Randomized Controlled Study to Assess the Efficacy of a Dietary Ingredient in Patients With Herni… (NCT00405041) | Clinical Trial Compass
CompletedPhase 2/3
Randomized Controlled Study to Assess the Efficacy of a Dietary Ingredient in Patients With Herniated Lumbar Disc Compression
Israel79 participantsStarted 2006-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 p…
What they're measuring
1
Measurements of herniated lumbar disc-related symptoms including sensorimotor neurological functions and pain sensations. And measurements of general quality of life based on the SF-36 questionnaire.
Timeframe: Within 14 days of treatment and follow-up at 30 and 60 days after treatment