The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in pelvic girdle pain using the Pelvic Girdle Questionnaire
研究概览
简要总结
The findings from this project may result in pain reduction and improved mobility in pregnant women with pelvic girdle pain in their second and third trimester.
详细描述
The primary objective of this unblinded randomized controlled trial is to determine whether superficial cryotherapy results in improved Numeric Pain Rating Scale (NPRS) scores among pregnant women with posterior pelvic girdle pain. The investigators hypothesize that superficial cryotherapy, in addition to receipt of an educational pamphlet, will result in improved NPRS scores compared to receipt of an educational pamphlet alone.
This study will include English-speaking pregnant women presenting to Loyola University Medical Center obstetrics or rehabilitation clinics in their second or third trimester with posterior pelvic girdle pain, defined as an NPRS score > 2 onset within the past 3 months and pain experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the [pubic] symphysis. NPRS scores will be measured as a continuous, numerical integer ranging from a value of 0 (No pain) to a value of 10 (Worst possible pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking pregnant women presenting in their second or third trimester with acute posterior PGP (occurring within the last 3 months). Trimester will be determined from the date of last menses or ultrasound date.
- •Current VAS pain score between 2-4
- •Written informed consent
排除标准
- •Non-English speaking pregnant women <18 or >50 years old
- •Women presenting with low back pain, or posterior pelvic pain in the first trimester (<13 weeks gestation).
- •Women with acute low back pain in 2nd and 3rd trimester
- •Women with anterior pelvic girdle pain (pubic symphysis) alone
- •Chronic low back pain (current or past history, defined as > 6 weeks of low back pain)
- •History of lumbar or pelvic fracture; degenerative disc disease; neoplasm; inflammatory disease; active urogenital infection or active gastrointestinal illness; previous surgery of the lumbar spine, pelvic girdle, hip joint or femur
- •History or signs of radiculopathy or other systemic neurologic disease
- •Narcotic medication use
研究组 & 干预措施
cryotherapy + education
intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
干预措施: Education (Other)
cryotherapy + education
intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
干预措施: Cryotherapy (Other)
education alone
The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
干预措施: Education (Other)
结局指标
主要结局
Change in pelvic girdle pain using the Pelvic Girdle Questionnaire
时间窗: On day 6
The change in the the Pelvic Girdle Questionnaire (PGQ) from baseline to day 6 (i.e., the delta value of PGQ) will be compared between the two groups. The PGQ measures problems with carrying out daily activities and ranges from 0 (no problem at all) to 100 (experiences problems to a large extent).
Change in pelvic girdle pain using the Numeric Pain Rating Scale
时间窗: On day 6
The change in the Numeric Pain Rating Scale (NPRS) from baseline to day 6 (i.e., the delta value of NPRS) will be compared between the two groups. NPRS scores range from 0 (no pain) to 10 (worst possible pain).
次要结局
未报告次要终点
研究者
Colleen M. Fitzgerald, MD, MS
MD, Professor
Loyola University