NCT06616272

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

Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain: Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Brain Concussion
• Neck Pain

Interventions

Type	Name	Description
OTHER	Cervical rehabilitation	* Manual joint mobilization (Grades I-V) of painful and restricted cervical spine segments. * Supine manual cervical traction to stretch and mobilize the cervical spinal tissues. * Manual soft tissue mobilization of the cervical, upper thoracic and/or shoulder muscles. * Passive stretching of hypertonic muscles and active strengthening of hypotonic muscles. * Motor-control and isometric exercises to activate the deep neck flexors.
OTHER	Standard Concussion Care	Standard Concussion Care interventions are individualized to each patient and their adjudicated profile(s)/moderating factor(s) and may include any/all of the following: * Behavioral regulation * Vestibular rehabilitation * Oculomotor rehabilitation * Exertion rehabilitation * Pharmacological management * Behavioral sleep intervention * \*Cervical spine rehabilitation (the variable of interest in this study) * Psychotherapy

Timeline

• Start date: 2025-08-28
• Primary completion: 2026-07-15
• Completion: 2026-07-15
• First posted: 2024-09-27
• Last updated: 2026-03-04

Locations

4 sites across 3 countries: United States, Ireland, United Kingdom