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Hypoalgesic Effect of Neural Mobilization

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ClinicalTrials.gov Identifier: NCT02595294
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco Unda Solano, Universidad Europea de Madrid

Study Description
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Brief Summary:
The purpose of these study is to compare the effectivity of the Cervical Lateral Glide physical therapy 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: Cervical Lateral Glide neural mobilization Not Applicable

Detailed Description:

The Cervical Lateral Glide (CLG) is a neural tissue mobilization technique capable of achieving a hypoalgesic effect during the onset of cervicobrachial pain symptoms. This happens through a series of complex physiologic interactions which are not fully understood. The CLG Physical therapy technique consists of controlled movements of the cervical and brachial plexus neural tissue. Hypoalgesic effect produced by CLG is associated to an increase in neural tissue mobility, edema, inflammation and intraneural pressure reduction, without any known side effects when applied properly, except for a momentary worsening of symptoms (the only known side effect of CLG), which is an important contrast to the wide and sometimes severe spectrum of side effects derived from drug therapy used to treat cervicobrachial pain.

It is believed that the hypoalgesic effect offered by neural tissue mobilization is a consequence of descending nervous system pain modulation activity and an improvement in the distinct biomechanical properties of the involved neural tissue.Despite the increase in scientific interest in evidence based options to treat pain and neural tissue mobilization techniques there is a current lack of enough controlled double blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the CLG and its specific effect over cervicobrachial pain. For this reason the present investigation consisted in the application of a treatment protocol based on CLG neural tissue mobilization in a controlled double blind clinical trial with the aim to assess its clinical effectiveness in treating pain symptoms

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Hypoalgesic Effect of 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


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cervical Lateral Glide
  • 15 minutes Cervical Lateral Glide neural mobilization
  • 5 times a week
  • During 6 weeks
  • Patient's adequate cervical spine linear alignment was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization.
 Procedure: Cervical Lateral Glide neural mobilization
Non-surgical non-invasive Cervical Lateral Glide 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 correct linear alignment of patient's cervical spine was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization.
Other Names:
  • Cervical Lateral Glide Neural Tissue Mobilization
  • Cervical Lateral Glide Neurodynamics
No Intervention: Waiting list control group
- Patients assigned to a 6 week waiting list to receive treatment


Outcome Measures
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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, 15 and 30 ]
    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 30 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 30 ]
    Cervical rotation was assessed in units of rotation degrees, using the cervical range-of-motion device (CROM).


Eligibility Criteria
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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.
Contacts and Locations
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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): NCT02595294


Locations
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Venezuela
"Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández "
San Diego, Carabobo, Venezuela, 02006
Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
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Principal Investigator: Francisco H Unda, PT, MSc Universidad Europea de Madrid
More Information
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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.
Salommon L W. Aply´s concise system of orthopedics and fractures. 3rd ed. Taylor Francis Group; 2005. 105-106 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: NCT02595294    
Other Study ID Numbers: CE0072015-2
CE0072015 ( Other Identifier: Comite de Bioetica Centro Policlinico la Viña )
First Posted: November 3, 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
Brachial Plexus Neuropathies
Neuritis