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| Name | Class |
|---|---|
| Insulin Dependent Diabetes Trust | UNKNOWN |
| American Pain Society | OTHER |
| Rosalind Franklin University of Medicine and Science | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal Biofeedback Assisted Relaxation | Experimental |
| |
| Discussion | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Biofeedback Assisted Relaxation | Behavioral | 6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Pain | Change in subjective pain rating from baseline to end of intervention |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D003920 | Diabetes Mellitus |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| Discussion with therapist | Behavioral | 6 sessions, 25 minutes each, discussing topics with a therapist. |
|
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |