Thermal Biofeedback for the Treatment of Diabetic Neuropathy
This study has been withdrawn prior to enrollment.
(We are currently changing clinics as our current location has closed unexpectedly)
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
First received: March 6, 2009
Last updated: January 5, 2011
Last verified: March 2009
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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:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
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 May 22, 2013