A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain Management
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Change in Pain Level as Measured by the Visual Analog Scale (VAS).
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation.
Investigators
Sheng Li
Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •has phantom limb pain (PLP) after amputation of one limb, upper or lower limb;
- •has chronic pain, \>3 months;
- •is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)
Exclusion Criteria
- •currently adjusting oral pain medications for their PLP;
- •has pain, but not PLP (e.g., from inflammation at the incision wound of the residual limb);
- •has a pacemaker, or other metal and/or implanted devices;
- •has cognitive impairment from brain injury or are not able to follow commands, or to give consent;
- •has amputation in multiple limbs;
- •have asthma or other pulmonary diseases;
- •are not medically stable;
- •have preexisting psychiatric disorders;
- •alcohol or drug abuse;
- •have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
Outcomes
Primary Outcomes
Change in Pain Level as Measured by the Visual Analog Scale (VAS).
Time Frame: Baseline, 10 minutes after intervention
VAS Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. Change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after intervention)\] - a positive value indicates that the score (and pain level) decreased
Secondary Outcomes
- Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)(Baseline, 5 minutes after intervention)
- Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)(Baseline, 5 minutes after intervention)