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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
40
* 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 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
UPMC sports medicine
Pittsburgh, Pennsylvania, United States
RECRUITINGGreenfield Clinic-Children's Wisconsin
Milwaukee, Wisconsin, United States
NOT_YET_RECRUITINGUPMC Sports Surgery Clinic
Dublin, Ireland
NOT_YET_RECRUITINGSports Medicine Northern Ireland
Belfast, United Kingdom
NOT_YET_RECRUITINGRecruitment rate
Enrolling 6 new participants per month
Time frame: 6 months
Treatment Adherence
Assess the rate of adherence to treatment with a goal of participant attending ≥ 75% (6 of 8) of scheduled visits.
Time frame: 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.
Time frame: 6 months
Adverse Event Rate
Rates of expected side effects and adverse events
Time frame: 2 months
Concussion Clinical Profile screen (CP screen)
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.
Time frame: Baseline, 4 week, 8 week
Numeric pain rating scale (NPRS)
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.
Time frame: Baseline, 4 week, 8 week
Neck Disability index (NDI)
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.
Time frame: Baseline, 4 week, 8 week
Pain, Enjoyment and General Activity Score (PEG)
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.
Time frame: Baseline, 4 week, 8 week
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