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

NCT ID: NCT02941133

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2020-03-31

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.

Conditions

Radiculitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Neural Mobilization Group

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

Group Type: EXPERIMENTAL

Neural Mobilization

Intervention Type: OTHER

Neural mobilization techniques aimed at the lumbar root that is affected

Standard Care Group

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

Group Type: EXPERIMENTAL

Standard Care

Intervention Type: OTHER

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

Interventions

Neural Mobilization

Neural mobilization techniques aimed at the lumbar root that is affected

Intervention Type: OTHER

Standard Care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michalis Efstathiou

OTHER

Sponsor Role: lead

Responsible Party

Michalis Efstathiou

Assosiate Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michalis Efstathiou, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Nicosia

Central Contacts

Michalis Efstathiou, MSc

Role: CONTACT

efstathiou.m@unic.ac.cy

+35799931840

Manos Stefanakis, PhD

Role: CONTACT

stefanakis.m@unic.ac.cy

+35796418779

References

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.

Reference Type: RESULT

PMID: 21116662 (View on PubMed)

Other Identifiers

MISS13

Identifier Type: -

Identifier Source: org_study_id