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NCT Number: NCT07469553

Chiropractic Care for Chronic Neck Pain: A Pilot Study

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Multimodal chiroprctic care

Procedure

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.

Enahnced usual care

Behavioral

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.

Primary outcomes

  1. Recrutiment feasibility

    Time frame: 12 months

    Number of particpants enrolled within the recruitment period

  2. Retention/completion rate

    Time frame: 16 and 24 weeks

    Proportion of participants completing assessments

  3. Intervention Adherence

    Time frame: 16 weeks

    Percentage attending ≥ 70% chiropractic sessions

Secondary outcomes

  1. Clinical outcomes

    Time frame: baseline, 16 and 24 weeks

    Neck pain intensity, Neck Pain Disability Index, Promis 29, Bothersomeness of Pain, Pain on Movement

  2. Biomarkers / mechanistic

    Time frame: baseline and 16 weeks

    Peak alpha frequency ERP amplitudes Gait speed and stride time variability Stride length Dual task cost (gait speed and variability)

Study contacts

Contact information is provided by the study sponsor or research team.

Macy Randolph, DC

CONTACT

[email protected]

617-732-6271

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Palmer College of Chiropractic

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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