Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis (Endo2017)

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.

Study Overview

• Status: Terminated
• Conditions: Endometriosis; Dysmenorrhea; Pelvic Pain
• Intervention / Treatment: Other: Manual Physical Therapy

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 Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32606
      • Clear Passage Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

This study focuses on female subjects with a medical diagnosis of endometriosis that experience pain with menstruation or pelvic pain not associated with menstruation between the ages of 18 and 65.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Manual Physical Therapy, retrospective; 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; 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.
Control, prospective; 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?

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

Collaborators and Investigators

• Sponsor: Clear Passage Therapies, Inc
• Investigators: Principal Investigator: Lawrence J Wurn, LMT, Clear Passage Therapies

Publications and helpful links

General Publications

• Rice AD, Patterson K, Wurn BF, King CR and Wurn LJ. Update on "Decreasing dyspareunia and dysmenorrhea in women with endometriosis via a manual physical therapy: results from 2 independent studies". Journal of Endometriosis and Pelvic Pain Disorders, 6(3):161-162, 2014.
• Wurn BF, Wurn LJ, Patterson K, King CR, Scharf ES. Decreasing dyspareunia and dysmenorrhea in women with endometriosis via a manual physical therapy: Results from two independent studies. Journal of Endometriosis and Pelvic Pain Disorders 3(4):188-196, 2011.

Helpful Links

• Study webpage

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): March 31, 2018

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: endometriosis; dysmenorrhea; pelvic pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Endometriosis; Dysmenorrhea; Pelvic Pain
• Other Study ID Numbers: ENDO-2017-C0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No