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临床试验/NCT03118154
NCT03118154终止不适用

Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis

Clear Passage Therapies, Inc1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Reported overall pain rating

研究概览

简要总结

This study will compare subjects with a history of pelvic or menstrual pain diagnosed with endometriosis treated at Clear Passage with untreated control subjects. The treatment group will be a retrospective chart review; the control subject group will be a prospective questionnaire based study.

The study will assess the changes in pain experienced by subjects treated with manual therapy at Clear Passage to untreated subjects with endometriosis.

详细描述

This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a diagnosis of endometriosis. These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of female subjects with a diagnosis of endometriosis not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 30 days apart. This will be accomplished using online forms with subjects able to complete the questionnaires with ease via the internet. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, as well as provide a control group for assessment of improvement for manual therapy interventions for patients with endometriosis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of endometriosis
  • Experience either pain with menstruation or other pelvic pain
  • Able to complete the questionnaires online

排除标准

  • Currently pregnant
  • Cancer diagnosis
  • Prior chemotherapy or radiation treatment(s)
  • Prior treatment at Clear Passage

结局指标

主要结局

Reported overall pain rating

时间窗: 30 days

Self reported values using the Pain Questionnaire

Reported Pain Intensity

时间窗: 30 days

Self reported values using the Pain Interference Questionnaire

Reported Global Health

时间窗: 30 days

Self reported values using the Global Health Questionnaire

Reported Sexual Function

时间窗: 30 days

Self reported values using the Female Sexual Function Index Questionnaire

次要结局

  • Correlations to positive treatment outcomes(30 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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