Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2020
Source General Hospital Sveti Duh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen
Opening of the mechanical interface of the nerve root, neurodynamics

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
General Hospital Sveti Duh

Outcome

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)
See also
  Status Clinical Trial Phase
Completed NCT03916705 - Thoraco-Lumbar Fascia Mobility N/A
Completed NCT04007302 - Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03600207 - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain N/A
Completed NCT04284982 - Periodized Resistance Training for Persistent Non-specific Low Back Pain N/A
Recruiting NCT05600543 - Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain N/A
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Completed NCT03673436 - Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Completed NCT02546466 - Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain N/A
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05156242 - Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain. N/A
Recruiting NCT04673773 - MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain. N/A
Completed NCT06049277 - Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain N/A
Completed NCT06049251 - ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises N/A
Completed NCT04980469 - A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle N/A
Completed NCT04055545 - High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects N/A
Recruiting NCT05944354 - Wearable Spine Health System for Military Readiness
Recruiting NCT05552248 - Assessment of the Safety and Performance of a Lumbar Belt
Completed NCT05801588 - Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life N/A
Completed NCT05811143 - Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.