Chiropractic Adjustment for Subluxations

(SHA Trial)

Overseen By Daekiara Smith-Ireland, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Life University

Must not be taking: Anticoagulants

Disqualifiers: Stroke, Whiplash, Pregnancy, Hypertension, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Our primary aim with this trial is to measure participant blinding following two simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments to assess if participants are able to identify their un-disclosed treatment group. Our secondary aims with this trial are to utilize electrocardiography (ECG), impedance cardiography (ICG), and gait analysis before either treatment session and after both treatment sessions to assess if there are any changes with the participants' measurements before and after a sham or genuine HVLA chiropractic treatment.

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

The trial does not specify if you need to stop taking your current medications, but it does require that you are not currently using anticoagulant therapy (blood thinners).

What data supports the effectiveness of the treatment Chiropractic adjustment for Subluxations?

Research shows that chiropractic care can lead to improvements in pain, disability, and quality of life for patients with back pain, as seen in a national study in Sweden. Additionally, older adult male veterans with chronic lower back pain reported significant improvements after chiropractic care. ^{1 2 3 4 5}

Is chiropractic adjustment generally safe for humans?

Chiropractic adjustments often lead to mild and temporary side effects, but serious adverse events are rare. Some cases of serious neurological issues have been reported, so more research is needed to better understand these risks. ^{2 6 7 8 9}

How does chiropractic adjustment for subluxations differ from other treatments?

Chiropractic adjustment for subluxations is unique because it focuses on correcting mechanical derangements in the spine, believed to disturb neurological function, through specific spinal manipulative techniques. This approach is distinct from other treatments as it uses manual or mechanical force to adjust the spine, aiming to address the root cause of the condition rather than just alleviating symptoms. ^{4 10 11 12 13}

Research Team

Margaret Sliwka, DC

Principal Investigator

Life University

Eligibility Criteria

This trial is for individuals with subluxations, which are misalignments of the spine. Participants will be randomly assigned to receive either simulated (sham) or genuine chiropractic adjustments. The study aims to see if they can tell which treatment they received.

Exclusion Criteria

Recent whiplash injury (within 3 months)

Being a DC or a DC student enrolled 4th quarter or above

Present, self-reported pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two sessions of either simulated/sham or genuine/real chiropractic spinal adjustments with a 1 week washout between each treatment

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of gait, heart rate variability, and participant blinding

1 week

1 visit (in-person)

Treatment Details

Interventions

• Chiropractic adjustment
• Sham adjustment

Trial Overview The trial is testing whether participants can distinguish between sham and real high velocity, low amplitude (HVLA) chiropractic adjustments. It also measures changes in heart function and walking patterns before and after treatments using ECG, ICG, and gait analysis.

Participant Groups

Group I: Genuine/real Experimental Treatment 1 Intervention

30 individuals receiving genuine/real chiropractic interventions

Group II: Simulated/sham Placebo Group 1 Intervention

30 individuals receiving simulated/sham chiropractic interventions

Who Is Running the Clinical Trial?

Life University

Lead Sponsor

Trials

21

Recruited

450+

Findings from Research

In a study involving 18 participants with low-back pain, both active chiropractic adjustments and sham treatments led to improvements in pain and well-being, but active treatments generally resulted in greater benefits.

Interestingly, 57% of participants who received the sham treatment believed it had a positive effect, highlighting the potential for placebo effects in chiropractic care and the importance of blinding in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary study of the effects of a placebo chiropractic treatment with sham adjustments. Hawk, C., Azad, A., Phongphua, C., et al.[2019]

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]

Between 2004 and 2012, there were 338 compensation claims related to chiropractic care in Denmark and Norway, with 300 claims analyzed; only 13.7% of these claims were approved for financial compensation, indicating a low approval rate compared to other healthcare providers.

The most common complaints included worsening symptoms after treatment and alleged disk herniations, with a significant portion of compensation costs linked to a few cases of serious adverse events like cervical artery dissection, suggesting that better patient education on treatment expectations could help reduce claims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensation claims for chiropractic in Denmark and Norway 2004-2012. Jevne, J., Hartvigsen, J., Christensen, HW.[2018]

Three serious neurological adverse events were reported in patients following chiropractic manipulation, including a vertebro-basilar stroke, neuropraxic injury of radial nerves, and a cervical epidural hematoma.

These cases suggest a potential causal relationship between chiropractic treatment and serious neurological complications, highlighting the need for a risk alert system to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chiropractic manipulation: reasons for concern? Gouveia, LO., Castanho, P., Ferreira, JJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of Treatment Outcomes in Nonspecific Low-Back Pain Patients With and Without Modic Changes Who Receive Chiropractic Treatment. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Chiropractic Clinical Outcomes Among Older Adult Male Veterans With Chronic Lower Back Pain: A Retrospective Review of Quality-Assurance Data. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Preliminary study of the effects of a placebo chiropractic treatment with sham adjustments. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Patient-reported improvements of pain, disability, and health-related quality of life following chiropractic care for back pain - A national observational study in Sweden. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Compensation claims for chiropractic in Denmark and Norway 2004-2012. [2018]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Reporting of adverse effects in randomised clinical trials of chiropractic manipulations: a systematic review. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Chiropractic manipulation: reasons for concern? [2022]

10. England pubmed.ncbi.nlm.nih.gov

The basis for spinal manipulation: chiropractic perspective of indications and theory. [2012]

11. England pubmed.ncbi.nlm.nih.gov

An epidemiological examination of the subluxation construct using Hill's criteria of causation. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Mechanical force, manually assisted short lever chiropractic adjustment. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Neurological effects of the adjustment. [2022]