Comparison of Neural Mobilization Techniques to Standard Care Treatment in Patients With Lumbar Radiculitis
Primary Purpose
Radiculitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neural Mobilization
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Radiculitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Neural Mobilization Group
Standard Care Group
Arm Description
Patients in this group will be treated with neural mobilization techniques.
Patients in this group will be treated with standard care (ultrasound, exercise, TENS, massage)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change
The questioner measures the level of patients' disability.
Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change
The questioner evaluates fear-avoidance beliefs of patients with low back pain in the clinical setting.
Handheld dynamometer - Measure assessing change
Changes in Muscle Strength assessed with the handheld dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02941133
Brief Title
Comparison of Neural Mobilization Techniques to Standard Care Treatment in Patients With Lumbar Radiculitis
Official Title
Effectiveness of Neural Mobilization Techniques Compared to Standard Care Treatment in Patients With Lumbar Radiculitis: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michalis Efstathiou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Background:
Radicular pain has been regarded as a distinct pain entity as its pathophysiology differs from that of somatic referred pain and nociceptive pain. Radicular lumbar pain describes sensitized nerve roots of the lumbar spine or peripheral nerve trunks that are capable of producing pain (usually below the knee) and/or other symptoms in the absence of true nerve tissue damage. This type of pain is evoked by ectopic discharges stemming from lumbar dorsal roots or their ganglions. The most common causes for this type of pain is the inflammatory environment that is produced by substances contained in the herniated material of injured lumbar intervertebral discs.
It has been suggested that patients presenting with functional (e.g. mechanosensitivity) but not structural nerve root problems, can be identified through screening and further classified as a discrete group of patients that benefit from specific neural mobilization techniques.
Neural mobilization techniques have gained considerable amount of attention amongst therapists and researchers for the assessment and treatment of painful conditions that occasionally involve a neural element in their pathophysiology such as lumbar radicular pain. Studies exploring the effect of neural mobilization techniques on patients with lumbar radicular pain have generally shown good results but they are lacking in adequate sample size and methodological quality.
The aim of this study is to compare the effectiveness of neural mobilization techniques to standard care physiotherapy treatment (ultrasound, general exercises, massage therapy, transcutaneous electrical nerve stimulation) in patients with lumbar radiculitis.
Participants:
Patients with low back pain that radiates to the lower limb.
Patients that satisfy the inclusion criteria will be screened and classified by another researcher into the distinct group of lumbar radiculitis. Another researcher will take baseline measurements and all patients of this sub-group will be randomly assigned to receive either neural mobilization or standard care physiotherapy treatment. Both groups will receive a total of 10 treatments twice per week for 5 weeks. Patients will be assessed using specific outcome measures prior to treatment (baseline), at 5 weeks (post treatment) and 6 months after treatment.
Statistical analysis:
Data will be analysed with the Statistical Package for the Social Sciences (SPSS), version 22. Intension to treat analysis will be applied. A two-way mixed-model analysis of variance will be used for outcome measures, with treatment groups (neural mobilization or standard care treatment) as the between-subject variable and time (baseline, 1 month follow up, six months follow up) as the within-subject variable. Comparison of baseline demographic characteristics will be analysed using the t-tests for continuous variables and the chi square tests for categorical variables.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neural Mobilization Group
Arm Type
Experimental
Arm Description
Patients in this group will be treated with neural mobilization techniques.
Arm Title
Standard Care Group
Arm Type
Experimental
Arm Description
Patients in this group will be treated with standard care (ultrasound, exercise, TENS, massage)
Intervention Type
Other
Intervention Name(s)
Neural Mobilization
Intervention Description
Neural mobilization techniques aimed at the lumbar root that is affected
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Ultrasound - Transcutaneous electrical nerve stimulation (TENS) - Massage therapy - Strengthening exercises
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) - Measure assessing change
Description
The VAS is a 100-point pain assessment scale ranging from 0 (no pain) to 100 (worst pain possible).
Time Frame
Change from baseline after 5 weeks and at 6 months
Secondary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change
Description
The questioner measures the level of patients' disability.
Time Frame
Change from baseline after 5 weeks and at 6 months
Title
Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change
Description
The questioner evaluates fear-avoidance beliefs of patients with low back pain in the clinical setting.
Time Frame
Change from baseline after 5 weeks and at 6 months
Title
Handheld dynamometer - Measure assessing change
Description
Changes in Muscle Strength assessed with the handheld dynamometer
Time Frame
Change from baseline after 5 weeks and at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michalis Efstathiou, MSc
Phone
+35799931840
Email
efstathiou.m@unic.ac.cy
First Name & Middle Initial & Last Name or Official Title & Degree
Manos Stefanakis, PhD
Phone
+35796418779
Email
stefanakis.m@unic.ac.cy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michalis Efstathiou, MSc
Organizational Affiliation
University of Nicosia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21116662
Citation
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.
Results Reference
result
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Comparison of Neural Mobilization Techniques to Standard Care Treatment in Patients With Lumbar Radiculitis
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