Low Back Pain
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTARTRA
ARTRA (glucosamine and chondroitin sulfate)
Sponsors
Unipharm, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 40-65 years, inclusively. 2. Pain intensity according to Visual Analogue Scale (VAS) \> 3 points. 3. Duration of back pain \> 12 weeks. 4. Pain reinforcement during movement in lumbar spine. 5. Osteoarthritis, spondylarthrosis, osteochondrosis. 6. Given written Informed consent form for participation in the study. 7. Treatment with ARTRA
Exclusion criteria
1. History of allergic reactions to chondroprotectors. 2. Participation in another clinical study within 30 days before screening or during this study. 3. Fibromyalgia. 4. Active neoplastic disease, history of neoplastic disease within 3 years before screening. 5. Paget's disease. 6. Degenerative spondylolisthesis. 7. Administration of anticonvulsant, antidepressant, barbiturate, anxiolytic, or muscle relaxant drugs for more than one week prior screening. 8. History of alcohol or drug abuse. 9. Frequent episodes of nausea, dyspepsia, pain in the epigastric region, diarrhea, face and extremities edema, dizziness and headache. 10. 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 11. Clinically significant renal disorders. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 3 months | Pain intensity on Visual Analogue Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | 3 months | — |
| Patient global assessment of efficacy | 3 months | — |
| NSAID consumption | 3 months | Number of patients taking NSAIDs |
Countries
Russia
Outcome results
None listed