Cervical Rehabilitation for Concussion Symptoms and Neck Pain

(ConCerv Trial)

Recruiting at 3 trial locations

Overseen By Cynthia L Holland, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Previous concussion, Ischemic events, Substance use, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Assess the feasibility of recruiting, enrolling and randomizing patients with concussion symptoms and neck pain to receive manual therapy and cervical rehabilitative exercises in addition to standard concussion treatment. In the usual care workflow provided at the participating concussion clinic, cervical spine rehab is not typically introduced until after week 4. The rationale is that neck pain is often a self-limiting condition that may resolve spontaneously, without the need for specific cervical spine rehab. This study is chiefly focused on feasibility aims that revolve around developing changes to barriers in workflow issues at the participating concussion clinic, that would allow for earlier introduction of cervical spine rehab.

Will I have to stop taking my current medications?

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.

Is cervical rehabilitation generally safe for humans?

The studies reviewed do not specifically address the safety of cervical rehabilitation, but they do suggest that it is used in various conditions like post-concussion syndrome and chronic cervical pain, indicating it is generally considered safe for these purposes. ^{1 2 3 4 5}

How does cervical rehabilitation differ from other treatments for concussion symptoms and neck pain?

Cervical rehabilitation is unique because it specifically targets the neck area to improve symptoms like neck pain and dizziness, which are often associated with concussions. This approach focuses on exercises that enhance neck muscle stability and joint position sense, potentially leading to better outcomes compared to general physical therapy. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Cervical rehabilitation for concussion symptoms and neck pain?

Research shows that cervical rehabilitation, which includes exercises and manual therapy, can improve neck pain and functional ability. A case study also reported improvements in post-concussion symptoms and reduced concussion incidence after cervical spine rehabilitation. ^{1 2 4 8 9}

Who Is on the Research Team?

Michael Schneider, PhD, DC

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals experiencing ongoing neck pain and concussion symptoms. Participants should be those who have not yet received cervical spine rehabilitation within the first four weeks post-injury, as this study aims to introduce such care earlier in the standard concussion treatment process.

Inclusion Criteria

I have moderate to severe neck pain or trouble moving my neck.

I was injured between 8 and 90 days ago.

I have been diagnosed with a concussion.

Exclusion Criteria

I have had a stroke or heart attack before.

I have had surgery on my neck spine before.

Previous concussion within the past 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either early or delayed cervical spine focused treatment combined with standard concussion care

8 weeks

2 visits/week for cervical spine treatment, 1 visit/week for standard care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cervical rehabilitation

Trial Overview The trial is testing whether adding manual therapy and exercises for the neck (cervical rehabilitation) to standard concussion care can be feasibly integrated into current clinical workflows and if it benefits patients with persistent symptoms more than standard care alone.

How Is the Trial Designed?

Group I: Early cervical spine focused treatment and standard concussion care Active Control 2 Interventions

The cervical spine focused treatment will start concurrently with the standard care once the participant is randomized to this group. The participants will receive early cervical spine focused treatment 2x/week for 4 weeks. In addition to the cervical spine focused treatment, this group will also receive standard concussion care interventions individualized to the participant's needs 1x/week concurrently during the same 4-week period of time. After 4 weeks, the participant will discontinue the cervical spine focused treatment but may continue with standard concussion care for an additional 4 weeks (maximum total treatment duration is 8 weeks).

Group II: Standard concussion care alone followed by delayed cervical spine focused treatment Active Control 2 Interventions

Participants randomized to the delayed cervical spine focused treatment group will only receive the standard concussion care (individualized to their needs) 1x/week for the initial 4 weeks. At the 4-week timepoint, the cervical spine focused treatment will be added to the standard concussion care at a frequency of twice a week for 4 weeks. Should a participant be cleared for return to activity prior to the end of the 4-week period, cervical spine focused treatment will be suspended. The maximum total treatment duration is 8 weeks; 1x/week for weeks 1-8 for the standard concussion care and 2x/week for weeks 4-8 for the cervical spine focused treatment.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

In a pilot study of 15 subjects with chronic cervical myofascial pain and dizziness, participants reported significant improvements in dizziness (59%), pain (69%), and function (71%) after undergoing a non-standardized rehabilitation program.

The study found a correlation between dizziness and pain, suggesting that addressing cervical pain may help alleviate dizziness, although further research is needed to determine the most effective rehabilitation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic cervical myofascial pain syndrome: Improvement in dizziness and pain with a multidisciplinary rehabilitation program. A pilot study. Krabak, BJ., Borg-Stein, J., Oas, JA.[2019]

This study will evaluate the effectiveness of various interventions on improving cervical joint position sense and balance in 168 participants with neck pain over a 6-week treatment period, with follow-ups at 3, 6, and 12 months.

The trial aims to provide evidence on how specific therapeutic exercises and manual therapy can not only alleviate neck pain but also address associated impairments in balance and joint position sense, which are crucial for overall functional ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of local treatment with and without sensorimotor and balance exercise in individuals with neck pain: protocol for a randomized controlled trial. Sremakaew, M., Jull, G., Treleaven, J., et al.[2018]

Patients with cervical disorders who had symptoms for more than 6 months showed significantly less functional improvement after physical therapy compared to those with symptoms lasting less than 1 month, indicating that symptom acuity affects recovery outcomes.

The study found that age, symptom duration, and the use of mobilization or manipulation techniques were significant factors influencing patient function at discharge, explaining over 35% of the variance in functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of acuity on physical therapy outcomes for patients with cervical disorders. Boissonnault, WG., Badke, MB.[2007]

In a study of 73 children and adolescents undergoing physical therapy after a concussion, 90% exhibited cervical impairments in at least three out of five assessment categories, highlighting the commonality of these issues post-injury.

The most frequently observed impairments were in posture (99%) and myofascial issues (98%), indicating that targeted physical therapy interventions should focus on these areas to effectively address cervical spine impairments following concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CHARACTERIZATION OF CERVICAL SPINE IMPAIRMENTS IN CHILDREN AND ADOLESCENTS POST-CONCUSSION. Tiwari, D., Goldberg, A., Yorke, A., et al.[2022]

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]

Over 50% of service members diagnosed with cervical pain (cervicalgia) had a documented mild traumatic brain injury (mTBI) within 90 days prior, indicating a strong association between these two conditions.

Less than 1% of service members were diagnosed with both cervicalgia and mTBI on the same day, suggesting that cervical pain often develops after the initial mTBI, which may complicate recovery and highlight the need for timely evaluation and treatment of neck injuries following concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Neck Pain in Soldiers as a Result of Mild Traumatic Brain Injury-Associated Trauma. Caberwal, T., Cecchini, AS., Wentz, LM., et al.[2023]

In a study of 312 patients with concussion, those experiencing neck or shoulder pain had significantly longer recovery times, more severe symptoms, and were more likely to miss over 5 days of school compared to those without such pain.

The presence of neck or shoulder pain was linked to increased sleep disturbances post-injury, suggesting that clinicians should consider early rehabilitation for patients reporting these symptoms to improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presence of Neck or Shoulder Pain Following Sport-Related Concussion Negatively Influences Recovery. Provance, AJ., Howell, DR., Potter, MN., et al.[2021]

Cervical exercise significantly reduced neck pain and disability in patients with post-traumatic stress disorder, with notable improvements in pain scores and disability indices after 6 weeks of exercise compared to conventional therapy.

The exercise program also positively impacted psychological factors, leading to a significant decrease in depression symptoms, although it did not significantly affect anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical feasibility of cervical exercise to improve neck pain, body function, and psychosocial factors in patients with post-traumatic stress disorder: a randomized controlled trial. Park, SD., Kim, SY.[2020]

The cervical range of motion instrument (CROM) showed significant intertester reliability for assessing cervical relocation, with an interclass correlation coefficient (ICC) indicating good consistency between different testers.

The study suggests that individuals with a history of neck pain may experience greater difficulty in the cervical relocation test (CRT), highlighting the potential for this test to help identify those at risk for cervical spine issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reliability of the cervical relocation test on people with and without a history of neck pain. Burke, S., Lynch, K., Moghul, Z., et al.[2018]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Chronic cervical myofascial pain syndrome: Improvement in dizziness and pain with a multidisciplinary rehabilitation program. A pilot study. [2019]

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

Effects of local treatment with and without sensorimotor and balance exercise in individuals with neck pain: protocol for a randomized controlled trial. [2018]

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

Influence of acuity on physical therapy outcomes for patients with cervical disorders. [2007]

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

CHARACTERIZATION OF CERVICAL SPINE IMPAIRMENTS IN CHILDREN AND ADOLESCENTS POST-CONCUSSION. [2022]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Prevalence of Neck Pain in Soldiers as a Result of Mild Traumatic Brain Injury-Associated Trauma. [2023]

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

Presence of Neck or Shoulder Pain Following Sport-Related Concussion Negatively Influences Recovery. [2021]

8. Japan pubmed.ncbi.nlm.nih.gov

Clinical feasibility of cervical exercise to improve neck pain, body function, and psychosocial factors in patients with post-traumatic stress disorder: a randomized controlled trial. [2020]

9. England pubmed.ncbi.nlm.nih.gov

The reliability of the cervical relocation test on people with and without a history of neck pain. [2018]