Recruiting

Tai Chi & Chiropractic

Sponsor:

Harvard University Faculty of Medicine

Code:

NCT05726331

Conditions

Neck Pain

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Chiropractic Care

Tai Chi

Enhanced Usual Care

Study Details

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).

Conditions

Neck Pain

Chronic Pain

Study ID

NCT05726331

Start date

Oct 25, 2023

Status verified date

Jan, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chiropractic Care, Tai Chi, and EUC

Participants assigned to this arm will receive 10 sessions of chiropractic care over 16 weeks, administered by chiropractors at collaborating clinics in the Greater Boston area. Participants assigned to this arm will also be enrolled in a community-based TC program. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain.

active comparator: Chiropractic care and EUC

Participants assigned to the chiropractic care+EUC arm will receive 10 sessions of chiropractic care over 16 weeks administered by chiropractors at collaborating clinics in the Greater Boston area. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain.

active comparator: EUC

Individuals assigned to the EUC alone group will be asked to continue their usual medical care as prescribed by their physician for 16 weeks. In addition, they will be asked to not seek chiropractic care or TC during the study. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain. We will also provide this arm of participants with increased attention in the form of biweekly calls from the study research assistants.

Interventions

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.

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.

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 measure

  • Recruitment rate [ Time Frame: Through study completion (an average of 18 months) ]
  • Retention rate [ Time Frame: Through study completion (an average of 18 months) ]
  • Intervention adherence [ Time Frame: Through study completion (an average of 18 months) ]

Central Contacts and Locations

Central contacts

Locations

Osher Clinical Center at Brigham and Women's Hospital

Recruiting

Chestnut Hill, Massachusetts, United States, 02199

Contacts

More Information

Sponsor

Harvard University Faculty of Medicine

Last update posted

Jan 19, 2024

Last verified

Jan, 2024

Keywords

  • chiropractic
  • Tai Chi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harvard University Faculty of Medicine on 2024-01-19.