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

Terminated

• Conditions: Pelvic Pain; Dysmenorrhea; Endometriosis
• Interventions: Other: Manual Physical Therapy

• Registration Number: NCT03118154
• Lead Sponsor: Clear Passage Therapies, Inc

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.

Study Timeline

• Study Start: 2017-03-31
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-18
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-26
• Primary Completion: 2017-10-01
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Manual Physical Therapy, retrospective	Manual Physical Therapy	Endometriosis subjects treated at Clear Passage with follow up to assess changes in pain and overall health in a retrospective chart review.

Primary Outcome Measures

Name	Time	Method
Reported overall pain rating	30 days	Self reported values using the Pain Questionnaire
Reported Pain Intensity	30 days	Self reported values using the Pain Interference Questionnaire
Reported Global Health	30 days	Self reported values using the Global Health Questionnaire
Reported Sexual Function	30 days	Self reported values using the Female Sexual Function Index Questionnaire

Secondary Outcome Measures

Name	Time	Method
Correlations to positive treatment outcomes	30 days	Medical history correlations for positive outcomes in subjects treated with manual therapy

Trial Locations

Locations (1)

Clear Passage Physical Therapy; 🇺🇸 Gainesville, Florida, United States