Pain Clinical Trial
Official title:
Translational Study of the Effects of Neural Mobilization in Patients With Lomboisquiatalgia
Verified date | March 2020 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 35 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | University of Sao Paulo | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Disability functional: Questionnaire Roland Morris - RMDQ | Questionnaire Roland Morris - RMDQ | 1 month | |
Other | Assess dysfunction in individuals with low back pain by analyzing the activities of daily living: Oswestry Low Back Pain Disability Questionnaire | Oswestry Low Back Pain Disability Questionnaire (ODQ) | 1 month | |
Other | Cytokine assay: immunohistochemistry - Milliplex®TM Map | Immunohistochemistry - Milliplex®TM Map (Millipore Corporation, Darmstadt- Germany) | 1 month | |
Primary | Pain: Visual Analog Scale | VAS - Visual Analog Scale | 1 month | |
Secondary | Quality of life: Questionnaire WHOQOL-bref | Questionnaire WHOQOL-bref | 1 month |
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