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Translational Study of the Effects of Neural Mobilization in Patients With Lomboisquiatalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671409
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
marucia chacur, University of Sao Paulo

Brief Summary:
The spinal nerve injury in humans often results in neuropathic pain characterized by spontaneous burning pain accompanied by allodynia and hyperalgesia. In this sense, lomboisquiatalgia is a neuropathy that is characterized by narrowing the intervertebral foramen of the lumbar vertebrae, leading a lumbar chronic pain which irradiate to a lower limb, being a clinical condition of difficult treatment. Neural Mobilization is a noninvasive technique used by physiotherapists. The technique aims to restore mobility and elasticity of the peripheral nervous system by tenses which are imposed on the roots, nerves, spinal cord and their respective meninges. This technique has been standardized in basic research and has shown promising results. However, clinically, this technique lacks randomized, controlled and double blind studies. Therefore, the investigators have to evaluate the effects of Neural Mobilization technique in patients with lomboisquiatalgia. In this study the investigators will treat patients three times a week, with ten minute treatment time per session, with 25 oscillations per minute for ten sessions. Many tools will be used to assess the effects of the protocol applied, for example: evaluation sheet, visual analogue scale (VAS), quality of life assessment - WHOQOL-bref questionnaire of Roland Morris disability, oswestry index on disability (version 2.0), enzyme-linked immunosorbent assays for the measurement of cytokines in the blood tissue. In this way, the investigators can contribute and understand the mechanisms involved in the rehabilitation process.

Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Pain Neuropathic Pain Other: Neural Mobilization (exercise) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Translational Study of the Effects of Neural Mobilization in Patients With Lomboisquiatalgia
Study Start Date : October 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : December 2019

Arm Intervention/treatment
Placebo Comparator: Control group
The exercise program will be drawn from the recommendations of the American College of Physicians and the American Pain Society for the treatment of low back pain. The exercise protocol consist of: Strengthening the abdominal muscles and erector spinae: will be three sets of 15 repetitions for each exercise with rest time between 2 minutes series; - Proprioceptive Neuromuscular Facilitation (PNF). The PNF technique will be the contract-relax the hamstrings by 6/2. Stretching the erector muscles of the spine, iliopsos, hamstrings, quadriceps and sural triceps: will be three three repetitions, with 30 seconds support time each stretch and rest time between sets 1 minute.
Other: Neural Mobilization (exercise)
Initially patients will be informed about the procedures. After the guidelines, the hip and knee are palpated to start the joint angles. Then, the knee joint is positioned in extension and remained so throughout the treatment. In addition, the hip joint is bent until the moment that will be perceived a minimum strength of the muscles of the posterior region of thigh and leg (discarding muscle stretching). Neural mobilization is started at the time when the ankle joint will be manipulated in dorsiflexion at a frequency of approximately 20 oscillations per minute, with a pause of 25 seconds of rest. In the last two minutes of therapy, we will include cervical flexion, in order to intend the neuraxis, keeping artuculares amplitudes.

Experimental: MOB Group
Initially patients will be informed about the procedures. After the guidelines, the hip and knee are palpated to start the joint angles. Then, the knee joint is positioned in extension and remained so throughout the treatment. In addition, the hip joint is bent until the moment that will be perceived a minimum strength of the muscles of the posterior region of thigh and leg (discarding muscle stretching). Neural mobilization is started at the time when the ankle joint will be manipulated in dorsiflexion at a frequency of approximately 20 oscillations per minute, with a pause of 25 seconds of rest. In the last two minutes of therapy, we will include cervical flexion, in order to intend the neuraxis, keeping artuculares amplitudes.
Other: Neural Mobilization (exercise)
Initially patients will be informed about the procedures. After the guidelines, the hip and knee are palpated to start the joint angles. Then, the knee joint is positioned in extension and remained so throughout the treatment. In addition, the hip joint is bent until the moment that will be perceived a minimum strength of the muscles of the posterior region of thigh and leg (discarding muscle stretching). Neural mobilization is started at the time when the ankle joint will be manipulated in dorsiflexion at a frequency of approximately 20 oscillations per minute, with a pause of 25 seconds of rest. In the last two minutes of therapy, we will include cervical flexion, in order to intend the neuraxis, keeping artuculares amplitudes.




Primary Outcome Measures :
  1. Pain: Visual Analog Scale [ Time Frame: 1 month ]
    VAS - Visual Analog Scale


Secondary Outcome Measures :
  1. Quality of life: Questionnaire WHOQOL-bref [ Time Frame: 1 month ]
    Questionnaire WHOQOL-bref


Other Outcome Measures:
  1. Disability functional: Questionnaire Roland Morris - RMDQ [ Time Frame: 1 month ]
    Questionnaire Roland Morris - RMDQ

  2. Assess dysfunction in individuals with low back pain by analyzing the activities of daily living: Oswestry Low Back Pain Disability Questionnaire [ Time Frame: 1 month ]
    Oswestry Low Back Pain Disability Questionnaire (ODQ)

  3. Cytokine assay: immunohistochemistry - Milliplex®TM Map [ Time Frame: 1 month ]
    Immunohistochemistry - Milliplex®TM Map (Millipore Corporation, Darmstadt- Germany)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Selected will be subject to meeting the following criteria: chronic low back pain radiating to the leg for more than three months from the narrowing of the intervertebral foramen of the lumbar vertebrae (lomboisquiatalgia), ie for more than 12 weeks; age ≥ 20 years; score ≥ 4 on analog pain scale (VAS); DN4 ≥ 4 on scale; both genders; positive for the following special tests: Slump-Test, the straight leg raising test, Lasègue Test, Rise Of Opposite Leg and Sign of Arc or Bowstring-Sign rope; score ≥ 4 on the Roland Morris Disability Questionnaire (RMDQ); ≥ moderate dysfunction in Oswestry Low Back Pain Disability Questionnaire.

Exclusion Criteria: Will be excluded from study subjects with the presence aged over 35 years, acute lumbar pain; recent history of violent trauma; spondylolisthesis or fibromyalgia; previous surgery column, any sequel that causes limitation in the lower limb range of motion (joint deformity), subjects suffering precaution for Neural Mobilization or cortical stimulation transmagnética as pacemaker, metal plates, screws, neurological disorders; systemic disease, immunosuppression, cancer patients, psychological disorders, cognitive disorders and failure, any kind of pain in other regions is not characteristic of lomboisquiatalgia and lack of cooperation or cognitive capacity to perform clinical procedures and pregnant women. The subjects will be kept blind to the treatment allocation. Researchers involved in the application of techniques will be kept blind throughout the development and analysis of the study.


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): NCT02671409


Locations
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Brazil
University of Sao Paulo
Sao Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: FABIO MARTINEZ DOS SANTOS, PHD University of Sao Paulo
Principal Investigator: MARINA RAMOS, PT University of Sao Paulo
Study Chair: MARUCIA CHACUR, PHD University of Sao Paulo
  Study Documents (Full-Text)

Documents provided by marucia chacur, University of Sao Paulo:
Study Protocol: New protocol  [PDF] March 10, 2019

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Responsible Party: marucia chacur, PHD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02671409    
Other Study ID Numbers: 2 44079115.1.1001.5511
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: semi-annual report
Additional relevant MeSH terms:
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Neuralgia
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases