Clinical trial NCT02941133: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Radiculitis
Lead sponsor: University of Nicosia
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale (VAS) - Measure assessing change
timeFrame: Change from baseline after 5 weeks and at 6 months
Secondary outcomes:
measure: Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change
timeFrame: Change from baseline after 5 weeks and at 6 months
measure: Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change
timeFrame: Change from baseline after 5 weeks and at 6 months
measure: Handheld dynamometer - Measure assessing change
timeFrame: Change from baseline after 5 weeks and at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Nicosia
name: Michalis Efstathiou, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.