Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHarvard University Faculty of Medicine
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Chiropractic Care
Other interventionChiropractic 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
Other interventionTai 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
Other interventionEnhanced 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).
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Chiropractic Care, Tai Chi, and EUCExperimental treatment 3 interventions
Group B: Chiropractic care and EUCActive comparator 2 interventions
Group C: EUCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
Time frame
Through study completion (an average of 18 months)2
Retention rate
Retention rate will be quantified by the proportion of subjects who remain in the study to complete the 24-week visit.
Time frame
Through study completion (an average of 18 months)3
Intervention adherence
Intervention adherence will be measured by collection of chiropractic visit attendance and Tai Chi class attendance data.
Time frame
Through study completion (an average of 18 months)Secondary outcomes
1
Pain intensity
Pain intensity over the past 7 days will be measured using an 11 point numerical rating scale with 0 indicating "no neck pain at all" and 10 indicating "worst neck pain imaginable".
Time frame
Baseline, 16-weeks, and 24-weeks2
Pain on movement (POM)
Pain on movement (POM) will be assessed using a previously validated and reliable protocol. Participants are asked to flex, extend, laterally flex, and laterally rotate their necks to the left and right. The evoked pain is measured on a 100mm visual analog scale (VAS), for each direction. An average POM score is then calculated from these data for each participant.
Time frame
Baseline, 16-weeks, and 24-weeks3
Bothersomeness of pain
Bothersomeness of Pain (BOP) in the past 7 days will measured on a 0-10 scale (0 indicating ''neck pain not at all bothersome'' and 10 indicating ''neck pain extremely bothersome'').
Time frame
Baseline, 16-weeks, and 24-weeks4
Disability
Functional neck-related disability will be measured using the Neck Disability Index. This validated and reliable 10-item questionnaire determines how participants see their neck pain affecting their daily activities. The maximum score is 50. Scores of ≤4 indicate no disability; 5 to 14 indicate mild disability, 15 to 24 moderate disability, and 25 to 34 severe disability. Scores \>35 indicate complete perceived disability.
Time frame
Baseline, 16-weeks, and 24-weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Harvard University Faculty of Medicine
Lead sponsor
Brigham and Women's Hospital
Collaborator
Source ClinicalTrials.gov