Chiropractic Care + Tai Chi for Chronic Neck Pain

(CONNECKTCARE Trial)

Overseen By Daniel Litrownik

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard University Faculty of Medicine

Disqualifiers: Chiropractic care, Yoga, Tai Chi, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 16 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how chiropractic care and Tai Chi might reduce pain and improve mobility for those with chronic neck pain not linked to a specific cause. Participants will divide into groups: some will receive only standard medical care, while others will also receive chiropractic sessions or a combination of chiropractic care and Tai Chi. It suits adults who have experienced neck pain for most of the week for at least three months. The trial aims to determine if these treatments can significantly manage everyday neck discomfort. As an unphased trial, it offers participants the chance to explore alternative treatments that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both chiropractic care and Tai Chi are generally safe for treating long-term neck pain. Chiropractic care often includes spinal adjustments and is considered effective and safe, with most side effects being mild and short-lived, such as soreness or stiffness that usually resolve on their own.

Tai Chi, a gentle form of exercise, is also regarded as safe. Although specific research on Tai Chi for neck pain is limited, it is known to be a low-risk activity. Both treatments do not involve medication, reducing the chance of drug-related side effects. Overall, both chiropractic care and Tai Chi are well-tolerated options for individuals with chronic neck pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the combination of chiropractic care and Tai Chi for chronic neck pain because it offers a holistic approach that integrates physical adjustment with mindful movement. Unlike standard treatments like medication or physical therapy, chiropractic care focuses on spinal alignment, which may provide immediate relief. Meanwhile, Tai Chi is a gentle exercise that enhances balance and flexibility, potentially improving long-term pain management. Together, these treatments could address both the physical and stress-related aspects of neck pain, offering a comprehensive alternative to traditional care.

What evidence suggests that this trial's treatments could be effective for chronic neck pain?

Research shows that chiropractic care, one of the treatments in this trial, can be as effective as other recommended treatments for long-term spine pain. Spinal manipulative therapy (SMT), a common chiropractic method, leads to small improvements in pain and movement over time. Studies have shown that Tai Chi, another treatment option in this trial, greatly reduces pain and enhances the quality of life for people with long-term neck pain. This trial will evaluate the combination of chiropractic care and Tai Chi, which might provide even better pain relief and aid movement due to their complementary effects. Early findings suggest this combination could be promising for those with chronic neck pain. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with chronic non-specific neck pain that occurs at least 5 days a week for over 3 months, with moderate to severe intensity. Participants must not have had chiropractic care or practiced Tai Chi regularly in the past year and should be free from major illnesses, unstable medical conditions, recent spinal procedures, or involvement in litigation related to disability/accident claims.

Inclusion Criteria

My neck pain has been 3 or more on a scale of 0 to 10 over the last week.

I have had neck pain almost every day for the last 3 months.

My neck pain affects my daily activities.

Exclusion Criteria

I have a disability that prevents me from exercising.

I have seen a chiropractor within the last year.

I do not have any major illness or mental health condition that needs immediate treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chiropractic care and/or Tai Chi training along with enhanced usual care over 16 weeks

16 weeks

10 chiropractic sessions, regular Tai Chi group training

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Long-term follow-up

Participants are assessed for longer-term outcomes and retention

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chiropractic Care
• Enhanced Usual Care
• Tai Chi

Trial Overview

The study is testing if combining chiropractic care with Tai Chi training can help reduce pain and disability in people suffering from chronic non-specific neck pain. It's a feasibility project where participants will receive either this combined treatment or enhanced usual care.

How Is the Trial Designed?

Group I: Chiropractic Care, Tai Chi, and EUC Experimental Treatment 3 Interventions

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.

Group II: EUC Active Control 1 Intervention

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.

Group III: Chiropractic care and EUC Active Control 2 Interventions

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.

Chiropractic Care is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Chiropractic Care for:

• Musculoskeletal disorders
• Neck pain
• Back pain
• Headaches

Approved in Canada as Chiropractic Care for:

• Musculoskeletal disorders
• Neck pain
• Back pain
• Headaches

Approved in European Union as Chiropractic Care for:

• Musculoskeletal disorders
• Neck pain
• Back pain
• Headaches

Who Is Running the Clinical Trial?

Harvard University Faculty of Medicine

Lead Sponsor

Trials

16

Recruited

25,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

Cervical manipulation and mobilization techniques for neck pain are generally effective but can be associated with rare serious adverse events, as highlighted by a review of studies from 1998 to 2009.

The review found that while 17 out of 76 studies reported no major adverse events, minor adverse events like transient neurological symptoms and increased neck pain were noted, indicating a need for better reporting of adverse events in manual therapy research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Carlesso, LC., Gross, AR., Santaguida, PL., et al.[2022]

A study involving 114 participants with chronic neck pain found that after 12 weeks, those practicing Tai Chi reported significantly less pain compared to a wait-list control group, indicating its efficacy as a treatment.

Tai Chi was found to be equally effective as conventional neck exercises in improving pain and quality of life, making it a suitable alternative for individuals who prefer Tai Chi over traditional exercise methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Tai Chi and Neck Exercises in the Treatment of Chronic Nonspecific Neck Pain: A Randomized Controlled Trial. Lauche, R., Stumpe, C., Fehr, J., et al.[2019]

A systematic review of 144 studies involving 227 cases of cervical spinal manipulation (CSM) found that cervical arterial dissection (CAD) occurred in 57% of adverse events, with women being more frequently affected, indicating a potential gender-related risk factor.

Despite the high incidence of CAD, the study could not identify a clear patient profile that predicts adverse events after CSM, highlighting the need for better reporting and standardized terminology in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with the use of cervical spine manipulation or mobilization and patient characteristics: A systematic review. Kranenburg, HA., Schmitt, MA., Puentedura, EJ., et al.[2022]

A review of 27 randomized clinical trials on neck pain treatment found that while many studies reported positive outcomes, the overall methodological quality was low, with only one-third scoring above 50 out of 100.

Effective treatments identified included electromagnetic therapy, manipulation, and active physiotherapy, which improved pain, range of motion, and daily activities, although some interventions like traction and acupuncture showed little to no benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical analysis of randomised clinical trials on neck pain and treatment efficacy. A review of the literature. Kjellman, GV., Skargren, EI., Oberg, BE.[2019]

The systematic review analyzed 20 trials involving various cervical treatments for neck pain, concluding that multiple treatment modalities, including manipulation and exercise, can significantly improve pain and range of motion in patients, while some treatments showed no benefits.

The guideline emphasizes the importance of risk management in chiropractic care, noting that while adverse events are rare, a systematic approach to managing potential risks, such as vertebral artery dissection, is essential for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chiropractic clinical practice guideline: evidence-based treatment of adult neck pain not due to whiplash. Anderson-Peacock, E., Blouin, JS., Bryans, R., et al.[2022]

A 51-year-old Marine with chronic neck pain experienced significant pain reduction from 8-9/10 to 0-2/10 after just five physical therapy sessions that included dry needling and auricular acupuncture, highlighting the efficacy of these techniques.

The patient also reported improved sleep quality and increased daily function, leading to an 85% reduction in medication use, suggesting that these treatment methods can provide lasting benefits and may be effective alternatives for those with chronic neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapy Treatment Of Chronic Neck Pain A Discussion And Case Study: Using Dry Needling And Battlefield Acupuncture. Guthrie, RM., Chorba, R.[2016]

A systematic review of six studies involving 716 participants found that traditional Chinese mind and body exercise (TCMBE) did not significantly improve pain intensity or functional mobility in individuals with neck pain compared to control groups.

However, TCMBE showed a positive effect on mental health outcomes, indicating it may have some benefits for psychological well-being despite lacking efficacy in physical pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Chinese Mind and Body Exercises for Neck Pain: A Meta-Analysis of Randomized Controlled Trials. Xie, YH., Liao, MX., Wang, MY., et al.[2023]

A systematic review of five studies on spinal manipulation (SM) found that about half of patients experience mild and transient adverse events after treatment, indicating that while side effects are common, they are generally not severe.

There is currently no reliable data on the incidence of serious adverse events related to spinal manipulation, suggesting that while they are likely rare, further research is needed to better understand their frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective investigations into the safety of spinal manipulation. Ernst, E.[2019]

A study involving 6342 chiropractic patients with chronic low back pain (CLBP) and chronic neck pain (CNP) found that over 90% reported high satisfaction with their chiropractic care, indicating its perceived effectiveness as a nonpharmacologic treatment.

Most patients were highly educated, non-Hispanic white females, and a significant reason for choosing chiropractic care was to avoid surgery, suggesting that chiropractic treatment is a popular alternative for managing chronic pain without resorting to more invasive options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Chiropractic Patients Being Treated for Chronic Low Back and Neck Pain. Herman, PM., Kommareddi, M., Sorbero, ME., et al.[2020]

This study will evaluate the effectiveness of a combined treatment of Traditional Chinese manual therapy (tuina) and specific therapeutic neck exercises in 88 patients with non-specific chronic neck pain (NSCNP) over 8 sessions in 4 weeks, followed by a 12-week follow-up.

The primary outcome will measure changes in neck pain intensity, while secondary outcomes will assess neck disability, range of motion, muscle endurance, and other related factors, with safety monitored through adverse event reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Combining Traditional Chinese Manual Therapy (Tuina) and Specific Therapeutic Neck Exercise in Young Adults with Non-Specific Chronic Neck Pain: Study Protocol for a Randomized Controlled Trial. Chen, L., Zhang, Q., Huang, Z., et al.[2023]

Traditional bone setting (TBS) was found to be more effective than conventional physiotherapy (PT) and massage (M) in reducing chronic neck pain (cNP) and improving disability, with 68.6% of TBS participants reporting significant benefits after one year.

Patients receiving TBS experienced fewer sick days and reduced reliance on painkillers compared to those in the PT and M groups, indicating not only its efficacy but also a potential advantage in overall health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of traditional bone setting in chronic neck pain: randomized clinical trial. Zaproudina, N., Hänninen, OO., Airaksinen, O.[2022]

Chiropractic care for neck or low-back pain is generally safe, with most adverse events being benign and self-limiting.

The incidence of severe complications from chiropractic manipulation is extremely low, making it a useful therapy with negligible risks for serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events following chiropractic care for subjects with neck or low-back pain: do the benefits outweigh the risks? Rubinstein, SM.[2022]

In a study involving 529 patients treated by 79 chiropractors, 63% reported recovery from neck pain at 3 months and 66% at 12 months, indicating that chiropractic care can be effective for long-term relief.

While 56% of patients experienced adverse events after treatment, most were mild and not severe, suggesting that the benefits of chiropractic treatment for neck pain generally outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits outweigh the risks for patients undergoing chiropractic care for neck pain: a prospective, multicenter, cohort study. Rubinstein, SM., Leboeuf-Yde, C., Knol, DL., et al.[2007]

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