Thermal Biofeedback for the Treatment of Diabetic Neuropathy

Northwestern University

Status: Completed

Conditions: Diabetic Neuropathy, Painful

Treatments: Behavioral: Thermal Biofeedback Assisted Relaxation; Behavioral: Discussion with therapist

Study type: Interventional

Funder types: Other

Identifiers

NCT00858351

200.97PY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Thermal Biofeedback Assisted Relaxation

Experimental group

Treatment:

Behavioral: Thermal Biofeedback Assisted Relaxation

Discussion

Active Comparator group

Treatment:

Behavioral: Discussion with therapist