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

Endometriosis Clinical Trial

— Endo2017  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03118154
• Other study ID #: ENDO-2017-C0100
• Status: Terminated
• Phase: N/A
• First received: April 5, 2017
• Last updated: September 22, 2017
• Start date: March 31, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: September 2017
• Source: Clear Passage Therapies, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 31, 2018
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Endometriosis
• Pelvic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Clear Passage Physical Therapy	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Clear Passage Therapies, Inc

Country where clinical trial is conducted

United States, 

References & 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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reported overall pain rating	Self reported values using the Pain Questionnaire	30 days
Primary	Reported Global Health	Self reported values using the Global Health Questionnaire	30 days
Primary	Reported Pain Intensity	Self reported values using the Pain Interference Questionnaire	30 days
Primary	Reported Sexual Function	Self reported values using the Female Sexual Function Index Questionnaire	30 days
Secondary	Correlations to positive treatment outcomes	Medical history correlations for positive outcomes in subjects treated with manual therapy	30 days

External Links

•   Study webpage