WithdrawnNot Applicable

Exercise Induced Hypoalgesia Diabetes

Stopped: Principal investigator decision

United States0Started 2022-08-01

Plain-language summary

The purpose of this research study is to learn whether different forms of exercise can reduce pain experienced by individuals with painful diabetic peripheral neuropathy.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Subjects between the ages of 18 - 65.
✓. Subjects with confirmed Diabetes Mellitus as defined by the American Diabetes Association (ADA), a glycosylated hemoglobin (HbA1c) of 6.5%, a fasting blood glucose \> 126 mg/dL, or an oral glucose tolerance test \> 200 mg/dL.
✓. Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
✓. Subjects who have neuropathic pain as defined by a minimum score of 4 or higher on the Douleur Neuropathique en 4 Questions (DN4). In addition, the location of pain must be present within the same region of neuropathy symptoms.
✓. Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.

Exclusion criteria

✕. Subjects who have pain due to some other form of neuropathy (chemo-induced neuropathy, alcohol induced neuropathy, exposure to toxins/chemicals, vitamin b12 deficiency, etc.) assessed via a medical history.
✕. Subjects with current or history of central nervous system disorders.
✕. Subjects with resting hypertension (HTN) \>/= 160/90 mmHg or known uncontrolled hypertension, coronary artery disease, heart failure, retinopathy, chronic obstructive pulmonary disease, end-stage renal disease, or current open foot ulcers.
✕. Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
✕. Subjects with Reynaud's disease or cold urticaria.
✕. All vulnerable populations including adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners, individuals with cognitive impairment.

What they're measuring

Change in Pain Pressure Threshold (PPT)

Timeframe: Baseline, 20 minutes

Trial details

NCT IDNCT05296642

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials