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

Condition(s) targeted: Back Pain

Intervention: Glucosamine sulphate (Drug); Ginger (Drug); Ginger-Avocado-Soya (Drug); Ginger-ibuprofen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ferrosan AS

Official(s) and/or principal investigator(s):
Keld Østergaard, MD, PhD, Principal Investigator, Affiliation: Slidgigtinstituttet A/S

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: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks

Secondary outcome:

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)

Minimum age: 30 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Slidgigtinstituttet A/S, Ishoj 2635, Denmark

Starting date: April 2006
Ending date: April 2007
Last updated: May 16, 2007