Thermal Biofeedback for the Treatment of Diabetic Neuropathy

NCT ID: NCT00858351

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-04-30

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.

Conditions

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Diabetic Neuropathy, Painful

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Thermal Biofeedback Assisted Relaxation

Group Type EXPERIMENTAL

Thermal Biofeedback Assisted Relaxation

Intervention Type BEHAVIORAL

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

Discussion

Group Type ACTIVE_COMPARATOR

Discussion with therapist

Intervention Type BEHAVIORAL

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

Interventions

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Thermal Biofeedback Assisted Relaxation

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

Intervention Type BEHAVIORAL

Discussion with therapist

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insulin Dependent Diabetes Trust

UNKNOWN

Sponsor Role collaborator

American Pain Society

OTHER

Sponsor Role collaborator

Rosalind Franklin University of Medicine and Science

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Angela Fidler Pfammatter, PhD

Postdoctoral Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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200.97PY

Identifier Type: -

Identifier Source: org_study_id

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