Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial
2021년 2월 3일 업데이트: University of Colorado, Denver
Headaches have been listed as 1 of the 10 most disabling conditions worldwide.
(Stovner et al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these complaints.
(Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach to the conservative care of this condition has yet to be determined.
The primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation.
This may further the current body of evidence by offering an alternative, potentially safer approach to the conservative care of individuals with this condition.
Additionally, results of this study may serve to drive a larger scale Randomized Clinical Trial (RCT) by offering information regarding feasibility of recruitment of individuals with chronic CeHs as well as timing and dosing of the intervention.
연구 개요
상태
완전한
정황
상세 설명
Headaches have been listed as 1 of the 10 most disabling conditions worldwide.
(Stovner et al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these complaints.
(Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach to the conservative care of this condition has yet to be determined.
Evidence suggests that manipulative therapy aimed at the cervical spine in combination with exercise is helpful in alleviating these symptoms.
(Jull et al., 2002) The risk of injury from cervical spine manipulative techniques has been documented to be remote (Haldeman et al., 2002; DiFabio 1999), however the potential consequences can be severe.
Therefore with inherently lower risks, thoracic spine manipulations may be a suitable alternative as the evidence is accumulating for its influence on the cervical spine.
(Mintken et al., 2010; Boyles et al., 2009; Cleland et al., 2005 & 2007 A & B, 2010; Flynn et al., 2001; Fernandez-de-las-penas et al., 2004; Piva et al., 2000; Browder et al., 2004) The primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation.
This may further the current body of evidence by offering an alternative, potentially safer approach to the conservative care of individuals with this condition.
Additionally, results of this study may serve to drive a larger scale RCT by offering information regarding feasibility of recruitment of individuals with chronic CeHs as well as timing and dosing of the intervention.
연구 유형
중재적
등록 (실제)
48
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Anschutz Medical Campus
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Between 18 and 60 years old Sjaastad et al for CeH, which included
- unilateral or unilateral dominant side-consistent headache associated with neck pain and aggravated by neck postures or movement (Sjaastad et al., 1998)
- joint tenderness in at least one of the three upper cervical joints (C0-C3) as assessed by manual palpation
- headache frequency of at least one per week over the past 2 months
Exclusion Criteria:
- red flags noted in the patient's Neck Medical Screening Questionnaire (e.g. tumor, fracture)
- metabolic diseases RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.)
- history of whiplash injury within the past six weeks
- evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes
- two or more positive neurologic signs consistent with nerve root compression, including any two of the following: muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps reflex), diminished or absent sensation to pinprick in any upper extremity dermatome
- prior surgery to the neck or thoracic spine
- chiropractic or physical therapy treatment for their headaches over the past 6-months
- bilateral headache description
- migraine headaches with or without aura
- workers compensation or pending legal action regarding their headaches
- inability to comply with treatment and follow-up schedule
- we will not recruit individuals whom the researcher is in a position to punish or reward, whether through grades, evaluations, or promotions
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Treatment (thoracic manipulation)
Patients in the initial manipulation group will attend physical therapy two sessions per week for 3 weeks for a total of 6 sessions.
Each treatment session will last for a total of 15 minutes.
After the initial manipulation group receives 3 weeks of treatment they will wait for 1-week, be retested, and then crossover into the other group.
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Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain.
다른 이름들:
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활성 비교기: Wait-list (thoracic manipulation)
When individuals are assigned to the wait-list control group they will serve as the control for 3 weeks while the initial manipulation group receives treatment.
After serving as the wait-list control condition for 3 weeks, this group will then return for testing and will receive the manipulation package as described below at 4 weeks.
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Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Headache Disability Index
기간: Baseline
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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Baseline
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Headache Disability Index
기간: 4 weeks
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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4 weeks
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Headache Disability Index
기간: 8 weeks
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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8 weeks
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Headache Disability Index
기간: 3 months
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numeric Pain Rating Scale
기간: Baseline
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An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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Baseline
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Numeric Pain Rating Scale
기간: 4 weeks
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An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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4 weeks
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Numeric Pain Rating Scale
기간: 8 weeks
|
An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
|
8 weeks
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Numeric Pain Rating Scale
기간: 3 months
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An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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3 months
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Pain Self Efficacy Questionnaire (PSEQ)
기간: Baseline
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The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
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Baseline
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Pain Self Efficacy Questionnaire (PSEQ)
기간: 4 weeks
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The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
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4 weeks
|
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Pain Self Efficacy Questionnaire (PSEQ)
기간: 8 weeks
|
The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
|
8 weeks
|
|
Pain Self Efficacy Questionnaire (PSEQ)
기간: 3 months
|
The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
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3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Amy W McDevitt, DPT, University of Colorado, Denver
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 5월 1일
기본 완료 (실제)
2019년 9월 19일
연구 완료 (실제)
2019년 9월 19일
연구 등록 날짜
최초 제출
2016년 3월 10일
QC 기준을 충족하는 최초 제출
2016년 3월 10일
처음 게시됨 (추정)
2016년 3월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 2월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 2월 3일
마지막으로 확인됨
2021년 2월 1일
추가 정보
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