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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02596815
Other study ID # CE0072015-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date October 2015

Study information

Verified date October 2019
Source Universidad Europea de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Device:
Goniometer


Locations

Country Name City State
Venezuela Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández San Diego Carabobo
Venezuela Centro de Medicina Fisica y de Rehabilitacion FISIOREH Valencia Carabobo

Sponsors (1)

Lead Sponsor Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Venezuela, 

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Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline using the Numeric Rating Scale for Pain at 1 hour 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 Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale 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
Secondary Cervical Rotation Range of Motion (CROM) 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 .
See also
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