Thermal Biofeedback for the Treatment of Diabetic Neuropathy

August 30, 2021 updated by: Angela Fidler Pfammatter, PhD, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Perceived Control
Time Frame: Change from mid-intervention (visit 4) to end of intervention
Change from mid-intervention (visit 4) to end of intervention
Temperature
Time Frame: Change within each session and across sessions from baseline to end of intervention
Change within each session and across sessions from baseline to end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

American Pain Society
Rosalind Franklin University of Medicine and Science
Insulin Dependent Diabetes Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 6, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200.97PY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Neuropathy, Painful

Clinical Trials on Thermal Biofeedback Assisted Relaxation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe