Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care
Combined Chiropractic Care and Tai Chi for Chronic Non-Specific Neck Pain
1 other identifier
interventional
48
1 country
1
Brief Summary
This feasibility project aims to evaluate the effectiveness of chiropractic care combined with Tai Chi (TC) training to reduce pain and disability in adults with chronic non-specific neck pain (CNNP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
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 3, 2023
CompletedFirst Posted
Study publicly available on registry
February 13, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedJanuary 19, 2024
January 1, 2024
2.5 years
February 3, 2023
January 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Recruitment rate
Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
Through study completion (an average of 18 months)
Retention rate
Retention rate will be quantified by the proportion of subjects who remain in the study to complete the 24-week visit.
Through study completion (an average of 18 months)
Intervention adherence
Intervention adherence will be measured by collection of chiropractic visit attendance and Tai Chi class attendance data.
Through study completion (an average of 18 months)
Secondary Outcomes (11)
Pain intensity
Baseline, 16-weeks, and 24-weeks
Pain on movement (POM)
Baseline, 16-weeks, and 24-weeks
Bothersomeness of pain
Baseline, 16-weeks, and 24-weeks
Disability
Baseline, 16-weeks, and 24-weeks
Health-related quality of life
Baseline, 16-weeks, and 24-weeks
- +6 more secondary outcomes
Study Arms (3)
Chiropractic Care, Tai Chi, and EUC
EXPERIMENTALParticipants assigned to this arm will receive 10 sessions of chiropractic care over 16 weeks, administered by chiropractors at collaborating clinics in the Greater Boston area. Participants assigned to this arm will also be enrolled in a community-based TC program. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain.
Chiropractic care and EUC
ACTIVE COMPARATORParticipants assigned to the chiropractic care+EUC arm will receive 10 sessions of chiropractic care over 16 weeks administered by chiropractors at collaborating clinics in the Greater Boston area. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain.
EUC
ACTIVE COMPARATORIndividuals assigned to the EUC alone group will be asked to continue their usual medical care as prescribed by their physician for 16 weeks. In addition, they will be asked to not seek chiropractic care or TC during the study. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain. We will also provide this arm of participants with increased attention in the form of biweekly calls from the study research assistants.
Interventions
Chiropractic care will be delivered by community-based chiropractors that meet pre-set qualifications. Chiropractic treatment protocol will be multimodal and will follow predefined standard operating procedures including the following 6 components: 1) Posture correction and spinal stabilization exercises; 2) Soft tissue release techniques; 3) Manual spinal manipulation; 4) Condition-specific education; 5) Myofascial strengthening and motor control training; 6) Ergonomic and lifestyle modifications/advice. Subjects randomized to chiropractic treatment groups will receive up to 10 chiropractic sessions over 16 weeks.
Tai Chi (TC) will be delivered by community based Tai Chi schools that meet pre-set qualifications. TC programs will emphasize core principles including biomechanically efficient alignment, relaxed integrated movements, deep breathing, and heightened body awareness. Subjects randomized to TC treatment group will attend at least one TC class per week for 16 weeks.
Enhanced Usual Care will include educational materials about neck pain provided by the study, in addition to usual medical care for CNNP. Usual care for CNNP generally includes medications (non-narcotic analgesics, NSAIDs, muscle relaxants), interventional pain management (e.g., steroid injections), and self-care exercises (all of which will be monitored and recorded in all three study arms).
Eligibility Criteria
You may qualify if:
- Chronic nonspecific neck pain at least 5 days a week for at least 3 consecutive months
- Neck pain averaged over past week of 3 or more on numerical rating scale ranging from 0 to 10, with 10 described as 'worst neck pain imaginable'
- Neck Disability Index score of 5 or greater
- Agreeable to participate in all study procedures and be randomized to all intervention groups
- Fluent in English
You may not qualify if:
- Currently, or having received chiropractic care in past 12 months
- Regular practice (on average, weekly) of Yoga, Tai Chi or Qigong in the past 6 months
- Any major systemic illness or unstable medical condition (e.g. Parkinson's disease, cancer) or psychiatric condition requiring immediate treatment or that could lead to difficulty complying with the protocol
- Any disability precluding exercise practice
- History of stroke, carotid artery dissection, or vertebral artery dissection
- Signs of myelopathy or carotid bruits or evidence of pathological hypermobility (e.g. Ehlers Danlos Syndrome) during the clinical exam
- Neck pain caused by congenital deformity of the spine that contraindicate treatment, neck pain related to neoplasm, inflammatory rheumatic disease, neurological disorder, active oncologic disease, severe affective disorder, addiction, or psychosis
- Neck pain associated with unstable radicular pain or radiculopathy
- Pregnancy
- Recent spinal injections (in the past 4 weeks)
- Neck pain with litigation
- Any prior cervical surgery/spinal surgery within previous year
- Persons currently involved in a disability/accident claim
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Osher Clinical Center at Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02199, United States
Related Publications (1)
Wayne PM, Vining R, Long CR, Burton WM, Litrownik D, Guzman J, Kilgore K, Hagan TJ, Rist PM, Kowalski MH. Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial. Contemp Clin Trials Commun. 2025 Apr 11;45:101482. doi: 10.1016/j.conctc.2025.101482. eCollection 2025 Jun.
PMID: 40321971DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 3, 2023
First Posted
February 13, 2023
Study Start
October 25, 2023
Primary Completion
April 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 19, 2024
Record last verified: 2024-01