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Hypoalgesic Effect of Neural Mobilization Versus Ibuprofen Pharmacologic Treatment

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ClinicalTrials.gov Identifier: NCT02593721
Recruitment Status : Completed
First Posted : November 1, 2015
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Francisco Unda Solano, Universidad Europea de Madrid

Tracking Information
First Submitted Date  ICMJE October 26, 2015
First Posted Date  ICMJE November 1, 2015
Last Update Posted Date January 4, 2017
Study Start Date  ICMJE July 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
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, 9 and 18 ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2017)
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
  • 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 18 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.
  • 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, 9 and 18 ]
    Cervical rotation was assessed in units of rotation degrees, using the cervical range-of-motion device (CROM).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypoalgesic Effect of Neural Mobilization Versus Ibuprofen Pharmacologic Treatment
Official Title  ICMJE Hypoalgesic Effect of Median Nerve Neural Mobilization Versus Ibuprofen Pharmacologic Treatment in Patients With Cervicobrachial Pain
Brief Summary 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervicobrachial Neuralgia
Intervention  ICMJE
  • 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
  • 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®
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Median Nerve Neural Mobilization
  • 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.
    Intervention: Drug: Ibuprofen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2015)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02593721
Other Study ID Numbers  ICMJE CE0072015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francisco Unda Solano, Universidad Europea de Madrid
Study Sponsor  ICMJE Universidad Europea de Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francisco H Unda, PT, MSc Universidad Europea de Madrid
PRS Account Universidad Europea de Madrid
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP