Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial.
Peter M Wayne, Robert Vining, Cynthia R Long...
https://pubmed.ncbi.nlm.nih.gov/40321971/Actively Recruiting
Led by Harvard University Faculty of Medicine · Updated on 2024-01-19
48
Participants Needed
1
Research Sites
35 weeks
Total Duration
Researchers are evaluating the combined effect of chiropractic care and Tai Chi training on reducing pain and disability in adults with chronic non-specific neck pain. This pilot study aims to assess the feasibility of recruiting, retaining, and safely monitoring participants, while also measuring clinical outcomes such as pain levels, disability, quality of life, self-efficacy, and psychological factors related to neck pain. The study is sponsored by Harvard University Faculty of Medicine and involves adults aged 18 to 65 with persistent neck pain. Participants will be randomly assigned to one of three groups one group will receive 10 chiropractic treatments over 16 weeks along with Tai Chi group training for 16 weeks and enhanced usual care, which includes educational materials a second group will receive chiropractic care plus enhanced usual care and a third group will receive only enhanced usual care with educational materials and biweekly check-in calls. Chiropractic care includes posture correction, soft tissue release, spinal manipulation, education, strengthening, and ergonomic advice. Tai Chi classes will be held weekly for 16 weeks. During the study, participants will be assessed at baseline, 16 weeks, and 24 weeks for pain intensity, pain on movement, disability, quality of life, self-efficacy, postural awareness, pain catastrophizing, fear of movement, and interoceptive awareness. Researchers will also monitor recruitment, retention, and adherence rates throughout the average 18-month study duration. Participants will be followed for 8 weeks after interventions end to evaluate longer-term outcomes and safety.
CONDITIONS
Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care
J
Jacqui Guzman, BA
D
Daniel Litrownik
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Harvard University Faculty of Medicine
Lead Sponsor
Brigham and Women's Hospital
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | MCC + Tai Chi + EUC | MCC + EUC | Current guideline‑supported care |
|---|---|---|---|
| What it is | Combined multimodal chiropractic treatment, weekly Tai Chi classes, and educational support alongside usual care | Multimodal chiropractic treatment plus educational support alongside usual care | Conservative care combining spinal manipulation and exercise is guideline‑recommended for chronic nonspecific neck pain |
| Role in trial | Investigational combination arm | Active comparator arm | Represents standard conservative care outside the trial |
| Primary use | To assess combined effect of chiropractic care and Tai Chi added to usual care | To evaluate effect of chiropractic care added to usual care | Typical recommended conservative management combining manual therapy and exercise |
| How it is given or performed | Up to 10 chiropractic sessions over 16 weeks plus at least one Tai Chi class per week for 16 weeks | Up to 10 chiropractic sessions over 16 weeks | Spinal manipulation plus guided exercise as delivered in clinical settings |
| Evidence status | Efficacy under evaluation in this pilot randomized trial; no results yet | Efficacy under evaluation; trial ongoing | Supported by systematic reviews and guidelines as effective conservative care |
| Important risks | Unclear; trial protocol includes manual therapy and exercise with generally low risk | Unclear; manual therapy carries low but potential rare risks | Generally low risk when provided by trained practitioners |
| Important limitations | Pilot trial not powered to assess clinical efficacy; feasibility focus | Seasonal or class attendance variability may affect adherence | Evidence quality varies and not all patients may access combined manual therapy plus exercise |
| Patient impact | Unknown until trial results are available | Impact under evaluation | Evidence supports improvement in pain and function |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive their assigned intervention which may include up to 10 chiropractic sessions over 16 weeks, weekly Tai Chi classes for 16 weeks, and/or enhanced usual care with educational materials. Participants follow their assigned treatment plan for 16 weeks.
Up to 10 chiropractic visits and weekly Tai Chi classes for 16 weeks depending on assignment
Duration - 8 weeks
Participants are followed for 8 weeks after the end of the treatment period to assess longer-term outcomes related to neck pain and quality of life.
Periodic follow-up contacts during 8 weeks after treatment
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Peter M Wayne, Robert Vining, Cynthia R Long...
https://pubmed.ncbi.nlm.nih.gov/40321971/Harvard University Faculty of Medicine
Lead Sponsor
Brigham and Women's Hospital
Collaborating Sponsor