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Completed

NCT Number: NCT04276519

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

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

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Key information

Conditions

Radiculopathy Lumbar Back Pain Disk Herniated Lumbar Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • Visual analogue pain scale (VAS) for the low back and radiculopathy, separately
  • Straight leg raise in supine position - nerve mobility test
  • EuroQol questionnaire - general health condition questionnaire
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age older than 60
  • Degenerative lumbar stenosis
  • Spondylolisthesis
  • Vertebrae fractures
  • Tumor metastasis

Treatment and study plan

Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen

Procedure

Opening of the mechanical interface of the nerve root, neurodynamics

Primary outcomes

  1. Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathy

    Time frame: Change from baseline pain subjectively reported value by Visual Analogic Scale compared to same values at discharge (mean value 8 days)

    Pain descriptor

  2. Straight leg raise

    Time frame: 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

  3. EuroQol questionnaire

    Time frame: 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

  4. Oswestry questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

General Hospital Sveti Duh

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 19, 2020
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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