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

Primary Purpose

Back Pain

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Glucosamine sulphate
Ginger
Ginger-Avocado-Soya
Ginger-ibuprofen
Sponsored by
Ferrosan AS
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring back pain

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Slidgigtinstituttet A/S

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
April 23, 2006
Last Updated
May 16, 2007
Sponsor
Ferrosan AS
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1. Study Identification

Unique Protocol Identification Number
NCT00317655
Brief Title
Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ferrosan AS

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Glucosamine sulphate
Intervention Type
Drug
Intervention Name(s)
Ginger
Intervention Type
Drug
Intervention Name(s)
Ginger-Avocado-Soya
Intervention Type
Drug
Intervention Name(s)
Ginger-ibuprofen
Primary Outcome Measure Information:
Title
mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of responders showing more than 15 mm improvement in pain relief
Title
mm pain relief (VAS) within past 7 days at weeks 1, 2, 4, 6, 9, and 12
Title
Function level according to Roland Morris-questionnaire (23 points)
Title
Patients' Global Impression of Change (pain)
Title
Patients' satisfaction with pain medication
Title
Use of rescue medication
Title
Adverse events profile
Title
Body weight (start and 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keld Østergaard, MD, PhD
Organizational Affiliation
Slidgigtinstituttet A/S
Official's Role
Principal Investigator
Facility Information:
Facility Name
Slidgigtinstituttet A/S
City
Ishoj
ZIP/Postal Code
2635
Country
Denmark

12. IPD Sharing Statement

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

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