NCT00858351

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

3.9 years

First QC Date

March 6, 2009

Last Update Submit

August 30, 2021

Conditions

Diabetic Neuropathy, Painful

Keywords

DiabetesNeuropathyPeripheralPainfulThermalTemperatureBiofeedbackRelaxationDiabetic

Outcome Measures

Primary Outcomes (1)

  • Subjective Pain

    Change in subjective pain rating from baseline to end of intervention

Secondary Outcomes (2)

  • 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

Study Arms (2)

Thermal Biofeedback Assisted Relaxation

EXPERIMENTAL
Behavioral: Thermal Biofeedback Assisted Relaxation

Discussion

ACTIVE COMPARATOR
Behavioral: Discussion with therapist

Interventions

Thermal Biofeedback Assisted RelaxationBEHAVIORAL

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

Thermal Biofeedback Assisted Relaxation
Discussion with therapistBEHAVIORAL

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

Discussion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis of Diabetic Neuropathy in Hands and/or Feet
  • Must have some sensation left in hands and feet

You may not qualify if:

  • Any partial or total amputation of an limb or digit
  • Any previous experience with biofeedback
  • Prior treatment for alcohol abuse
  • Severe Psychopathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes MellitusPain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

November 1, 2007

Primary Completion

October 1, 2011

Study Completion

April 1, 2012

Last Updated

September 5, 2021

Record last verified: 2021-08