Clinical trial NCT06523036: Integrating Chiropractic Care and Mind-Body Training for the Treatment of Nonspecific Chronic Neck Pain
Official title: Integrating Chiropractic Care and Mind-Body Training for the Treatment of Nonspecific Chronic Neck Pain in Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Nurse-Patient Relations
Keywords: Chiropractic
Tai Chi
Integrative Medicine
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Chronic neck pain is particularly prevalent among nurses. Nurses experiencing neck pain frequently report its impacts including decreased job satisfaction and reduced productivity. In recent years, non-pharmacologic approaches have increasingly been used treatments for the management of neck pain. Exercise and manual therapies represent two of the most common non-pharmacologic interventions for pain. The purpose of this study was to perform a pilot study of combined multimodal chiropractic care and Tai Chi for neck pain in nurses to help inform the design of a future, full-scale pragmatic trial.

Detailed description: The lifetime prevalence of chronic neck pain is approximately 50%, and it is associated with substantial societal and individual burden. Neck pain is prevalent among healthcare workers, specifically among nurses. About 45% of nurses experience neck pain, but rates may vary by population and nursing type. Neck pain in nurses significantly contributes to sickness absence and negatively impacts nurses' productivity and performance at work. Neck pain is a burden on nurses' individual health and on the healthcare system as a whole. Two of the most common non-pharmacological approaches for the management of neck pain are exercise and manual therapies, and there is some evidence that multimodal approaches combining the two are more effective than unimodal strategies. Given the widespread availability in most metropolitan areas of both Tai Chi and chiropractic care, development of an evidence-based care regimen integrating Tai Chi mind-body self-care with chiropractic represents a practical strategy for management of neck pain.

To help inform the design of a larger-scale trial evaluating the combined effects of Tai Chi and chiropractic care for neck pain, the investigators propose to conduct a single-arm pilot study to evaluate the feasibility of delivering coordinated chiropractic care and Tai Chi via community-practitioners for nurses at Mass General Brigham Hospitals with chronic neck pain. 21 nurses with chronic neck pain that meet all study eligibility criteria will be recruited to receive 10 chiropractic treatments and weekly Tai Chi training over 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Nurses employed at Mass General Brigham Hospitals
* Chronic nonspecific neck pain at least 5 days a week for at least 3 consecutive months
* Neck pain level of 3 or higher as reported on a numerical scale ranging from 0 to 10, with 10 described as 'worst neck pain imaginable'
* Agreeable to participate and commit to study interventions
* Neck Disability Index score of 5 or greater
* 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 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 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
timeFrame: 6 months
measure: Retention
timeFrame: 16 weeks
measure: Adherence to interventions
timeFrame: 16 weeks
Secondary outcomes:
measure: Pain Severity
timeFrame: Assessed at baseline and at week 16.
measure: Neck Disability Index (NDI)
timeFrame: Assessed at baseline and at week 16.
measure: Pain on Movement (POM)
timeFrame: Assessed at baseline and at week 16.
measure: Bothersomeness of Pain
timeFrame: Assessed at baseline and at week 16.
measure: Patient Reported Outcome Measures Information System 29 (PROMIS-29)
timeFrame: Assessed at baseline and at week 16.
measure: Maslach Burnout Inventory (MBI)
timeFrame: Assessed at baseline and at week 16.
measure: Generalized Self-Efficacy Scale (GSES)
timeFrame: Assessed at baseline and at week 16.
measure: Hospital Anxiety and Depression Scale
timeFrame: Assessed at baseline and at week 16.
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Assessed at baseline and at week 16.
measure: Tampa Scale for Kinesiophobia
timeFrame: Assessed at baseline and at week 16.
measure: Stanford Presenteeism Scale, 6-item version (SPS-6)
timeFrame: Assessed at baseline and at week 16.
measure: Trail Making Test II
timeFrame: Assessed at baseline and at week 16.
measure: Gait Speed
timeFrame: Assessed at baseline and at week 16.
measure: Postural Awareness Scale
timeFrame: Assessed at baseline and at week 16.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Osher Center for Integrative Health
state: Massachusetts
Study officials:
References: