Determination of Analgesic Effect From One Transcranial Magnetic Stimulation(TMS)Treatment Following Vaginal Reconstructive Surgery.
| Status: | Withdrawn |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | December 2016 |
Determination of the Analgesic Effects of One Session of Postoperative Left Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation (TMS) Following Vaginal Reconstructive Surgery.
To determine whether real TMS is more effective than sham TMS in reducing pain following
surgery
surgery
To determine the amount of opiate and pain medication administered in the week following
surgery. Subjects will receive an identical pain control regimen. Participants will undergo
TMS motor threshold assessment at the ETSU Innovation Lab prior to the planned surgery. At
this appointment a baseline Beck Depression Inventory (BDI), Center for Epidemiological
Studies 10-item Depression scale (CES-D) and visual analog scale (VAS) ratings of pain and
mood will be obtained.VAS ratings will also be done each evening over the following week.
One day after surgery, the subject will return to the Innovation lab for TMS. A total of 22
subjects will be recruited for the study. At the return visit, 11 will receive 40 minutes of
10 Hz repetitive TMS at 120% of rMT (4-second stimulation trains with 26-second
interstimulus intervals). The other 11 participants will receive sham treatment under
identical settings. Participants, medical staff providing clinical care to patients and
raters will not know whether participants receive real or sham TMS. Patients will keep a log
of pain medications used over the following week in addition to the VAS ratings. Follow-up
will occur one week after the TMS therapy. The subject will turn in logs and repeat BDI and
CES-D scales.
surgery. Subjects will receive an identical pain control regimen. Participants will undergo
TMS motor threshold assessment at the ETSU Innovation Lab prior to the planned surgery. At
this appointment a baseline Beck Depression Inventory (BDI), Center for Epidemiological
Studies 10-item Depression scale (CES-D) and visual analog scale (VAS) ratings of pain and
mood will be obtained.VAS ratings will also be done each evening over the following week.
One day after surgery, the subject will return to the Innovation lab for TMS. A total of 22
subjects will be recruited for the study. At the return visit, 11 will receive 40 minutes of
10 Hz repetitive TMS at 120% of rMT (4-second stimulation trains with 26-second
interstimulus intervals). The other 11 participants will receive sham treatment under
identical settings. Participants, medical staff providing clinical care to patients and
raters will not know whether participants receive real or sham TMS. Patients will keep a log
of pain medications used over the following week in addition to the VAS ratings. Follow-up
will occur one week after the TMS therapy. The subject will turn in logs and repeat BDI and
CES-D scales.
Inclusion Criteria: Dental fillings, implants, and bridge work are permitted. -
Exclusion Criteria: Metal objects within 30 cm of the brain. These include cochlear
implants, stents, vagus nerve stimulators, heart devices, bullet fragments, or jewelry.
Monitors, earrings, hearing aids, eyeglasses, jewelry, hair barrettes, cell phones, and
digital sound recording device players will be removed. Actively suicidal. Older than 70
years. Seizures, strokes, dementia, or movement disorders. Pregnant or nursing. Permanent
makeup with metal ink. Medication known to increase risk of seizures.
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