Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care

Harvard University Faculty of Medicine

Status: Enrolling

Conditions: Chronic Pain; Neck Pain

Treatments: Other: Enhanced Usual Care; Other: Chiropractic Care; Other: Tai Chi

Study type: Interventional

Funder types: Other

Identifiers

NCT05726331

2021A014141

Details and patient eligibility

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).

Full 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).

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Chiropractic Care, Tai Chi, and EUC

Experimental group

Description:

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.

Treatment:

Other: Chiropractic Care

Other: Enhanced Usual Care

Other: Tai Chi

Chiropractic care and EUC

Active Comparator group

Description:

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.

Treatment:

Other: Chiropractic Care

Other: Enhanced Usual Care

EUC

Active Comparator group

Description:

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.

Treatment:

Other: Enhanced Usual Care