Brain Concussion, Neck Pain
Conditions
Keywords
concussion care, cervical rehabilitation, neck pain
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.
Interventions
OTHERCervical 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.
OTHERStandard 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
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 6 months | Enrolling 6 new participants per month |
| Treatment Adherence | 2 months | Assess the rate of adherence to treatment with a goal of participant attending ≥ 75% (6 of 8) of scheduled visits. |
| Conversion Rate | 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. |
| Adverse Event Rate | 2 months | Rates of expected side effects and adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concussion Clinical Profile screen (CP screen) | 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. |
| Numeric pain rating scale (NPRS) | 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. |
| Neck Disability index (NDI) | 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. |
| Pain, Enjoyment and General Activity Score (PEG) | 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. |
Countries
Ireland, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORMichael J Schneider, DC, PhD
University of Pittsburgh
Outcome results
None listed