Status:
COMPLETED
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions:
Pain Management
Eligibility:
All Genders
18-75 years
Phase:
NA
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 manage...
Detailed Description
Subjects will receive 10-session BreEStim and 10-session EStim treatment in a random order. The interval between BreEStim and EStim is at least 2 weeks. The following assessment will be made before an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04751526
Start Date
April 2 2021
End Date
February 22 2024
Last Update
March 20 2025
Active Locations (1)
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1
The University of Texas Health Science Center
Houston, Texas, United States, 77030