Hypoalgesic Effect of Neural Mobilization Versus Ibuprofen Pharmacologic Treatment

January 1, 2017 updated by: Francisco Unda Solano, Universidad Europea de Madrid

Hypoalgesic Effect of Median Nerve Neural Mobilization Versus Ibuprofen Pharmacologic Treatment in Patients With Cervicobrachial Pain

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Venezuela
    • Carabobo
      • Valencia, Carabobo, Venezuela, 02001
        • Centro de Medicina Fisica y de Rehabilitacion FISIOREH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Procedure: 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.
Other Names:
  • Neural Tissue Mobilization of the Median Nerve
  • Median Nerve Neurodynamics
ACTIVE_COMPARATOR: 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.
Drug: 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.
Other Names:
  • Addaprin®
  • Advil®
  • Caldolor®
  • Cedaprin®
  • I-Prin®
  • Midol®
  • Motrin®
  • Motrin® IB
  • NeoProfen®
  • Profen IB®
  • Proprinal®
  • Ultraprin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline using the Numeric Rating Scale for Pain at 1 hour
Time Frame: at baseline and 1 hour after the application of treatment, corresponding to intervention sessions 1, 15 and 30
The Numeric Rating Scale (NRS) is an 11 point scale for patient self-reporting of pain, it was employed to evaluate the presence and relieve of cervicobrachial pain symptoms
at baseline and 1 hour after the application of treatment, corresponding to intervention sessions 1, 15 and 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale
Time Frame: at baseline, corresponding to intervention session 1 and 30 of treatment.
The Disabilities of the Arm, Shoulder and Hand ( QuickDASH) Test is a self-report short questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.
at baseline, corresponding to intervention session 1 and 30 of treatment.
Change from baseline cervical rotation range of motion at 1 hour
Time Frame: at baseline and 1 hour after the application of treatment, corresponding to intervention sessions 1 and 30
Cervical rotation was assessed in units of rotation degrees, using the cervical range-of-motion device (CROM).
at baseline and 1 hour after the application of treatment, corresponding to intervention sessions 1 and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (ESTIMATE)

November 1, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 1, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE0072015 (Comite de Bioetica Centro Policlinico la Viña)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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