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Comparison Between Magnetic Field and Laser Therapy in Management of Trigeminal Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05075707
Recruitment Status : Not yet recruiting
First Posted : October 13, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Amira Hussin Hussin Mohammed, Delta University for Science and Technology

Brief Summary:
Trigeminal neuralgia (TN) was defined by The International Association for the Study of Pain (IASP) as severe, sudden, usually unilateral, stabbing, brief, recurrent attacks of pain in one or more distributional branches of the trigeminal nerve. The purpose of the current study will to investigate the effect of Low level laser therapy versus electromagnetic therapy on diabetic trigeminal neuralgia pain intensity and amplitude of the compound muscle action potential of the masseter and temporalis muscles in diabetic TN patients.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Other: Electromagnetic therapy. Other: Low level laser therapy (LLLT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Magnetic Field and Laser Therapy in Management of Diabetic Trigeminal Neuralgia
Estimated Study Start Date : October 2, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: control group
Participants will receive the descriptive medication by neurologist
Experimental: electromagnetic group
Participants will receive the descriptive medication by neurologist in addition to electromagnetic therapy. Electromagnetic therapy will be applied for 20 min/session for three days each week for two months.
Other: Electromagnetic therapy.
Electromagnetic therapy will be applied for 20 min/ session for (3 days/ week for two months) to the group intervention.

Experimental: low laser therapy group
Participants will receive the descriptive medication by neurologist in addition to low laser therapy. Low laser therapy will be applied for 20 min/session for three days each week for two months.
Other: Low level laser therapy (LLLT)
Low level laser therapy (LLLT) will be applied for 20 min/session laser scanner for three days each week for two months to the group intervention.




Primary Outcome Measures :
  1. Studies using electromyography and complex muscle action potentials [ Time Frame: at the beginning of the study ]
    All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated before interventions.

  2. Studies using electromyography and complex muscle action potentials [ Time Frame: by the end of successful two month of intervention ]
    All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated after two month of interventions.

  3. Visual analogue scale (VAS) [ Time Frame: at the beginning of the study ]
    All the participants were instructed to express their pain by Visual analogue scale (VAS) before the interventions.

  4. Visual analogue scale (VAS) [ Time Frame: by the end of successful two month of intervention ]
    All the participants were instructed to express their pain by Visual analogue scale (VAS) after two month of interventions.



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants will between the ages of 25 and 45, will of both sexes (male and female), diabetic type two patients with chronic trigeminal neuralgia, (from three to six months).
  • Patients will awake, cooperative, and free of psychiatric issues (as determined by a psychologist) as well as difficulties resulting from orthopaedic or special sensory deficits.

Exclusion Criteria:

  • Patients will ruled out if they developed TN due to a tumour, herpes zoster, or any other reason other than diabetes, such as significant coagulation dysfunction, cardiopulmonary dysfunction or previous invasive treatment (ethanol, radiofrequency, Gama-knife microvascular decompression, glycerinum injection).
  • They will not have a previous disability in the face.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075707


Contacts
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Contact: Amira Hussin Mohammed, PHD 02001144495063 amira_hussin77@yahoo.com

Sponsors and Collaborators
Delta University for Science and Technology
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Responsible Party: Amira Hussin Hussin Mohammed, Assistant. Professor of physical therapy, Department of Physical Therapy for Pediatrics, Delta University for Science and Technology
ClinicalTrials.gov Identifier: NCT05075707    
Other Study ID Numbers: magnetic and laser therapy
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) will be available to other researchers after 12 month from publishing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After 12 month from publishing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases