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临床试验 NCT06616272 (ConCerv) 针对脑震荡，颈部疼痛目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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匹兹堡大学Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain (ConCerv)
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临床试验NCT06616272 (ConCerv)是一项针对脑震荡，颈部疼痛的干预性研究试验，目前试验状态为招募中。试验始于2025年8月28日，计划招募40名患者。该研究由匹兹堡大学主导，预计于2025年12月15日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年11月12日。
简要概括
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):
- early cervical spine focused treatment combined with standard concussion care.
- 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.
官方标题
Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain: Pilot Study
疾病
脑震荡颈部疼痛出版物
关于此临床试验发表的科学文章和研究论文：- Kontos AP, Elbin RJ, Trbovich A, Womble M, Said A, Sumrok VF, French J, Kegel N, Puskar A, Sherry N, Holland C, Collins M. Concussion Clinical Profiles Screening (CP Screen) Tool: Preliminary Evidence to Inform a Multidisciplinary Approach. Neurosurgery. 2020 Aug 1;87(2):348-356. doi: 10.1093/neuros/nyz545.
- Quatman-Yates CC, Hunter-Giordano A, Shimamura KK, Landel R, Alsalaheen BA, Hanke TA, McCulloch KL. Physical Therapy Evaluation and Treatment After Concussion/Mild Traumatic Brain Injury. J Orthop Sports Phys Ther. 2020 Apr;50(4):CPG1-CPG73. doi: 10.2519/jospt.2020.0301.
- McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen RG, Guskiewicz K, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med. 2013 Apr;47(5):250-8. doi: 10.1136/bjsports-2013-092313. No abstract available.
- McCrory PR, Ariens T, Berkovic SF. The nature and duration of acute concussive symptoms in Australian football. Clin J Sport Med. 2000 Oct;10(4):235-8. doi: 10.1097/00042752-200010000-00002.
- Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
- Hurwitz EL, Carragee EJ, van der Velde G, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Cote P, Hogg-Johnson S, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: noninvasive interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S123-52. doi: 10.1097/BRS.0b013e3181644b1d.
- Reid SA, Rivett DA, Katekar MG, Callister R. Sustained natural apophyseal glides (SNAGs) are an effective treatment for cervicogenic dizziness. Man Ther. 2008 Aug;13(4):357-66. doi: 10.1016/j.math.2007.03.006. Epub 2007 Oct 22.
- van der Walt K, Tyson A, Kennedy E. How often is neck and vestibulo-ocular physiotherapy treatment recommended in people with persistent post-concussion symptoms? A retrospective analysis. Musculoskelet Sci Pract. 2019 Feb;39:130-135. doi: 10.1016/j.msksp.2018.12.004. Epub 2018 Dec 11.
- Jones C, Sterling M. Clinimetrics: Neck Disability Index. J Physiother. 2021 Apr;67(2):144. doi: 10.1016/j.jphys.2020.09.001. Epub 2021 Mar 19. No abstract available.
- Cleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126.
其他研究标识符
- ConCerv
- STUDY24040157
NCT编号
实际开始日期
2025-08-28
最近更新发布
2025-11-12
预计完成日期
2025-12-15
计划入组人数
40
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
concussion care
cervical rehabilitation
neck pain
cervical rehabilitation
neck pain
主要目的
其他
分配方式
随机
干预模型
交叉
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照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). | Cervical 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. Standard 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 |
阳性对照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. | Cervical 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. Standard 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 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Recruitment rate | Enrolling 6 new participants per month | 6 months |
Treatment Adherence | Assess the rate of adherence to treatment with a goal of participant attending ≥ 75% (6 of 8) of scheduled visits. | 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. | 6 months |
Adverse Event Rate | Rates of expected side effects and adverse events | 2 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. | 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. | 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. | 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. | Baseline, 4 week, 8 week |
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
12 Years
适龄性别
全部
- 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
- 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
匹兹堡大学543 个活跃的临床试验可供探索研究责任方
Michael Schneider, DC, PhD, 主要研究者, Professor, University of Pittsburgh
研究中心联系人
联系人: Cynthia L Holland, MPH, 4129046126, [email protected]
4 位于 3 个国家/地区的研究中心
Pennsylvania
UPMC sports medicine, Pittsburgh, Pennsylvania, 15203, United States
Cynthia L Holland, 联系人, 4129046126, [email protected]
招募中
Wisconsin
Greenfield Clinic-Children's Wisconsin, Milwaukee, Wisconsin, 53227, United States
Jeff King, DC, 联系人, 2628255139, [email protected]
Amy Nader, 联系人, 4149557314, [email protected]
尚未招募
UPMC Sports Surgery Clinic, Dublin, Ireland
Ciaran Cosgrave, 联系人, +353 1 526 2030, [email protected]
Louise Keating, 联系人, +353 1 4022259, [email protected]
尚未招募
Sports Medicine Northern Ireland, Belfast, United Kingdom
Alan Rankin, 联系人, 028 9019 0290, [email protected]
Louise Keating, 联系人, +353 1 4022259, [email protected]
尚未招募