Thermal Biofeedback for the Treatment of Diabetic Neuropathy

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT00858351

Collaborator

Insulin Dependent Diabetes Trust (Other), American Pain Society (Other), Rosalind Franklin University of Medicine and Science (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathy, Painful	Behavioral: Thermal Biofeedback Assisted Relaxation Behavioral: Discussion with therapist	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thermal Biofeedback Assisted Relaxation	Behavioral: Thermal Biofeedback Assisted Relaxation 6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded.
Active Comparator: Discussion	Behavioral: Discussion with therapist 6 sessions, 25 minutes each, discussing topics with a therapist.

Arm

Intervention/Treatment

Experimental: Thermal Biofeedback Assisted Relaxation

Behavioral: Thermal Biofeedback Assisted Relaxation

6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded.

Active Comparator: Discussion

Behavioral: Discussion with therapist

6 sessions, 25 minutes each, discussing topics with a therapist.

Outcome Measures

Primary Outcome Measures

Subjective Pain [Change in subjective pain rating from baseline to end of intervention]

Secondary Outcome Measures

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]