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

NCT02671409 | Completed DMC

• 1 other identifier: 2 44079115.1.1001.5511
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Mechanical; Pain; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Pain: Visual Analog Scale

  VAS - Visual Analog Scale

  1 month

Secondary Outcomes (1)

• Quality of life: Questionnaire WHOQOL-bref

  1 month

Other Outcomes (3)

• Disability functional: Questionnaire Roland Morris - RMDQ

  1 month

• Assess dysfunction in individuals with low back pain by analyzing the activities of daily living: Oswestry Low Back Pain Disability Questionnaire

  1 month

• Cytokine assay: immunohistochemistry - Milliplex®TM Map

  1 month

Study Arms (2)

Control group

PLACEBO COMPARATOR

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)

MOB Group

EXPERIMENTAL

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)

Interventions

Neural Mobilization (exercise) OTHER

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.

Control group; MOB Group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Low Back Pain; Pain; Neuralgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• FABIO MARTINEZ DOS SANTOS, PHD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• MARINA RAMOS, PT

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• MARUCIA CHACUR, PHD

  University of Sao Paulo

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 2, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)