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Clinical Trials/CTRI/2017/06/008739
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
ab India Pvt limited

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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