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Behavioural Intervention

Cervical Rehabilitation for Concussion Symptoms and Neck Pain (ConCerv Trial)

N/A

Waitlist Available

Led By Michael J Schneider, DC, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Diagnosed concussion

Must not have

Prior history of ischemic/vascular events

Prior fracture and or dislocation/subluxation of the cervical spine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if it's possible to enroll patients with concussion symptoms and neck pain in a study where they will receive manual therapy and neck exercises along with standard concussion treatment. Currently, neck rehabilitation

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves physical therapy techniques, potential side effects may include temporary increases in neck pain or headaches. However, these treatments are generally considered safe with minimal risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with a concussion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stroke or heart attack before.

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I have had a previous fracture or dislocation in my neck.

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I have had surgery on my neck spine before.

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I have been treated for my current symptoms before.

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I have been treated for neck pain or headaches in the last year.

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I have been diagnosed with inflammatory arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Event Rate

Conversion Rate

Recruitment rate

+1 more

Secondary study objectives

Concussion Clinical Profile screen (CP screen)

Neck Disability index (NDI)

Numeric pain rating scale (NPRS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Early cervical spine focused treatment and standard concussion careActive Control2 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 treatmentActive Control2 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.

0 / 8Eligibility criteria met