Thermal Biofeedback for the Treatment of Diabetic Neuropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetic Neuropathy, Painful

Intervention / Treatment
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* Behavioral: Thermal Biofeedback Assisted Relaxation
* Behavioral: Discussion with therapist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Pain |  | Change in subjective pain rating from baseline to end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Neuropathy, Peripheral, Painful, Thermal, Temperature, Biofeedback, Relaxation, Diabetic