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

NCT06616272 | Recruiting

• 1 other identifier: STUDY24040157
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Brain Concussion; Neck Pain

Keywords

concussion care; cervical rehabilitation; neck pain

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Enrolling 6 new participants per month

  6 months

• Treatment Adherence

  Assess the rate of adherence to treatment with a goal of participant attending ≥ 75% (6 of 8) of scheduled visits.

  2 months

• Conversion Rate

  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

  Rates of expected side effects and adverse events

  2 months

Secondary Outcomes (4)

• Concussion Clinical Profile screen (CP screen)

  Baseline, 4 week, 8 week

• Numeric pain rating scale (NPRS)

  Baseline, 4 week, 8 week

• Neck Disability index (NDI)

  Baseline, 4 week, 8 week

• Pain, Enjoyment and General Activity Score (PEG)

  Baseline, 4 week, 8 week

Study Arms (2)

Early cervical spine focused treatment and standard concussion care

ACTIVE COMPARATOR

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; Other: Standard Concussion Care

Standard concussion care alone followed by delayed cervical spine focused treatment

ACTIVE COMPARATOR

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; Other: Standard Concussion Care

Interventions

Cervical rehabilitation OTHER

* 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.

Early cervical spine focused treatment and standard concussion care; Standard concussion care alone followed by delayed cervical spine focused treatment

Standard Concussion Care OTHER

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

Early cervical spine focused treatment and standard concussion care; Standard concussion care alone followed by delayed cervical spine focused treatment

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• days post injury
• English Speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (4)

UPMC sports medicine

Pittsburgh, Pennsylvania, 15203, United States

RECRUITING

Greenfield Clinic-Children's Wisconsin

Milwaukee, Wisconsin, 53227, United States

NOT YET RECRUITING

UPMC Sports Surgery Clinic

Dublin, Ireland

NOT YET RECRUITING

Sports Medicine Northern Ireland

Belfast, United Kingdom

NOT YET RECRUITING

Related Publications (10)

• 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.

  PMID: 31950187 BACKGROUND

• 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.

  PMID: 32241234 BACKGROUND

• 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.

  PMID: 23479479 BACKGROUND

• 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.

  PMID: 11086747 BACKGROUND

• 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.

  PMID: 28666405 BACKGROUND

• 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.

  PMID: 18204386 BACKGROUND

• 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.

  PMID: 17951095 BACKGROUND

• 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.

  PMID: 30583251 BACKGROUND

• 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.

  PMID: 33753016 BACKGROUND

• 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.

  PMID: 18164333 BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Neck Pain

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael J Schneider, DC, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia L Holland, MPH

CONTACT

4129046126; clh197@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 27, 2024
• Study Start: August 28, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IE (1); GB (1)