Neck PainNCT07469553
Chiropractic Care for Chronic Neck Pain: A Pilot Study
A study testing Multimodal chiroprctic care in people with Neck Pain, run by Brigham and Women's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Multimodal chiroprctic care
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chiropractic Care for Chronic Neck Pain: A Pilot Randomized Controlled Trial Evaluating Feasibility, Clinical Outcomes, and EEG/Gait Biomarkers
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.
Read the 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
- Neck Pain
- Being tested
- Multimodal chiroprctic care, Enahnced usual care
- Keywords
- neck pain, chiropractic care, EEG, gait, randomized trial
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal chiroprctic careProcedure or surgery
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Multimodal chiroprctic care; Behavioral: 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. Receives: Behavioral: Enahnced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recrutiment feasibility
Number of particpants enrolled within the recruitment period
Measured: 12 months
Retention/completion rate
Proportion of participants completing assessments
Measured: 16 and 24 weeks
Intervention Adherence
Percentage attending ≥ 70% chiropractic sessions
Measured: 16 weeks
Secondary outcomes (2)
Clinical outcomes
Neck pain intensity, Neck Pain Disability Index, Promis 29, Bothersomeness of Pain, Pain on Movement
Measured: 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)
Measured: baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Palmer College of Chiropractic
- Responsible party
- Principal investigator, Peter M. Wayne, Ph.D., Brigham and Women's Hospital
- Investigators
- Peter Wayne, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469553
- Sponsor's protocol ID
- 2025P001245
- Other IDs
- GR0117830
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic Care for Chronic Neck Pain: A Pilot Randomized Controlled Trial Evaluating Feasibility, Clinical Outcomes, and EEG/Gait Biomarkers
- ClinicalTrials.gov ID
- NCT07469553
- Acronym / sponsor ID
- 2025P001245
- Conditions
- Neck Pain
- Keywords
- neck pain, chiropractic care, EEG, gait, randomized trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Palmer College of Chiropractic
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic trial
| Arm | Type | Receives |
|---|---|---|
| Multimodal chiropractic care | Experimental | Procedure: Multimodal chiroprctic care, Behavioral: Enahnced usual 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. |
| Enhanced usual care | Active comparator | Behavioral: Enahnced 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal 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. | Procedure or surgery | Multimodal chiropractic care |
| Enahnced 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. | Behavioural | Enhanced usual care, Multimodal chiropractic care |
Primary outcome
Recrutiment feasibility
Time frame: 12 months
Number of particpants enrolled within the recruitment period
Retention/completion rate
Time frame: 16 and 24 weeks
Proportion of participants completing assessments
Intervention Adherence
Time frame: 16 weeks
Percentage attending ≥ 70% chiropractic sessions
2 secondary outcomes
Clinical outcomes
Time frame: baseline, 16 and 24 weeks
Biomarkers / mechanistic
Time frame: baseline and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Neck Pain
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Non-specific Chronic Neck Pain
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Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
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Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
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Effects of Cervical SNAGs With and Without Thoracic Manipulation on Neck Pain and Disability in Smartphone Users
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Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Wayne, PhD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal chiroprctic care in people with Neck Pain, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Macy Randolph, DC (617-732-6271, pwayne@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recrutiment feasibility (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.