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
|Condition or disease||Intervention/treatment||Phase|
|Leprosy Neuropathy||Device: LLLT Device: Sham LLLT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|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)|
|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|
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).
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.
- 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.
- 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.
- 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.
- 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
- 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).
- 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.
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
|Contact: Elaine F Sabino, firstname.lastname@example.org|
|Contact: Centro M Bernardes Goulart, email@example.com|
|National Reference Center for Sanitary Dermatology and Leprosy||Recruiting|
|Uberlandia, Minas Gerais, Brazil, 38413018|
|Contact: Elaine F Sabino, master +5534998172121 firstname.lastname@example.org|
|Contact: Isabela M Bernardes Goulart, doctorate +5534991644408 email@example.com|
|Principal Investigator: Elaine F Sabino, master|
|Study Director:||Isabela M Bernardes Goulart, doctorate||Federal University of Uberlandia|
|Principal Investigator:||Elaine F Sabino, master||Federal University of Uberlandia|