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Completed

NCT Number: NCT03049605

Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Diabetic Neuropathy

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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic therapy

Device

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

Device

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.

Only medical treatment

Drug

Fifteen patients with diabetic peripheral neuropathy were treated with antidiabtic drugs and lyrica 150 milligram daily

Other names: Lyrica 150 milligram

Primary outcomes

  1. Motor and sensory conduction velocity of the lower limb nerves

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Feb 10, 2017
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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