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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometriosis, Pelvic Pain, Dysmenorrhea

Intervention / Treatment
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* Other: Manual Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Manual Physical Therapy, retrospective<br>Endometriosis subjects treated at Clear Passage with follow up to assess changes in pain and overall health in a retrospective chart review. | Other: Manual Physical Therapy<br>* Manual Physical Therapy intervention using the Clear Passage Approach (CPA). The focus of the CPA is to deform adhesions throughout the body using a variety of manual therapy techniques and modalities.<br>|
| Control, prospective<br>Endometriosis control subjects not treated at Clear Passage that complete two questionnaires, 30 days apart, to assess changes in their pain levels. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported overall pain rating | Self reported values using the Pain Questionnaire | 30 days | 
| Reported Global Health | Self reported values using the Global Health Questionnaire | 30 days | 
| Reported Pain Intensity | Self reported values using the Pain Interference Questionnaire | 30 days | 
| Reported Sexual Function | Self reported values using the Female Sexual Function Index Questionnaire | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations to positive treatment outcomes | Medical history correlations for positive outcomes in subjects treated with manual therapy | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, pelvic pain, dysmenorrhea