Neck PainNCT05726331
Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care
A study testing Chiropractic Care and Tai Chi in people with Neck Pain and Chronic Pain, run by Harvard University Faculty of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Chiropractic Care and Tai Chi
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
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 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
Show all 13Show 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 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniel Litrownik contact
United States1 site, 1 recruiting
- Recruiting
Osher Clinical Center at Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02199
Jacqui Guzman, BA, 617-732-9418, jguzman5@bwh.harvard.edu
About this study
Official title: Combined Chiropractic Care and Tai Chi for Chronic Non-Specific Neck Pain
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).
Read the 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).
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Chiropractic Care, Tai Chi, Enhanced Usual Care
- Keywords
- chiropractic, Tai Chi
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic CareOther
Chiropractic care will be delivered by community-based chiropractors that meet pre-set qualifications. Chiropractic treatment protocol will be multimodal and will follow predefined standard operating procedures including the following 6 components: 1) Posture correction and spinal stabilization exercises; 2) Soft tissue release techniques; 3) Manual spinal manipulation; 4) Condition-specific education; 5) Myofascial strengthening and motor control training; 6) Ergonomic and lifestyle modifications/advice. Subjects randomized to chiropractic treatment groups will receive up to 10 chiropractic sessions over 16 weeks.
Tai ChiOther
Tai Chi (TC) will be delivered by community based Tai Chi schools that meet pre-set qualifications. TC programs will emphasize core principles including biomechanically efficient alignment, relaxed integrated movements, deep breathing, and heightened body awareness. Subjects randomized to TC treatment group will attend at least one TC class per week for 16 weeks.
Enhanced Usual CareOther
Also called EUC
Enhanced Usual Care will include educational materials about neck pain provided by the study, in addition to usual medical care for CNNP. Usual care for CNNP generally includes medications (non-narcotic analgesics, NSAIDs, muscle relaxants), interventional pain management (e.g., steroid injections), and self-care exercises (all of which will be monitored and recorded in all three study arms).
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic Care, Tai Chi, and EUC | Experimental | Participants assigned to this arm will receive 10 sessions of chiropractic care over 16 weeks, administered by chiropractors at collaborating clinics in the Greater Boston area. Participants assigned to this arm will also be enrolled in a community-based TC program. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain. Receives: Other: Chiropractic Care; Other: Tai Chi; Other: Enhanced Usual Care |
| Chiropractic care and EUC | Active comparator | Participants assigned to the chiropractic care+EUC arm will receive 10 sessions of chiropractic care over 16 weeks administered by chiropractors at collaborating clinics in the Greater Boston area. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain. Receives: Other: Chiropractic Care; Other: Enhanced Usual Care |
| EUC | Active comparator | Individuals assigned to the EUC alone group will be asked to continue their usual medical care as prescribed by their physician for 16 weeks. In addition, they will be asked to not seek chiropractic care or TC during the study. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain. We will also provide this arm of participants with increased attention in the form of biweekly calls from the study research assistants. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
Measured: Through study completion (an average of 18 months)
Retention rate
Retention rate will be quantified by the proportion of subjects who remain in the study to complete the 24-week visit.
Measured: Through study completion (an average of 18 months)
Intervention adherence
Intervention adherence will be measured by collection of chiropractic visit attendance and Tai Chi class attendance data.
Measured: Through study completion (an average of 18 months)
Secondary outcomes (11)
Pain intensity
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".
Measured: Baseline, 16-weeks, and 24-weeks
Pain on movement (POM)
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.
Measured: Baseline, 16-weeks, and 24-weeks
Bothersomeness of pain
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'').
Measured: Baseline, 16-weeks, and 24-weeks
Disability
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.
Measured: Baseline, 16-weeks, and 24-weeks
Health-related quality of life
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.
Measured: Baseline, 16-weeks, and 24-weeks
Self-efficacy
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.
Measured: Baseline, 16-weeks, and 24-weeks
Postural awareness
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.
Measured: Baseline, 16-weeks, and 24-weeks
Pain Catastrophizing Scale
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.
Measured: Baseline, 16-weeks, and 24-weeks
Fear of Movement
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.
Measured: Baseline, 16-weeks, and 24-weeks
Interoceptive Awareness
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.
Measured: Baseline, 16-weeks, and 24-weeks
Perceptions of treatments
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.
Measured: Baseline and 16-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start25 Oct 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard University Faculty of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Peter Wayne, Harvard University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726331
- Sponsor's protocol ID
- 2021A014141
- Status last verified
- Jan 2024
- First submitted
- 3 Feb 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wayne PM, Vining R, Long CR, Burton WM, Litrownik D, Guzman J, Kilgore K, Hagan TJ, Rist PM, Kowalski MH. Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial. Contemp Clin Trials Commun. 2025 Apr 11;45:101482. doi: 10.1016/j.conctc.2025.101482. eCollection 2025 Jun.
PubMed 40321971
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Chiropractic Care and Tai Chi for Chronic Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT05726331
- Acronym / sponsor ID
- 2021A014141
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- chiropractic, Tai Chi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Harvard University Faculty of MedicineUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Feb 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chiropractic Care, Tai Chi, and EUC | Experimental | Other: Chiropractic Care, Other: Tai Chi, Other: Enhanced Usual CareParticipants assigned to this arm will receive 10 sessions of chiropractic care over 16 weeks, administered by chiropractors at collaborating clinics in the Greater Boston area. Participants assigned to this arm will also be enrolled in a community-based TC program. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain. |
| Chiropractic care and EUC | Active comparator | Other: Chiropractic Care, Other: Enhanced Usual CareParticipants assigned to the chiropractic care+EUC arm will receive 10 sessions of chiropractic care over 16 weeks administered by chiropractors at collaborating clinics in the Greater Boston area. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain. |
| EUC | Active comparator | Other: Enhanced Usual CareIndividuals assigned to the EUC alone group will be asked to continue their usual medical care as prescribed by their physician for 16 weeks. In addition, they will be asked to not seek chiropractic care or TC during the study. Participants will also be given a neck-pain self-care book that explains common causes and management strategies for neck pain. We will also provide this arm of participants with increased attention in the form of biweekly calls from the study research assistants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 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 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
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 |
|---|---|---|
| Chiropractic CareChiropractic care will be delivered by community-based chiropractors that meet pre-set qualifications. Chiropractic treatment protocol will be multimodal and will follow predefined standard operating procedures including the following 6 components: 1) Posture correction and spinal stabilization exercises; 2) Soft tissue release techniques; 3) Manual spinal manipulation; 4) Condition-specific education; 5) Myofascial strengthening and motor control training; 6) Ergonomic and lifestyle modifications/advice. Subjects randomized to chiropractic treatment groups will receive up to 10 chiropractic sessions over 16 weeks. | Other | Chiropractic Care, Tai Chi, and EUC, Chiropractic care and EUC |
| Tai ChiTai Chi (TC) will be delivered by community based Tai Chi schools that meet pre-set qualifications. TC programs will emphasize core principles including biomechanically efficient alignment, relaxed integrated movements, deep breathing, and heightened body awareness. Subjects randomized to TC treatment group will attend at least one TC class per week for 16 weeks. | Other | Chiropractic Care, Tai Chi, and EUC |
| Enhanced Usual CareAlso: EUCEnhanced Usual Care will include educational materials about neck pain provided by the study, in addition to usual medical care for CNNP. Usual care for CNNP generally includes medications (non-narcotic analgesics, NSAIDs, muscle relaxants), interventional pain management (e.g., steroid injections), and self-care exercises (all of which will be monitored and recorded in all three study arms). | Other | Chiropractic Care, Tai Chi, and EUC, Chiropractic care and EUC, EUC |
Primary outcome
Recruitment rate
Time frame: 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
Time frame: 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
Time frame: 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.
11 secondary outcomes
Pain intensity
Time frame: Baseline, 16-weeks, and 24-weeks
Pain on movement (POM)
Time frame: Baseline, 16-weeks, and 24-weeks
Bothersomeness of pain
Time frame: Baseline, 16-weeks, and 24-weeks
Disability
Time frame: Baseline, 16-weeks, and 24-weeks
Health-related quality of life
Time frame: Baseline, 16-weeks, and 24-weeks
Self-efficacy
Time frame: Baseline, 16-weeks, and 24-weeks
Postural awareness
Time frame: Baseline, 16-weeks, and 24-weeks
Pain Catastrophizing Scale
Time frame: Baseline, 16-weeks, and 24-weeks
Fear of Movement
Time frame: Baseline, 16-weeks, and 24-weeks
Interoceptive Awareness
Time frame: Baseline, 16-weeks, and 24-weeks
Perceptions of treatments
Time frame: Baseline and 16-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 40321971Wayne PM, Vining R, Long CR, Burton WM, Litrownik D, Guzman J, Kilgore K, Hagan TJ, Rist PM, Kowalski MH. Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial. Contemp Clin Trials Commun. 2025 Apr 11;45:101482. doi: 10.1016/j.conctc.2025.101482. eCollection 2025 Jun.
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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.
Daniel Litrownik contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic Care and Tai Chi in people with Neck Pain and Chronic Pain, run by Harvard University Faculty of Medicine 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 19 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqui Guzman, BA (617-732-9418, jguzman5@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through study completion (an average of 18 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 NCT05726331, 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 19 Jan 2024.