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Not Yet RecruitingNCT07469553

Chiropractic Care for Chronic Neck Pain: A Pilot Study

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Brigham and Women's Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREMultimodal chiroprctic care10 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.
BEHAVIORALEnahnced usual careEducational 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.

Timeline

Start date
2026-04-01
Primary completion
2027-06-30
Completion
2027-09-30
First posted
2026-03-13
Last updated
2026-03-13

Source: ClinicalTrials.gov record NCT07469553. Inclusion in this directory is not an endorsement.