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Hypoalgesic Effect of Median Nerve Neural Mobilization Compared to a Controlled Group

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ClinicalTrials.gov Identifier: NCT02596815
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco Unda Solano, Universidad Europea de Madrid

Brief Summary:
The purpose of these study is to compare the effectivity of the Median Nerve Neural Mobilization technique to the complete absence of treatment in a group of patients who suffer cervicobrachial pain.

Condition or disease Intervention/treatment Phase
Cervicobrachial Neuralgia Procedure: Median Nerve Neural Mobilization Device: Goniometer Not Applicable

Detailed Description:

Median Nerve Neural Mobilization (MNNM) is a non invasive physical therapy technique that achieves pain relief through mechanical stimulation of the Median Nerve and the brachial plexus. It is believed that the hypoalgesic effect offered by the neural tissue mobilization procedure is a consequence of descending nervous system pain modulation activity and an improvement in the distinct biomechanical and sensitive properties of the involved neural tissue. The neural tissue mobilization procedure is associated to an increase in nerve mobility, edema, inflammation and intraneural pressure reduction without any known side effects when applied properly which is an important contrast to the wide variety of side effects caused by commonly used drug therapy to treat cervicobrachial pain.

Despite the crescent interest among the scientific community in evidence based options to treat pain there is a current lack of enough controlled double blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the (MNNM) and its specific effect over cervicobrachial pain. For this reason the present investigation consisted in the application of a treatment protocol based on Median Nerve Neural Mobilization in a controlled double blind clinical trial with the aim to assess its clinical effectiveness in treating pain symptoms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypoalgesic Effect of Median Nerve Neural Mobilization in Cervicobrachial Pain Compared to a Controlled Group
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Median Nerve Neural Mobilization
15 minute Median Nerve Neural Mobilization sessions 3 times a week 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
Nonsurgical noninvasive 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

Device: Goniometer
Active Comparator: Waiting list control group
Patients assigned to a 6 week waiting list to receive treatment
Procedure: Median Nerve Neural Mobilization
Nonsurgical noninvasive 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

Device: Goniometer



Primary Outcome Measures :
  1. Change from baseline using the Numeric Rating Scale for Pain at 1 hour [ Time Frame: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1, 9 and 18. ]
    the Numeric Rating scale for Pain (NRS) is an 11 point scale for patient self reporting of pain in which 0 points represents the total absence of pain and 10 points the worst state of pain, it was employed to evaluate the presence and relieve of cervicobrachial pain symptoms.


Secondary Outcome Measures :
  1. Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale [ Time Frame: at baseline, corresponding to intervention days 1 and 18 of treatment ]
    The disabilities of the arm quick test (Quick DASH) is a self report short questionnaire designed to measure physical function and symptoms in people with any or several musculoskeletal disorders of the upper limb.

  2. Cervical Rotation Range of Motion (CROM) [ Time Frame: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1 and 18 . ]
    Cervical rotation was assessed in units of rotation degrees, using the cervical range of motion device (CROM).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596815


Locations
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Venezuela
Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández
San Diego, Carabobo, Venezuela, 02006
Centro de Medicina Fisica y de Rehabilitacion FISIOREH
Valencia, Carabobo, Venezuela, 02001
Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
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Principal Investigator: Francisco H Unda, PT, MSc Universidad Europea de Madrid
Additional Information:
Publications of Results:
Walton Walter WJ. Brain´s Diseases Of The Nervous System. London: Oxford UP; 1969
Elvey R HT. Neural tissue evaluation and treatment, Donatelli R, Physical Therapy of the Shoulder,. 3rd ed. Livingstone C, editor. New York; 1997
Cueco T. La columna cervical ; Sindromes clínicos y su tratamiento manipulativo. Panamericano E, editor. 2008. 40-41 p.
Hsu E, Argof C, Galluzi K DA. Problem based pain management. Press CU, editor. 2013. 57 p.
Carson VB. Mental health nursing: the nurse-patient journey W.B. Saunders. 2000: p. 423
Sella G. Practical Guide to Chronic Pain Syndromes Compression Neuropathies Chap 8. Press C, editor. 2009. 85-98 p.
Borenstein D. Low Back and Neck Pain. Low Back and Neck Pain [Internet]. 2004. p. 771-849. Available from: http://www.sciencedirect.com/science/ article/pii/B9780721692777500283
Pfizer Inc. Neurontin ® ( gabapentin ) Capsules Neurontin ® ( gabapentin ) Tablets Neurontin ® ( gabapentin ) Oral Solution. Neurontin Packag Inser. 2009;(LAB-01069.1):1-29.
Aronson JK. Side Effects of Drugs Annual: A World Wide Yearly Survey of New Data in Adverse Drug Reactions. Newnes. 2014. p.1056-137
X. Casado-Zumeta. Efectividad de la fisioterapia manual en el dolor cervicobraquial neuropático: una revisión sistematica. Fisioterapia. 2015;37(4).
Hinkelmann K. Designe and análisis of experiments, Volume I, Introduction to experiment designe. 2, editor. Wiley; 2008
Bailey A R Designe of comparative experiments. Cambridge University Press; 2008.

Other Publications:
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Responsible Party: Francisco Unda Solano, PHD Student, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT02596815    
Other Study ID Numbers: CE0072015-3
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Neuralgia
Brachial Plexus Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Brachial Plexus Neuropathies
Neuritis