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

This study has been completed.
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00404079
First received: November 23, 2006
Last updated: April 4, 2011
Last verified: February 2011
Results First Received: February 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Drug: Glucosamine sulphate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Trial participation required no wash out, run-in or transtion phase. Patients were excluded if they fulfilled any of the exclusion criteria.

Reporting Groups
  Description
Glucosamine Sulphate The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
Placebo Placebo was taken daily and orally in capsule forms for 6 months

Participant Flow:   Overall Study
    Glucosamine Sulphate     Placebo  
STARTED     125     125  
COMPLETED     103     105  
NOT COMPLETED     22     20  
Lost to follow up, adverse event etc                 22                 20  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Glucosamine Sulphate The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
Placebo Placebo was taken daily and orally in capsule forms for 6 months
Total Total of all reporting groups

Baseline Measures
    Glucosamine Sulphate     Placebo     Total  
Number of Participants  
[units: participants]
  125     125     250  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     113     115     228  
>=65 years     12     10     22  
Gender  
[units: participants]
     
Female     54     67     121  
Male     71     58     129  
Region of Enrollment  
[units: participants]
     
Norway     125     125     250  



  Outcome Measures

1.  Primary:   Roland Morris Disability Questionnaire   [ Time Frame: 1 year ]

2.  Secondary:   Visual Analogue Scale   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   EuroQol-5D   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: philip.wilkens@medisin.uio.no


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Dr. Oliver Grundnes, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00404079     History of Changes
Other Study ID Numbers: 28130805
Study First Received: November 23, 2006
Results First Received: February 21, 2011
Last Updated: April 4, 2011
Health Authority: Norway: Norwegian Medicines Agency