Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Diabetic Neuropathy

Diabetes Clinical Trial

Official title:

Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Neuropathy in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049605
• Other study ID #: 2014171
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2017
• Last updated: February 9, 2017
• Start date: January 25, 2014
• Est. completion date: January 1, 2017

Study information

• Verified date: February 2017
• Source: Dammam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Magnetic therapy
low intensity pulsed magnetic therapy with a frequency of 200 Hertz and intensity of 50 Gauss . Magnetic device will be applied on each patient from a comfortable supine lying position. After the connection of appliance to electrical supply, the actions of PEMF will be directed and adjusted over lumbar spine, hip regions and calf muscles of both lower limbs.
• laser therapy
laser therapy of Helium neon infrared laser (850 nano-meter) was used in continuous wave mode from a comfortable prone lying position on the whole plantar surface of the foot and the lumbo-sacral area by four points, and two points laterally to the spine.

Drug:
• Only medical treatment
Fifteen patients with diabetic peripheral neuropathy were treated with antidiabtic drugs and lyrica 150 milligram daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dammam University

References & Publications (1)

Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. Epub 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor and sensory conduction velocity of the lower limb nerves	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 37?. (Asad et al 2009).	30-45 minutes

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