Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain: Pilot Study
概览
- 阶段
- 不适用
- 干预措施
- Cervical rehabilitation
- 疾病 / 适应症
- Brain Concussion
- 发起方
- University of Pittsburgh
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Recruitment rate
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
Michael Schneider, DC, PhD
Professor
University of Pittsburgh
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Early cervical spine focused treatment and 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).
干预措施: Cervical rehabilitation
Early cervical spine focused treatment and 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).
干预措施: Standard Concussion Care
Standard concussion care alone followed by delayed cervical spine focused treatment
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.
干预措施: Cervical rehabilitation
Standard concussion care alone followed by delayed cervical spine focused treatment
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.
干预措施: Standard Concussion Care
结局指标
主要结局
Recruitment rate
时间窗: 6 months
Enrolling 6 new participants per month
Treatment Adherence
时间窗: 2 months
Assess the rate of adherence to treatment with a goal of participant attending ≥ 75% (6 of 8) of scheduled visits.
Conversion Rate
时间窗: 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
时间窗: 2 months
Rates of expected side effects and adverse events
次要结局
- Concussion Clinical Profile screen (CP screen)(Baseline, 4 week, 8 week)
- Numeric pain rating scale (NPRS)(Baseline, 4 week, 8 week)
- Neck Disability index (NDI)(Baseline, 4 week, 8 week)
- Pain, Enjoyment and General Activity Score (PEG)(Baseline, 4 week, 8 week)