Clinical trial NCT05726331: Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care
Official title: Combined Chiropractic Care and Tai Chi for Chronic Non-Specific Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Chronic Pain
Keywords: chiropractic
Tai Chi
Lead sponsor: Harvard University Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2023-02-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This is a three-armed, mixed-methods pilot study. 48 adults with CNNP will be randomized to receive either 1) 10 chiropractic treatments (delivered over 16 weeks) with concurrent TC training (16 weeks of group training) plus enhanced usual care (EUC) with CNNP educational materials); 2) chiropractic care plus EUC; or 3) EUC alone. Individuals will be followed for 8 weeks after the end of their intervention period to assess longer-term outcomes. Our primary outcomes will be focused on the feasibility of recruiting, retaining and monitoring the safety of adults with CNNP into our trial. Secondary clinical outcomes include following patients centered-outcomes: pain, disability, health-related quality of life, self-efficacy, cognitive and affective outcomes (postural awareness, pain catastrophizing, fear of movement, interoceptive awareness).

Eligibility criteria: 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
* 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Through study completion (an average of 18 months)
measure: Retention rate
timeFrame: Through study completion (an average of 18 months)
measure: Intervention adherence
timeFrame: Through study completion (an average of 18 months)
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Pain on movement (POM)
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Bothersomeness of pain
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Disability
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Health-related quality of life
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Self-efficacy
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Postural awareness
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Pain Catastrophizing Scale
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Fear of Movement
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Interoceptive Awareness
timeFrame: Baseline, 16-weeks, and 24-weeks
measure: Perceptions of treatments
timeFrame: Baseline and 16-weeks
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Osher Clinical Center at Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: