Diabetic Neuropathy, PainfulNCT00858351
Thermal Biofeedback for the Treatment of Diabetic Neuropathy
A study testing Thermal Biofeedback Assisted Relaxation and Discussion with therapist in people with Diabetic Neuropathy, Painful, run by Northwestern University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- Thermal Biofeedback Assisted Relaxation and Discussion with therapist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of Diabetic Neuropathy in Hands and/or Feet
- Must have some sensation left in hands and feet
Who cannot join
- Any partial or total amputation of an limb or digit
- Any previous experience with biofeedback
- Prior treatment for alcohol abuse
- Severe Psychopathology
About this study
Official title: A Placebo-Controlled Trial of Thermal Biofeedback Assisted Relaxation for the Treatment of Diabetic Neuropathy: An Evaluation of Outcomes and Mechanisms
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.
Read the 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.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- Thermal Biofeedback Assisted Relaxation, Discussion with therapist
- Keywords
- Diabetes, Neuropathy, Peripheral, Painful, Thermal, Temperature, Biofeedback, Relaxation, Diabetic
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Biofeedback Assisted RelaxationBehavioural
6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded.
Discussion with therapistBehavioural
6 sessions, 25 minutes each, discussing topics with a therapist.
| Study group | Role | What they receive |
|---|---|---|
| Thermal Biofeedback Assisted Relaxation | Experimental | Not described Receives: Behavioral: Thermal Biofeedback Assisted Relaxation |
| Discussion | Active comparator | Not described Receives: Behavioral: Discussion with therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Pain
Measured: Change in subjective pain rating from baseline to end of intervention
Secondary outcomes (2)
Perceived Control
Measured: Change from mid-intervention (visit 4) to end of intervention
Temperature
Measured: Change within each session and across sessions from baseline to end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startNov 2007
- Primary completionOct 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy, PainfulStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Insulin Dependent Diabetes Trust, American Pain Society, Rosalind Franklin University of Medicine and Science
- Responsible party
- Principal investigator, Angela Fidler Pfammatter, PhD, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858351
- Sponsor's protocol ID
- 200.97PY
- Status last verified
- Aug 2021
- First submitted
- 6 Mar 2009
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Trial of Thermal Biofeedback Assisted Relaxation for the Treatment of Diabetic Neuropathy: An Evaluation of Outcomes and Mechanisms
- ClinicalTrials.gov ID
- NCT00858351
- Acronym / sponsor ID
- 200.97PY
- Conditions
- Diabetic Neuropathy, Painful
- Keywords
- Diabetes, Neuropathy, Peripheral, Painful, Thermal, Temperature, Biofeedback, Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Insulin Dependent Diabetes Trust, American Pain Society, Rosalind Franklin University of Medicine and Science
- Study start
- Nov 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermal Biofeedback Assisted Relaxation | Experimental | Behavioral: Thermal Biofeedback Assisted Relaxation |
| Discussion | Active comparator | Behavioral: Discussion with therapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical Diagnosis of Diabetic Neuropathy in Hands and/or Feet
- Must have some sensation left in hands and feet
Key exclusion criteria (4 listed)
- Any partial or total amputation of an limb or digit
- Any previous experience with biofeedback
- Prior treatment for alcohol abuse
- Severe Psychopathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal Biofeedback Assisted Relaxation6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded. | Behavioural | Thermal Biofeedback Assisted Relaxation |
| Discussion with therapist6 sessions, 25 minutes each, discussing topics with a therapist. | Behavioural | Discussion |
Primary outcome
Subjective Pain
Time frame: Change in subjective pain rating from baseline to end of intervention
2 secondary outcomes
Perceived Control
Time frame: Change from mid-intervention (visit 4) to end of intervention
Temperature
Time frame: Change within each session and across sessions from baseline to end of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Biofeedback Assisted Relaxation and Discussion with therapist in people with Diabetic Neuropathy, Painful, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Pain (time frame: Change in subjective pain rating from baseline to end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.