Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- Clear Passage Therapies, Inc
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Reported overall pain rating
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of endometriosis
- •Experience either pain with menstruation or other pelvic pain
- •Able to complete the questionnaires online
Exclusion Criteria
- •Currently pregnant
- •Cancer diagnosis
- •Prior chemotherapy or radiation treatment(s)
- •Prior treatment at Clear Passage
Outcomes
Primary Outcomes
Reported overall pain rating
Time Frame: 30 days
Self reported values using the Pain Questionnaire
Reported Pain Intensity
Time Frame: 30 days
Self reported values using the Pain Interference Questionnaire
Reported Global Health
Time Frame: 30 days
Self reported values using the Global Health Questionnaire
Reported Sexual Function
Time Frame: 30 days
Self reported values using the Female Sexual Function Index Questionnaire
Secondary Outcomes
- Correlations to positive treatment outcomes(30 days)