NCT05726331 · Harvard University Faculty of Medicine
Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care
What this study is about
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).
View original scientific description
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).
Interventions
OTHER
Chiropractic Care
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.
OTHER
Tai Chi
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.
OTHER
Enhanced Usual Care
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).
Primary outcome measures
Recruitment rate
Time frame: Through study completion (an average of 18 months)
Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
Retention rate
Time frame: Through study completion (an average of 18 months)
Retention rate will be quantified by the proportion of subjects who remain in the study to complete the 24-week visit.
Intervention adherence
Time frame: Through study completion (an average of 18 months)
Intervention adherence will be measured by collection of chiropractic visit attendance and Tai Chi class attendance data.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Where
- Chestnut Hill, Massachusetts
Collaborators
Brigham and Women's Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 19, 2024 · Source of record for eligibility and locations