Chiropractic Care + Group Medical Visits for Chronic Pain

(GOLDEN Trial)

Overseen By Wren M Burton, DC, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Chiropractic care, Spinal surgery, Nursing home, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if combining chiropractic care with group medical visits can reduce chronic spine pain in adults over 65. Chiropractic care is known to ease pain, and group visits may support pain management, so researchers hope combining them will be even more effective. The trial tests whether this combination is practical and beneficial for individuals with long-lasting neck, mid-back, or lower back pain. It suits those who have experienced spine pain almost daily for at least three months and can attend both in-person and virtual sessions. As an unphased trial, this study offers a unique opportunity to explore innovative pain management strategies without the constraints of traditional phase requirements.

Do I need to stop taking my current medications to join the trial?

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.

What prior data suggests that chiropractic care and group medical visits are safe for chronic pain management in adults over 65?

Research has shown that chiropractic care is generally safe, though some individuals might experience mild side effects. In one study, the most common issues included increased pain (27%), headaches (15%), fatigue (12%), pain spreading to other areas (6%), and dizziness (4%). Another study found that individuals receiving chiropractic treatments reported fewer negative effects compared to other treatments.

Studies suggest that group medical visits are a promising approach to managing long-term pain, as they have helped reduce the need for pain medication. Overall, both chiropractic care and group medical visits are considered safe, with few serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining chiropractic care with group medical visits for managing chronic pain because it offers a holistic approach that addresses both physical and social aspects of the condition. Unlike typical treatments like medication or physical therapy, this approach integrates hands-on spinal adjustments with supportive, interactive group sessions, potentially enhancing both physical relief and emotional well-being. The virtual format of group medical visits also adds convenience, allowing participants to connect from the comfort of their homes, which may increase accessibility and adherence to the treatment.

What evidence suggests that combining chiropractic care and group medical visits could be effective for chronic spine pain?

Research has shown that chiropractic care can reduce low back pain in the short term, especially when combined with regular medical treatments. Studies also suggest that group medical visits, where people share support and experiences, can help manage chronic pain. In this trial, participants will receive both chiropractic care and group medical visits, aiming to improve outcomes for chronic spine pain, particularly in adults over 65. Although specific data on using both approaches together is lacking, the idea is that they could work well in combination. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 65 with chronic neck, thoracic, or low back pain that occurs at least 5 days a week for the past 3 months. Participants must rate their pain as 3+ on a scale of 0-10 and have some disability due to it. They need internet access, reliable transportation, willingness to follow study procedures, and must be fluent in English.

Inclusion Criteria

I can use a smart device or computer with internet access.

I have a reliable way to get to my study visits and chiropractic treatments.

I agree to follow all study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combined chiropractic care and group medical visits

8 weeks

8 weekly chiropractic visits and 8 weekly virtual group medical visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chiropractic Care
• Group Medical Visits

Trial Overview The study is testing if combining chiropractic care with group medical visits can help reduce chronic spine pain in older adults more than these treatments separately. It's exploring how feasible this combined approach is and gathering data for future trials.

How Is the Trial Designed?

Group I: Combined chiropractic care and group medical visits Experimental Treatment 2 Interventions

Participants will attend 8 weekly chiropractic visits (40-minutes for initial visit, 20-minutes for remaining 7). Participants will simultaneously enroll in 8 weekly 90-minute virtual group medical visits.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8667562/

Visit Frequency and Outcomes for Patients Using Ongoing ... Unconditional (time-only) models showed patients on average had mild pain and function and significant, but slight improvements in these over the 3-month ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2680417

Effect of Usual Medical Care Plus Chiropractic Care vs ... Conclusions and Relevance Chiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000560

Combined chiropractic care and Tai Chi for chronic neck pain Participants in the groups receiving chiropractic care alone or both chiropractic care and TC intervention will attend >70 % of intervention visits/sessions.

4. acatoday.org acatoday.org/research/what-research-shows/

What Research Shows About Chiropractic Low back pain initiated with a doctor of chiropractic (DC) saves 20 to 40 percent on health care costs when compared with care initiated through a medical ...

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-020-03330-1

Predictors of visit frequency for patients using ongoing ... This study examines the predictors of visit frequency in a large sample of patients with CLBP and CNP using ongoing chiropractic care.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3224760/

Outcomes of usual chiropractic, harm & efficacy, the ouch study The most common adverse events were increased pain (27%), headache (15%), tiredness (12%), radiating pain (6%), and dizziness (4%). Participants who received ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161475425000028

Observational Study of the Safety of Chiropractic vs ... Among 291 604 patients, 182 596 (63%) received chiropractic care. For CMT vs PDT, the rate for any measured adverse outcome was 20% lower; for ...

8. backinactionbodyworks.com backinactionbodyworks.com/blog/chiropractic-adjustments-and-patient-outcomes-what-the-statistics-reveal

Chiropractic Adjustments and Patient Outcomes Many patients report high satisfaction with chiropractic care, with over 77% describing it as very effective, and 94% experiencing at least a 30 ...

9. nature.com nature.com/articles/s41598-023-28520-4

A retrospective analysis of the incidence of severe adverse ... This study examined the incidence and severity of adverse events (AEs) of patients receiving chiropractic spinal manipulative therapy (SMT).