Acupuncture for Pain Control in the Emergency Department
2015年12月3日 更新者：Gi Young Yang、Korean Medicine Hospital of Pusan National University
Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial
Acupuncture is widely used for managing acute and chronic pain conditions. In the context of an emergency department (ED), patients often present with non-emergent acute pain symptoms. This may result in a delayed triage process and inefficient emergent management. An integrative patient-care approach in emergency departments has been explored that may improve patient satisfaction and promote efficient use of healthcare resources for non-emergent patients in the ED. This implies there is a potential role for acupuncture in such contexts. The aim of this pilot study is to assess the effectiveness and safety of acupuncture as an add-on intervention for patients with non-emergent acute musculoskeletal pain and primary headaches in an ED setting.
Hypotheses of this study are as follows:
- A single session of add-on acupuncture, with standard ED management, can reduce pain levels in non-emergent acute pain, compared to standard ED management alone.
- A single session of add-on acupuncture to standard ED management can reduce additional consumption of healthcare resources for management of non-emergent acute pain, compared to standard ED management alone.
This study aimed to include 40 participants, 20 in the acupuncture plus standard ED management group and 20 in the standard ED management alone group.
調査の概要
状態
終了しました
研究の種類
介入
入学 (実際)
17
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
-
-
Kyungsangnamdo
-
Yangsan、Kyungsangnamdo、大韓民国、626770
- Pusan National University Yangsan Hospital
-
-
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
19年歳以上 (大人、高齢者)
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:
- Aged over 19 years with acute pain defined as pain occurring within 72 hours of ED presentation
- Acute neck pain with no evidence of neurological abnormality
- Acute headache which meets the classification criteria of a primary headache as described by the International Headache Society (code 1 to 4)
- Acute ankle injury with no evidence of fracture or complete tear of ligaments
Exclusion Criteria:
- Any suspected non-musculoskeletal cause (neoplasm or neurological complications) for neck or ankle pain
- Any suspected secondary headaches classified by codes 5 to 12 in the International Classification of Headache Disorders, 2nd edition
- Pain due to bone fracture or joint dislocation
- Pain with fever (defined by a temperature above 37.5 °C)
- Inappropriate at the ED physician's discretion
- Pain level of less than 4 points of pain intensity on the Numerical Rating Scale (NRS) (range 0 to 10) at the completion of observations after the standard ED management
- Pregnant women
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：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Standard ED management alone
Radiographic and physical examinations to exclude fractures or other serious conditions will be performed for all patients before considering eligibility in the study.
After completion of the examination, patients who have pain of at least a level 4, as measured by the Wong-Baker scale (ranges 0 to 10), will receive intravenous or intramuscular injections of non-steroidal anti-inflammatory drugs (NSAIDs) for immediate pain control.
All patients will be observed 30 minutes after the administration of the NSAIDs.
In patients with primary headaches who respond poorly to the initial NSAID injection, an intravenous injection of opioid analgesics will be provided.
After these initial standard ED management interventions, patients who are still suffering from acute pain will be asked to participate in the trial.
During the study, rescue medication for immediate pain control will be allowed for patients allocated to both groups.
|
|
|
実験的：Acupuncture plus standard ED management
The patients in this group will receive a single session of individualized acupuncture treatment delivered by a certified Korean Medicine Doctor (KMD) specialized (or in-training) in acupuncture and moxibustion medicine and with at least 3 years of clinical experience.
The acupuncture formulas will be composed based on the individual patient's symptoms and at the KMD's discretion.
Acupuncture treatments will be provided in line with standard ED management, the same as in the control group.
|
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 |
|---|---|---|
|
Immediate reduction in pain intensity
時間枠：at ED discharge (within 3 hours from ED admission)
|
Participant-perceived reduction of pain intensity will be measured by the pain Numerical Rating Scale (NRS) (Range 0 to 10 referring 0 to no pain and 10 to extreme pain)
|
at ED discharge (within 3 hours from ED admission)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Short-term reduction in pain intensity
時間枠：72 hours after the ED discharge
|
Participant-perceived reduction of pain intensity will be measured by the the pain NRS (Range 0 to 10 referring 0 to no pain and 10 to extreme pain)
|
72 hours after the ED discharge
|
|
Short-term disability due to neck pain (only for patients with neck pain)
時間枠：72 hours after the ED discharge
|
Participant-perceived reduction of disability due to neck pain will be measured by a 10-item questionnaire.
Changes from baseline on the Neck Disability Index (NDI) will be used.
|
72 hours after the ED discharge
|
|
Immediate and short-term patient global assessment for treatment outcomes
時間枠：at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
|
Patients' global assessments for overall treatment outcomes will be measured by a single item with a 5-point Likert scale question (much improved, somewhat improved, the same as baseline, somewhat worsened, much worsened)
|
at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
|
|
Use of rescue medication in the ED
時間枠：at ED discharge (within 3 hours from ED admission)
|
Use of additional rescue medication for relieving pain will be measured by electronic medical charts
|
at ED discharge (within 3 hours from ED admission)
|
|
Use of additional medication or healthcare resources
時間枠：72 hours after the ED discharge
|
Use of additional medication or healthcare resources (such as hospital admissions and outpatient clinic visits) will be measured by patients' self-reports via telephone interviews.
|
72 hours after the ED discharge
|
|
Length of stay in the ED
時間枠：at ED discharge (within 3 hours from ED admission)
|
Length of stay in the ED (from group allocation to the ED discharge) will be measured by electronic medical charts.
|
at ED discharge (within 3 hours from ED admission)
|
|
Proportion of treatment responder
時間枠：at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
|
Proportion of treatment responder is defined as patients who have experienced at least a 50% reduction in pain intensity from baseline values; these values will be calculated using the pain intensity VAS scores.
|
at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
|
|
Adverse events
時間枠：at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge
|
All expected or unexpected adverse events in both groups will be measured during the allocated intervention process and during the entire follow-up period.
Types and frequency of occurrences of adverse events will be measured.
|
at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient acceptability of acupuncture treatment
時間枠：72 hours after the ED discharge
|
Participant-perceived acceptability of acupuncture treatment will be measured by a single item with a 5-point Likert scale question (acupuncture was very helpful, somewhat helpful, don't know, somewhat not helpful, very not helpful).
|
72 hours after the ED discharge
|
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：Gi Young Yang, PhD、Korean Medicine Hospital, Pusan National University
- 主任研究者：Ji Ho Ryu, PhD、Pusan National University Yangsan Hospital
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
2013年12月1日
一次修了 (実際)
2015年11月1日
研究の完了 (実際)
2015年11月1日
試験登録日
最初に提出
2013年11月27日
QC基準を満たした最初の提出物
2013年12月11日
最初の投稿 (見積もり)
2013年12月17日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年12月7日
QC基準を満たした最後の更新が送信されました
2015年12月3日
最終確認日
2015年12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。