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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276519
• Other study ID #: 01-2748
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: July 1, 2016

Study information

• Verified date: February 2020
• Source: General Hospital Sveti Duh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Disk Herniated Lumbar
• Low Back Pain
• Radiculopathy
• Radiculopathy Lumbar

Intervention

Procedure:
• Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen
Opening of the mechanical interface of the nerve root, neurodynamics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Sveti Duh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

•   Clinical neurodynamics
•   Holy Spirit Clinical Hospital