Thermal Biofeedback for the Treatment of Diabetic Neuropathy
- Conditions
- Diabetic Neuropathy, Painful
- Registration Number
- NCT00858351
- Lead Sponsor
- Northwestern University
- Brief Summary
The purpose of this study is to examine potential treatment options for a condition in diabetics that causes tingling, pain, and numbness in the hands and /or feet, also known as diabetic peripheral neuropathy.
- Detailed Description
Participants attend 6 sessions lasting from 35 minutes to 2 hours (depending on the session). Sessions can be scheduled once or twice per week. Sessions involve a walking task, filling out questionnaires, and having temperature of hands and feet monitored. This study involves no drugs, blood draws, or any other invasive procedures. Participants are urged to continue the treatment of diabetes and diabetic neuropathy as directed by their physician for the duration of their involvement with the study. After 3 months, a packet of questionnaires will be mailed with a stamped addressed envelope to be returned.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Clinical Diagnosis of Diabetic Neuropathy in Hands and/or Feet
- Must have some sensation left in hands and feet
- Any partial or total amputation of an limb or digit
- Any previous experience with biofeedback
- Prior treatment for alcohol abuse
- Severe Psychopathology
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Subjective Pain Change in subjective pain rating from baseline to end of intervention
- Secondary Outcome Measures
Name Time Method Perceived Control Change from mid-intervention (visit 4) to end of intervention Temperature Change within each session and across sessions from baseline to end of intervention