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

October 2, 2019 updated by: Francisco Unda Solano, Universidad Europea de Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

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
      • San Diego, Carabobo, Venezuela, 02006
        • Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández
      • 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

14 years to 41 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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

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 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.
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.

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 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.
at baseline, corresponding to intervention days 1 and 18 of treatment
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).
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 .

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)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE0072015-3

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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