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

Not Applicable

Recruiting

• Conditions: Brain Concussion; Neck Pain
• Interventions: Other: Cervical rehabilitation; Other: Standard Concussion Care

• Registration Number: NCT06616272
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Start: 2025-05-15
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early cervical spine focused treatment and standard concussion care	Cervical rehabilitation	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).
Early cervical spine focused treatment and standard concussion care	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).
Standard concussion care alone followed by delayed cervical spine focused treatment	Cervical rehabilitation	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.
Standard concussion care alone followed by delayed cervical spine focused treatment	Standard Concussion Care	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

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