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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04276519
Enrollment
20
Registered
2020-02-19
Start date
2016-04-01
Completion date
2016-07-01
Last updated
2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disk Herniated Lumbar, Low Back Pain, Radiculopathy Lumbar

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.

Interventions

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

Opening of the mechanical interface of the nerve root, neurodynamics

Sponsors

General Hospital Sveti Duh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants didn't know in which group they were allocated.

Intervention model description

Experimental group and a control group. Prospective, randomised, clinical study.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathyChange from baseline pain subjectively reported value by Visual Analogic Scale compared to same values at discharge (mean value 8 days)Pain descriptor
Straight leg raiseChange 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 questionnaireChange 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 questionnaireChange 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026