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Study protocol
Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial
Shifen Xu
Shanghai Municipal Hospital of Traditonal Chinese Medicine, Shanghai University of Traditional Chinese Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5595-3480
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial.
Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT.
Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial.
Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573
Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial
Keywords
Electroacupuncture, postoperative pain, nasal endoscopic surgery, RCT, randomized controlled trial, clinical trial
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CURRENT STATUS: Published
Version 2
Posted 08 Jan, 2020
Published
On 11 Feb, 2020
No community comments so far
Reviewer #2 agreed
On 09 Jan, 2020
Review #2 received
Received 09 Jan, 2020
Editorial decision: Accept
On 09 Jan, 2020
Review #1 received
Received 08 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Editor assigned
On 03 Jan, 2020
Submission checks complete
On 02 Jan, 2020
No comments provided
Review #2 received
Received 13 Dec, 2019
Editorial decision: Major revision
On 13 Dec, 2019
Review #1 received
Received 20 Nov, 2019
Reviewer #2 agreed
On 18 Nov, 2019
Reviewer #1 agreed
On 15 Nov, 2019
Reviewers invited
Invitations sent on 22 Oct, 2019
Editor assigned
On 18 Sep, 2019
Submission checks complete
On 03 Sep, 2019
First submitted
On 31 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Integrative & Complementary Medicine
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial
Shifen Xu
Shanghai Municipal Hospital of Traditonal Chinese Medicine, Shanghai University of Traditional Chinese Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5595-3480
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 08 Jan, 2020
Published
On 11 Feb, 2020
No community comments so far
Reviewer #2 agreed
On 09 Jan, 2020
Review #2 received
Received 09 Jan, 2020
Editorial decision: Accept
On 09 Jan, 2020
Review #1 received
Received 08 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Editor assigned
On 03 Jan, 2020
Submission checks complete
On 02 Jan, 2020
No comments provided
Review #2 received
Received 13 Dec, 2019
Editorial decision: Major revision
On 13 Dec, 2019
Review #1 received
Received 20 Nov, 2019
Reviewer #2 agreed
On 18 Nov, 2019
Reviewer #1 agreed
On 15 Nov, 2019
Reviewers invited
Invitations sent on 22 Oct, 2019
Editor assigned
On 18 Sep, 2019
Submission checks complete
On 03 Sep, 2019
First submitted
On 31 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Integrative & Complementary Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial.
Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT.
Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial.
Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573
Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial
Figure 1