Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Diabetic Neuropathy

Phase 2

Completed

• Conditions: Diabetes
• Interventions: Device: laser therapy; Device: Magnetic therapy; Drug: Only medical treatment

• Registration Number: NCT03049605
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

Brief Summary

This study are to:

* Evaluate effect of magnetic therapy on peripheral neuropathy in diabetic patients.

* Evaluate effect of laser therapy on peripheral neuropathy in diabetic patients.

* Compare effects of magnetic therapy with that of laser therapy on peripheral neuropathy in diabetic patients.

Detailed Description

Sixty- five male and female diabetic patients with peripheral neuropathy will be selected to participate in this study. They will be equally divided into two groups Group-I: Twenty five patient with diabetic peripheral neuropathy will be exposed to low intensity pulsed magnetic therapy Group-II: Twenty five patients with diabetic peripheral neuropathy will be exposed for 24 treatment sessions of laser therapy Group-III 15 patient received only medical treatment

Study Timeline

• Study Start: 2014-01-25
• Primary Completion: 2015-01-01
• Study Completion: 2017-01-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-09
• Last Update Submitted: 2017-02-09
• Study First Posted: 2017-02-10
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• All diabetic patients with peripheral neuropathy will be selected to participate in this study.
• Their age ranges from 35 to 65 years old.
• All patients under medical control (optimal blood glucose). such as analgesic medications (e.g. opiates, anti-depressants, anticonvulsants and diabetic drugs to control blood glucose).

Exclusion Criteria

• Patients have DPN due to other causes than diabetes
• Ulcers in either foot
• Lack of blood sugar control
• Other nervous system impairments
• Visual problems
• Unstable medical conditions
• Pregnancy
• Metallic implants
• Alcohol or drug abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Therapy	laser therapy	Twenty five patients were treated with 24 sessions of laser therapy at a rate of two sessions / week for three months. Each patient will be exposed to Helium neon infrared laser (850 nano-meter continuous wave mode from a comfortable prone lying position.
Magnetic Therapy	Magnetic therapy	Twenty five patient were exposed to low intensity pulsed magnetic therapy with a frequency of 200 Hertz and intensity of 50 Gauss for 30 minutes / session for 2 times per week for 3 months .
Medical therapy	Only medical treatment	Fifteen patients were received only medical treatment .

Primary Outcome Measures

Name	Time	Method
Motor and sensory conduction velocity of the lower limb nerves	30-45 minutes	it is used for measuring motor and sensory conduction velocity: For this purpose nerve conduction studies (NCSs) will be performed for all patients including evaluation of bilateral peroneal and tibia motor nerves and sural sensory nerves (Asad 2009). Patients with NCV from 33-48m /sec will be recruited in this study (Pericz and Cvetkovic 2006 , and Graak 2009). All measurement will be done at stander room temperature of 25 c. The skin temperature of the leg was maintained at 37ᴄ. (Asad et al 2009).