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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of Low Level Laser Therapy Effects in Peripheral Nerves Patient Affected With Leprosy : Randomized Controlled Trial

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

Detailed Summary:

Leprosy is an infectious disease caused by Mycobacterium leprae, which is an obligate intracellular bacillus with the capacity to invade cells of the peripheral nervous system (Nations et al., 1998). This disease presents polymorphic clinical features, and the destruction of peripheral nerves is relevant, resulting in irreversible disabilities with great social and psychological impact (Martins et al., 2008).

Among the 250,000 new cases of leprosy detected worldwide every year, 12% to 55% demonstrate diagnosis of sensory, motor or autonomic neuropathy (Saunderson et al., 2000). The destruction of nerve fibers in patients with leprosy can be established by the presence of inflammatory process and the development of autoimmunity and cytotoxicity (Birdi et al., 1996), including nerve growth factor (Facer et al., 1998), glia cells' adhesion molecules, interferon-gamma,Transforming Growth Factor - Beta (Goulart et al., 1996; Goulart et al., 2000), Tumor Necroses Factor-alpha (Singh, 1998) and interleukins (IL-6, IL-8, IL-12 and IL-10) (Mendonça et al., 2008).

Low Level Laser Therapy (LLLT) has been demonstrated as a promising treatment in neural rehabilitation. Some studies, has demonstrated that LLLT presented positive results in improving nerve conduction velocity. The literature has provided evidences for the effectiveness of LLLT treatment in neural rehabilitation, and it may be a promising tool for leprosy neuropathies rehabilitation.

LLLT provided improvements in clinical and electrophysiological parameters in humans with ulnar neuropathy and this modality showed a satisfying short-term effectiveness in the treatment of this pathology (Ozkan et al., 2014). Other studies have shown that the LLLT application in diabetic polyneuropathy presented positive results in impro
Sponsor: Federal University of Uberlandia

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Federal University of Uberlandia

Dates:
Date Received: February 14, 2017
Date Started: January 27, 2017
Date Completion: March 1, 2019
Last Updated: March 1, 2017
Last Verified: March 2017