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

NCT05075707 | Completed

• 1 other identifier: magnetic and laser therapy
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (4)

• Studies using electromyography and complex muscle action potentials

  All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated before interventions.

  at the beginning of the study

• Studies using electromyography and complex muscle action potentials

  All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated after two month of interventions.

  by the end of successful two month of intervention

• Visual analogue scale (VAS)

  All the participants were instructed to express their pain by Visual analogue scale (VAS) before the interventions.

  at the beginning of the study

• Visual analogue scale (VAS)

  All the participants were instructed to express their pain by Visual analogue scale (VAS) after two month of interventions.

  by the end of successful two month of intervention

Study Arms (3)

control group

NO INTERVENTION

Participants will receive the descriptive medication by neurologist

electromagnetic group

EXPERIMENTAL

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.

low laser therapy group

EXPERIMENTAL

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)

Interventions

Electromagnetic therapy. OTHER

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

electromagnetic group

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.

low laser therapy group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

AAA

Cairo, Egypt

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Magnetic Field Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Laser Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant. Professor of physical therapy, Department of Physical Therapy for Pediatrics

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 13, 2021
• Study Start: October 15, 2021
• Primary Completion: February 22, 2022
• Study Completion: February 23, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After 12 month from publishing.

Locations

EG (1)