Hypoalgesic Effect of Neural Mobilization Versus Ibuprofen Pharmacologic Treatment
NCT ID: NCT02593721
Last Updated: 2017-01-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-07-31
Study Completion Date
2015-09-30
Brief Summary
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The purpose of this study is to compare the effectivity of Median Nerve Neural Mobilization and oral Ibuprofen in treating patients who suffer cervicobrachial pain
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Detailed Description
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Median Nerve Neural Mobilization and Ibuprofen both relieve cervicobrachial pain, but this happens through different mechanisms and with a different onset of side effects. Median Nerve Neural Mobilization is a physical therapy technique that achieves pain relief through mechanical stimulation of the median nerve and the brachial plexus. The proper mechanical stimulation of the nerve and its surrounding neural tissue induces a wide variety of physiologic responses that may reduce cervicobrachial pain including the activation of descending nervous system pain modulation mechanisms, all though the entire set of underlying reasons for this pain reduction is not completely understood. Among the effects caused by the Neural Tissue Mobilization that produce pain relief are: intraneural edema reduction, changes on the intraneural nerve pressure,dispersion of pro-inflammatory substances and an increase in nerve mobility
Ibuprofen is a nonsteroidal anti-inflammatory drug used worldwide to control pain, fever and inflammation.Oral intake of Ibuprofen produces a hypoalgesic effect due to biochemical inhibition of the COX enzymes, which convert arachidonic acid to prostaglandin H2 (PGH2). PGH2, which in turn, is converted by other enzymes to several types of prostaglandins and thromboxanes (which are mediators of pain and inflammation).
Side effects derived from the oral intake of Ibuprofen are related to its systemic action and can be severe in some patients. This fact suggests that oral Ibuprofen may not be suitable to use in all types of patients suffering from cervicobrachial pain, meanwhile the Median Nerve Neural Mobilization has little to no side effects known. This reveals a point of interest in determining comparative effectiveness between this two therapeutic options in the treatment of cervicobrachial pain.
Ibuprofen is a nonsteroidal anti-inflammatory drug used worldwide to control pain, fever and inflammation.Oral intake of Ibuprofen produces a hypoalgesic effect due to biochemical inhibition of the COX enzymes, which convert arachidonic acid to prostaglandin H2 (PGH2). PGH2, which in turn, is converted by other enzymes to several types of prostaglandins and thromboxanes (which are mediators of pain and inflammation).
Side effects derived from the oral intake of Ibuprofen are related to its systemic action and can be severe in some patients. This fact suggests that oral Ibuprofen may not be suitable to use in all types of patients suffering from cervicobrachial pain, meanwhile the Median Nerve Neural Mobilization has little to no side effects known. This reveals a point of interest in determining comparative effectiveness between this two therapeutic options in the treatment of cervicobrachial pain.
Conditions
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Cervicobrachial Neuralgia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Median Nerve Neural Mobilization
15 minute Median Nerve Neural Mobilization sessions 5 times a week (monday to Friday) during 6 continuous weeks The maximum degree of elbow extension applied in the Median Nerve neural mobilization procedure was determined through the use of a Universal Goniometer Device.
Group Type
EXPERIMENTAL
Median Nerve Neural Mobilization
Intervention Type
PROCEDURE
Non-surgical non-invasive Median Nerve neural mobilization procedure was applied by a physical therapist continuously during 2 minutes in 5 different occasions with 1 minute of rest between each 2 minute application of the Neural Mobilization technique. The intervention was applied during a period of 6 weeks. The maximum level of elbow extension movement degree without the reproduction of symptoms during the application of the Median Nerve Neural mobilization treatment was determined through the baseline use of a Universal Goniometer Device.
Ibuprofen
A single daily 400 mg dose of oral Ibuprofen that can be increased depending on patient tolerance to a maximum dose of 1200 mg/day equally divided in 3 oral intakes of the drug every 8 hours during 6 continuous weeks.
Group Type
ACTIVE_COMPARATOR
Ibuprofen
Intervention Type
DRUG
The active comparator group received an oral Ibuprofen treatment. The starting dose was of 400 mg/day and it was increased to a maximum of 1200 mg/day divided in 3 oral intakes every 8 hours depending on patient tolerance.The intervention was applied during a period of 6 weeks.
Interventions
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Median Nerve Neural Mobilization
Non-surgical non-invasive Median Nerve neural mobilization procedure was applied by a physical therapist continuously during 2 minutes in 5 different occasions with 1 minute of rest between each 2 minute application of the Neural Mobilization technique. The intervention was applied during a period of 6 weeks. The maximum level of elbow extension movement degree without the reproduction of symptoms during the application of the Median Nerve Neural mobilization treatment was determined through the baseline use of a Universal Goniometer Device.
Intervention Type
PROCEDURE
Ibuprofen
The active comparator group received an oral Ibuprofen treatment. The starting dose was of 400 mg/day and it was increased to a maximum of 1200 mg/day divided in 3 oral intakes every 8 hours depending on patient tolerance.The intervention was applied during a period of 6 weeks.
Intervention Type
DRUG
Other Intervention Names
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Neural Tissue Mobilization of the Median Nerve
Median Nerve Neurodynamics
Addaprin®
Advil®
Caldolor®
Cedaprin®
I-Prin®
Midol®
Motrin®
Motrin® IB
NeoProfen®
Profen IB®
Proprinal®
Ultraprin®
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of cervicobrachial pain confirmed by magnetic resonance imaging
* Presence of unilateral symptoms of arm pain, paresthesia or numbness in the upper extremity during at least 3 continuous months previous to the application of treatment.
* Positive results in all of the following tests: Spurling, Distraction, and Upper Limb
* Presence of unilateral symptoms of arm pain, paresthesia or numbness in the upper extremity during at least 3 continuous months previous to the application of treatment.
* Positive results in all of the following tests: Spurling, Distraction, and Upper Limb
Exclusion Criteria
* Contraindication in the use of nonsteroidal anti inflammatory drugs (NSAIDs)
* The use of any type of treatment, therapy, procedure or drug to relieve pain
* Patients who are under anticonvulsant, antidepressant or psychotropic medication
* Vertebral instability
* Vertebral osteoporosis
* Vertebral or spine infection.
* Neurologic diseases of genetic, infectious or neoplastic origin
* Cervical stenosis myelopathy
* Pregnancy
* Kinesiophobia
* Endocrine disorders and menopause
* History of spine surgery
* Intellectual disability, severe mental illness, intoxication, severe sleep deprivation, Alzheimer's disease.
* The use of any type of treatment, therapy, procedure or drug to relieve pain
* Patients who are under anticonvulsant, antidepressant or psychotropic medication
* Vertebral instability
* Vertebral osteoporosis
* Vertebral or spine infection.
* Neurologic diseases of genetic, infectious or neoplastic origin
* Cervical stenosis myelopathy
* Pregnancy
* Kinesiophobia
* Endocrine disorders and menopause
* History of spine surgery
* Intellectual disability, severe mental illness, intoxication, severe sleep deprivation, Alzheimer's disease.
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Universidad Europea de Madrid
OTHER
Sponsor Role
lead
Responsible Party
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Francisco Unda Solano
PHD Student
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Francisco H Unda, PT, MSc
Role: PRINCIPAL_INVESTIGATOR
Universidad Europea de Madrid
Locations
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Centro de Medicina Fisica y de Rehabilitacion FISIOREH
Valencia, Carabobo, Venezuela
Site Status
Countries
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Venezuela
References
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Related Links
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http://dash.iwh.on.ca/about-dash
DASH Outcome Measure Institute for Work \& Health
Other Identifiers
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CE0072015
Identifier Type: -
Identifier Source: org_study_id
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