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

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ClinicalTrials.gov Identifier: NCT03118154
Recruitment Status : Terminated (Recruitment)
First Posted : April 18, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Endometriosis Pelvic Pain Dysmenorrhea 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.

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Reported overall pain rating [ Time Frame: 30 days ]
    Self reported values using the Pain Questionnaire

  2. Reported Global Health [ Time Frame: 30 days ]
    Self reported values using the Global Health Questionnaire

  3. Reported Pain Intensity [ Time Frame: 30 days ]
    Self reported values using the Pain Interference Questionnaire

  4. Reported Sexual Function [ Time Frame: 30 days ]
    Self reported values using the Female Sexual Function Index Questionnaire


Secondary Outcome Measures :
  1. Correlations to positive treatment outcomes [ Time Frame: 30 days ]
    Medical history correlations for positive outcomes in subjects treated with manual therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118154


Locations
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United States, Florida
Clear Passage Physical Therapy
Gainesville, Florida, United States, 32606
Sponsors and Collaborators
Clear Passage Therapies, Inc
Investigators
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Principal Investigator: Lawrence J Wurn, LMT Clear Passage Therapies
Additional Information:
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.

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Responsible Party: Clear Passage Therapies, Inc
ClinicalTrials.gov Identifier: NCT03118154    
Other Study ID Numbers: ENDO-2017-C0100
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clear Passage Therapies, Inc:
endometriosis
pelvic pain
dysmenorrhea
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Dysmenorrhea
Pain
Neurologic Manifestations
Menstruation Disturbances
Pathologic Processes