Neck PainNCT06523036
Integrating Chiropractic Care and Mind-Body Training for the Treatment of Nonspecific Chronic Neck Pain
A study testing Combined chiropractic care and Tai Chi in people with Neck Pain and Nurse-Patient Relations, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Nurse-Patient Relations
- What is being tested?
- Combined chiropractic care and Tai Chi
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2020to 2 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Center for Integrative Health
Boston, Massachusetts, 02215
About this study
Official title: Integrating Chiropractic Care and Mind-Body Training for the Treatment of Nonspecific Chronic Neck Pain in Nurses
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.
Read the 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.
- Conditions
- Neck Pain, Nurse-Patient Relations
- Being tested
- Combined chiropractic care and Tai Chi
- Keywords
- Chiropractic, Tai Chi, Integrative Medicine
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined chiropractic care and Tai ChiProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Combined chiropractic care and Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Rate of enrollment (number of interested participants/number enrolled) and the percentage of eligible participants who consented to participate.
Measured: 6 months
Retention
Percentage of participants who completed the 16-week intervention and follow-up measures.
Measured: 16 weeks
Adherence to interventions
Proportion of participants who attend 70% of the chiropractic visits and 60% of the weekly Tai Chi classes.
Measured: 16 weeks
Secondary outcomes (14)
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".
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline and at week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start7 May 2020
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter M. Wayne, Ph.D., Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523036
- Sponsor's protocol ID
- 2019P003845
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39169834
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Chiropractic Care and Mind-Body Training for the Treatment of Nonspecific Chronic Neck Pain in Nurses
- ClinicalTrials.gov ID
- NCT06523036
- Acronym / sponsor ID
- 2019P003845
- Conditions
- Neck Pain, Nurse-Patient Relations
- Keywords
- Chiropractic, Tai Chi, Integrative Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined chiropractic care and Tai Chi | Experimental | Procedure: Combined chiropractic care and Tai ChiAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined chiropractic care and Tai ChiChiropractic 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. | Procedure or surgery | Combined chiropractic care and Tai Chi |
Primary outcome
Recruitment
Time frame: 6 months
Rate of enrollment (number of interested participants/number enrolled) and the percentage of eligible participants who consented to participate.
Retention
Time frame: 16 weeks
Percentage of participants who completed the 16-week intervention and follow-up measures.
Adherence to interventions
Time frame: 16 weeks
Proportion of participants who attend 70% of the chiropractic visits and 60% of the weekly Tai Chi classes.
14 secondary outcomes
Pain Severity
Time frame: Assessed at baseline and at week 16.
Neck Disability Index (NDI)
Time frame: Assessed at baseline and at week 16.
Pain on Movement (POM)
Time frame: Assessed at baseline and at week 16.
Bothersomeness of Pain
Time frame: Assessed at baseline and at week 16.
Patient Reported Outcome Measures Information System 29 (PROMIS-29)
Time frame: Assessed at baseline and at week 16.
Maslach Burnout Inventory (MBI)
Time frame: Assessed at baseline and at week 16.
Generalized Self-Efficacy Scale (GSES)
Time frame: Assessed at baseline and at week 16.
Hospital Anxiety and Depression Scale
Time frame: Assessed at baseline and at week 16.
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Assessed at baseline and at week 16.
Tampa Scale for Kinesiophobia
Time frame: Assessed at baseline and at week 16.
Stanford Presenteeism Scale, 6-item version (SPS-6)
Time frame: Assessed at baseline and at week 16.
Trail Making Test II
Time frame: Assessed at baseline and at week 16.
Gait Speed
Time frame: Assessed at baseline and at week 16.
Postural Awareness Scale
Time frame: Assessed at baseline and at week 16.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 39169834Burton 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined chiropractic care and Tai Chi in people with Neck Pain and Nurse-Patient Relations, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06523036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.