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

NCT04276519 | Completed

• 1 other identifier: 01-2748
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Radiculopathy Lumbar; Disk Herniated Lumbar; Low Back Pain

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Experimental

EXPERIMENTAL

Physiotherapeutic non-invasive position-induced opening of the intervertebral foramen and pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol.

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

Control group

ACTIVE COMPARATOR

Pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol.

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

Interventions

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

Opening of the mechanical interface of the nerve root, neurodynamics

Control group; Experimental

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• General Hospital Sveti Duh: lead

Related Links

• Holy Spirit Clinical Hospital
• Clinical neurodynamics

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anita Marcinko Budincevic

  Clinic of Neurology, Sveti Duh Clinical Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants didn't know in which group they were allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science in Physiotherapy

Model Details: Experimental group and a control group. Prospective, randomised, clinical study.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 19, 2020
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share