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Completed

NCT Number: NCT00317655

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

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.

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Key information

Conditions

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

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Slidgigtinstituttet A/S

Ishøj, 2635, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucosamine sulphate

Drug

Ginger

Drug

Ginger-Avocado-Soya

Drug

Ginger-ibuprofen

Drug

Primary outcomes

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

Secondary outcomes

  1. Percentage of responders showing more than 15 mm improvement in pain relief

  2. mm pain relief (VAS) within past 7 days at weeks 1, 2, 4, 6, 9, and 12

  3. Function level according to Roland Morris-questionnaire (23 points)

  4. Patients' Global Impression of Change (pain)

  5. Patients' satisfaction with pain medication

  6. Use of rescue medication

  7. Adverse events profile

  8. Body weight (start and 12 weeks)

Sponsors and collaborators

Lead sponsor

Ferrosan AS

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Apr 25, 2006
Registry last updated
May 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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