Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain - a Randomized, Double Blind, Placebo-Controlled Clinical Investigation With Parallel Groups for 3 Months to Enlighten Joint Health

Conditions
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Back Pain

Intervention / Treatment
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* Drug: Glucosamine sulphate
* Drug: Ginger
* Drug: Ginger-Avocado-Soya
* Drug: Ginger-ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glucosamine sulphate|nan|
|Drug: Ginger|nan|
|Drug: Ginger-Avocado-Soya|nan|
|Drug: Ginger-ibuprofen|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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back pain