A Pilot Randomized Controlled Trial of Vaginal Cryotherapy for the Treatment of Pelvic Floor Myofascial Pain.
A Pilot Randomized Controlled Trial of Vaginal Cryotherapy for the Treatment of Pelvic Floor Myofascial Pain.
复制标题
阴道冷冻疗法治疗盆底肌筋膜疼痛的随机对照试验。
DOI：
10.1007/s00192-023-05692-1
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发表时间：
2024
影响因子：
1.8
通讯作者：
Lowder,JerryL
中科院分区：
文献类型：
--
作者：
Morsy,Haidy;Meister,Melanie;Spitznagle,Theresa;Scott,Carter;Zhang,Tianyi;Ghetti,Chiara;Chu,Christine;Sutcliffe,Siobhan;Lowder,JerryL
盆底肌筋膜疼痛（PFMP）是慢性盆腔疼痛和盆底疾病症状的常见但未被认识的组成部分，其治疗方式有限，研究充分。我们的目的是确定的效果，阴道冷冻治疗PFMP与palping. MethodsAfter一个标准化的PFMP筛选检查，个人疼痛评分≥4/10在≥1的四个肌肉群被邀请参加一项随机对照试验比较患者进行阴道冷冻治疗与对照组。在两个武器的参与者可以选择参加一个单一的在办公室治疗; 2周，在家里每天治疗;或both.ResultsBetween 2019年3月和2021年9月，共163名参与者被招募和随机分组：80冷冻治疗，83对照组。63例（28例冷冻治疗; 35例对照）完成了门诊治疗，56例（32例冷冻治疗; 24例对照）完成了家庭治疗。在门诊比较中，两组的平均疼痛评分均显著降低：冷冻治疗组（5.13 vs 4.10;p=0.02）和对照组（5.60 vs 4.72;p<0.01），两组之间的降低幅度相似（p=0.75）。在家庭比较中，冷冻治疗组的平均疼痛评分显著降低（6.34 vs 4.75;p<0.01），对照组无显著性差异（5.41对4.66; p=0.07），导致组间无显著差异（p=0.14）.结论单次冷冻治疗和2周每日冷冻治疗后，触诊骨盆底肌筋膜疼痛均得到改善。有趣的是，室温治疗也改善了疼痛评分。这些发现是否反映了冷和室温阴道内治疗的治疗效果或安慰剂效应尚不清楚，但应在更大的研究中探索。
Introduction and hypothesisPelvic floor myofascial pain (PFMP) is a common but underrecognized component of chronic pelvic pain and pelvic floor disorders symptoms with limited, well-studied treatment modalities. Our objective was to determine the effect of vaginal cryotherapy on PFMP with palpation.MethodsFollowing a standardized PFMP screening examination, individuals with a pain score ≥4/10 in ≥1 of four muscle groups were invited to participate in a randomized controlled trial comparing patients undergoing vaginal cryotherapy with controls. Participants in both arms could choose to participate in a single in-office treatment; a 2-week, at-home daily treatment; or both.ResultsBetween March 2019 and September 2021, a total of 163 participants were enrolled and randomized: 80 to cryotherapy, and 83 to the control group. Sixty-three (28 cryotherapy; 35 controls) completed in-office treatment and 56 (32 cryotherapy; 24 controls) completed at-home therapy. In the in-office comparison, mean pain scores decreased significantly in both arms: cryotherapy (5.13 vs 4.10;p=0.02) and controls (5.60 vs 4.72;p<0.01), with a similar magnitude of reduction between arms (p=0.75). In the at-home comparison, mean pain scores decreased significantly in the cryotherapy arm (6.34 vs 4.75;p<0.01), and nonsignificantly in the control arm (5.41 vs 4.66;p=0.07), resulting in a nonsignificant difference between arms (p=0.14).ConclusionsPelvic floor myofascial pain with palpation improved following both a single cryotherapy session and 2 weeks of daily cryotherapy. Interestingly, pain scores also improved with room temperature therapy. Whether these findings reflect a therapeutic effect of both cold and room temperature intravaginal therapy or a placebo effect is unclear but should be explored in larger studies.