Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain
Phase 4
Completed
- Conditions
- Back Pain
- Registration Number
- NCT00317655
- Lead Sponsor
- Ferrosan AS
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks
- Secondary Outcome Measures
Name Time Method Percentage of responders showing more than 15 mm improvement in pain relief 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) Patients' satisfaction with pain medication Use of rescue medication Adverse events profile Body weight (start and 12 weeks)
Trial Locations
- Locations (1)
Slidgigtinstituttet A/S
🇩🇰Ishoj, Denmark