Thermal Biofeedback for the Treatment of Diabetic Neuropathy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00858351

Enrollment

Registered

2009-03-09

Start date

2007-11-30

Completion date

2012-04-30

Last updated

2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy, Painful

Keywords

Diabetes, Neuropathy, Peripheral, Painful, Thermal, Temperature, Biofeedback, Relaxation, Diabetic

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.

Interventions

BEHAVIORALThermal Biofeedback Assisted Relaxation

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

BEHAVIORALDiscussion with therapist

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Subjective Pain	Change in subjective pain rating from baseline to end of intervention

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026