Thermal Biofeedback for the Treatment of Diabetic Neuropathy - Full Text View

Sponsor:	Rosalind Franklin University of Medicine and Science
Collaborators:	Insulin Dependent Diabetes Trust American Pain Society
Information provided by:	Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier:	NCT00858351

Purpose

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	Intervention
Diabetic Neuropathy, Painful	Behavioral: Thermal Biofeedback Assisted Relaxation Behavioral: Discussion with therapist

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Further study details as provided by Rosalind Franklin University of Medicine and Science:

Primary Outcome Measures:

Subjective Pain [ Time Frame: Change in subjective pain rating from baseline to end of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Perceived Control [ Time Frame: Change from mid-intervention (visit 4) to end of intervention ] [ Designated as safety issue: No ]
Temperature [ Time Frame: Change within each session and across sessions from baseline to end of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Kenneth Kessler, Ph.D., Associate Professor, Rosalind Franklin Univeristy of Medicine and Science
ClinicalTrials.gov Identifier:	NCT00858351 History of Changes
Other Study ID Numbers:	200.97PY
Study First Received:	March 6, 2009
Last Updated:	January 5, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Rosalind Franklin University of Medicine and Science:

Diabetes
Neuropathy
Peripheral
Painful
Thermal

Temperature
Biofeedback
Relaxation
Diabetic

Additional relevant MeSH terms:

Diabetic Neuropathies
Pain
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases

Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on February 09, 2012