NCT06523036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

2.7 years

First QC Date

July 22, 2024

Last Update Submit

July 26, 2024

Conditions

Neck PainNurse-Patient Relations

Keywords

ChiropracticTai ChiIntegrative Medicine

Outcome Measures

Primary Outcomes (3)

  • Recruitment

    Rate of enrollment (number of interested participants/number enrolled) and the percentage of eligible participants who consented to participate.

    6 months

  • Retention

    Percentage of participants who completed the 16-week intervention and follow-up measures.

    16 weeks

  • Adherence to interventions

    Proportion of participants who attend 70% of the chiropractic visits and 60% of the weekly Tai Chi classes.

    16 weeks

Secondary Outcomes (14)

  • Pain Severity

    Assessed at baseline and at week 16.

  • Neck Disability Index (NDI)

    Assessed at baseline and at week 16.

  • Pain on Movement (POM)

    Assessed at baseline and at week 16.

  • Bothersomeness of Pain

    Assessed at baseline and at week 16.

  • Patient Reported Outcome Measures Information System 29 (PROMIS-29)

    Assessed at baseline and at week 16.

  • +9 more secondary outcomes

Study Arms (1)

Combined chiropractic care and Tai Chi

EXPERIMENTAL

All participants will be enrolled in a 16-week intervention period during which time they will receive 10 chiropractic treatments in addition to weekly Tai Chi training.

Procedure: Combined chiropractic care and Tai Chi

Interventions

Combined chiropractic care and Tai ChiPROCEDURE

Chiropractic will be personalized to the patients clinical needs within the scope of chiropractic practice in the Commonwealth of Massachusetts including: posture correction/spinal stabilization exercises; soft tissue relaxation techniques; spinal manipulation/mobilization; breathing and relaxation techniques; stretches, self-care; ergonomic modifications; bracing and supports. Chiropractic will be administered by one of two chiropractors at the Osher Clinical Center. Tai Chi will take place at one of two schools used in prior NIH funded trials.

Combined chiropractic care and Tai Chi

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osher Center for Integrative Health

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Burton W, Wayne PM, Litrownik D, Long CR, Vining R, Rist P, Kilgore K, Lisi A, Kowalski MH. Integrating Chiropractic Care and Tai Chi Training for the Treatment of Chronic Nonspecific Neck Pain in Nurses: A Single-Arm Mixed-Methods Pilot Trial. J Integr Complement Med. 2024 Dec;30(12):1189-1199. doi: 10.1089/jicm.2024.0043. Epub 2024 Aug 22.

    PMID: 39169834DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

May 7, 2020

Primary Completion

February 2, 2023

Study Completion

February 2, 2023

Last Updated

July 29, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Given the pilot nature of this study, de-identified aggregate data will be shared in the dissemination of the main trial findings. As done with other trials in the Division of Preventive Medicine at Brigham and Women's Hospital, new research collaborations will be encouraged that make use of the data collected during this trial. Investigators interested in using data from this trial will be directed to contact the multiple principle investigators for data access. At all times, we are fully cognizant of and will scrupulously follow the guidelines of the Health Insurance Portability and Accountability Act (HIPAA), to ensure that participants' rights and confidentiality are not compromised.

Locations

US(1)