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The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00404079
Recruitment Status : Completed
First Posted : November 27, 2006
Results First Posted : April 29, 2011
Last Update Posted : April 29, 2011
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by:
Oslo University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Drug: Glucosamine sulphate
Drug: Placebo
Enrollment 250
Recruitment Details The trial was conducted at Oslo University Hospital Outpatient Clinic. Recruitment occurred between December 2006 and July 2008 in Oslo Norway, mostly via referrals by general practitioners, physiotherapists, and chiropractors.
Pre-assignment Details Trial participation required no wash out, run-in or transtion phase. Patients were excluded if they fulfilled any of the exclusion criteria.
Arm/Group Title Glucosamine Sulphate Placebo
Hide Arm/Group Description The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months Placebo was taken daily and orally in capsule forms for 6 months
Period Title: Overall Study
Started 125 125
Completed 103 105
Not Completed 22 20
Reason Not Completed
Lost to follow up, adverse event etc             22             20
Arm/Group Title Glucosamine Sulphate Placebo Total
Hide Arm/Group Description The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months Placebo was taken daily and orally in capsule forms for 6 months Total of all reporting groups
Overall Number of Baseline Participants 125 125 250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 125 participants 250 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
113
  90.4%
115
  92.0%
228
  91.2%
>=65 years
12
   9.6%
10
   8.0%
22
   8.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 125 participants 250 participants
Female
54
  43.2%
67
  53.6%
121
  48.4%
Male
71
  56.8%
58
  46.4%
129
  51.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 125 participants 125 participants 250 participants
125 125 250
1.Primary Outcome
Title Roland Morris Disability Questionnaire
Hide Description The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis followed the intention to treat principle. Imputation was performed with mulitple imputation.
Arm/Group Title Placebo Glucosamine Sulphate
Hide Arm/Group Description:
Oral intake of placebo capsules
Glucosamine sulphate was taken daily and orally in capsule forms for 6 months
Overall Number of Participants Analyzed 125 125
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-24)
9  (4) 9  (4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments Null hypothesis was glucosamine sulfate is not superior to placebo to reduce pain and disability associated with chronic low back pain. Power calculation was based on a 3 point difference between the groups with the primary outcome. Data was analysed with linear mixed models
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.5
Parameter Dispersion
Type: Standard Deviation
Value: 4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Visual Analogue Scale
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title EuroQol-5D
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame Reports of adverse events were collected during the intervention period of 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glucosamine Sulphate Placebo
Hide Arm/Group Description The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months Placebo was taken daily and orally in capsule forms for 6 months
All-Cause Mortality
Glucosamine Sulphate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Glucosamine Sulphate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/125 (0.00%)   0/125 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glucosamine Sulphate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/125 (0.00%)   0/125 (0.00%) 
Free participation and the focus on glucosamine may attract a certain type of patients with specific personality traits. Adjunctive management was permitted, which may influence outcome. Compliance was assessed by capsule counts.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Project Manager: Philip Wilkens
Organization: Oslo University Hospital Ullevaal
Phone: 004723016140
Responsible Party: Dr. Oliver Grundnes, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00404079     History of Changes
Other Study ID Numbers: 28130805
First Submitted: November 23, 2006
First Posted: November 27, 2006
Results First Submitted: February 21, 2011
Results First Posted: April 29, 2011
Last Update Posted: April 29, 2011