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

NCT00317655 | Completed Phase 4

• 2 other identifiers: Jointcare/Fe/1/DKEudractnr. 2005-002691-15
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Keywords

back pain

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

• 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

Interventions

Glucosamine sulphate DRUG

Ginger DRUG

Ginger-Avocado-Soya DRUG

Ginger-ibuprofen DRUG

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• "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

Sponsors & Collaborators

• Ferrosan AS: lead

Study Sites (1)

Slidgigtinstituttet A/S

Ishøj, 2635, Denmark

Location

MeSH Terms

Conditions

Back Pain

Interventions

Glucosamine; ginger extract

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Keld Østergaard, MD, PhD

  Slidgigtinstituttet A/S

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2006
• First Posted: April 25, 2006
• Study Start: April 1, 2006
• Study Completion: April 1, 2007
• Last Updated: May 17, 2007

Record last verified: 2007-05

Locations

DK (1)