Clinical trial NCT04276519: Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy Lumbar
Disk Herniated Lumbar
Low Back Pain
Lead sponsor: General Hospital Sveti Duh
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group and a control group. Prospective, randomised, clinical study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathy
timeFrame: Change from baseline pain subjectively reported value by Visual Analogic Scale compared to same values at discharge (mean value 8 days)
measure: Straight leg raise
timeFrame: Change from baseline nerve mobility objectively reported value by straight leg raise compared to same values at discharge (mean value 8 days)
measure: EuroQol questionnaire
timeFrame: Change from baseline general health condition subjectively reported value by EuroQol questionnaire compared to same values at discharge (mean value 8 days)
measure: Oswestry questionnaire
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinic of Neurology, Sveti Duh Clinical Hospital
name: Anita Marcinko Budincevic
role: STUDY_CHAIR
References: