Diabetic peripheral neuropathy. Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention 1: The first intervention group: laser therapy with low energy level, wavelength: 660 to 860 nm, power: 20 to 250 mW, density: 0.45 to 70 J/cm2, number of sessions: 10 sessions, follow-up
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age range from 40 to 70 years Diabetic peripheral neuropathy confirmed by a specialist doctor HbA1c : 6 - 10 % 5 to 10 years have passed since the patient's history of diabetes.
Exclusion criteria
Exclusion criteria: History of unstable systemic diseases History of malignancy History of uncontrolled thyroid disease (hyper or hypothyroid) History of heart failure, arrhythmia (presence of cardiac pacemaker) Cerebral circulation disorders Severe peripheral circulation disorders according to ABI index less than 0.5 Fever of unknown origin Tuberculosis and lung problems Presence of other neurological disorders Pregnancy Drug or alcohol abuse History of sensitivity to light therapy The existence of psychogenic diseases and depression Body mass index greater than 30 (morbid obesity) In general, the contraindications of iontophoresis and laser therapy can also be considered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale. Timepoint: Before the intervention and after the last treatment session. Method of measurement: Using a visual chart of pain intensity.;Pain pressure threshold. Timepoint: Before the intervention and after the last treatment session. Method of measurement: Using a digital algometer.;Tibial motor nerve conduction velocity. Timepoint: Before the intervention and after the last treatment session. Method of measurement: Electromyography.;Ankle brachial index. Timepoint: Before the intervention and after the last treatment session. Method of measurement: Digital pressure gauge and calculation.;The delicate touch of the soles of the feet. Timepoint: Before the intervention and after the last treatment session. Method of measurement: 10 gram monofilament (number of diagnostic points).;Peripheral nerve disorders. Timepoint: Before the intervention and after the last treatment session. Method of measurement: Michigan Neuropathy Questionnaire.;Balance (static, dynamic and balance progress). Timepoint: Before the intervention and after the last treatment session. Method of measurement: The 4-Stage Balance Test, Functional Reach Test, Timed “Up and Go” Test.;SF-36 questionnaire. Timepoint: Before the intervention and after the last treatment session. Method of measurement: SF-36 questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSedigheh Sadat Naimi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed