Hypoalgesic Effect of Neural Mobilization Versus Ibuprofen Pharmacologic Treatment

Phase 2

Completed

• Conditions: Cervicobrachial Neuralgia
• Interventions: Procedure: Median Nerve Neural Mobilization; Drug: Ibuprofen

• Registration Number: NCT02593721
• Lead Sponsor: Universidad Europea de Madrid

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-01
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Median Nerve Neural Mobilization	Median Nerve Neural Mobilization	15 minute Median Nerve Neural Mobilization sessions 5 times a week (monday to Friday) 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.
Ibuprofen	Ibuprofen	A single daily 400 mg dose of oral Ibuprofen that can be increased depending on patient tolerance to a maximum dose of 1200 mg/day equally divided in 3 oral intakes of the drug every 8 hours during 6 continuous weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline using the Numeric Rating Scale for Pain at 1 hour	at baseline and 1 hour after the application of treatment, corresponding to intervention sessions 1, 15 and 30	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale	at baseline, corresponding to intervention session 1 and 30 of treatment.	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.
Change from baseline cervical rotation range of motion at 1 hour	at baseline and 1 hour after the application of treatment, corresponding to intervention sessions 1 and 30	Cervical rotation was assessed in units of rotation degrees, using the cervical range-of-motion device (CROM).

Trial Locations

Locations (1)

Centro de Medicina Fisica y de Rehabilitacion FISIOREH; 🇻🇪 Valencia, Carabobo, Venezuela