Clinical trial NCT06616272: Cervical Spine Focused Treatment for Patients with Persistent Concussion Symptoms and Neck Pain
Official title: Cervical Spine Focused Treatment for Patients with Persistent Concussion Symptoms and Neck Pain: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Concussion
Neck Pain
Keywords: concussion care
cervical rehabilitation
neck pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Treatment Adherence
timeFrame: 2 months
measure: Conversion Rate
timeFrame: 6 months
measure: Adverse Event Rate
timeFrame: 2 months
Secondary outcomes:
measure: Concussion Clinical Profile screen (CP screen)
timeFrame: Baseline, 4 week, 8 week
measure: Numeric pain rating scale (NPRS)
timeFrame: Baseline, 4 week, 8 week
measure: Neck Disability index (NDI)
timeFrame: Baseline, 4 week, 8 week
measure: Pain, Enjoyment and General Activity Score (PEG)
timeFrame: Baseline, 4 week, 8 week
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC sports medicine
state: Pennsylvania
city: Milwaukee
country: United States
facility: Greenfield Clinic-Children's Wisconsin
state: Wisconsin
city: Dublin
country: Ireland
facility: UPMC Sports Surgery Clinic
city: Belfast
country: United Kingdom
facility: Sports Medicine Northern Ireland
Study officials:
affiliation: University of Pittsburgh
name: Michael J Schneider, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.