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

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ClinicalTrials.gov Identifier: NCT03072004
Recruitment Status : Unknown
Verified March 2017 by Elaine Fávaro Pípi Sabino, Federal University of Uberlandia.
Recruitment status was:  Recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Elaine Fávaro Pípi Sabino, Federal University of Uberlandia

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

Condition or disease Intervention/treatment Phase
Leprosy Neuropathy Device: LLLT Device: Sham LLLT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Low Level Laser Therapy Effects in Peripheral Nerves Patient Affected With Leprosy : Randomized Controlled Trial
Actual Study Start Date : January 27, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Leprosy

Arm Intervention/treatment
Sham Comparator: Control
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
That group receive application "sham LLLT". The laser will be turned off, but the procedure will be the same as with the LLLT group

Experimental: Low Level Laser Therapy
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
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.




Primary Outcome Measures :
  1. Change from Baseline Conduction Velocity at 28 days after LLLT. [ Time Frame: Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application. ]
    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.


Secondary Outcome Measures :
  1. Change from Baseline Muscle Strength at 28 days after LLLT. [ Time Frame: Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application. ]
    will be assessed muscles innervated by ulnar and common fibular nerves according to the Scale Assessment of Muscular Strength by Kendall et al., 1995. In this scale, there is a score from 0 to 5 that indicates score 5 to complete range of motion against gravity and resistance maxima manual and score 0 without muscle contraction.

  2. Change from Baseline Tactile Sensitivity at 28 days after LLLT. [ Time Frame: Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application. ]

    will be used a set of six Semmes-Weinstein monofilaments (Kit prepared by SORRI team, Bauru/SP), to evaluate threshold values for touch. The filament size was marked with the log forces, which are said to represent the threshold values for touch; 0,05 gramas (g) (normal sensation), 0.2g (diminished light touch), 2.0g (diminished protective sensation), 4.00g and 10g(loss of protective sensation of the hands and feet), 300g (feeling of pressure in hand) and black color (no sensation).

    In the tactile sensitivity of ulnar and median nerves , each evaluated point will be received a score from 0 to 5, the final score obtained by summing points : 1,2 and 3 to the median nerve ; 4.5 and 6 for the ulnar nerve , with a maximum score of 15 for each nerve. For the common peroneal nerve will be considered only point 10, with a maximum score of 5. For the tibial nerve will be evaluated 9 points, with a maximum score of 45.


  3. Change from Baseline Pain intensity at 28 days after LLLT. [ Time Frame: Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application. ]
    This scale will be used to evaluate the intensity of pain in the innervated region of the ulnar and/or peroneal nerves. There is a score from 0 to 10, 0 indicating no pain and 10 indicating severe pain

  4. Change from Baseline Tissue temperature variations of the body surface at 28 days after LLLT [ Time Frame: Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application. ]
    Infrared thermographic consisting of a thermal camera, a computer and a monitor will be used to detect temperature differences after LLLT treatment in leprosy patients. The device calibration is automatic, as recommended by the manufacturer, occurring constantly while connected. A precise thermometer (Minipa®, Brazil) will be used to monitor the room temperature, which will be maintained between 23 and 24 °C. To carry out the acquisition of the thermal images, recommendations of the Brazilian Association of Medical Thermology (ABRATERM) will be followed. The room relative humidity lower than 60% and cutaneous emissivity was set to 0.98. Camera positioned on a tripod 50 cm away from the patient. After we take images, some areas of hands and feet will be chosen on the same anatomical locations for all patientes. The mean ΔTs (temperature differences) for each area will be subsequently calculated (ThermaCAM Researcher Professional, version 2.10, FLIR Systems).

  5. Change from Screening of Activity Limitation and Safety Awareness Scale at 28 days after LLLT. [ Time Frame: Patients will be assessed one day before the first day of LLLT application and after 28 days of LLLT application. ]
    This scale will be used to evaluate of activity limitation and risk awareness. It includes assessment of the eyes, hands, feet (mobility) and self-care. SALSA scores range from 10 to 80, with 10-24 allocated to patients without significant limitations; 25-39 for mild limitations and 40-49; 50- 59 and 60-80 for moderate, severe and very severe limitations, respectively. The risk awareness score ranges from 0 to 11, with higher scores indicating greater awareness of the risks involved in daily life activities.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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).

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072004


Contacts
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Contact: Elaine F Sabino, master +553499817213499817212121 elainefavarosabino@gmail.com
Contact: Centro M Bernardes Goulart, doctorate +5534998172121 imbg34998172121oulart@gmail.com

Locations
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Brazil
National Reference Center for Sanitary Dermatology and Leprosy Recruiting
Uberlandia, Minas Gerais, Brazil, 38413018
Contact: Elaine F Sabino, master    +5534998172121    elainefavarosabino@gmail.com   
Contact: Isabela M Bernardes Goulart, doctorate    +5534991644408    imbgoulart@gmail.com   
Principal Investigator: Elaine F Sabino, master         
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
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Study Director: Isabela M Bernardes Goulart, doctorate Federal University of Uberlandia
Principal Investigator: Elaine F Sabino, master Federal University of Uberlandia
Publications:
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Responsible Party: Elaine Fávaro Pípi Sabino, Principal Investigator, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT03072004    
Other Study ID Numbers: 37474214.4.0000.5152
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This project doesn´t have a plan to make individual participant data available to other researchers. The datas are available only for our researcher group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elaine Fávaro Pípi Sabino, Federal University of Uberlandia:
Leprosy
Neuropathy
LLLT
Additional relevant MeSH terms:
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Leprosy
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections