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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether chiropractic adjustments can improve nervous system function in individuals with post-concussion syndrome. Participants will receive six weeks of chiropractic care, with various assessments tracking changes. The trial seeks individuals who have experienced a concussion and have ongoing symptoms such as headaches, dizziness, or concentration difficulties for at least three months. Participants should be comfortable wearing sensors and walking on a treadmill. This trial is ideal for those who have not received similar treatments or chiropractic adjustments in the past month. As an unphased trial, it offers participants a unique opportunity to contribute to groundbreaking research in chiropractic care for post-concussion syndrome.

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 prior data suggests that chiropractic adjustment is safe for individuals with post-concussion syndrome?

Research has shown that chiropractic adjustments are generally safe, with most people experiencing only mild and temporary side effects, such as soreness or slight discomfort after a session. Serious problems, like strokes, are rare.

In studies on chiropractic care for post-concussion syndrome, patients demonstrated improvements, and no major safety concerns were reported. This suggests that most people handle chiropractic adjustments well. However, it's important to consider the benefits and risks and consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for post-concussion syndrome, which often include medication and cognitive therapy, chiropractic adjustment offers a hands-on approach to address symptoms. Researchers are excited about this treatment because it focuses on manual spinal adjustments, which may help alleviate symptoms like headaches and dizziness by improving spinal alignment and nervous system function. This non-invasive method provides a potential alternative for those seeking relief without pharmaceuticals, appealing to individuals interested in holistic and integrative healthcare options.

What evidence suggests that chiropractic adjustment might be an effective treatment for post-concussion syndrome?

Research has shown that chiropractic care, including spinal adjustments, might help alleviate symptoms of post-concussion syndrome. Some studies have found improvements in eye movement and cognitive issues. A series of case reports noted that symptoms like headaches and dizziness improved after chiropractic treatment. Additionally, a review of various studies found that chiropractic care is as effective as standard physical therapy in easing symptoms. These findings suggest that chiropractic adjustments, which participants in this trial will receive, might help relieve symptoms of post-concussion syndrome. ^{1 2 6 7 8}

Who Is on the Research Team?

Ahmed Qazi

Principal Investigator

Life University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7815178/

Multi-modal management of sport and non-sport related ... This case series describes the multi-modal treatment plans delivered by two chiropractic sports specialists for the management of post-concussive symptoms ...

2. withpower.com withpower.com/trial/phase-syndrome-11-2023-feb59

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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0161475424000423

Effect of Chiropractic Intervention on Oculomotor and ... This study aimed to establish if chiropractic care can improve oculomotor and cognitive symptoms in individuals with persistent postconcussion syndrome (PPCS).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8915715/

Clinical Effectiveness and Efficacy of Chiropractic Spinal ... Interestingly, a review of pragmatic trials found that chiropractic care (always including SMT) was as effective as standard physical therapy (106).

5. journal.parker.edu journal.parker.edu/article/78084-the-impact-of-chiropractic-management-on-a-15-year-old-male-diagnosed-with-post-concussion-syndrome-and-whiplash-a-case-report

THE IMPACT OF CHIROPRACTIC MANAGEMENT ON A ... This case study demonstrates improvements in post-concussion symptoms and whiplash in a 15-year-old male following chiropractic care.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5021900/

Chiropractic Management of Musculoskeletal Symptoms in ... This case demonstrates the improvement of postconcussion syndrome in a 14-year-old male hockey player under chiropractic management.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06151184/post-concussion-syndrome-and-chiropractic

Post-concussion Syndrome and Chiropractic This proof-of-concept trial will explore the effects of manual chiropractic adjustments on nervous system function in individuals with post-concussion syndrome.

8. journal.parker.edu journal.parker.edu/article/78066

CHIROPRACTIC MANAGEMENT OF THE ... This case series demonstrated improvements in post-concussion syndrome in all 6 patients. The results observed in this case series suggest an encouraging ...