Clinical trial NCT03118154: Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis
Official title: Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Endometriosis
Pelvic Pain
Dysmenorrhea
Keywords: endometriosis
pelvic pain
dysmenorrhea
Lead sponsor: Clear Passage Therapies, Inc
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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.

Eligibility 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

Primary outcomes:
measure: Reported overall pain rating
timeFrame: 30 days
measure: Reported Global Health
timeFrame: 30 days
measure: Reported Pain Intensity
timeFrame: 30 days
measure: Reported Sexual Function
timeFrame: 30 days
Secondary outcomes:
measure: Correlations to positive treatment outcomes
timeFrame: 30 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Clear Passage Physical Therapy
state: Florida
Study officials:
affiliation: Clear Passage Therapies
name: Lawrence J Wurn, LMT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.