Endometriosis, Pelvic Pain
Conditions
Brief summary
The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.
Detailed description
The investigators propose to conduct a clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-month "baseline" period (no TENS unit use for endometriosis flares) followed by a 3-month "treatment" period (TENS unit use for endometriosis flares). Potential subjects will be pre-screened in the Penn State Minimally Invasive GYN (MIGS) Surgery Clinic for pathologically diagnosed endometriosis and from the Penn State MIGS endometriosis database. Potential subjects will then be called to evaluate the remainder of the inclusion and exclusion criteria. If fulfilled, potential subjects will follow up at the enrollment visit (Visit 1) where consent is reviewed and signed. The baseline QOL and FSFI REDCap surveys will be completed at this visit. Subjects will be set up to receive automated links to complete diary entries and surveys directly in REDCap. Prior to initiating TENS unit use for endometriosis flare-related pain, subjects will record daily entries into RedCap during episodes of endometriosis flares for 3 months. Each entry will record their VAS pain score as well as medication intake and bleeding profile. Subjects will then be mailed the TENS unit at the 3 months mark into the study. Subjects will then complete entries with TENS use at their discretion for the following 3 months and record TENS unit use duration, frequency, and side effects in addition to the documentation of pain, medication and bleeding. At the end of the study, subjects will complete a QOL and FSFI survey.
Interventions
DEVICEOvira Transcutaneous Electrical Nerve Stimulation Unit
TENS units have a wide application from treatment of chronic back pain, chronic abdominal pain, cancer pain, perioperative pain, and labor pain.19-24 TENS units have been shown to be well-tolerated with minimal side effects and have been successful in reducing pain as well as pain medication use in patients with primary dysmenorrhea, which excludes pathology such as endometriosis. 11-18 Certain TENS units have also been FDA approved for the general indication of pelvic pain.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-month "baseline" period (no TENS unit use during endometriosis flares) followed by a 3-month "treatment" period (TENS unit use during endometriosis flares).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Females ages 18-45 years at time of enrollment 2. A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis 3. Average monthly endometriosis pain flare 4. Naïve TENS user
Exclusion criteria
1. TENS device exclusion: 1. Implantable devices (pacemaker, Interstim, etc.) 2. Cardiac arrhythmia 3. Open skin sores over areas of placement 2. Pregnancy 3. Nursing or trying to conceive at this time 4. Post-operative \<12 weeks from abdominal or pelvic surgery 5. Planned surgery or hormonal medication changes for duration of study if applicable 6. Non-English speaking or inability to read and understand English 7. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily VAS Pain Score | Baseline period (months 1-3) and treatment period (months 4-6) | Daily pain during endometriosis flares were recorded using a Visual Analog Scale (VAS), a horizontal line measuring pain from 0 (no pain) to 100 (worst pain). Per subject, an average pain score was calculated for the baseline period (no TENS use) and treatment period (TENS use). Change (treatment minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents worse outcome, change in the negative direction represents improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Score From Baseline to End of Study Using the EHP30 Questionnaire | Baseline and end of study (6 months) | Change in quality of life from baseline to end of study using the Endometriosis Health Profile (EHP30) questionnaire. Scores range from 0 (best health status) to 100 (worst health status). Change (end of study minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents worse outcome, change in the negative direction represents improvement. |
| Change in Female Sexual Function Index (FSFI) Total Score From Baseline to End of Study | Baseline and end of study (6 months) | Change in FSFI validated survey scores from baseline to end of study among participants who are currently partnered. FSFI total score ranges from 2.0 (poor) to 36.0 (best). Change (end of study minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents improvement, change in the negative direction represents worse outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKristin W Riley, MD
Penn State Health Hershey Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 28.6 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 7 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed