Session Information
Session Title: Orthopedics, Low Back Pain and Rehabilitation
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Chronic back pain affects a significant proportion of the population. MRI-defined inflammatory lesions have been used to differentiate between axial spondyloarthritis and mechanical back pain, but the frequency of inflammatory lesions in mechanical back pain has not been ascertained. The efficacy of celecoxib in chronic, mechanical back pain and its effects on MRI inflammatory lesions have not been established.
Methods:
A randomized, double-blind trial of celecoxib versus acetaminophen was conducted. Fifty two patients (52% male, mean age 40y)with back pain for at least 3 months, a total back pain score ≥4/10 and without clinical or radiographic evidence of axial spondyloarthritis were randomized to celecoxib (200mg twice daily, n=25) or acetaminophen (500mg twice daily, n=27) for four weeks. Total back pain, Oswestry Disability Index (ODI), nocturnal back pain, patient global assessment, morning stiffness, SF-36 mental component scale (MCS) and physical component scale (PCS), CRP, ESR and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI index for inflammation of the sacroiliac joints (SIJ) and spine were measured at baseline and four weeks.
Results:
A greater improvement was observed for celecoxib than for acetaminophen in total back pain (p=0.01), Oswestry Disability Index (p=0.003) and nocturnal back pain (p=0.01). A trend was observed for greater improvement in patient global assessment with celecoxib (p=0.07). The SPARCC MRI index was low at baseline and no change was seen over four weeks in either treatment group.
Conclusion:
To our knowledge, this is the first study to demonstrate the efficacy of celecoxib compared with acetaminophen in chronic mechanical back pain. MRI-defined inflammatory lesions were infrequent. This finding has implications for the specificity of MRI-defined inflammatory lesions in axial spondyloarthritis.
Table 1 Mean (SD) outcome measures from baseline to week 4
|
|
Acetaminophen (n=27) |
Celecoxib (n=25) |
P value for change in acetaminophen group versus change in celecoxib group |
||||||
|
|
Baseline |
Week 4 |
Mean of differences |
P value |
Baseline |
Week 4 |
Mean of differences |
P value |
|
|
Total back pain (0-10) |
5.8 (2.1) |
5.1 (2.4) |
-0.7 (1.8) |
0.04 |
6.5 (1.7) |
4.2 (2.6) |
-2.3 (2.6) |
0.0001 |
0.01 |
|
ODI (0-100) |
19.2 (9.1) |
17.6 (10.0) |
-1.6 (4.3) |
0.08 |
20.3 (8.2) |
13.1 (8.9) |
-7.1 (7.8) |
0.0002 |
0.003 |
|
Nocturnal back pain (0-10) |
4.5 (2.5) |
4.8 (2.8) |
0.3 (2.8) |
0.59 |
4.7 (2.3) |
3.0 (2.7) |
-1.7 (2.6) |
0.003 |
0.01 |
|
Patient global (0-10) |
4.6 (2.1) |
4.1 (2.4) |
-0.5 (1.7) |
0.16 |
4.7 (2.8) |
3.0 (2.6) |
-1.7 (2.8) |
0.0066 |
0.07 |
|
Morning stiffness (0-10) |
5.0 (2.7) |
4.4 (2.5) |
-0.6 (1.8) |
0.12 |
3.0 (2.8) |
2.5 (2.6) |
0-.6 (2.9) |
0.34 |
– |
|
SF-36 MCS |
47.4 (9.6) |
47.7 (10.2) |
0.3 (6.3) |
0.82 |
44.7 (11.6) |
47.7 (12.1) |
3.0 (12.2) |
0.24 |
– |
|
SF-36 PCS |
39.0 (11.4) |
41.9 (11.1) |
2.8 (5.7) |
0.02 |
39.5 (9.2) |
44.1 (9.2) |
4.6 (6.6) |
0.0025 |
0.38 |
|
CRP (mg/L) |
2.7 (4.4) |
2.2 (4.1) |
-0.5 (3.8) |
0.51 |
2.1 (2.2) |
2.1 (2.4) |
0.0 |
>0.99 |
– |
|
ESR (mm/h) |
8.4 (9.5) |
6.7 (7.4) |
-1.7 (3.6) |
0.02 |
5.0 (4.0) |
5.3 (4.0) |
0.3 (3.9) |
0.71 |
– |
|
MRI index SIJ (0-72) |
1.6 (2.3) |
1.6 (2.3) |
0.1 (0.4) |
0.48 |
0.9 (1.6) |
0.9 (1.4) |
-0.02 (1.06) |
0.93 |
– |
|
MRI index spine(0-108) |
4.3 (4.8) |
4.8 (5.3) |
0.49 (1.44) |
0.09 |
6.03 (4.60) |
5.63 |
-0.41 (1.04) |
0.06 |
– |
Disclosure:
D. Wallis,
None;
F. D. O’Shea,
None;
D. Salonen,
None;
N. Haroon,
Janssen Pharmaceutica Product, L.P.,
5,
Pfizer Inc,
5,
Amgen,
5,
Abbott Laboratories,
5;
A. Anton,
None;
L. A. Passalent,
None;
R. Morton,
None;
C. Hawke,
None;
J. Blair,
None;
R. D. Inman,
Abbott Immunology Pharmaceuticals,
5,
Janssen Pharmaceutica Product, L.P.,
5,
UCB,
5,
Pfizer Inc,
5.
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