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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if participants can distinguish between real and fake chiropractic adjustments. It also examines changes in heart and movement measurements following the treatments. The trial includes two groups: one receiving genuine chiropractic adjustments and the other receiving fake ones. Individuals without recent chiropractic care or certain medical issues, such as severe spine problems or heart conditions, may qualify. As an unphased trial, it provides a unique opportunity to contribute to understanding the effects of chiropractic care.

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 prior data suggests that chiropractic adjustments are safe?

Research has shown that chiropractic adjustments are generally safe for most people. Studies have found that serious side effects are rare. However, some individuals might experience mild effects after a session, such as headaches or soreness in the treated area. These minor effects typically resolve within a few days. Overall, chiropractic treatments are considered low risk, but consulting a healthcare provider is advisable if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about chiropractic adjustments for subluxations because they offer a non-invasive, drug-free approach that differs from standard treatments like pain medications or surgery. Chiropractic care focuses on manual adjustments to realign the spine, which can address the root cause of pain rather than just masking symptoms. This method may provide a more holistic and sustainable solution for individuals seeking alternatives to traditional medical interventions.

What evidence suggests that chiropractic adjustments could be effective for subluxations?

This trial will compare genuine chiropractic adjustments with sham adjustments. Studies have shown that chiropractic adjustments can help reduce pain. For example, one study found that chiropractic care was more effective than a placebo and worked better than muscle relaxants for some conditions. Research also shows that specific chiropractic treatments can significantly improve neck pain and related issues. Many patients report feeling healthier overall after receiving chiropractic care for spine misalignments. While some people may experience mild side effects, overall evidence suggests that chiropractic care can be a useful treatment for pain and spine problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Margaret Sliwka, DC

Principal Investigator

Life University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11016242/

Vertebral Subluxation and Systems Biology - PubMed Central In this paper we synthesize an expansive body of literature examining the multifaceted influence of chiropractic care on processes within and modulators of the ...

2. withpower.com withpower.com/trial/phase-subluxation-3-2025-3a5a6

Chiropractic Adjustment for Subluxations (SHA Trial) A systematic review of five studies on spinal manipulation (SM) found that about half of patients experience mild and transient adverse events after treatment, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2732255/

Neck pain and disability outcomes following chiropractic ... Statistically significant clinically meaningful improvements in neck pain NRS (P < 0.01) and disability NDI (P < 0.01) after an average of 13.6 days of specific ...

4. charlestonchirostudio.com charlestonchirostudio.com/blog/chiropractic-approach-to-subluxation-correction/

Effective Chiropractic Approach to Subluxation Correction Many of our patients have experienced significant improvements in their health through Chiropractic Approach to Subluxation Correction. For instance, one ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161475404000983

A Randomized Clinical Trial Comparing Chiropractic ... Chiropractic was more beneficial than placebo in reducing pain and more beneficial than either placebo or muscle relaxants in reducing GIS.

6. mayoclinic.org mayoclinic.org/tests-procedures/chiropractic-adjustment/about/pac-20393513

Chiropractic adjustment Some people have minor side effects for a few days after chiropractic adjustment. These may include having headaches or pain in the parts of the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1905885/

Adverse effects of spinal manipulation: a systematic review Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects.

8. modernchiropracticchicago.com modernchiropracticchicago.com/the-safety-of-chiropractic-adjustments-an-evidence-based-perspective/

The Safety of Chiropractic Adjustments The risk of serious adverse effects is low, and the more common side effects are typically mild and short-lived. As with any medical treatment, ...

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).

10. medicalnewstoday.com medicalnewstoday.com/articles/chiropractic-injuries

Chiropractic injuries: Risks, frequency, and when to get help Chiropractic treatments may cause minor, temporary side effects, such as discomfort, stiffness, or a headache. In rare cases, people also report severe events.