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NCT07469553

Chiropractic Care for Chronic Neck Pain: A Pilot Study

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Chiropractic Care for Chronic Neck Pain: A Pilot Randomized Controlled Trial Evaluating Feasibility, Clinical Outcomes, and EEG/Gait Biomarkers

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2027-09-30

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Neck Pain

Interventions

PROCEDURE

Multimodal chiroprctic 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.

BEHAVIORAL

Enahnced 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.

Inclusion Criteria: 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. Exclusion Criteria: * 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).