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

Not Applicable

Completed

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

• Registration Number: NCT04276519
• Lead Sponsor: General Hospital Sveti Duh

Brief Summary

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

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 Timeline

• Study Start: 2016-04-01
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-17
• Last Update Submitted: 2020-02-17
• Study First Posted: 2020-02-19
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen	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.
Control group	Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen	Pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol.

Primary Outcome Measures

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