Cervical spine treatment for concussion patients with neck pain
Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain: Pilot Study
This study is testing whether early neck treatment can help people with ongoing concussion symptoms and neck pain feel better compared to just standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 50 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 4 sites (Pittsburgh, Pennsylvania and 3 other locations) |
| Trial ID | NCT06616272 on ClinicalTrials.gov |
What this trial studies
This study assesses the feasibility of recruiting and randomizing patients who have persistent concussion symptoms and neck pain to receive early cervical rehabilitation in addition to standard concussion care. Participants will be divided into two groups: one receiving early cervical spine treatment and the other receiving standard care followed by delayed cervical treatment. The study aims to identify barriers in the current workflow at the concussion clinic to allow for earlier intervention. The primary endpoint will be evaluated after 4 weeks of cervical rehabilitation, with a total participation duration of 8 weeks.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with a concussion who also experience moderate to severe neck pain or difficulty moving their neck.
Not a fit: Patients with a history of recent concussions, prior cervical spine surgery, or those with specific exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery outcomes for patients suffering from both concussion symptoms and neck pain.
How similar studies have performed: While this approach is novel in its focus on early cervical rehabilitation for concussion patients, similar studies have shown promise in addressing related symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed concussion * Patient endorses neck pain OR difficulty moving their neck (moderate or severe; score of 2 or 3 for items 16 and 25 from concussion CP screen) * Willingness to be randomized * 8-90 days post injury * English Speaking Exclusion Criteria: * Previous concussion within the past 6 months * Prior history of ischemic/vascular events * Previous treatment for current symptoms * Prior treatment for neck pain/headaches in the past year * Workers' compensation claim and/or litigation associated with injury * Diagnosed substance use disorder * Prior cervical spine surgery * Prior fracture and or dislocation/subluxation of the cervical spine * Diagnosed inflammatory arthritis
Where this trial is running
Pittsburgh, Pennsylvania and 3 other locations
- UPMC sports medicine — Pittsburgh, Pennsylvania, United States (Recruiting)
- Greenfield Clinic-Children's Wisconsin — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
- UPMC Sports Surgery Clinic — Dublin, Ireland (Not_yet_recruiting)
- Sports Medicine Northern Ireland — Belfast, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Michael J Schneider, DC, PhD — University of Pittsburgh
- Study coordinator: Cynthia L Holland, MPH
- Email: clh197@pitt.edu
- Phone: 4129046126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.