Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Diabetic Neuropathy

NCT ID: NCT03049605

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-25

Study Completion Date

2017-01-01

Brief Summary

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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

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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

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
By randomization of participants recruitment

Study Groups

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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 .

Group Type EXPERIMENTAL

Magnetic therapy

Intervention Type 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

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.

Group Type EXPERIMENTAL

laser therapy

Intervention Type 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.

Medical therapy

Fifteen patients were received only medical treatment .

Group Type EXPERIMENTAL

Only medical treatment

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Only medical treatment

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

Intervention Type DRUG

Other Intervention Names

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Lyrica 150 milligram

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enas F. Alananey, PhD

Role: STUDY_DIRECTOR

Associate professor university of Dammam

References

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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.

Reference Type RESULT
PMID: 15834546 (View on PubMed)

Other Identifiers

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2014171

Identifier Type: -

Identifier Source: org_study_id

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