Laser Therapy for Patients With Systemic Lupus Erythematosus

NCT04453215 | Completed DMC

• 1 other identifier: 1298
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that has detrimental effects on connective tissue and other organs. The musculoskeletal system is one of the most affected systems in this group of patients including the temporomandibular joint. The most common symptoms when muscle involvement in SLE are muscle atrophy decreased muscle strength and myopathy. SLE activity and long-term corticosteroid use are thought to be responsible for these symptoms, thus, SLE patients are accepted to be at higher risk for temporomandibular joint disorders (TMD). Low-level laser therapy(LLLT) is frequently used in the treatment of TMD due to its pain relief and anti-inflammatory effect. Thus, in this study, LLLT has been used to evaluate this treatment modality on the chewing function and pain values of SLE patients with myogenic TMD.

Conditions

Systemic Lupus Erythematosus; Muscle Pain; Chewing Function

Outcome Measures

Primary Outcomes (2)

• pain value

  Pain intensity was evaluated by using Visual Analog Scale(VAS).

  2 months

• chewing function

  The chewing function was evaluated by measuring the geometric mean diameter of crushed test food.

  2 months

Study Arms (3)

test group

EXPERIMENTAL

SLE patients treated with infrared laser irradiation

Device: GaAlAs semiconductor diode laser device

placebo group

PLACEBO COMPARATOR

SLE patients treated with red laser irradiation

Device: GaAlAs semiconductor diode laser device

control group

NO INTERVENTION

no therapy group

Interventions

GaAlAs semiconductor diode laser device DEVICE

low-level laser therapy

placebo group; test group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having myogenic temporomandibular joint disorder,
• Following a stable medical regime,
• Showing minimum pain intensity of 50 mm on the visual analog scale.

You may not qualify if:

• Having concurrent systemic diseases,
• Using antimalarial drugs,
• Wearing removable prosthesis,
• History of facial trauma.

Sponsors & Collaborators

• Dr. Merve Benli: lead

Study Sites (1)

Istanbul university,Faculty of Dentistry

Fatih, 34452, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Myalgia

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• merve benli, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

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: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 1, 2020
• Study Start: January 12, 2019
• Primary Completion: December 23, 2019
• Study Completion: March 15, 2020
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available when confirmed, and it will be available for one year.
• Access Criteria: The study protocol and patient selection will be shared.

Locations

TU (1)