Thermal Biofeedback for the Treatment of Diabetic Neuropathy

Not Applicable

Completed

• Conditions: Diabetic Neuropathy, Painful
• Interventions: Behavioral: Thermal Biofeedback Assisted Relaxation; Behavioral: Discussion with therapist

• 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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Primary Completion: 2011-10
• Study Completion: 2012-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Clinical Diagnosis of Diabetic Neuropathy in Hands and/or Feet
• Must have some sensation left in hands and feet

Exclusion Criteria

• 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

Arm && Interventions

Group	Intervention	Description
Thermal Biofeedback Assisted Relaxation	Thermal Biofeedback Assisted Relaxation	-
Discussion	Discussion with therapist	-

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