement
Time frame: baseline, 16 and 24 weeks
Biomarkers / mechanistic
Peak alpha frequency ERP amplitudes Gait speed and stride time variability Stride length Dual task cost (gait speed and variability)
Time frame: baseline and 16 weeks
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