Prospective randomised double-blind placebo-controlled trial to establish the effectiveness of glucosamine sulphate and chondroitin sulphate in the treatment of non-specific mechanical low back pain

ISRCTN ISRCTN25275611
DOI https://doi.org/10.1186/ISRCTN25275611
Secondary identifying numbers N0084089157
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
14/11/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr A Mohsen
Scientific

Orthopaedic Department
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Phone +44 (0)1482 328541

Study information

Study designProspective randomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesIs glucosamine sulphate/chondroitin sulphate a useful tool in the armamentarium of the low back pain specialist in treating low back pain regardless of various combinations of biopsychosocial factors being present?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Low back pain
InterventionGlucosamine sulphate and chondroitin sulphate vs placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Glucosamine sulphate and chondroitin sulphate
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/08/2000
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants200 patients, 100 in each arm of the study
Key inclusion criteriaAll eligible male and female patients with back pain would be invited to participate in the trial
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/08/2000
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Orthopaedic Department
Hull
HU3 2JZ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The North and South Bank Research and Development Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan