Jorge Vas1, María Carmen Cintado2,3, José Manuel Aranda-Regules4, Inmaculada Aguilar1, Francisco Rivas Ruiz5,6. 1. Pain Treatment Unit, Doña Mercedes Primary Health Care Center, Dos Hermanas, Spain. 2. Hospital Valle Del Guadalhorce, Pizarra, Málaga, Spain. 3. Departamento de Farmacología, Facultad de Medicina, Universidad de Málaga, Málaga, Spain. 4. Alcudia Primary Health Care Center, Alcudia, Mallorca, Spain. 5. Support Research Unit, Costa del Sol Hospital, Marbella, Spain. 6. Research Network for Health Services in Chronic Diseases (REDISSEC), Madrid, Spain.
Abstract
INTRODUCTION:Ear acupuncture carried out in primary care by trained midwives, with no specialist training in acupuncture, may be effective in alleviating pregnancy-related lower back and/or posterior pelvic girdle pain (LBPGP). The objective of this study was to assess the effect of ear acupuncture associated with standard obstetric care, in the primary-care setting, on LBPGP experienced by pregnant women. MATERIAL AND METHODS: This four-group, multicenter, randomized controlled trial was conducted at 18 public primary care centers in three regions in Spain, with the participation of 220 pregnant women at 24-36 weeks of gestation, aged 18 years or more, diagnosed with pregnancy-related LBPGP and who had not previously receivedear acupuncture. The trial was conducted from March 2014 to December 2016. Participants were randomly assigned (1:1:1:1) to receive standard obstetric care plus two sessions (over 2 weeks) of verum ear acupuncture, or nonspecific ear acupuncture, or placebo ear acupuncture, or standard obstetric care alone. The primary outcome was change in pain intensity, assessed using a visual analog scale (0-100 mm) from baseline to the end of treatment (T2). Secondary outcomes included change or presence of pain at 3 months (T3) and at 1 year (T4) postpartum, and changes in responses to the Roland-Morris disability questionnaire (RMDQ) and Short Form-12 Health Survey (SF-12) at the end of treatment. RESULTS:A total of 55 women were randomized to each group, and 205 completed the study. With respect to baseline values, the reduction in pain intensity among the verum ear acupuncture group vs standard obstetric care was significantly greater, both at T2 (65.8%, 95%CI 56.2-75.3 vs 25.1%, 95%CI 15.3-34.9) and at T3 (93.8%, 95%CI 88.7-99.0 vs 67.9%, 95%CI 55.3-80.5). Moreover, significant changes were found in the verum ear acupuncture group vs standard obstetric care at T2, in reduced RMDQ scores (70.9%, 95%CI 61.8-80.1 vs 21.2%, 95%CI 8.6-33.7) and in increased SF-12 scores on the physical scale (40.5%, 95%CI 31.5-49.4 vs 8.1%, 95%CI 0.8-15.5). CONCLUSIONS: After 2 weeks of treatment, ear acupuncture applied by midwives and associated with standard obstetric care significantly reduces lumbar and pelvic pain in pregnant women, improves quality of life and reduces functional disability.
RCT Entities:
INTRODUCTION:Ear acupuncture carried out in primary care by trained midwives, with no specialist training in acupuncture, may be effective in alleviating pregnancy-related lower back and/or posterior pelvic girdle pain (LBPGP). The objective of this study was to assess the effect of ear acupuncture associated with standard obstetric care, in the primary-care setting, on LBPGP experienced by pregnant women. MATERIAL AND METHODS: This four-group, multicenter, randomized controlled trial was conducted at 18 public primary care centers in three regions in Spain, with the participation of 220 pregnant women at 24-36 weeks of gestation, aged 18 years or more, diagnosed with pregnancy-related LBPGP and who had not previously received ear acupuncture. The trial was conducted from March 2014 to December 2016. Participants were randomly assigned (1:1:1:1) to receive standard obstetric care plus two sessions (over 2 weeks) of verum ear acupuncture, or nonspecific ear acupuncture, or placebo ear acupuncture, or standard obstetric care alone. The primary outcome was change in pain intensity, assessed using a visual analog scale (0-100 mm) from baseline to the end of treatment (T2). Secondary outcomes included change or presence of pain at 3 months (T3) and at 1 year (T4) postpartum, and changes in responses to the Roland-Morris disability questionnaire (RMDQ) and Short Form-12 Health Survey (SF-12) at the end of treatment. RESULTS: A total of 55 women were randomized to each group, and 205 completed the study. With respect to baseline values, the reduction in pain intensity among the verum ear acupuncture group vs standard obstetric care was significantly greater, both at T2 (65.8%, 95%CI 56.2-75.3 vs 25.1%, 95%CI 15.3-34.9) and at T3 (93.8%, 95%CI 88.7-99.0 vs 67.9%, 95%CI 55.3-80.5). Moreover, significant changes were found in the verum ear acupuncture group vs standard obstetric care at T2, in reduced RMDQ scores (70.9%, 95%CI 61.8-80.1 vs 21.2%, 95%CI 8.6-33.7) and in increased SF-12 scores on the physical scale (40.5%, 95%CI 31.5-49.4 vs 8.1%, 95%CI 0.8-15.5). CONCLUSIONS: After 2 weeks of treatment, ear acupuncture applied by midwives and associated with standard obstetric care significantly reduces lumbar and pelvic pain in pregnant women, improves quality of life and reduces functional disability.
Authors: Yu-Qing Zhang; Rui-Min Jiao; Claudia M Witt; Lixing Lao; Jian-Ping Liu; Lehana Thabane; Karen J Sherman; Mike Cummings; Dawn P Richards; Eun-Kyung Anna Kim; Tae-Hun Kim; Myeong Soo Lee; Michael E Wechsler; Benno Brinkhaus; Jun J Mao; Caroline A Smith; Wei-Juan Gang; Bao-Yan Liu; Zhi-Shun Liu; Yan Liu; Hui Zheng; Jia-Ni Wu; Alonso Carrasco-Labra; Mohit Bhandari; Philip J Devereaux; Xiang-Hong Jing; Gordon Guyatt Journal: BMJ Date: 2022-03-30