Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, native collagen type 2, paracetamol
Brief summary
The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint pain and function and its effects on urinary biological markers related to cartilage degeneration in patients with knee osteoarthritis.
Detailed description
39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36), Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.
Interventions
DRUGparacetamol
1500 mg
DRUGparacetamol+native collagen type 2
paracetamol (1500 mg) + native collagen type 2 (10mg)
Sponsors
Eskisehir Osmangazi University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 45-70 years with the diagnosis of primary knee OA according to the American College of Rheumatology (ACR) criteria, Kellgren Lawrence radiological stage II or III and knee pain -
Exclusion criteria
Patients with intraarticular injections or physical therapy within the last year, a previous lower extremity surgery, oral treatment with glucosamine chondroitin or other natural health products within the last month, serious concomitant systemic diseases, peripheral or central neurological disorder, hypersensitivity to paracetamol or se¬vere cardiac, renal, hepatic, hematologic disease \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking) | 3 months | Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score | 3 months | Post treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases. |
| the Change From Baseline in 20 Meters Walking Time | 3 months | Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses |
| the Change From Baseline in Short Form 36 / Bodily Pain Subgroup | 3 months | Post treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better |
| the Change From Baseline in Coll2-1 Levels | 3 months | Post treatment comparison of Coll2-1 levels between groups |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paracetamol The 1st group includes 19 patients given 1500mg/day paracetamol for three months
paracetamol: 1500 mg | 19 |
| Native Collagen Type 2 + Paracetamol The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg) | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Paracetamol | Native Collagen Type 2 + Paracetamol | Total |
|---|---|---|---|
| Age, Continuous | 58.84 years STANDARD_DEVIATION 6.55 | 57.65 years STANDARD_DEVIATION 8.73 | 58.2 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants | 20 Participants | 39 Participants |
| Region of Enrollment Turkey | 19 participants | 20 participants | 39 participants |
| Sex: Female, Male Female | 17 Participants | 19 Participants | 36 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracetamol | the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking) | 3 score on a scale |
| Native Collagen Type 2 + Paracetamol | the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking) | 3 score on a scale |
Secondary
the Change From Baseline in 20 Meters Walking Time
Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol | the Change From Baseline in 20 Meters Walking Time | 18.84 seconds | Standard Deviation 4.79 |
| Native Collagen Type 2 + Paracetamol | the Change From Baseline in 20 Meters Walking Time | 18 seconds | Standard Deviation 3.49 |
Secondary
the Change From Baseline in Coll2-1 Levels
Post treatment comparison of Coll2-1 levels between groups
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracetamol | the Change From Baseline in Coll2-1 Levels | 130 microgram/ml |
| Native Collagen Type 2 + Paracetamol | the Change From Baseline in Coll2-1 Levels | 155.25 microgram/ml |
Secondary
the Change From Baseline in Short Form 36 / Bodily Pain Subgroup
Post treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracetamol | the Change From Baseline in Short Form 36 / Bodily Pain Subgroup | 51 score |
| Native Collagen Type 2 + Paracetamol | the Change From Baseline in Short Form 36 / Bodily Pain Subgroup | 52 score |
Secondary
the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Post treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases.
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracetamol | the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score | 52 units on a scale |
| Native Collagen Type 2 + Paracetamol | the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score | 44 units on a scale |