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

Sponsor
Universidad Europea de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT02596815
Collaborator
(none)
51
Enrollment
2
Locations
2
Arms
3
Duration (Months)
25.5
Patients Per Site
8.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Median Nerve Neural Mobilization
  • Device: Goniometer
 N/A

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 Design

Study Type:
Interventional
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 :
Jul 1, 2015
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline using the Numeric Rating Scale for Pain at 1 hour [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 [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) [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández San Diego Carabobo Venezuela 02006
    2 Centro de Medicina Fisica y de Rehabilitacion FISIOREH Valencia Carabobo Venezuela 02001

    Sponsors and Collaborators

    • Universidad Europea de Madrid

    Investigators

    • Principal Investigator: Francisco H Unda, PT, MSc, Universidad Europea de Madrid

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Francisco Unda Solano, PHD Student, Universidad Europea de Madrid
    ClinicalTrials.gov Identifier:
    NCT02596815
    Other Study ID Numbers:
    • CE0072015-3
    First Posted:
    Nov 4, 2015
    Last Update Posted:
    Oct 4, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Neuralgia
    Brachial Plexus Neuritis

    Study Results

    No Results Posted as of Oct 4, 2019