Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation

Randomized Controlled Trial to Investigate the Feasibility of a New Protocol for Treatment of Acute Low Back Pain and Sciatica From Lumbar Radiculopathy and Intervertebral Disc Herniation: Non-invasive Position-Induced Opening of the Intervertebral Foramen

Efficiency of the conservative mechanical lumbosacral nerve root decompression, as an adjunct to pharmacological treatment, in the case of acute lumbosacral radiculopathy.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Disk Herniated Lumbar; Radiculopathy Lumbar
• Intervention / Treatment: Procedure: Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen

Detailed Description

Non-invasive Position-Induced Opening of the Intervertebral Foramen in sidelying position, as an adjunct to pharmacological treatment, was used in the case of acute lumbosacral radiculopathy.

20 examinees were split into two groups, 10 in the experimental and 10 in the control group. Experimental group was given positional opening of the intervert. foramen, together with pharmacological treatment - steroid antiinflammatory drug - dexamethasone, nonsteroid antiinflammatory drugs and pain killers while control group was given just the same pharmacological treatment and recommended rest.

Measured dependent variables were:

1. Visual analogue pain scale (VAS) for the low back and radiculopathy, separately
2. Straight leg raise in supine position - nerve mobility test
3. EuroQol questionnaire - general health condition questionnaire
4. Oswestry questionnaire - activities of daily living (ADL) specific questionnaire for low back pain and lumbosacral radiculopathies Inclusive criteria were: Age between 20 - 60, lumbar disc herniation recognized by the MRI, lumbosacral radiculopathy with symptoms such as radicular pain, sensation dysfunctions or motor dysfunctions, recognized by electromyography (EMG) diagnostics.

Exclusive criteria: age more than 60, degenerative lumbar stenosis, spondylolisthesis, vertebra fractures, tumours.

Conclusion: Physiotherapy with a positional, mechanical decompression of the compressed lumbosacral nerve root, as an adjunct to pharmacological treatment, is proved to be efficient with the lumbosacral radiculopathy. It is recommended to be applied since the first day of a patient admittance in the hospital if there is a position that can reduce the pain.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 20 - 60
2. Lumbar disc herniation proved by MRI
3. Lumbosacral radiculopathy with symptoms of radicular pain, sensation dysfunction, and motor dysfunction proved by EMG diagnostics.

Exclusion Criteria:

1. Age older than 60
2. Degenerative lumbar stenosis
3. Spondylolisthesis
4. Vertebrae fractures
5. Tumor metastasis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Physiotherapeutic non-invasive position-induced opening of the intervertebral foramen and pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol.	Procedure: Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen; Opening of the mechanical interface of the nerve root, neurodynamics
Active Comparator: Control group; Pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol.	Procedure: Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen; Opening of the mechanical interface of the nerve root, neurodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathy	Pain descriptor	Change from baseline pain subjectively reported value by Visual Analogic Scale compared to same values at discharge (mean value 8 days)
Straight leg raise	Nerve mobility test for lower lumbar nerve roots and n. ischiadicus	Change from baseline nerve mobility objectively reported value by straight leg raise compared to same values at discharge (mean value 8 days)
EuroQol questionnaire	General health condition questionnaire	Change from baseline general health condition subjectively reported value by EuroQol questionnaire compared to same values at discharge (mean value 8 days)
Oswestry questionnaire	ADLs specific questionnaire for LBP and lumbosacral radiculopathy	Change from baseline activity of daily living specific questionnaire for low back pain and lumbosacral radiculopathy subjectively reported value by Oswestry questionnaire compared to same values at discharge (mean value 8 days)

Collaborators and Investigators

• Sponsor: General Hospital Sveti Duh
• Investigators: Study Chair: Anita Marcinko Budincevic, Clinic of Neurology, Sveti Duh Clinical Hospital

Publications and helpful links

Helpful Links

• Holy Spirit Clinical Hospital
• Clinical neurodynamics

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement; Radiculopathy
• Other Study ID Numbers: 01-2748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No