Chiropractic Adjustment for Post-Concussion Syndrome

(PCS Trial)

Recruiting at 1 trial location

Overseen By Daekiara Smith-Ireland, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Life University

Must not be taking: Short-acting benzodiazepines

Disqualifiers: Schizophrenia, Bipolar, Malignant hypertension, POTS, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking short-acting benzodiazepines like midazolam or triazolam.

What data supports the effectiveness of the treatment Chiropractic Adjustment for Post-Concussion Syndrome?

Some studies suggest that chiropractic care, including spinal manipulation, may help improve post-concussion symptoms. For example, a case series showed that individualized, multi-modal treatment plans, which included chiropractic care, were effective in managing post-concussive symptoms in different stages of recovery. ^{1 2 3 4 5}

Is chiropractic adjustment generally safe for humans?

Chiropractic adjustments can lead to mild and temporary side effects, but serious adverse events are rare. Some cases have reported serious issues like strokes and nerve injuries, suggesting a need for caution and further research on safety. ^{1 4 6 7 8}

How is chiropractic adjustment different from other treatments for post-concussion syndrome?

Chiropractic adjustment for post-concussion syndrome is unique because it involves manual spinal manipulation and may include exercises for the neck and balance systems, which are not typically part of standard treatments. This approach is part of a multi-modal plan that can be tailored to individual needs, potentially offering benefits for various stages of recovery. ^{1 3 4 5 9}

What is the purpose of this trial?

This proof-of-concept trial will explore the effects of manual chiropractic adjustments on nervous system function in individuals with post-concussion syndrome. This study will aim to recruit 10 individuals to receive 6 weeks of chiropractic care with 3 assessment periods. The participants will undergo a baseline assessment, mid-trial assessment, and post-trial assessment. The participants will wear an electroencephalography (EEG) cap for a neural assessment during an event related potential. They will wear electrical diodes to measure electrocardiography (ECG), impedance cardiography (ICG), and electrodermal activity (EDA) throughout the study and during an orthostatic challenge. Additional sensors will be placed on the participant to measure interlimb symmetry patterns during gait while walking on a treadmill.

Research Team

Ahmed Qazi

Principal Investigator

Life University

Eligibility Criteria

Adults diagnosed with post-concussion syndrome (PCS) or those who believe they've had a concussion, experiencing symptoms like headaches and memory issues for at least 3 months. Participants must be able to wear sensors, walk on a treadmill, and have not received chiropractic adjustments or similar treatments in the last three months. Exclusions include serious mental disorders, certain physical conditions affecting blood pressure or gait, hearing impairments, recent surgeries, pregnancy, and high suicide risk.

Inclusion Criteria

I can make my own healthcare decisions.

Diagnosed by a physician with PCS OR self-identifies as having a concussion based on responses to the HELPS screening tool

I haven't had a chiropractic adjustment in the last 3 months.

Exclusion Criteria

I have a condition that causes fainting when I stand up.

I had surgery or an injury to my bones or skull in the last 3 months.

I have untreated osteoporosis or unstable joints.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 6 weeks of chiropractic care with assessments at weeks 0, 2, and 6

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Chiropractic adjustment

Trial Overview The trial is testing if manual chiropractic adjustments can improve nervous system function in people with PCS. It involves 10 participants receiving chiropractic care over six weeks with assessments using EEG for brain activity and other sensors to monitor heart rate variability and movement patterns during different activities.

Participant Groups

Group I: Post-concussion syndrome participants Experimental Treatment 1 Intervention

Post-concussion syndrome participants will all receive manual chiropractic adjustment interventions.

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

Approved in United States as Chiropractic Adjustment for:

• Post-concussion Syndrome
• Neck Pain
• Headaches
• Back Pain
• Dizziness

Approved in Canada as Chiropractic Care for:

• Post-concussion Syndrome
• Musculoskeletal Disorders
• Neck Pain
• Headaches

Approved in European Union as Manual Chiropractic Adjustment for:

• Post-concussion Syndrome
• Neck Pain
• Headaches
• Back Pain

Who Is Running the Clinical Trial?

Life University

Lead Sponsor

Trials

21

Recruited

450+

Findings from Research

A 14-year-old male hockey player with postconcussion syndrome showed significant improvement in symptoms and neurocognitive testing scores after receiving chiropractic care, including manipulative therapy and therapeutic exercises over 5 treatments in 20 days.

The patient was able to return to play following chiropractic management, suggesting that chiropractic interventions may be beneficial for athletes experiencing prolonged postconcussion symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chiropractic Management of Musculoskeletal Symptoms in a 14-Year-Old Hockey Player With Postconcussion Symptoms: A Case Report. Olson, HM., Tunning, MJ., Boesch, RJ.[2020]

Osteopathic manipulative treatment (OMT) shows positive effects on symptom resolution for athletes suffering from concussions and postconcussive syndrome (PCS), based on a review of nine studies.

However, the majority of the existing literature is qualitative and lacks high-quality randomized control trials, indicating a need for more rigorous research to fully understand the efficacy of OMT in treating these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic manipulative treatment for concussions and postconcussive syndrome in athletes: a literature review. Thomas, KD., Lombard, ZK., Shadiack, AL.[2023]

A case study of a motor vehicle collision victim showed that osteopathic manipulative treatment (OMT) led to direct and progressive improvement in post-concussion symptoms (PCS), suggesting its potential as an effective adjunct therapy.

This report is the first to explore OMT for PCS management in polytrauma patients within an organized trauma system, highlighting the need for further research to evaluate its efficacy across various injury mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulative Treatment Relieves Post-concussion Symptoms in a Case of Polytrauma. Baltazar, GA., Kolwitz, C., Petrone, P., et al.[2020]

A 27-year-old professional rugby player with a history of 20 concussions showed significant improvement in post-concussion syndrome after 30 sessions of cervical rehabilitation, with lasting benefits observed over 6 years.

Post-treatment, the player's cervical spinal alignment improved significantly, and he experienced only two additional concussions in the following six years, suggesting that correcting cervical alignment may help reduce the risk of future concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-concussion syndrome and concussion incidence improved in a pro rugby player following cervical spine rehab: case study and 6-year follow-up. Strauss, S., Lightstone, DF., Fedorchuk, C., et al.[2023]

Individualized, multi-modal treatment plans for post-concussive symptoms (PCS) showed efficacy across different stages of recovery in three cases, suggesting a tailored approach is beneficial.

The study indicates that the distinction between sport-related and non-sport-related concussions may not be necessary, and highlights the potential role of chiropractors as valuable members of the healthcare team in managing PCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-modal management of sport and non-sport related concussion by chiropractic sports specialists: a case series. Germann, D., Marshall, C., Kazemi, M.[2023]

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]

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]

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 literature review identified only five relevant articles on chiropractic management of concussion in sports, indicating that this is a developing area of research with limited published evidence.

No adverse outcomes were reported from chiropractic management of concussed athletes, suggesting that chiropractic care may be safe, but there is a need for standardized assessment tools and adherence to current concussion guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chiropractic and concussion in sport: a narrative review of the literature. Johnson, CD., Green, BN., Nelson, RC., et al.[2022]

References

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

Chiropractic Management of Musculoskeletal Symptoms in a 14-Year-Old Hockey Player With Postconcussion Symptoms: A Case Report. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Osteopathic manipulative treatment for concussions and postconcussive syndrome in athletes: a literature review. [2023]

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

Osteopathic Manipulative Treatment Relieves Post-concussion Symptoms in a Case of Polytrauma. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Post-concussion syndrome and concussion incidence improved in a pro rugby player following cervical spine rehab: case study and 6-year follow-up. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Multi-modal management of sport and non-sport related concussion by chiropractic sports specialists: a case series. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Chiropractic manipulation: reasons for concern? [2022]

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

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

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

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

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

Chiropractic and concussion in sport: a narrative review of the literature. [2022]