Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain
NCT ID: NCT06616272
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-08-28
2025-12-15
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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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).
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.
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
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.
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.
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
50 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Michael Schneider, DC, PhD
Professor
Principal Investigators
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Michael J Schneider, DC, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC sports medicine
Pittsburgh, Pennsylvania, United States
Greenfield Clinic-Children's Wisconsin
Milwaukee, Wisconsin, United States
UPMC Sports Surgery Clinic
Dublin, , Ireland
Sports Medicine Northern Ireland
Belfast, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Cynthia L Holland
Role: primary
Jeff King, DC
Role: primary
Amy Nader
Role: backup
Ciaran Cosgrave
Role: primary
Louise Keating
Role: backup
Alan Rankin
Role: primary
Louise Keating
Role: backup
References
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Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
Kontos AP, Elbin RJ, Trbovich A, Womble M, Said A, Sumrok VF, French J, Kegel N, Puskar A, Sherry N, Holland C, Collins M. Concussion Clinical Profiles Screening (CP Screen) Tool: Preliminary Evidence to Inform a Multidisciplinary Approach. Neurosurgery. 2020 Aug 1;87(2):348-356. doi: 10.1093/neuros/nyz545.
Quatman-Yates CC, Hunter-Giordano A, Shimamura KK, Landel R, Alsalaheen BA, Hanke TA, McCulloch KL. Physical Therapy Evaluation and Treatment After Concussion/Mild Traumatic Brain Injury. J Orthop Sports Phys Ther. 2020 Apr;50(4):CPG1-CPG73. doi: 10.2519/jospt.2020.0301.
McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen RG, Guskiewicz K, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med. 2013 Apr;47(5):250-8. doi: 10.1136/bjsports-2013-092313. No abstract available.
McCrory PR, Ariens T, Berkovic SF. The nature and duration of acute concussive symptoms in Australian football. Clin J Sport Med. 2000 Oct;10(4):235-8. doi: 10.1097/00042752-200010000-00002.
Hurwitz EL, Carragee EJ, van der Velde G, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Cote P, Hogg-Johnson S, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: noninvasive interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S123-52. doi: 10.1097/BRS.0b013e3181644b1d.
Reid SA, Rivett DA, Katekar MG, Callister R. Sustained natural apophyseal glides (SNAGs) are an effective treatment for cervicogenic dizziness. Man Ther. 2008 Aug;13(4):357-66. doi: 10.1016/j.math.2007.03.006. Epub 2007 Oct 22.
van der Walt K, Tyson A, Kennedy E. How often is neck and vestibulo-ocular physiotherapy treatment recommended in people with persistent post-concussion symptoms? A retrospective analysis. Musculoskelet Sci Pract. 2019 Feb;39:130-135. doi: 10.1016/j.msksp.2018.12.004. Epub 2018 Dec 11.
Jones C, Sterling M. Clinimetrics: Neck Disability Index. J Physiother. 2021 Apr;67(2):144. doi: 10.1016/j.jphys.2020.09.001. Epub 2021 Mar 19. No abstract available.
Cleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126.
Other Identifiers
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STUDY24040157
Identifier Type: -
Identifier Source: org_study_id