Back to results

Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care

Primary Purpose

Neck Pain, Chronic Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Chiropractic Care

Tai Chi

Enhanced Usual Care

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring chiropractic, Tai Chi

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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 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 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

Sites / Locations

Osher Clinical Center at Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Chiropractic Care, Tai Chi, and EUC

Chiropractic care and EUC

EUC

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Recruitment rate

Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.

Retention rate

Retention rate will be quantified by the proportion of subjects who remain in the study to complete the 24-week visit.

Intervention adherence

Intervention adherence will be measured by collection of chiropractic visit attendance and Tai Chi class attendance data.

Secondary Outcome Measures

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".

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.

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'').

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05726331

First Posted

February 3, 2023

Last Updated

September 14, 2023

Sponsor

Harvard University Faculty of Medicine

Collaborators

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05726331

Brief Title

Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care

Official Title

Combined Chiropractic Care and Tai Chi for Chronic Non-Specific Neck Pain

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 14, 2023 (Anticipated)

Primary Completion Date

April 30, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harvard University Faculty of Medicine

Collaborators

Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain, Chronic Pain

Keywords

chiropractic, Tai Chi

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chiropractic Care, Tai Chi, and EUC

Arm Type

Experimental

Arm Description

Arm Title

Chiropractic care and EUC

Arm Type

Active Comparator

Arm Description

Arm Title

EUC

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Chiropractic Care

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Tai Chi

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Enhanced Usual Care

Other Intervention Name(s)

EUC

Intervention Description

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).

Primary Outcome Measure Information:

Title

Recruitment rate

Description

Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.

Time Frame

Through study completion (an average of 18 months)

Title

Retention rate

Description

Retention rate will be quantified by the proportion of subjects who remain in the study to complete the 24-week visit.

Time Frame

Through study completion (an average of 18 months)

Title

Intervention adherence

Description

Intervention adherence will be measured by collection of chiropractic visit attendance and Tai Chi class attendance data.

Time Frame

Through study completion (an average of 18 months)

Secondary Outcome Measure Information:

Title

Pain intensity

Description

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".

Time Frame