Hypoalgesic Effect of Neural Mobilization Versus Ibuprofen Pharmacologic Treatment

Cervicobrachial Neuralgia Clinical Trial

Official title:

Hypoalgesic Effect of Median Nerve Neural Mobilization Versus Ibuprofen Pharmacologic Treatment in Patients With Cervicobrachial Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593721
• Other study ID #: CE0072015
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 26, 2015
• Last updated: January 1, 2017
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2017
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela : Ministerio del Poder Popular para la Salud
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectivity of Median Nerve Neural Mobilization and oral Ibuprofen in treating patients who suffer cervicobrachial pain

Description:

Median Nerve Neural Mobilization and Ibuprofen both relieve cervicobrachial pain, but this happens through different mechanisms and with a different onset of side effects. Median Nerve Neural Mobilization is a physical therapy technique that achieves pain relief through mechanical stimulation of the median nerve and the brachial plexus. The proper mechanical stimulation of the nerve and its surrounding neural tissue induces a wide variety of physiologic responses that may reduce cervicobrachial pain including the activation of descending nervous system pain modulation mechanisms, all though the entire set of underlying reasons for this pain reduction is not completely understood. Among the effects caused by the Neural Tissue Mobilization that produce pain relief are: intraneural edema reduction, changes on the intraneural nerve pressure,dispersion of pro-inflammatory substances and an increase in nerve mobility

Ibuprofen is a nonsteroidal anti-inflammatory drug used worldwide to control pain, fever and inflammation.Oral intake of Ibuprofen produces a hypoalgesic effect due to biochemical inhibition of the COX enzymes, which convert arachidonic acid to prostaglandin H2 (PGH2). PGH2, which in turn, is converted by other enzymes to several types of prostaglandins and thromboxanes (which are mediators of pain and inflammation).

Side effects derived from the oral intake of Ibuprofen are related to its systemic action and can be severe in some patients. This fact suggests that oral Ibuprofen may not be suitable to use in all types of patients suffering from cervicobrachial pain, meanwhile the Median Nerve Neural Mobilization has little to no side effects known. This reveals a point of interest in determining comparative effectiveness between this two therapeutic options in the treatment of cervicobrachial pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervicobrachial Neuralgia
• Neuralgia

Intervention

Procedure:
• Median Nerve Neural Mobilization
Non-surgical non-invasive 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.

Drug:
• Ibuprofen
The active comparator group received an oral Ibuprofen treatment. The starting dose was of 400 mg/day and it was increased to a maximum of 1200 mg/day divided in 3 oral intakes every 8 hours depending on patient tolerance.The intervention was applied during a period of 6 weeks.

Locations

Country	Name	City	State
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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* Note: There are 104 references in all — Click here to view all references

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 (NRS) is an 11 point scale for patient self-reporting of pain, it was employed to evaluate the presence and relieve of cervicobrachial pain symptoms	at baseline and 1 hour after the application of treatment, corresponding to intervention sessions 1, 15 and 30	No
Secondary	Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale	The Disabilities of the Arm, Shoulder and Hand ( QuickDASH) Test is a self-report short questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.	at baseline, corresponding to intervention session 1 and 30 of treatment.	No
Secondary	Change from baseline cervical rotation range of motion at 1 hour	Cervical rotation was assessed in units of rotation degrees, using the cervical range-of-motion device (CROM).	at baseline and 1 hour after the application of treatment, corresponding to intervention sessions 1 and 30	No

External Links

•   DASH Outcome Measure Institute for Work & Health