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임상시험 NCT06616272 (ConCerv)은(는) 뇌진탕, 목 통증에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain (ConCerv)

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임상시험 NCT06616272 (ConCerv)은(는) 뇌진탕, 목 통증에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 8월 28일에 시작되어 40명의 참여자를 모집하고 있습니다. 피츠버그 대학교이(가) 진행하며, 2025년 12월 15일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 12일에 갱신되었습니다.
간단한 개요
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.

상세한 설명
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.

공식 제목

Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain: Pilot Study

질환/상태
뇌진탕목 통증
출판물
이 임상 시험에 대해 발표된 과학 논문 및 연구 자료.
기타 연구 식별자
  • ConCerv
  • STUDY24040157
NCT 번호
NCT06616272
실제 연구 시작일
2025-08-28
최신 업데이트 게시
2025-11-12
예상 연구 완료일
2025-12-15
계획된 등록 인원
40
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
concussion care
cervical rehabilitation
neck pain
주요 목적
기타
설계 할당
무작위배정
중재 모델
교차설계
맹검 (마스킹)
단일맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
활성 대조군Early 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
활성 대조군Standard 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
주요결과변수
결과변수측정값 설명시간 범위
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
이차결과변수
결과변수측정값 설명시간 범위
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
적격성 기준

연령대
어린이, 성인
최소 연령
12 Years
참여 가능한 성별
전체
  • 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
University of Pittsburgh logo피츠버그 대학교543개의 진행 중인 임상시험 탐색 가능
연구 책임자
Michael Schneider, DC, PhD, 책임연구자, Professor, University of Pittsburgh
연구 대표 연락처
연락처: Cynthia L Holland, MPH, 4129046126, [email protected]
4 3개국에 임상시험 장소

Pennsylvania

UPMC sports medicine, Pittsburgh, Pennsylvania, 15203, United States
Cynthia L Holland, 연락처, 4129046126, [email protected]
모집중

Wisconsin

Greenfield Clinic-Children's Wisconsin, Milwaukee, Wisconsin, 53227, United States
Jeff King, DC, 연락처, 2628255139, [email protected]
Amy Nader, 연락처, 4149557314, [email protected]
대상자모집전
UPMC Sports Surgery Clinic, Dublin, Ireland
Ciaran Cosgrave, 연락처, +353 1 526 2030, [email protected]
Louise Keating, 연락처, +353 1 4022259, [email protected]
대상자모집전
Sports Medicine Northern Ireland, Belfast, United Kingdom
Alan Rankin, 연락처, 028 9019 0290, [email protected]
Louise Keating, 연락처, +353 1 4022259, [email protected]
대상자모집전