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

May 15, 2026 updated by: Michael Schneider, DC, PhD, University of Pittsburgh

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • UPMC Sports Surgery Clinic
  • United Kingdom
      • Belfast, United Kingdom
        • Sports Medicine Northern Ireland
  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15203
        • UPMC sports medicine
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53227
        • Greenfield Clinic-Children's Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early cervical spine focused treatment and standard concussion care
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).
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
Active Comparator: Standard concussion care alone followed by delayed cervical spine focused treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 6 months
Enrolling 6 new participants per month
6 months
Treatment Adherence
Time Frame: 2 months
Assess the rate of adherence to treatment with a goal of participant attending ≥ 75% (6 of 8) of scheduled visits.
2 months
Conversion Rate
Time Frame: 6 months
Ratio of concussion patients with neck pain approached about participation or referred for screening to those actually screened. As well as conversion rate of concussion patients screened for participation to those enrolled and randomized.
6 months
Adverse Event Rate
Time Frame: 2 months
Rates of expected side effects and adverse events
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concussion Clinical Profile screen (CP screen)
Time Frame: Baseline, 4 week, 8 week
Patient reported outcome regarding their concussion symptoms. The raw score ranges from 0 to 87. The scale helps identify specific clinical profiles and associated modifiers in concussion patients.
Baseline, 4 week, 8 week
Numeric pain rating scale (NPRS)
Time Frame: Baseline, 4 week, 8 week
Patient reported measure regarding average neck pain over past week. The score range from 0 to 10 where 0 is no pain and 10 is considered the worst pain imaginable.
Baseline, 4 week, 8 week
Neck Disability index (NDI)
Time Frame: Baseline, 4 week, 8 week
Patient reported outcome regarding their neck pain related disability. The scale ranges from 0-50 that are then converted to percentages. The scores are interpreted as: 0-20%: minimal disability; 21-40%: moderate disability; 41-60%: severe disability; and >60%: complete disability.
Baseline, 4 week, 8 week
Pain, Enjoyment and General Activity Score (PEG)
Time Frame: Baseline, 4 week, 8 week
Patient reported outcome regarding their pain and its interference to enjoyment in life and general activity in the past week. The scale has three individual items that are scored from 0 to 10. The overall score is the average of the three individual item scores rounded to the nearest whole number for clinical use.
Baseline, 4 week, 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Michael J Schneider, DC, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2025

Primary Completion (Actual)

April 15, 2026

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY24040157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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