Integrating Chiropractic Care and Mind-Body Training for the Treatment of Nonspecific Chronic Neck Pain
NCT Number: NCT06523036
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain|Nurse-Patient Relations
Interventions: PROCEDURE: Combined chiropractic care and Tai Chi
Sponsor: Brigham and Women's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2020-05-07
Completion Date: 2023-02-02
Locations: Osher Center for Integrative Health, Boston, Massachusetts, 02215, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Pain Severity, Measured using a 11-point numerical rating scale (NRS) with 0 indicating "no pain at all" and 10 indicating "worst neck pain imaginable"., Assessed at baseline and at week 16.|Neck Disability Index (NDI), Self-report questionnaire used to determine how neck pain impacts daily activities of living and self-related neck pain disability. Scores range from 10 - 60. Higher scores indicate greater disability., Assessed at baseline and at week 16.|Pain on Movement (POM), 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 11-point numerical rating scale (NRS) with 0 indicating "no pain at all" and 10 indicating "worst neck pain imaginable", for each direction. An average score is taken, with scores closer to 10 indicating more pain., Assessed at baseline and at week 16.|Bothersomeness of Pain, Measured using a 11-point numerical rating scale (NRS) with 0 indicating "neck pain not at all bothersome" and 10 indicating "neck pain extremely bothersome"., Assessed at baseline and at week 16.|Patient Reported Outcome Measures Information System 29 (PROMIS-29), A system of validated, highly reliable self-reported measures of health status for physical, mental, and social well-being. Raw scores are rescaled to standardized T-scores with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the item being measured., Assessed at baseline and at week 16.|Maslach Burnout Inventory (MBI), A 3-section, 22-item self-report introspective psychological inventory pertaining to occupational burnout. Raw scores for the first subscale range from 0-54, for the second range from 0-30, and for the third range from 0-48. A higher score in the first two sections and a low score in the last section may indicate the presence of burnout., Assessed at baseline and at week 16.|Generalized Self-Efficacy Scale (GSES), The GSES 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 to complete the task., Assessed at baseline and at week 16.|Hospital Anxiety and Depression Scale, A 14-item self-report questionnaire, with two seven-item sub scales, that measures current feelings of anxiety and depression. The total score for each sub scale ranges from 0-21, with higher scores representing higher levels of depression and anxiety., Assessed at baseline and at week 16.|Multidimensional Assessment of Interoceptive Awareness (MAIA), A self-report questionnaire consisting of 8 scales, addressing 5 dimensions of body awareness. Dimensions are scored individually, and scores for each question are between 0-5, where higher scores equate to more awareness of bodily sensation., Assessed at baseline and at week 16.|Tampa Scale for Kinesiophobia, A 17-item self-report instrument that measures pain-related fear. Scores range from 17-68, with higher scores indicating higher levels of kinesiophobia., Assessed at baseline and at week 16.|Stanford Presenteeism Scale, 6-item version (SPS-6), SPS-6 is a 6-item questionnaire assessing work quality and productivity. Scores range from 6-30, with higher scores indicating increased presenteeism., Assessed at baseline and at week 16.|Trail Making Test II, This two part cognitive tests is scored based on the number of sections it takes to complete each part of the test. Scores higher than the population average indicate higher degrees of cognitive impairment., Assessed at baseline and at week 16.|Gait Speed, Will be assessed using the ZenoTM Walkway, developed by ProtoKinetics (https://www.protokinetics.com). Participants will be asked to complete walking trials under a quiet walking condition, a fast-speed walking condition, and while completing a cognitive dual task., Assessed at baseline and at week 16.|Postural Awareness Scale, This 12-item self-report scale includes items that describe the awareness of body posture and postural control. Scores range from 12-84, with higher scores indicating greater postural awareness., Assessed at baseline and at week 16.