Back Pain
Conditions
Keywords
back pain
Brief summary
The main purpose of this study is to investigate the ability of some dietary supplement products to affect general joint health and life quality in a selected population with back pain. The study is randomized and double - blind, with parallel groups receiving treatment for a duration of 12 weeks.
Interventions
Sponsors
Ferrosan AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Chronic back pain daily or almost daily for at least 3 months prior to inclusion * Patient classified as I or II according to Quebec Task Force * No intake of glucosamine sulphate, ginger, or avocado-soya extract during last 3 months * Fertile women should, at start, have a negative pregnancy test and during test use acceptable prevention methods (p-pills, intrauterine device \[IUD\], depot gestagen, subdermal implant, hormonal vaginal ring or transdermal depot plaster). * Anxiolytics, muscle relaxants, physiotherapy, chiropractic treatment, or training should not have been used during last 3 months.
Exclusion criteria
* Serious disease (eg. heart disease, cancer (within past 5 years), kidney disease, blood diseases, inflammatory diseases (eg. chronic rheumatoid arthritis, fibromyalgia) * Suspicion that back pain is caused by osteoporosis, other arthritic condition than osteoarthritis, cancer, infection, pain from organ disease or psychosomatic cancer disease. * Uncontrolled elevated blood pressure, defined as systolic ≥ 160 mm Hg or diastolic ≥ 90 mm Hg. * VAS measurement at inclusion less than ved 30 mm or over 90 mm. * Prehistory of ulcer, stomach surgery, or inflammatory bowel disease * Pain relief medication besides must not be taken during study. * Patients in need of non-steroidal anti-inflammatory drugs (NSAIDs), morphine, or similar medication are not eligible. Same is also valid for patients in need of injections or acupuncture. * Back surgery within 6 months before inclusion or earlier surgery without effect * Heart aspirin (low dose), ulcer medication, or blood thinning medication * Alcohol abuse * Depression * Pregnancy or breastfeeding * Allergy to crustaceans or known intolerance for glucosamine sulphate, ginger, avocado, soy, or ibuprofen * Allergy or asthma released by salicylic acid or other arthritis medication (NSAIDs) * Patient who is seeking pension due to back pain or has other economical interests connected to his/her back pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| mm pain relief (VAS) within past 7 days at weeks 1, 2, 4, 6, 9, and 12 | — |
| Function level according to Roland Morris-questionnaire (23 points) | — |
| Patients' Global Impression of Change (pain) | — |
| Percentage of responders showing more than 15 mm improvement in pain relief | — |
| Use of rescue medication | — |
| Adverse events profile | — |
| Body weight (start and 12 weeks) | — |
| Patients' satisfaction with pain medication | — |
Countries
Denmark
Outcome results
None listed