Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stiftelsen Helse og Rehabilitering | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability. Some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar spine is most likely to OA processes in knees and hips, hence GS could have comparable symptomatic and structural effect on lumbar OA.
Study hypothesis: No difference in treatment effect exists between oral intake of GS- or placebo-capsules for patients' with chronic low back pain measured with Roland Morris Disability Questionnaire.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucosamine Sulphate | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosamine sulphate | Drug | Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Roland Morris Disability Questionnaire | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | 1 year | |
| EuroQol-5D | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Oliver Grundnes, MD | Ullevaal University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulleval Universtiy Hospital | Oslo | Oslo | 0450 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20606148 | Result | Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial. JAMA. 2010 Jul 7;304(1):45-52. doi: 10.1001/jama.2010.893. | |
| 22900984 | Derived | Wilkens P, Storheim K, Scheel I, Berg L, Espeland A. No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial. J Negat Results Biomed. 2012 Aug 17;11:13. doi: 10.1186/1477-5751-11-13. |
Not provided
Not provided
Trial participation required no wash out, run-in or transtion phase. Patients were excluded if they fulfilled any of the exclusion criteria.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Glucosamine Sulphate | The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months |
| FG001 | Placebo | Placebo was taken daily and orally in capsule forms for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Glucosamine Sulphate | The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months |
| BG001 | Placebo | Placebo was taken daily and orally in capsule forms for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Roland Morris Disability Questionnaire | 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. | The number of participants for analysis followed the intention to treat principle. Imputation was performed with mulitple imputation. | Posted | Mean | Standard Deviation | units on a scale (0-24) | 1 year |
|
Reports of adverse events were collected during the intervention period of 6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glucosamine Sulphate | The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager: Philip Wilkens | Oslo University Hospital Ullevaal | 004723016140 | philip.wilkens@medisin.uio.no |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005944 | Glucosamine |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months |
|
| 22718223 | Derived | Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Prognostic factors of prolonged disability in patients with chronic low back pain and lumbar degeneration in primary care: a cohort study. Spine (Phila Pa 1976). 2013 Jan 1;38(1):65-74. doi: 10.1097/BRS.0b013e318263bb7b. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Glucosamine Sulphate |
Glucosamine sulphate was taken daily and orally in capsule forms for 6 months |
|
|
|
| Secondary | Visual Analogue Scale | Not Posted | 1 year |
| Secondary | EuroQol-5D | Not Posted | 1 year |
| 0 |
| 125 |
| 0 |
| 125 |
| EG001 | Placebo | Placebo was taken daily and orally in capsule forms for 6 months | 0 | 125 | 0 | 125 |
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |