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Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis.

Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD - Arthritis Res. Ther. (2010)

Bottom Line: Change in VAS pain intensity from baseline to week 8 was categorized (<0%, 0%-<15%, 15%-<30%, 30%-<50%, 50%-<70%, and > or = 70%) without regard to treatment and compared in each category with the mean change from baseline in each AUSCAN subindex and the global rating of disease.Pearson correlations between changes in outcome measures from baseline to week 8 were calculated.Pearson correlations confirmed significant associations (P < 0.001) between change in VAS pain intensity and changes in AUSCAN pain (correlation coefficient [r] = 0.81), AUSCAN function (r = 0.75), AUSCAN stiffness (r = 0.66), and global rating of disease (r = 0.76).

View Article: PubMed Central - HTML - PubMed

Affiliation: Private Practice (Rheumatology), P,O, Box 30813, Santa Barbara, CA 93130, USA. hrbarthel@earthlink.net.

ABSTRACT

Introduction: Nonsteroidal anti-inflammatory drugs are recommended for the relief of pain associated with hand osteoarthritis (OA) but do not alter the underlying structural changes that contribute to impaired physical function. The current analysis examined the relationship of pain relief with measures of function and global rating of disease in patients with hand OA.

Methods: This was a combined analysis of 2 prospective, randomized, double-blind, 8-week, multicenter, parallel-group studies comparing diclofenac sodium 1% gel with placebo gel (vehicle) in patients with radiographically confirmed mild to moderate hand OA. Patients (n = 783) aged > or = 40 years applied diclofenac sodium 1% gel (2 g) or vehicle to each hand 4 times daily for 8 weeks. Outcome measures included pain intensity assessed on a 100-mm Visual Analog Scale (VAS); the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) subscales for pain, stiffness, and physical function (100-mm VAS); and a global rating of disease (100-mm VAS). Change in VAS pain intensity from baseline to week 8 was categorized (<0%, 0%-<15%, 15%-<30%, 30%-<50%, 50%-<70%, and > or = 70%) without regard to treatment and compared in each category with the mean change from baseline in each AUSCAN subindex and the global rating of disease. Pearson correlations between changes in outcome measures from baseline to week 8 were calculated.

Results: Changes in VAS pain intensity were accompanied by similar changes in AUSCAN scores and global rating of disease. Pearson correlations confirmed significant associations (P < 0.001) between change in VAS pain intensity and changes in AUSCAN pain (correlation coefficient [r] = 0.81), AUSCAN function (r = 0.75), AUSCAN stiffness (r = 0.66), and global rating of disease (r = 0.76).

Conclusions: Pain relief correlated with improvements in physical function, stiffness, and global rating of disease in patients with hand OA, irrespective of treatment. This suggests that pain or anticipation of pain inhibits physical function and influences patient perception of disease severity in hand OA. These results also suggest that any intervention to relieve the pain of hand OA may improve function and patient perception of disease severity, despite the absence of a disease-modifying mechanism of action.

Trial registration: Clinicaltrials.gov NCT00171652, NCT00171665.

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CONSORT diagram describing study pooling and post-hoc analysis in relation to original study design.
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Figure 1: CONSORT diagram describing study pooling and post-hoc analysis in relation to original study design.

Mentions: Of 1,252 patients screened, 783 were randomly assigned to receive diclofenac sodium 1% gel (n = 400) or vehicle (n = 383) (Figure 1). In all, 701 (89.5%) patients completed the study. All 783 were included in the correlation analysis. The majority of patients were female (80.2%) and white (93.6%) (Table 1). Mean (standard deviation [SD]) VAS pain intensity (71.1 [15.1] mm) was moderate to severe. Mean scores on the three AUSCAN subindices and global rating of disease also reflected moderate pain, functional impairment, and impact of disease on patients' sense of well-being. Nearly half of the patients (46.1%) had Kellgren-Lawrence grade 3 OA, indicating moderate rather than mild anatomic disease (Table 2), but baseline mean VAS pain intensity scores were similar (approximately 70 mm) for each grade. In addition, mean changes from baseline through week 8 in VAS pain intensity, on the three AUSCAN subindices, and global rating of disease were similar for patients with Kellgren-Lawrence grades 1, 2, and 3. Most patients had radiographic evidence of sclerosis (63.3%), joint space narrowing (78.0%), and osteophytes (78.3%). More than a third (38.6%) had subchondral cysts. A majority (58%) had a pain reduction of at least 30%. At least 10% of patients fell within each of the pain reduction categories (Table 3).


Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis.

Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD - Arthritis Res. Ther. (2010)

CONSORT diagram describing study pooling and post-hoc analysis in relation to original study design.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2875633&req=5

Figure 1: CONSORT diagram describing study pooling and post-hoc analysis in relation to original study design.
Mentions: Of 1,252 patients screened, 783 were randomly assigned to receive diclofenac sodium 1% gel (n = 400) or vehicle (n = 383) (Figure 1). In all, 701 (89.5%) patients completed the study. All 783 were included in the correlation analysis. The majority of patients were female (80.2%) and white (93.6%) (Table 1). Mean (standard deviation [SD]) VAS pain intensity (71.1 [15.1] mm) was moderate to severe. Mean scores on the three AUSCAN subindices and global rating of disease also reflected moderate pain, functional impairment, and impact of disease on patients' sense of well-being. Nearly half of the patients (46.1%) had Kellgren-Lawrence grade 3 OA, indicating moderate rather than mild anatomic disease (Table 2), but baseline mean VAS pain intensity scores were similar (approximately 70 mm) for each grade. In addition, mean changes from baseline through week 8 in VAS pain intensity, on the three AUSCAN subindices, and global rating of disease were similar for patients with Kellgren-Lawrence grades 1, 2, and 3. Most patients had radiographic evidence of sclerosis (63.3%), joint space narrowing (78.0%), and osteophytes (78.3%). More than a third (38.6%) had subchondral cysts. A majority (58%) had a pain reduction of at least 30%. At least 10% of patients fell within each of the pain reduction categories (Table 3).

Bottom Line: Change in VAS pain intensity from baseline to week 8 was categorized (<0%, 0%-<15%, 15%-<30%, 30%-<50%, 50%-<70%, and > or = 70%) without regard to treatment and compared in each category with the mean change from baseline in each AUSCAN subindex and the global rating of disease.Pearson correlations between changes in outcome measures from baseline to week 8 were calculated.Pearson correlations confirmed significant associations (P < 0.001) between change in VAS pain intensity and changes in AUSCAN pain (correlation coefficient [r] = 0.81), AUSCAN function (r = 0.75), AUSCAN stiffness (r = 0.66), and global rating of disease (r = 0.76).

View Article: PubMed Central - HTML - PubMed

Affiliation: Private Practice (Rheumatology), P,O, Box 30813, Santa Barbara, CA 93130, USA. hrbarthel@earthlink.net.

ABSTRACT

Introduction: Nonsteroidal anti-inflammatory drugs are recommended for the relief of pain associated with hand osteoarthritis (OA) but do not alter the underlying structural changes that contribute to impaired physical function. The current analysis examined the relationship of pain relief with measures of function and global rating of disease in patients with hand OA.

Methods: This was a combined analysis of 2 prospective, randomized, double-blind, 8-week, multicenter, parallel-group studies comparing diclofenac sodium 1% gel with placebo gel (vehicle) in patients with radiographically confirmed mild to moderate hand OA. Patients (n = 783) aged > or = 40 years applied diclofenac sodium 1% gel (2 g) or vehicle to each hand 4 times daily for 8 weeks. Outcome measures included pain intensity assessed on a 100-mm Visual Analog Scale (VAS); the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) subscales for pain, stiffness, and physical function (100-mm VAS); and a global rating of disease (100-mm VAS). Change in VAS pain intensity from baseline to week 8 was categorized (<0%, 0%-<15%, 15%-<30%, 30%-<50%, 50%-<70%, and > or = 70%) without regard to treatment and compared in each category with the mean change from baseline in each AUSCAN subindex and the global rating of disease. Pearson correlations between changes in outcome measures from baseline to week 8 were calculated.

Results: Changes in VAS pain intensity were accompanied by similar changes in AUSCAN scores and global rating of disease. Pearson correlations confirmed significant associations (P < 0.001) between change in VAS pain intensity and changes in AUSCAN pain (correlation coefficient [r] = 0.81), AUSCAN function (r = 0.75), AUSCAN stiffness (r = 0.66), and global rating of disease (r = 0.76).

Conclusions: Pain relief correlated with improvements in physical function, stiffness, and global rating of disease in patients with hand OA, irrespective of treatment. This suggests that pain or anticipation of pain inhibits physical function and influences patient perception of disease severity in hand OA. These results also suggest that any intervention to relieve the pain of hand OA may improve function and patient perception of disease severity, despite the absence of a disease-modifying mechanism of action.

Trial registration: Clinicaltrials.gov NCT00171652, NCT00171665.

Show MeSH
Related in: MedlinePlus