Diana Taylor1, Christine Miaskowski, Joel Kohn. 1. Department of Family Health Care Nursing, School of Nursing, University of California-San Francisco, 94143-0606, USA. Diana.Taylor@nursing.ucsf.edu
Abstract
OBJECTIVES: To develop and test the safety and effectiveness of an acupressure garment (the Relief Brief) in decreasing the pain and symptom distress associated with dysmenorrhea. DESIGN: A randomized clinical trial applied a 2 (Relief Brief use or control group) x 3 (baseline and two treatment measurement occasions) mixed factorial design. PARTICIPANTS: Sixty-one (61) women with moderately severe primary dysmenorrhea were randomly assigned to the standard treatment control group or the Relief Brief acupressure device group after one pretreatment menses, with 58 women reporting the effect on their pain during two post-treatment menstrual cycles. The acupressure garment: The Relief Brief is a cotton Lycra panty brief with a fixed number of lower abdominal and lower back latex foam acupads that provide pressure to dysmenorrhea-relieving Chinese acupressure points. OUTCOME MEASURES: Menstrual pain severity (worst pain and symptom intensity), pain medication use, and adverse effects were analyzed using between-groups and repeated measures analyses of treatment effects. Statistical and clinical significance criteria were applied a priori. RESULTS: For pain measures and pain medication use, the group main effect, time main effect and group x time interaction were statistically significant. Median pain medication use, the same for both groups at baseline (6 pills per day), dropped to 2 pills per day for the Relief Brief group but remained at 6 pills for the control group at the second treatment cycle. Predicted clinical significance criteria were surpassed: almost all (90%) women wearing the Relief Brief obtained at least a 25% reduction in menstrual pain severity (a 2-3 point drop) compared to only 8% of the control group (z = 6.07; p < 0.05). Relief Brief use was associated with at least a 50% decline in menstrual pain symptom intensity in more than two thirds of the women. CONCLUSIONS: An acupressure device is an effective and safe nonpharmacologic strategy for the treatment of primary dysmenorrhea. With design modifications, it could serve as a main treatment modality for women who suffer from primary dysmenorrhea and do not wish to or cannot use the conventional pharmacologic agents. In addition, this acupressure device may serve as an adjuvant therapy to medication in more severe cases of dysmenorrhea.
RCT Entities:
OBJECTIVES: To develop and test the safety and effectiveness of an acupressure garment (the Relief Brief) in decreasing the pain and symptom distress associated with dysmenorrhea. DESIGN: A randomized clinical trial applied a 2 (Relief Brief use or control group) x 3 (baseline and two treatment measurement occasions) mixed factorial design. PARTICIPANTS: Sixty-one (61) women with moderately severe primary dysmenorrhea were randomly assigned to the standard treatment control group or the Relief Brief acupressure device group after one pretreatment menses, with 58 women reporting the effect on their pain during two post-treatment menstrual cycles. The acupressure garment: The Relief Brief is a cotton Lycra panty brief with a fixed number of lower abdominal and lower back latex foam acupads that provide pressure to dysmenorrhea-relieving Chinese acupressure points. OUTCOME MEASURES: Menstrual pain severity (worst pain and symptom intensity), pain medication use, and adverse effects were analyzed using between-groups and repeated measures analyses of treatment effects. Statistical and clinical significance criteria were applied a priori. RESULTS: For pain measures and pain medication use, the group main effect, time main effect and group x time interaction were statistically significant. Median pain medication use, the same for both groups at baseline (6 pills per day), dropped to 2 pills per day for the Relief Brief group but remained at 6 pills for the control group at the second treatment cycle. Predicted clinical significance criteria were surpassed: almost all (90%) women wearing the Relief Brief obtained at least a 25% reduction in menstrual pain severity (a 2-3 point drop) compared to only 8% of the control group (z = 6.07; p < 0.05). Relief Brief use was associated with at least a 50% decline in menstrual pain symptom intensity in more than two thirds of the women. CONCLUSIONS: An acupressure device is an effective and safe nonpharmacologic strategy for the treatment of primary dysmenorrhea. With design modifications, it could serve as a main treatment modality for women who suffer from primary dysmenorrhea and do not wish to or cannot use the conventional pharmacologic agents. In addition, this acupressure device may serve as an adjuvant therapy to medication in more severe cases of dysmenorrhea.