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Hypoalgesic Effect of Neural Mobilization

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ClinicalTrials.gov Identifier: NCT02595294
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco Unda Solano, Universidad Europea de Madrid

Tracking Information
First Submitted Date  ICMJE October 26, 2015
First Posted Date  ICMJE November 3, 2015
Last Update Posted Date October 4, 2019
Study Start Date  ICMJE July 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
Change from baseline using the Numeric Rating Scale for Pain at 1 hour [ Time Frame: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1, 15 and 30 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
Change from baseline using the Numeric Rating Scale for Pain at 1 hour [ Time Frame: 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.
Change History Complete list of historical versions of study NCT02595294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
  • Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale [ Time Frame: at baseline, corresponding to intervention days 1 and 30 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.
  • Cervical Rotation Range of Motion (CROM) [ Time Frame: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1 and 30 ]
    Cervical rotation was assessed in units of rotation degrees, using the cervical range-of-motion device (CROM).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
  • Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale [ Time Frame: 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.
  • Cervical Rotation Range of Motion (CROM) [ Time Frame: 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypoalgesic Effect of Neural Mobilization
Official Title  ICMJE Hypoalgesic Effect of Neural Mobilization in Cervicobrachial Pain Compared to a Controlled Group
Brief Summary The purpose of these study is to compare the effectivity of the Cervical Lateral Glide physical therapy neural mobilization technique to the complete absence of treatment in a group of patients who suffer cervicobrachial pain.
Detailed Description

The Cervical Lateral Glide (CLG) is a neural tissue mobilization technique capable of achieving a hypoalgesic effect during the onset of cervicobrachial pain symptoms. This happens through a series of complex physiologic interactions which are not fully understood. The CLG Physical therapy technique consists of controlled movements of the cervical and brachial plexus neural tissue. Hypoalgesic effect produced by CLG is associated to an increase in neural tissue mobility, edema, inflammation and intraneural pressure reduction, without any known side effects when applied properly, except for a momentary worsening of symptoms (the only known side effect of CLG), which is an important contrast to the wide and sometimes severe spectrum of side effects derived from drug therapy used to treat cervicobrachial pain.

It is believed that the hypoalgesic effect offered by neural tissue mobilization is a consequence of descending nervous system pain modulation activity and an improvement in the distinct biomechanical properties of the involved neural tissue.Despite the increase in scientific interest in evidence based options to treat pain and neural tissue mobilization techniques there is a current lack of enough controlled double blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the CLG and its specific effect over cervicobrachial pain. For this reason the present investigation consisted in the application of a treatment protocol based on CLG neural tissue mobilization in a controlled double blind clinical trial with the aim to assess its clinical effectiveness in treating pain symptoms

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cervicobrachial Neuralgia
Intervention  ICMJE Procedure: Cervical Lateral Glide neural mobilization
Non-surgical non-invasive Cervical Lateral Glide 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 correct linear alignment of patient's cervical spine was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization.
Other Names:
  • Cervical Lateral Glide Neural Tissue Mobilization
  • Cervical Lateral Glide Neurodynamics
Study Arms  ICMJE
  • Experimental: Cervical Lateral Glide
    • 15 minutes Cervical Lateral Glide neural mobilization
    • 5 times a week
    • During 6 weeks
    • Patient's adequate cervical spine linear alignment was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization.
    Intervention: Procedure: Cervical Lateral Glide neural mobilization
  • No Intervention: Waiting list control group
    - Patients assigned to a 6 week waiting list to receive treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2015)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02595294
Other Study ID Numbers  ICMJE CE0072015-2
CE0072015 ( Other Identifier: Comite de Bioetica Centro Policlinico la Viña )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francisco Unda Solano, Universidad Europea de Madrid
Study Sponsor  ICMJE Universidad Europea de Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francisco H Unda, PT, MSc Universidad Europea de Madrid
PRS Account Universidad Europea de Madrid
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP