DiabetesPhase 2NCT03049605
Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Diabetic Neuropathy
A Phase 2 study testing Magnetic therapy, laser therapy and Only medical treatment in people with Diabetes, run by Imam Abdulrahman Bin Faisal University.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Magnetic therapy, laser therapy and Only medical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2014to 1 Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Metallic implants
- Alcohol or drug abuse.
About this study
Official title: Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Neuropathy in Diabetic Patients
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.
Read the 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
- Conditions
- Diabetes
- Being tested
- Magnetic therapy, laser therapy, Only medical treatment
- Keywords
- Neuropathies laser and magnetic therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic therapyDevice
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 therapyDevice
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 treatmentDrug
Also called Lyrica 150 milligram
Fifteen patients with diabetic peripheral neuropathy were treated with antidiabtic drugs and lyrica 150 milligram daily
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Device: laser therapy |
| Medical therapy | Experimental | Fifteen patients were received only medical treatment . Receives: Drug: Only medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start25 Jan 2014
- Primary completion1 Jan 2015
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enas F. Alananey, PhD, Study director, Associate professor university of Dammam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049605
- Sponsor's protocol ID
- 2014171
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The individuals date not shared but the final results comments will appear only
Publications
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.
PubMed 15834546
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Neuropathy in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03049605
- Acronym / sponsor ID
- 2014171
- Conditions
- Diabetes
- Keywords
- Neuropathies laser and magnetic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 25 Jan 2014 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnetic Therapy | Experimental | Device: Magnetic therapyTwenty 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 . |
| Laser Therapy | Experimental | Device: laser therapyTwenty 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. |
| Medical therapy | Experimental | Drug: Only medical treatmentFifteen patients were received only medical treatment . |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- Patients have DPN due to other causes than diabetes
- Ulcers in either foot
- Lack of blood sugar control
- Other nervous system impairments
- Visual problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic therapylow 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. | Device | Magnetic Therapy |
| laser therapylaser 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. | Device | Laser Therapy |
| Only medical treatmentAlso: Lyrica 150 milligramFifteen patients with diabetic peripheral neuropathy were treated with antidiabtic drugs and lyrica 150 milligram daily | Drug | Medical therapy |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Results publication: PubMed 15834546Bosi 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.
- it is a scientific locationLink provided by the sponsor.
- Individual participant dataSharing planned: No. The individuals date not shared but the final results comments will appear only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas F. Alananey, PhD study director
Associate professor university of Dammam
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnetic therapy, laser therapy and Only medical treatment in people with Diabetes, run by Imam Abdulrahman Bin Faisal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor and sensory conduction velocity of the lower limb nerves (time frame: 30-45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.