Effect of hypertonic saline injection in diabetic neuropathy

Phase 3

• Conditions: Diabetic neuropathy.; Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified; E08.40

• Registration Number: IRCT20170517034008N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Presence of pain, paresthesia and sympoms of diabetic neuropathy over the past month
Ages between 30-60
Complete and sign written consent

Exclusion Criteria

Infection, tumor or any skin lesions at the site of intervention
Severe foot deformity
History of chemotherapy
Pregnancy
Lumbosacral canal stenosis or discopathy
Trauma
Rheumatologic and collagen vascular disease(CVD)
Spinal cord injury(SCI)
Traumatic brain injury(TBI)
Cerebrovascular accident(CVA)
Other nerve injuries and neuropathies
History of coagulopathy disorders
History of allergy to the drugs being used in the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is an assessment tool for neuropathic pain, called Douleur Neuropathique 4 questionnaire(DN4) score. Timepoint: For each subject, the Douleur Neuropathique 4 questionnaire outcome measure is completed at baseline, first, second and 8th week after treatment. Method of measurement: Douleur Neuropathique 4 questionnaire to assess neuropathic pain.