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

NCT ID: NCT05726331

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2026-12-31

Brief Summary

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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

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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).

Conditions

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Neck Pain Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Chiropractic Care

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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).

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.

Group Type ACTIVE_COMPARATOR

Chiropractic Care

Intervention Type OTHER

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.

Enhanced Usual Care

Intervention Type OTHER

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).

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type OTHER

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).

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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).

Intervention Type OTHER

Other Intervention Names

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EUC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Harvard University Faculty of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Peter Wayne

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Osher Clinical Center at Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jacqui Guzman, BA

Role: CONTACT

617-732-9418

Daniel Litrownik

Role: CONTACT

Facility Contacts

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Jacqui Guzman, BA

Role: primary

617-732-9418

References

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Wayne PM, Vining R, Long CR, Burton WM, Litrownik D, Guzman J, Kilgore K, Hagan TJ, Rist PM, Kowalski MH. Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial. Contemp Clin Trials Commun. 2025 Apr 11;45:101482. doi: 10.1016/j.conctc.2025.101482. eCollection 2025 Jun.

Reference Type DERIVED
PMID: 40321971 (View on PubMed)

Other Identifiers

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2021A014141

Identifier Type: -

Identifier Source: org_study_id

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