Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial
2021年2月3日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
48
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Anschutz Medical Campus
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～60年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Headache Disability Index
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Numeric Pain Rating Scale
時間枠：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
時間枠：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
時間枠：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
|
|
Numeric Pain Rating Scale
時間枠：3 months
|
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)
時間枠：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)
時間枠：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)
時間枠：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
|
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Pain Self Efficacy Questionnaire (PSEQ)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Amy W McDevitt, DPT、University of Colorado, Denver
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年5月1日
一次修了 (実際)
2019年9月19日
研究の完了 (実際)
2019年9月19日
試験登録日
最初に提出
2016年3月10日
QC基準を満たした最初の提出物
2016年3月10日
最初の投稿 (見積もり)
2016年3月15日
学習記録の更新
投稿された最後の更新 (実際)
2021年2月4日
QC基準を満たした最後の更新が送信されました
2021年2月3日
最終確認日
2021年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。