Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Diabetic Neuropathy

NCT03049605 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2014171
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes

Keywords

Neuropathies laser and magnetic therapy

Outcome Measures

Primary Outcomes (1)

• 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 37ᴄ. (Asad et al 2009).

  30-45 minutes

Study Arms (3)

Magnetic Therapy

EXPERIMENTAL

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 .

Device: Magnetic therapy

Laser Therapy

EXPERIMENTAL

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.

Device: laser therapy

Medical therapy

EXPERIMENTAL

Fifteen patients were received only medical treatment .

Drug: Only medical treatment

Interventions

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.

Magnetic Therapy

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.

Laser Therapy

Only medical treatment DRUG

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

Also known as: Lyrica 150 milligram

Medical therapy

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Related 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. doi: 10.1007/s00125-005-1734-2. Epub 2005 Apr 15.

  PMID: 15834546 RESULT

Related Links

• it is a scientific location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Magnetic Field Therapy; Laser Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Enas F. Alananey, PhD

  Associate professor university of Dammam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: By randomization of participants recruitment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: January 25, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2017
• Last Updated: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share