Low Level Laser Therapy Effects in Peripheral Nerves Patient With Leprosy.

NCT03072004 | Unknown DMC

• 1 other identifier: 37474214.4.0000.5152
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

We are going to investigate leprosy patients with neuropathies. This problem can lead to changes in nerve function and lead to disability. We will investigate a protocol with LLLT to improve pain, inflammation, and to prevent disabilities. We will test two groups, which will be divided into control and LLLT treated patients. In this groups we will perform quantitative measurements of the following parameters before and after the protocol application: electroneuromyography and muscle strength measurements, evaluation of activity limitation and risk awareness, evaluation of tactile sensitivity and evaluation of temperatures of hands and feet. Averages for all parameters will be compared before and after treatment (12 application sessions). We believe that LLLT can become an important alternative treatment to improve conduction velocity, tactile sensitivity, temperatures of hands and feet, muscle strength and pain, which will prevent nerve damage and disabilities

Conditions

Leprosy Neuropathy

Keywords

Leprosy; Neuropathy; LLLT

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Conduction Velocity at 28 days after LLLT.

  Will be performed on the MEB4200K, the active recording electrode is placed on the center o the muscle belly, and the reference electrode is placed distally, over the muscle tendon. Below is a description of the technique employed in each of these nerves: Ulnar Motor Nerve: Normal values: Amplitude≥ 3.80mv, conduction velocity ≥ 50m/s, distal latency ≤ 3.1 m/s. Delta conduction velocity (difference between the distal segment and the elbow segment)≥10m/s; (b)Common Peroneal Motor Study: Normal values: Amplitude ≥ 2.80 mv, conduction velocity ≥ 40m/s, distal latency(handle)≤ 5.0 msec. Delta conduction velocity (difference between the distal segment and the peroneal head segment)≥10m/s.

  Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application.

Secondary Outcomes (5)

• Change from Baseline Muscle Strength at 28 days after LLLT.

  Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application.

• Change from Baseline Tactile Sensitivity at 28 days after LLLT.

  Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application.

• Change from Baseline Pain intensity at 28 days after LLLT.

  Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application.

• Change from Baseline Tissue temperature variations of the body surface at 28 days after LLLT

  Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application.

• Change from Screening of Activity Limitation and Safety Awareness Scale at 28 days after LLLT.

  Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application.

Study Arms (2)

Control

SHAM COMPARATOR

Leprosy patients with focal demyelinating neuropathy in compression sites of the ulnar and common peroneal nerves who will receive application "sham LLLT". The laser will be turned off, but the procedure will be the same as with the Low Level Laser Therapy (LLLT) group

Device: Sham LLLT

Low Level Laser Therapy

EXPERIMENTAL

Leprosy patients with focal demyelinating neuropathy in compression sites of the ulnar and common peroneal nerves who will receive intervention with low-intensity laser therapy (LLLT).

Device: LLLT

Interventions

LLLT DEVICE

The LLLT will be applied using a diode laser device (Recover Laser MMOptics, São Carlos/SP- Brazil) with parameters: 808nm, continuous output, 100mW, 8J. Laser probe will be applied directly and perpendicularly in skin contact (5 points), the time of irradiation will be 80 seconds per point, and treatments will be applied for three times a week for 12 sessions.

Low Level Laser Therapy

Sham LLLT DEVICE

That group receive application "sham LLLT". The laser will be turned off, but the procedure will be the same as with the LLLT group

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• leprosy patients;
• patients who show signs of focal demyelinating neuropathy in compression sites of the ulnar and common peroneal nerves by ENM;
• patients with borderline tuberculoid (BT), borderline-borderline (BB), borderline lepromatous (BL) and lepromatous (LL) leprosy forms;
• patients under multidrug therapy (MDT) and;
• (d) patients who live in Uberlândia (Minas Gerais/Brazil).

You may not qualify if:

• patient diagnosed with other forms of peripheral neuropathies, diagnosed with diabetes and arterial hypertension;
• patient physically disabled;
• patient with cognitive impairment and;
• who refuse to sign a consent form.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

National Reference Center for Sanitary Dermatology and Leprosy

Uberlândia, Minas Gerais, 38413018, Brazil

RECRUITING

Related Publications (2)

• Ozkan FU, Saygi EK, Senol S, Kapci S, Aydeniz B, Aktas I, Gozke E. New treatment alternatives in the ulnar neuropathy at the elbow: ultrasound and low-level laser therapy. Acta Neurol Belg. 2015 Sep;115(3):355-60. doi: 10.1007/s13760-014-0377-9. Epub 2014 Oct 16.

  PMID: 25319131 BACKGROUND

• Khamseh ME, Kazemikho N, Aghili R, Forough B, Lajevardi M, Hashem Dabaghian F, Goushegir A, Malek M. Diabetic distal symmetric polyneuropathy: effect of low-intensity laser therapy. Lasers Med Sci. 2011 Nov;26(6):831-5. doi: 10.1007/s10103-011-0977-z. Epub 2011 Aug 19.

  PMID: 21853320 BACKGROUND

MeSH Terms

Conditions

Leprosy

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Isabela M Bernardes Goulart, doctorate

  Federal University of Uberlandia

  STUDY DIRECTOR

• Elaine F Sabino, master

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine F Sabino, master

CONTACT

+553499817213499817212121; elainefavarosabino@gmail.com

Centro M Bernardes Goulart, doctorate

CONTACT

+5534998172121; imbg34998172121oulart@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We will analyze leprosy patients with neuropathy. These patients will be randomly divided in: (a) Control: who will receive simulated application "sham" of LLLT; and (b) LLLT: who will receive LLLT (830 nm, continuous emission, 100mW output power and 3J power density). Treatments will occur in 12 sessions (3 times per week) on the nerves: a)ulnar: around the ulnar nerve at the elbow region, and b)common peroneal: surrounding fibular head. For the inclusion criteria will be selected leprosy patients (tuberculoid and borderline tuberculoid forms) with focal demyelinating neuropathy of the ulnar and common peroneal nerves by electroneuromyography (ENMG); patients without leprosy reactions and corticoid use. We will perform measurements of the following parameters before and after the LLLT protocol application: ENMG Muscle Strength; Tactile Sensitivity measured; Pain Intensity; Incapacity grade; Infrared thermography; Screening of Activity Limitation and Safety Awareness scale.

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 7, 2017
• Study Start: January 27, 2017
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2019
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)