Hypoalgesic Effect of Neural Mobilization Versus Ibuprofen Pharmacologic Treatment

NCT02593721 | Completed Phase 2 DMC

• 1 other identifier: CE0072015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Cervicobrachial Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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.

• 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

Study Arms (2)

Median Nerve Neural Mobilization

EXPERIMENTAL

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.

Procedure: Median Nerve Neural Mobilization

Ibuprofen

ACTIVE COMPARATOR

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.

Drug: Ibuprofen

Interventions

Median Nerve Neural Mobilization PROCEDURE

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.

Also known as: Neural Tissue Mobilization of the Median Nerve, Median Nerve Neurodynamics

Median Nerve Neural Mobilization

Ibuprofen DRUG

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.

Also known as: Addaprin®, Advil®, Caldolor®, Cedaprin®, I-Prin®, Midol®, Motrin®, Motrin® IB, NeoProfen®, Profen IB®, Proprinal®, Ultraprin®

Ibuprofen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Centro de Medicina Fisica y de Rehabilitacion FISIOREH

Valencia, Carabobo, 02001, Venezuela

Location

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Related Links

• DASH Outcome Measure Institute for Work \& Health

MeSH Terms

Conditions

Brachial Plexus Neuritis

Interventions

Ibuprofen; Midol

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuritis

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Francisco H Unda, PT, MSc

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD Student

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 2, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 4, 2017

Record last verified: 2017-01

Locations

VE (1)