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
NCT number | NCT04276519 |
Other study ID # | 01-2748 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2016 |
Est. completion date | July 1, 2016 |
Verified date | February 2020 |
Source | General Hospital Sveti Duh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Efficiency of the conservative mechanical lumbosacral nerve root decompression, as an adjunct to pharmacological treatment, in the case of acute lumbosacral radiculopathy.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
General Hospital Sveti Duh |
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) |
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