Efficacy of acupuncture on pelvic pain in patients with endometriosis: study protocol for a randomized, single-blind, multi-center, placebo-controlled trial

Ruining Liang, Peishuang Li, Xuemei Peng, Ling Xu, Pei Fan, Jiahua Peng, Xu Zhou, Chunlin Xiao, Miao Jiang, Ruining Liang, Peishuang Li, Xuemei Peng, Ling Xu, Pei Fan, Jiahua Peng, Xu Zhou, Chunlin Xiao, Miao Jiang

Abstract

Background: Endometriosis is a chronic gynecological disease that is characterized by the presence of endometrial tissue outside the uterine cavity. The main symptoms include dysmenorrhea, dyspareunia, chronic pelvic pain, and infertility. These symptoms impair the lives of most of the women suffering from the disease. Surgical resection of endometriotic lesions is an effective means of treating dysmenorrhea, but the risk of recurrence is high. Western medicine has limited use for treating it due to side effects and ineffectiveness. The purpose of this study is to verify the effectiveness and safety of acupuncture.

Methods/design: This trial will be carried out in four parts. A total of 106 eligible patients with pelvic pain related to endometriosis will be randomly assigned into two groups, in a 1:1 ratio, as the treatment group or the control group. The participants assigned to the treatment group will be treated with acupuncture treatment at Guanyuan (CV4), Sanyinjiao (SP6), Taichong (LR3), Zhaohai (KI6) and Qichong (ST30) while the control group will receive acupuncture at non-acupoints. The trial will include three menstrual cycles of treatment and three menstrual cycles of follow-up. The primary outcome is pelvic pain that will be assessed by means of a 10-cm visual analog scale (VAS). At each stage, we will evaluate the safety of the acupuncture treatment.

Discussion: The study will compare the effectiveness and safety of acupuncture with comfort needles on pelvic pain related to endometriosis in the hope of providing significant evidence for using acupuncture on pelvic pain related to endometriosis.

Trial registration: ClinicalTrials.gov, ID: NCT03125304 . Registered on 30 April 2017.

Keywords: Acupuncture; Endometriosis; Pelvic pain; Study protocol.

Conflict of interest statement

Ethics approval and consent to participate

This study protocol was reviewed and approved by the Ethics Committee of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine (No. 201605). Patients who agree to participate in the trial will sign a consent form.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow diagram

References

    1. Giudice LC. Clinical practice. Endometriosis. N Engl J Med. 2010;362(25):2389–2398. doi: 10.1056/NEJMcp1000274.
    1. Moradi M, Parker M, Sneddon A, Lopez V, Ellwood D. Impact of endometriosis on women’s lives: a qualitative study. BMC Womens Health. 2014;14(1):123. doi: 10.1186/1472-6874-14-123.
    1. Morotti M, Vincent K, Becker CM. Mechanisms of pain in endometriosis. Eur J Obstet Gynecol Reprod Biol. 2017;209(2):8–13. doi: 10.1016/j.ejogrb.2016.07.497.
    1. Guo SW. Recurrence of endometriosis and its control. Hum Reprod Update. 2009;15(4):441. doi: 10.1093/humupd/dmp007.
    1. Sinaii N, Cleary SD, Younes N, Ballweg ML, Stratton P. Treatment utilization for endometriosis symptoms: a cross-sectional survey study of lifetime experience. Fertil Steril. 2007;87(6):1277–1286. doi: 10.1016/j.fertnstert.2006.11.051.
    1. Langevin HM, Yandow JA. Relationship of acupuncture points and meridians to connective tissue planes. Anat Rec. 2002;269(6):257–265. doi: 10.1002/ar.10185.
    1. Wang SM, Kain ZN, White P. Acupuncture analgesia: I. The scientific basis. Anesth Analg. 2008;106(2):602. doi: 10.1213/01.ane.0000277493.42335.7b.
    1. Kim SY, Lee H, Chae Y, Park HJ, Lee H. A systematic review of cost-effectiveness analyses alongside randomised controlled trials of acupuncture. Acupunct Med. 2012;30(4):273–285. doi: 10.1136/acupmed-2012-010178.
    1. Chung YC, Chen HH, Yeh ML. Acupoint stimulation intervention for people with primary dysmenorrhea: Systematic review and meta-analysis of randomized trials. Complement Ther Med. 2012;20(5):353–363. doi: 10.1016/j.ctim.2012.02.008.
    1. Smith CA, Zhu X, He L, Song J. Acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2011;1:CD007854.
    1. Zhu X, Hamilton KD, Mcnicol ED. Acupuncture for pain in endometriosis. Cochrane Database Syst Rev. 2011;131(9):CD007864.
    1. Brown J, Farquhar C. Endometriosis: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2014;3(3):CD009590.
    1. Gui-Wen WU, Zhang P, Jing LI, Wang P, Lin C, Ni-Juan HU, et al. Effect of acupuncture at Sanyinjiao (SP6) on the infrared temperature of Guanyuan (CV4) and Sanyinjiao in dysmenorrhea patients. Shanghai J Acupunct Moxibustion. 2016;35(6):631–635.
    1. Kremer E, Atkinson JH., Jr Pain measurement: construct validity of the affective dimension of the McGill Pain Questionnaire with chronic benign pain patients. Pain. 1981;11(1):93–100. doi: 10.1016/0304-3959(81)90142-1.
    1. Jones G, Kennedy S, Barnard A, Wong J, Jenkinson C. Development of an endometriosis quality-of-life instrument: The Endometriosis Health Profile-30. Obstet Gynecol. 2001;98(2):258–264.
    1. Kerns RD, Turk DC, Rudy TE. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI) Pain. 1985;23(4):345. doi: 10.1016/0304-3959(85)90004-1.
    1. Beck A, Steer R, Brown G. Beck Depression Inventory-II. 1996,490–498.San Antonio: The Psychological Corporation. .
    1. Mcnair D, Lorr M, Droppleman L. Manual for the Profile of Mood States. 1971. .
    1. Ferguson L, Scheman J. Patient Global Impression of Change scores within the context of a chronic pain rehabilitation program. J Pain. 2009;10(4):S73. doi: 10.1016/j.jpain.2009.01.258.
    1. Wickström K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017,13:35–40.
    1. Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009;1(1):51–54.
    1. Hamer RM, Simpson PM. Last observation carried forward versus mixed models in the analysis of psychiatric clinical trials. Am J Psychiatr. 2009;166(6):639. doi: 10.1176/appi.ajp.2009.09040458.
    1. Macpherson H, Asghar A. Acupuncture needle sensations associated with De Qi: a classification based on experts' ratings. J Altern Complement Med. 2006;12(7):633–637. doi: 10.1089/acm.2006.12.633.
    1. Rong P, Zhu B, Li Y, Gao X, Ben H, Li Y, et al. Mechanism of acupuncture regulating visceral sensation and mobility. Front Med. 2011;5(2):151. doi: 10.1007/s11684-011-0129-7.
    1. Morotti M, Vincent K, Brawn J, Zondervan KT, Becker CM. Peripheral changes in endometriosis-associated pain. Hum Reprod Update. 2014;20(5):717. doi: 10.1093/humupd/dmu021.
    1. Lumley MA, Cohen JL, Borszcz GS, Cano A, Radcliffe AM, Porter LS, et al. Pain and emotion: a biopsychosocial review of recent research. J Clin Psychol. 2011;67(9):942. doi: 10.1002/jclp.20816.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner