Effect of laser therapy treatment on diabetic peripheral neuropathic pain in older adults

Not Applicable

Conditions: Health Condition 1: null- persons with type 2 diabetes mellitus

Registration Number: CTRI/2017/06/008739

Lead Sponsor: ab India Pvt limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 40

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of laser therapy will be measured on following : <br/ ><br>1.Pain <br/ ><br>2.IMMUNE Function <br/ ><br>3.Health, Functional Status, and life satisfaction measures <br/ ><br>4. Quantitative assessmentTimepoint: patient will be evaluated before and after intervention ( 0 and 3 months)

Secondary Outcome Measures

Name	Time	Method
Effect of laser therapy will be measured on following : <br/ ><br>1.Pain <br/ ><br>2.IMMUNE Function <br/ ><br>3.Health, Functional StaTimepoint: after 12 weeks of therapy