Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial
Introduction Chronic musculoskeletal pain causes a significant burden on health and quality of life and may result from inadequate treatment of acute musculoskeletal pain. The emergency department (ED) represents a novel setting in which to test non-pharmacological interventions early in the pain tr...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/9/e061661.full |
| _version_ | 1811181132874514432 |
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| author | Catherine A Staton Alexander Limkakeng Stephanie A Eucker Oliver Glass Mitchell R Knisely Amy O’Regan Christi De Larco Michelle Mill Austin Dixon Olivia TumSuden Erica Walker Juliet C Dalton Ann Miller W Maxwell Alex Gordee Maggie Kuchibhatla Sheinchung Chow |
| author_facet | Catherine A Staton Alexander Limkakeng Stephanie A Eucker Oliver Glass Mitchell R Knisely Amy O’Regan Christi De Larco Michelle Mill Austin Dixon Olivia TumSuden Erica Walker Juliet C Dalton Ann Miller W Maxwell Alex Gordee Maggie Kuchibhatla Sheinchung Chow |
| author_sort | Catherine A Staton |
| collection | DOAJ |
| description | Introduction Chronic musculoskeletal pain causes a significant burden on health and quality of life and may result from inadequate treatment of acute musculoskeletal pain. The emergency department (ED) represents a novel setting in which to test non-pharmacological interventions early in the pain trajectory to prevent the transition from acute to chronic pain. Acupuncture is increasingly recognised as a safe, affordable and effective treatment for pain and anxiety in the clinic setting, but it has yet to be established as a primary treatment option in the ED.Methods and analysis This pragmatic clinical trial uses a two-stage adaptive randomised design to determine the feasibility, acceptability and effectiveness of acupuncture initiated in the ED and continued in outpatient clinic for treating acute musculoskeletal pain. The objective of the first (treatment selection) stage is to determine the more effective style of ED-based acupuncture, auricular acupuncture or peripheral acupuncture, as compared with no acupuncture. All arms will receive usual care at the discretion of the ED provider blinded to treatment arm. The objective of the second (effectiveness confirmation) stage is to confirm the impact of the selected acupuncture arm on pain reduction. An interim analysis is planned at the end of stage 1 based on probability of being the best treatment, after which adaptations will be considered including dropping the less effective arm, sample size re-estimation and unequal treatment allocation ratio (eg, 1:2) for stage 2. Acupuncture treatments will be delivered by licensed acupuncturists in the ED and twice weekly for 1 month afterward in an outpatient clinic.Ethics and dissemination This study has been reviewed and approved by the Duke University Health System Institutional Review Board. Informed consent will be obtained from all participants. Results will be disseminated through peer-review publications and public and conference presentations.Trial registration number NCT04290741. |
| first_indexed | 2024-04-11T09:14:35Z |
| format | Article |
| id | doaj.art-13d9b6acf9b94045a4e42a1b18766c6a |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T09:14:35Z |
| publishDate | 2022-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-13d9b6acf9b94045a4e42a1b18766c6a2022-12-22T04:32:24ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2022-061661Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trialCatherine A Staton0Alexander Limkakeng1Stephanie A Eucker2Oliver Glass3Mitchell R Knisely4Amy O’Regan5Christi De Larco6Michelle Mill7Austin Dixon8Olivia TumSuden9Erica Walker10Juliet C Dalton11Ann Miller W Maxwell12Alex Gordee13Maggie Kuchibhatla14Sheinchung Chow15Department of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, USADepartment of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, USADepartment of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, USADepartment of Medicine, Division of General Internal Medicine, Duke University School of Medicine, Durham, North Carolina, USADuke University School of Nursing, Durham, North Carolina, USADepartment of Population Health Sciences, Duke University, Durham, North Carolina, USADepartment of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, USADepartment of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, USADepartment of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, USAUNC Adams School of Dentistry, Chapel Hill, North Carolina, USADepartment of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, USADuke Office of Clinical Research, Duke University, Durham, North Carolina, USADurham Veterans Affairs Health Care System, Durham, North Carolina, USADepartment of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USADepartment of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USADepartment of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USAIntroduction Chronic musculoskeletal pain causes a significant burden on health and quality of life and may result from inadequate treatment of acute musculoskeletal pain. The emergency department (ED) represents a novel setting in which to test non-pharmacological interventions early in the pain trajectory to prevent the transition from acute to chronic pain. Acupuncture is increasingly recognised as a safe, affordable and effective treatment for pain and anxiety in the clinic setting, but it has yet to be established as a primary treatment option in the ED.Methods and analysis This pragmatic clinical trial uses a two-stage adaptive randomised design to determine the feasibility, acceptability and effectiveness of acupuncture initiated in the ED and continued in outpatient clinic for treating acute musculoskeletal pain. The objective of the first (treatment selection) stage is to determine the more effective style of ED-based acupuncture, auricular acupuncture or peripheral acupuncture, as compared with no acupuncture. All arms will receive usual care at the discretion of the ED provider blinded to treatment arm. The objective of the second (effectiveness confirmation) stage is to confirm the impact of the selected acupuncture arm on pain reduction. An interim analysis is planned at the end of stage 1 based on probability of being the best treatment, after which adaptations will be considered including dropping the less effective arm, sample size re-estimation and unequal treatment allocation ratio (eg, 1:2) for stage 2. Acupuncture treatments will be delivered by licensed acupuncturists in the ED and twice weekly for 1 month afterward in an outpatient clinic.Ethics and dissemination This study has been reviewed and approved by the Duke University Health System Institutional Review Board. Informed consent will be obtained from all participants. Results will be disseminated through peer-review publications and public and conference presentations.Trial registration number NCT04290741.https://bmjopen.bmj.com/content/12/9/e061661.full |
| spellingShingle | Catherine A Staton Alexander Limkakeng Stephanie A Eucker Oliver Glass Mitchell R Knisely Amy O’Regan Christi De Larco Michelle Mill Austin Dixon Olivia TumSuden Erica Walker Juliet C Dalton Ann Miller W Maxwell Alex Gordee Maggie Kuchibhatla Sheinchung Chow Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial BMJ Open |
| title | Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial |
| title_full | Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial |
| title_fullStr | Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial |
| title_full_unstemmed | Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial |
| title_short | Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial |
| title_sort | acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic a protocol for an adaptive pragmatic randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/9/e061661.full |
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