What this study is
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).
What's being tested
- Chiropractic Care
Intervention · OTHER
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
Intervention · OTHER
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
Intervention · OTHER
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).
Study details
- Official title
- Combined Chiropractic Care and Tai Chi for Chronic Non-Specific Neck Pain
- Sponsor
- Harvard University Faculty of Medicine
- Conditions
- Neck Pain · Chronic Pain
- Enrolling
- 48 people
- Starts
- 2023-10-25
- Est. completion
- 2026-12-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOsher Clinical Center at Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
- Jacqui Guzman, BA · Contact617-732-9418jguzman5@bwh.harvard.edu
Recruiting
Study team
Sponsor
Harvard University Faculty of Medicine
Study ID 2021A014141
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.