Cervical Spine Focused Treatment for Patients with Persistent Concussion Symptoms and Neck Pain

Last updated: March 25, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Chronic Pain

Neck Pain

Treatment

Cervical rehabilitation

Standard Concussion Care

Clinical Study ID

NCT06616272
STUDY24040157
  • Ages 12-50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Cervical rehabilitation
Phase:
Study Start date:
May 15, 2025
Estimated Completion Date:
August 15, 2025

Study Description

This is a a single site pilot randomized controlled trial consisting of a total of 40 participants with concussion and neck pain, randomized to one of two groups (n=20 per group):

  1. early cervical spine focused treatment combined with standard concussion care.

  2. standard concussion care alone for 4 weeks, followed by delayed introduction (after 4 weeks) of cervical spine focused treatment (which is the usual care workflow at our clinical partner site.)

Both groups will receive the combination of cervical spine focused treatment and standard concussion care; the only variation being the timing of the introduction of the cervical spine care.

The primary endpoint will be 4 weeks from start of cervical rehabilitation intervention. The secondary would be the point of discharge. The duration of active participation in the study will be 8 weeks for the participants.

Connect with a study center

  • UPMC Sports Surgery Clinic

    Dublin,
    Ireland

    Site Not Available

  • Sports Medicine Northern Ireland

    Belfast,
    United Kingdom

    Site Not Available

  • UPMC sports medicine

    Pittsburgh, Pennsylvania 15203
    United States

    Active - Recruiting

  • Greenfield Clinic-Children's Wisconsin

    Milwaukee, Wisconsin 53227
    United States

    Site Not Available

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