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Thermal Biofeedback for the Treatment of Diabetic Neuropathy

Primary Purpose

Diabetic Neuropathy, Painful

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermal Biofeedback Assisted Relaxation
Discussion with therapist
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy, Painful focused on measuring Diabetes, Neuropathy, Peripheral, Painful, Thermal, Temperature, Biofeedback, Relaxation, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Thermal Biofeedback Assisted Relaxation

    Discussion

    Arm Description

    Outcomes

    Primary Outcome Measures

    Subjective Pain

    Secondary Outcome Measures

    Perceived Control
    Temperature

    Full Information

    First Posted
    March 6, 2009
    Last Updated
    August 30, 2021
    Sponsor
    Northwestern University
    Collaborators
    Insulin Dependent Diabetes Trust, American Pain Society, Rosalind Franklin University of Medicine and Science
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00858351
    Brief Title
    Thermal Biofeedback for the Treatment of Diabetic Neuropathy
    Official Title
    A Placebo-Controlled Trial of Thermal Biofeedback Assisted Relaxation for the Treatment of Diabetic Neuropathy: An Evaluation of Outcomes and Mechanisms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University
    Collaborators
    Insulin Dependent Diabetes Trust, American Pain Society, Rosalind Franklin University of Medicine and Science

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Neuropathy, Painful
    Keywords
    Diabetes, Neuropathy, Peripheral, Painful, Thermal, Temperature, Biofeedback, Relaxation, Diabetic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Thermal Biofeedback Assisted Relaxation
    Arm Type
    Experimental
    Arm Title
    Discussion
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Thermal Biofeedback Assisted Relaxation
    Intervention Description
    6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Discussion with therapist
    Intervention Description
    6 sessions, 25 minutes each, discussing topics with a therapist.
    Primary Outcome Measure Information:
    Title
    Subjective Pain
    Time Frame
    Change in subjective pain rating from baseline to end of intervention
    Secondary Outcome Measure Information:
    Title
    Perceived Control
    Time Frame
    Change from mid-intervention (visit 4) to end of intervention
    Title
    Temperature
    Time Frame
    Change within each session and across sessions from baseline to end of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Thermal Biofeedback for the Treatment of Diabetic Neuropathy

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