NCT07469553

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

February 18, 2026

Last Update Submit

June 24, 2026

Conditions

Neck Pain

Keywords

neck painchiropractic careEEGgaitrandomized trial

Outcome Measures

Primary Outcomes (3)

  • Recrutiment feasibility

    Number of particpants enrolled within the recruitment period

    12 months

  • Retention/completion rate

    Proportion of participants completing assessments

    16 and 24 weeks

  • Intervention Adherence

    Percentage attending ≥ 70% chiropractic sessions

    16 weeks

Secondary Outcomes (2)

  • Clinical outcomes

    baseline, 16 and 24 weeks

  • Biomarkers / mechanistic

    baseline and 16 weeks

Study Arms (2)

Multimodal chiropractic care

EXPERIMENTAL

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.

Procedure: Multimodal chiroprctic careBehavioral: Enahnced usual care

Enhanced usual care

ACTIVE COMPARATOR

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.

Behavioral: Enahnced usual care

Interventions

Multimodal chiroprctic carePROCEDURE

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.

Multimodal chiropractic care
Enahnced usual careBEHAVIORAL

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.

Enhanced usual careMultimodal chiropractic care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Wayne, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Macy Randolph, DC

CONTACT

617-732-6271pwayne@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Statisticians until data are cleaned and locked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pragmatic trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Osher Center for Integrative Health

Study Record Dates

First Submitted

February 18, 2026

First Posted

March 13, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

June 26, 2026

Record last verified: 2026-06