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Completed

NCT Number: NCT05075707

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

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.

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AAA

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Electromagnetic therapy.

Other

Electromagnetic therapy will be applied for 20 min/ session for (3 days/ week for two months) to the group intervention.

Low level laser therapy (LLLT)

Other

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology

Other

Registry information

Official study title

Magnetic Field and Laser Therapy in Management of Diabetic Trigeminal Neuralgia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2021
Registry last updated
Mar 16, 2022

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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