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

Ferrosan AS175 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

175

Conditions

Back Pain

Interventions

Glucosamine sulphateDRUG

GingerDRUG

Ginger-Avocado-SoyaDRUG

Ginger-ibuprofenDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Slidgigtinstituttet A/S

Ishøj, Denmark

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.