NCT00858351

Thermal Biofeedback for the Treatment of Diabetic Neuropathy

A Placebo-Controlled Trial of Thermal Biofeedback Assisted Relaxation for the Treatment of Diabetic Neuropathy: An Evaluation of Outcomes and Mechanisms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
BEHAVIORAL	Thermal Biofeedback Assisted Relaxation	6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded.
BEHAVIORAL	Discussion with therapist	6 sessions, 25 minutes each, discussing topics with a therapist.

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-10-01
• Completion: 2012-04-01
• First posted: 2009-03-09
• Last updated: 2021-09-05