Low Back Pain
Conditions
Keywords
Chronic low back pain
Brief summary
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.
Interventions
Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months
DRUGPlacebo
Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months
Sponsors
Stiftelsen Helse og Rehabilitering
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Low back pain for more than 6 months * Patient older than 25 years old * MRI findings comparable with lumbar degenerative/osteoarthritic changes.
Exclusion criteria
* Spinal stenosis with neurological deficits * Spinal prolapse with neurological deficits * Rheumatoid arthritis, psoriatic arthritis, * Old lumbar fractures * Chronic pain syndromes (e.g. fibromyalgia) * Psychosocial status not suitable for participation * Pregnancy * Breastfeeding * Allergic to shellfish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland Morris Disability Questionnaire | 1 year | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale | 1 year |
| EuroQol-5D | 1 year |
Countries
Norway
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Glucosamine Sulphate The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months | 125 |
| Placebo Placebo was taken daily and orally in capsule forms for 6 months | 125 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to follow up, adverse event etc | 22 | 20 |
Baseline characteristics
| Characteristic | Glucosamine Sulphate | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 10 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants | 115 Participants | 228 Participants |
| Region of Enrollment Norway | 125 participants | 125 participants | 250 participants |
| Sex: Female, Male Female | 54 Participants | 67 Participants | 121 Participants |
| Sex: Female, Male Male | 71 Participants | 58 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 125 | 0 / 125 |
| serious Total, serious adverse events | 0 / 125 | 0 / 125 |
Outcome results
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.
Time frame: 1 year
Population: The number of participants for analysis followed the intention to treat principle. Imputation was performed with mulitple imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Roland Morris Disability Questionnaire | 9 units on a scale (0-24) | Standard Deviation 4 |
| Glucosamine Sulphate | Roland Morris Disability Questionnaire | 9 units on a scale (0-24) | Standard Deviation 4 |
Comparison: 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 modelsp-value: 0.05Mixed Models Analysis
p-value: 0.05Mixed Models Analysis
Secondary
EuroQol-5D
Time frame: 1 year
Secondary
Visual Analogue Scale
Time frame: 1 year