Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616272
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Cervical Spine Focused Treatment for Patients with Persistent Concussion Symptoms and Neck Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cervical Spine Focused Treatment for Patients with Persistent Concussion Symptoms and Neck Pain Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ConCerv
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
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 n20 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None