Radiculitis Clinical Trial
Official title:
Effectiveness of Neural Mobilization Techniques Compared to Standard Care Treatment in Patients With Lumbar Radiculitis: A Randomized Clinical Trial
The purpose of this study is to determine the effectiveness of neural mobilization techniques compared to standard care treatment in patients with lumbar radiculitis.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2/Phase 3 | |
| Withdrawn |
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