Acupuncture as adjunctive therapy for acute renal colic caused by urinary calculi: study protocol for a randomized controlled trial.
Acupuncture
Acute renal colic
Randomized controlled trial
Sham acupuncture
Urinary calculi
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
25 Sep 2021
25 Sep 2021
Historique:
received:
10
11
2020
accepted:
04
09
2021
entrez:
26
9
2021
pubmed:
27
9
2021
medline:
29
9
2021
Statut:
epublish
Résumé
Acute renal colic caused by urinary calculi (ARCUC) has a considerable impact on the quality of life. Acupuncture might be a potential treatment option. However, the evidence is limited. We will conduct this trial to evaluate the efficacy and safety of acupuncture as adjunctive treatment to diclofenac for ARCUC. A total of 80 eligible patients who are diagnosed with urinary stone renal colic will be randomly allocated to the acupuncture group or the sham acupuncture group. Each patient will receive 1 session of acupuncture or sham acupuncture. The primary outcome will be the response rate of patients achieving a reduction of > 50% on visual analog score (VAS) from baseline to 10 min after treatment. Secondary outcomes will include the VAS, remedial analgesia, re-visit and admission rate, blinding assessment, credibility and expectancy, and adverse event. All patients who receive randomization will be included in the intent-to-treat analysis. The finding of this trial will provide evidence on the efficacy and safety of acupuncture for the treatment of ARCUC. The results of this study will be published in peer-reviewed journals. ClinicalTrials.gov ChiCTR 1900025202 . Registered on August 16, 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Acute renal colic caused by urinary calculi (ARCUC) has a considerable impact on the quality of life. Acupuncture might be a potential treatment option. However, the evidence is limited. We will conduct this trial to evaluate the efficacy and safety of acupuncture as adjunctive treatment to diclofenac for ARCUC.
METHODS/DESIGN
METHODS
A total of 80 eligible patients who are diagnosed with urinary stone renal colic will be randomly allocated to the acupuncture group or the sham acupuncture group. Each patient will receive 1 session of acupuncture or sham acupuncture. The primary outcome will be the response rate of patients achieving a reduction of > 50% on visual analog score (VAS) from baseline to 10 min after treatment. Secondary outcomes will include the VAS, remedial analgesia, re-visit and admission rate, blinding assessment, credibility and expectancy, and adverse event. All patients who receive randomization will be included in the intent-to-treat analysis.
DISCUSSION
CONCLUSIONS
The finding of this trial will provide evidence on the efficacy and safety of acupuncture for the treatment of ARCUC. The results of this study will be published in peer-reviewed journals.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov ChiCTR 1900025202 . Registered on August 16, 2019.
Identifiants
pubmed: 34563246
doi: 10.1186/s13063-021-05600-2
pii: 10.1186/s13063-021-05600-2
pmc: PMC8466746
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
652Subventions
Organisme : Beijing Municipal Science and Technology Commission
ID : Z181100001718219
Organisme : Beijing Hospitals Authority
ID : PZ2021015
Informations de copyright
© 2021. The Author(s).
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