Thermal Biofeedback for the Treatment of Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00858351
Recruitment Status : Completed
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

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Subjective Pain [ Time Frame: Change in subjective pain rating from baseline to end of intervention ]

Secondary Outcome Measures :
  1. Perceived Control [ Time Frame: Change from mid-intervention (visit 4) to end of intervention ]
  2. Temperature [ Time Frame: Change within each session and across sessions from baseline to end of intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Angela Pfammatter, MS, Postdoctoral Fellow, Northwestern University Identifier: NCT00858351     History of Changes
Other Study ID Numbers: 200.97PY
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Angela Pfammatter, MS, Northwestern University:

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases