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ABSTRACT: Background
Shoulder pain is an uncomfortable feeling in the muscle around the shoulder. The cause of myalgia is the accumulation of lactic acid in muscles and impaired blood circulation, which is called blood stasis in traditional East Asian medicine. This study aimed to explore the therapeutic effect of Gyejibongnyeong-Hwan (GBH) for shoulder discomfort related to blood stasis before and after treatment.Methods/design
This study will be a double-centre, randomised, wait-list controlled pilot trial. Participants with shoulder pain and with a visual analogue scale score of 4 or higher out of 10, blood stasis score of 9 or higher, and triglyceride level of ?150?mg/dl or total cholesterol level of ?200?mg/dl will be recruited from two university hospitals. A total of 40 participants will be assigned to the immediate and waiting treatment groups. The immediate treatment group will receive GBH for 8?weeks on enrolment while the waiting treatment group will receive GBH for 8-16?weeks after 8?weeks of controlled waiting. The primary outcome is shoulder pain, and the secondary outcomes are the blood stasis score, blood pressure, ankle-brachial pressure index, brachial-ankle pulse wave velocity, body mass index, waist circumference, indexes of oximetry, and levels of blood lipid, blood sugar, resistin, C-reactive protein, serum amyloid P, and D-dimer.Discussion
The results of this pilot trial will be the bases for a full-scale clinical trial of GBH.Trial registration
Clinical Research Information Service, KCT0003837. Registered on 23 April 2019. https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14258.
SUBMITTER: Jang S
PROVIDER: S-EPMC7027269 | biostudies-literature | 2020 Feb
REPOSITORIES: biostudies-literature
Jang Soobin S Sung Hyun Kyung HK Ko Mi Mi MM Shin Seon Mi SM Go Ho-Yeon HY Jung Jeeyoun J
Trials 20200217 1
<h4>Background</h4>Shoulder pain is an uncomfortable feeling in the muscle around the shoulder. The cause of myalgia is the accumulation of lactic acid in muscles and impaired blood circulation, which is called blood stasis in traditional East Asian medicine. This study aimed to explore the therapeutic effect of Gyejibongnyeong-Hwan (GBH) for shoulder discomfort related to blood stasis before and after treatment.<h4>Methods/design</h4>This study will be a double-centre, randomised, wait-list con ...[more]