NCT03118154

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

April 5, 2017

Last Update Submit

September 22, 2017

Conditions

EndometriosisPelvic PainDysmenorrhea

Keywords

endometriosispelvic paindysmenorrhea

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Correlations to positive treatment outcomes

    30 days

Study Arms (2)

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

Control, prospective

Endometriosis control subjects not treated at Clear Passage that complete two questionnaires, 30 days apart, to assess changes in their pain levels.

Interventions

Manual Physical TherapyOTHER

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.

Manual Physical Therapy, retrospective

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clear Passage Physical Therapy

Gainesville, Florida, 32606, United States

Location

Related Publications (2)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

EndometriosisPelvic PainDysmenorrhea

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMenstruation DisturbancesPathologic Processes

Study Officials

  • Lawrence J Wurn, LMT

    Clear Passage Therapies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 18, 2017

Study Start

March 31, 2017

Primary Completion

October 1, 2017

Study Completion

March 31, 2018

Last Updated

September 26, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)