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

Sponsor
Delta University for Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT05075707
Collaborator
(none)
120
1
3
4.3
27.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Electromagnetic therapy.
  • Other: Low level laser therapy (LLLT)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 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
Actual Study Start Date :
Oct 15, 2021
Actual Primary Completion Date :
Feb 22, 2022
Actual Study Completion Date :
Feb 23, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Studies using electromyography and complex muscle action potentials [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 [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 AAA Cairo Egypt

Sponsors and Collaborators

  • Delta University for Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Oct 13, 2021
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022