Trial Outcomes & Findings for The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain (NCT NCT00404079)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

250 participants

Primary outcome timeframe

1 year

Results posted on

2011-04-29

Participant Flow

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.

Trial participation required no wash out, run-in or transtion phase. Patients were excluded if they fulfilled any of the exclusion criteria.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	125	125
Overall Study COMPLETED	103	105
Overall Study NOT COMPLETED	22	20

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to follow up, adverse event etc	22	20

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glucosamine Sulphate n=125 Participants The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months	Placebo n=125 Participants Placebo was taken daily and orally in capsule forms for 6 months	Total n=250 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=5 Participants	115 Participants n=7 Participants	228 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	67 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	58 Participants n=7 Participants	129 Participants n=5 Participants
Region of Enrollment Norway	125 participants n=5 Participants	125 participants n=7 Participants	250 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The number of participants for analysis followed the intention to treat principle. Imputation was performed with mulitple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=125 Participants Oral intake of placebo capsules	Glucosamine Sulphate n=125 Participants Glucosamine sulphate was taken daily and orally in capsule forms for 6 months
Roland Morris Disability Questionnaire	9 units on a scale (0-24) Standard Deviation 4	9 units on a scale (0-24) Standard Deviation 4

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

Adverse Events

Glucosamine Sulphate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Project Manager: Philip Wilkens

Oslo University Hospital Ullevaal

Phone: 004723016140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place