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Completed

NCT Number: NCT00858351

Thermal Biofeedback for the Treatment of Diabetic Neuropathy

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.

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Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermal Biofeedback Assisted Relaxation

Behavioral

6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded.

Discussion with therapist

Behavioral

6 sessions, 25 minutes each, discussing topics with a therapist.

Primary outcomes

  1. Subjective Pain

    Time frame: Change in subjective pain rating from baseline to end of intervention

Secondary outcomes

  1. Perceived Control

    Time frame: Change from mid-intervention (visit 4) to end of intervention

  2. Temperature

    Time frame: Change within each session and across sessions from baseline to end of intervention

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Mar 9, 2009
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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