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

NCT ID: NCT04276519

Last Updated: 2020-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2016-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Radiculopathy Lumbar Disk Herniated Lumbar Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental group and a control group. Prospective, randomised, clinical study.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Opening of the mechanical interface of the nerve root, neurodynamics

Control group

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Opening of the mechanical interface of the nerve root, neurodynamics

Interventions

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

Opening of the mechanical interface of the nerve root, neurodynamics

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital Sveti Duh

OTHER

Sponsor Role lead

Responsible Party

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Sinisa Poznic

Master of Science in Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anita Marcinko Budincevic

Role: STUDY_CHAIR

Clinic of Neurology, Sveti Duh Clinical Hospital

Related Links

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http://www.kbsd.hr/

Holy Spirit Clinical Hospital

Other Identifiers

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01-2748

Identifier Type: -

Identifier Source: org_study_id

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