CTRI/2017/06/008739
Recruiting
N/A
A pilot randomized clinical trial on the effect of Laser Therapy treatment on diabetic peripheral neuropathic pain in older adults
ab India Pvt limited0 sites40 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- persons with type 2 diabetes mellitus
- Sponsor
- ab India Pvt limited
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Type 2 diabetes
- •2\.Chronic, unresolved neuropathic pain of the feet for more than 3 months
- •3\.Age 60 or older
- •4\.English/Hindi speaking
- •5\.From Delhi and National capital region, so that able to meet the treatment schedule and easily be followed up.
- •6\.Previous integrative medicine, dietary supplementation, or other alternative approaches for diabetic neuropathic pain are permitted, but diary of use must be kept during trial.
Exclusion Criteria
- •1\.Type 1 diabetes
- •2\.Lower extremity open wounds
- •3\.Psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
- •4\.Bleeding disorders
- •5\.Aphasia or sensory, motor, and/or visual disturbances that could interfere with assessments
- •6\.Patient with life expectancy less than 3 years, due to end stage diseases of any vital organ like renal, thyroid, hepatic, gastrointestinal, or seizure.
- •7\.Any malignancy treatedwith chemotherapy or radiotherapy in the previous two years
- •8\.T\-score \> 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI; Derogatis\&Melisaratos, 1983\)
- •9\.A score 29 or higher on the Beck Depression Inventory\-II (BDI; Beck, Steer, \& Brown, 1996\)
- •10\.Severe cognitive impairment by score of 17 or less in MMSE scale
Outcomes
Primary Outcomes
Not specified
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