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

Not Applicable

Recruiting

• Conditions: Neck Pain; Chronic Pain

• Registration Number: NCT05726331
• Lead Sponsor: Harvard University Faculty of Medicine

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).

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-13
• Study Start: 2023-10-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment rate	Through study completion (an average of 18 months)	Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
Retention rate	Through study completion (an average of 18 months)	Retention rate will be quantified by the proportion of subjects who remain in the study to complete the 24-week visit.
Intervention adherence	Through study completion (an average of 18 months)	Intervention adherence will be measured by collection of chiropractic visit attendance and Tai Chi class attendance data.

Secondary Outcome Measures

Name	Time	Method
Pain on movement (POM)	Baseline, 16-weeks, and 24-weeks	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.
Disability	Baseline, 16-weeks, and 24-weeks	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.
Self-efficacy	Baseline, 16-weeks, and 24-weeks	Self-efficacy will be measured using the General Self-Efficacy Scale (GSES). The GSES measures a participant's confidence in their ability to respond to environmental demands and challenges. The scale consists of 10 items with a 4-point Likert response scale ranging from 1 ("not at all true") to 4 ("exactly true"). Higher summed scores indicate greater self efficacy (SE) to complete the task.
Postural awareness	Baseline, 16-weeks, and 24-weeks	Postural awareness will be measured using the Postural Awareness Scale (PAS) which includes 12 items that describe the awareness of body posture and postural control. Higher scores indicate more awareness and control of one's posture.
Fear of Movement	Baseline, 16-weeks, and 24-weeks	Fear of Movement will be measured using the Tampa Scale for Kinesiophobia. This instrument consists of 17 items that measure pain-related fear with higher scores indicating higher levels of kinesiophobia.
Interoceptive Awareness	Baseline, 16-weeks, and 24-weeks	Interoceptive awareness, the sensitivity toward stimuli originating from within the body, will be measured using the Multidimensional Assessment of Interoceptive Awareness (MAIA) which consists of 40 items resulting in eight separate dimensions of interoceptive awareness; higher scores represent higher awareness.
Perceptions of treatments	Baseline and 16-weeks	Qualitative interviews will be employed to further probe participants' perceptions of chiropractic care with and without the addition of TC training focusing on: a) understanding facilitators and barriers to participation in a pragmatic trial utilizing community-based practitioners, and b) patient-centered experiences that might inform outcome measures to use in a future trial.
Bothersomeness of pain	Baseline, 16-weeks, and 24-weeks	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'').
Health-related quality of life	Baseline, 16-weeks, and 24-weeks	The (Profile Physical and Mental Health Summary Scores) PROMIS-29 will be used to characterize global health-related quality of life. This validated, reliable, and widely used instrument includes 7 key domains: Physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. All items except for a single question evaluating pain intensity are rated on a 5-point Likert scale. PROMIS-29 has excellent psychometric properties and offers the ability to compare scores across conditions and to general population norms.
Pain Catastrophizing Scale	Baseline, 16-weeks, and 24-weeks	The Pain Catastrophizing Scale will be used to assess catastrophic thinking associated with pain. This instrument consists of 13 items that measure rumination, magnification, and helplessness related to pain. Higher scores correspond to higher levels of catastrophic thinking associated with pain.
Pain intensity	Baseline, 16-weeks, and 24-weeks	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".

Trial Locations

Locations (1)

Osher Clinical Center at Brigham and Women's Hospital; 🇺🇸 Chestnut Hill, Massachusetts, United States