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

Primary Purpose

Trigeminal Neuralgia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Electromagnetic therapy.

Low level laser therapy (LLLT)

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

control group

electromagnetic group

low laser therapy group

Arm Description

Participants will receive the descriptive medication by neurologist

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Visual analogue scale (VAS)

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

Visual analogue scale (VAS)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05075707

First Posted

September 19, 2021

Last Updated

March 11, 2022

Sponsor

Delta University for Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT05075707

Brief Title

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

Official Title

Magnetic Field and Laser Therapy in Management of Diabetic Trigeminal Neuralgia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

October 15, 2021 (Actual)

Primary Completion Date

February 22, 2022 (Actual)

Study Completion Date

February 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Delta University for Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigeminal Neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Description

Participants will receive the descriptive medication by neurologist

Arm Title

electromagnetic group

Arm Type

Experimental

Arm Description

Arm Title

low laser therapy group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Electromagnetic therapy.

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Low level laser therapy (LLLT)

Intervention Description

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 Measure Information:

Title

Studies using electromyography and complex muscle action potentials

Description

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

Time Frame

at the beginning of the study

Title

Studies using electromyography and complex muscle action potentials

Description

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

Time Frame

by the end of successful two month of intervention

Title

Visual analogue scale (VAS)

Description

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

Time Frame

at the beginning of the study

Title

Visual analogue scale (VAS)

Description

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

Time Frame

by the end of successful two month of intervention

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

AAA

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data (IPD) will be available to other researchers after 12 month from publishing.

IPD Sharing Time Frame

After 12 month from publishing.

Learn more about this trial

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

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