Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Chronic Low Back Pain

Study Overview
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Brief Summary
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To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment of non-specific low-back pain of lumbosacral localization in ambulatory care.

Detailed Description
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We enrolled patients between 40 and 65 years of age who had low back pain for at least 12 weeks with a pain intensity >3 on a 0-10 point visual analogue scale (VAS). Major exclusion criteria were presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or drug abuse. All patients were treated with ARTRA (combination of glucosamine hydrochloride 500 mg and chondroitin sulfate 500 mg in tab; Unipharm Inc.) at a dose of 1 tab bid for the first month and then 1 tab daily for the next two months. The primary endpoint was pain intensity (at rest and movement) as measured on a 0-10 point VAS. Secondary endpoints included Oswestry Disability Index, patient global assessment of efficacy (0-5 scale) and NSAID consumption.

Official Title
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Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Non-specific Chronic Low Back Pain of Lumbosacral Localization in Ambulatory Care

Conditions
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Low Back Pain

Intervention / Treatment
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* Dietary Supplement: ARTRA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 40-65 years, inclusively. Pain intensity according to Visual Analogue Scale (VAS) > 3 points. Duration of back pain > 12 weeks. Pain reinforcement during movement in lumbar spine. Osteoarthritis, spondylarthrosis, osteochondrosis. Given written Informed consent form for participation in the study. Treatment with ARTRA Exclusion Criteria: History of allergic reactions to chondroprotectors. Participation in another clinical study within 30 days before screening or during this study. Fibromyalgia. Active neoplastic disease, history of neoplastic disease within 3 years before screening. Paget's disease. Degenerative spondylolisthesis. Administration of anticonvulsant, antidepressant, barbiturate, anxiolytic, or muscle relaxant drugs for more than one week prior screening. History of alcohol or drug abuse. Frequent episodes of nausea, dyspepsia, pain in the epigastric region, diarrhea, face and extremities edema, dizziness and headache. History of any disease that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject during participation in the study Clinically significant renal disorders. -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ARTRA<br>Patients with low back pain treated with ARTRA. | Dietary Supplement: ARTRA<br>* ARTRA (glucosamine and chondroitin sulfate)<br>* Other names: Chondroitin sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain intensity on Visual Analogue Scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index |  | 3 months | 
| Patient global assessment of efficacy |  | 3 months | 
| NSAID consumption | Number of patients taking NSAIDs | 3 months |