Thermal Biofeedback for the Treatment of Diabetic Neuropathy
This study has been completed.
Rosalind Franklin University of Medicine and Science
First Posted: March 9, 2009
Last Update Posted: May 12, 2015
Insulin Dependent Diabetes Trust
American Pain Society
Information provided by (Responsible Party):
Angela Pfammatter, MS, Northwestern University
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.
|Diabetic Neuropathy, Painful||Behavioral: Thermal Biofeedback Assisted Relaxation Behavioral: Discussion with therapist|
|Study Design:||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|
Resource links provided by NLM:
Further study details as provided by Angela Pfammatter, MS, Northwestern University:
Primary Outcome Measures:
- Subjective Pain [ Time Frame: Change in subjective pain rating from baseline to end of intervention ]
Secondary Outcome Measures:
- Perceived Control [ Time Frame: Change from mid-intervention (visit 4) to end of intervention ]
- Temperature [ Time Frame: Change within each session and across sessions from baseline to end of intervention ]
|Study Start Date:||November 2007|
|Study Completion Date:||April 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|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.
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.
Contacts and Locations
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