EuroPainClinics® Study V (Prospective Observational Study)

Study Overview
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Brief Summary
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In this prospective observational trial the effect of the Endoscopic discectomy microinvasive therapy should be examined in (approximately 500) adult patients with low back pain.

Official Title
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EuroPainClinics® Study V (Prospective Observational Study)

Conditions
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Back Pain, Intervertebral Disc Herniation

Intervention / Treatment
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* Procedure: Endoscopic disectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lumbar disc prolapse with unilateral radiculopathy, on clinical evaluation, positive straight leg raise or femoral stretch test, and identification of a single nerve root lesion on MRI Exclusion Criteria: The exlusion criteria: bilateral root symptoms, double root involvement, cauda equina syndrome and negative MRI Picture for disc herniation, unsigned infomed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transforaminal endoscopic discectomy<br> | Procedure: Endoscopic disectomy<br>* Endoscopic discectomy is an established method for treatment of lumbar disc herniation. Edoscopic discectomy provides a safe and minimal access corridor for lumbar discectomy. The technique also allows early postoperative mobilization and faster return to work.<br>|
| Active Comparator: interlaminar endoscopic discectomy<br> | Procedure: Endoscopic disectomy<br>* Endoscopic discectomy is an established method for treatment of lumbar disc herniation. Edoscopic discectomy provides a safe and minimal access corridor for lumbar discectomy. The technique also allows early postoperative mobilization and faster return to work.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol | All acquired information will be noted in to the special anonymous protocol | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2.Pain localization as assessed by note of radiating dermatome as neurologic examination | All acquired information will be noted in to the special anonymous protocol | 3 years | 
| 3.Pain progress as assessed by global pain scale | All acquired information will be noted in to the special anonymous protocol | 3 years | 
| 4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids | All acquired information will be noted in to the special anonymous protoco | 3 years |