Comparison of Neural Mobilization Techniques to Standard Care Treatment in Patients With Lumbar Radiculitis

NCT02941133 | Unknown

• 1 other identifier: MISS13
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the effectiveness of neural mobilization techniques compared to standard care treatment in patients with lumbar radiculitis.

Conditions

Radiculitis

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) - Measure assessing change

  The VAS is a 100-point pain assessment scale ranging from 0 (no pain) to 100 (worst pain possible).

  Change from baseline after 5 weeks and at 6 months

Secondary Outcomes (3)

• Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change

  Change from baseline after 5 weeks and at 6 months

• Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change

  Change from baseline after 5 weeks and at 6 months

• Handheld dynamometer - Measure assessing change

  Change from baseline after 5 weeks and at 6 months

Study Arms (2)

Neural Mobilization Group

EXPERIMENTAL

Patients in this group will be treated with neural mobilization techniques.

Other: Neural Mobilization

Standard Care Group

EXPERIMENTAL

Patients in this group will be treated with standard care (ultrasound, exercise, TENS, massage)

Other: Standard Care

Interventions

Neural Mobilization OTHER

Neural mobilization techniques aimed at the lumbar root that is affected

Neural Mobilization Group

Standard Care OTHER

Ultrasound - Transcutaneous electrical nerve stimulation (TENS) - Massage therapy - Strengthening exercises

Standard Care Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with low back pain and pain that radiates in the lower limb
• Duration of symptoms \> 6 weeks
• Patients willing to be reassessed after 6 months
• Patients willing to give written informed consent

You may not qualify if:

• History of spinal surgery
• History of surgery or injury in the lower limbs in the past 6 months
• Signs and symptoms of central nervous system involvement
• Nerve root blocks for the past 6 weeks
• History of diabetes
• History of polyneuropathies
• History of vascular pathologies in the lower limbs
• History of systemic pathologies
• History of inflammatory arthropathies

Sponsors & Collaborators

• Michalis Efstathiou: lead

Related Publications (1)

• Schafer A, Hall T, Muller G, Briffa K. Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study. Eur Spine J. 2011 Mar;20(3):482-90. doi: 10.1007/s00586-010-1632-2. Epub 2010 Dec 1.

  PMID: 21116662 RESULT

MeSH Terms

Conditions

Radiculopathy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michalis Efstathiou, MSc

  University of Nicosia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michalis Efstathiou, MSc

CONTACT

+35799931840; efstathiou.m@unic.ac.cy

Manos Stefanakis, PhD

CONTACT

+35796418779; stefanakis.m@unic.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assosiate Lecturer

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: September 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 5, 2017

Record last verified: 2017-05