Status:
COMPLETED
Randomized Controlled Study to Assess the Efficacy of a Dietary Ingredient in Patients With Herniated Lumbar Disc Compression
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Assaf-Harofeh Medical Center
Conditions:
Herniated Disc
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of the study is to evaluate the efficacy of a neuroprotective dietary supplement in patients suffering from herniated lumbar disc causing nerve root compression.
Detailed Description
Herniated lumbar discs exert pressure on nerves in the spine leading to pain, numbness, tingling and weakness of the leg, sometimes termed "sciatica". This syndrome affects about 1-2% of the populatio...
Eligibility Criteria
Inclusion
- Men and women with diagnosis of herniated lumbar disc with nerve root compression, up to 3 months from beginning of symptoms.
- Participants' age: 18 - 75 years.
- Participants diagnosed by: i) computerized tomography CT or magnetic resonance imaging (MRI) when necessary; ii) neurological sensorimotor functional examination; iii) standard motor power scale; iv) pain sensation scales including the multidimensional tools: the Visual Analogue Scale of Pain Intensity for back and leg pain, the McGill Pain Questionnaire, and the Oswestry Disability Index; and v) Quality of life assessment based on the SF-36 questionnaire.
- Women must be non-pregnant, non-lactating, or sterilized, or postmenopausal.
- Participants must give a signed informed consent.
Exclusion
- Participants with any significant clinical, medical or surgical condition, such as: cardiovascular (including those with hypertension and treated with antihypertensive agents), pulmonary, hepatic, renal, immune, endocrine, metabolic, digestive, malignancy, or allergic.
- Participants with low back pain emanating from causes other than herniated lumbar disc.
- Participants with any neuromuscular diseases.
- Participants with any musculoskeletal diseases.
- Participants with any neurological diseases.
- Participants with any history of alcohol or substance abuse within the last 2 years.
- Participants with gastric ulcer history.
- Participants who took any experimental drug within 90 days prior to screening.
- Women who are pregnant or breast feeding.
- Participants participating in other clinical trials.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00405041
Start Date
November 1 2006
End Date
April 1 2008
Last Update
April 10 2008
Active Locations (1)
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1
Tel Aviv Souraski Medical Center
Tel Aviv, Israel, 64239