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Patellofemoral Osteoarthritis does not affect Tolerability of Traditional Therapeutic Exercise in Individuals with Tibiofemoral Osteoarthritis
Abstracts / Osteoarthritis and Cartilage 25 (2017) S76eS444
Purpose: Erosive hand osteoarthritis (OA) is a significant cause of pain and disability that may be associated with functional impairments similar to rheumatoid arthritis. Understanding the characteristics of subjects enrolled in erosive hand OA clinical trials and the reasons that subjects are declared ineligible for these trials is important since it may not only reduce the screen failure rate in future trials but may also better delineate the epidemiology of erosive hand OA and provide insight into optimal use of erosive hand OA therapies in clinical practice. Methods: The ILLUSTRATE-H study (NCT02384538) was a 6 month study in the United States and Western Europe that assessed the symptomatic and structural efficacy of ABT-981 (an anti-IL-1a/b dual variable domain [DVD] immunoglobulin) of erosive hand OA subjects with at least 1 erosion on hand x-ray, clinical signs of inflammation in at least 3 joints, and moderate to severe hand pain 6 on a NRS-11 scale. At baseline screening, 132 subjects were enrolled and 426 subjects were deemed ineligible for the study. The demographic characteristics of subjects (age, sex, and race) enrolled in the study versus those deemed ineligible were compared with t tests for continuous variables and with chi-square tests for dichotomous variables. The frequencies of each inclusion and exclusion criteria for which subjects were deemed ineligible for the study were tabulated. Satterthwaite and Fisher’s exact tests were conducted for continuous and dichotomous data, respectively, to identify demographic differences associated with not satisfying each of the individual inclusion and exclusion criteria. Results: Subjects enrolled in the ILLUSTRATE-H study were more likely to be older (65.8 vs. 63.9; p ¼ 0.024), female (84.8% vs. 76.8%; p ¼ 0.047) and white (98.5 vs. 91.0; p ¼ 0.004) compared to subjects deemed ineligible for the study, respectively (Table 1). The most frequent reasons for screen failure were absence of erosions on hand x-rays (50.9%), BMI out of range (12.4%), hand pain < 6 on a NRS-11 scale (9.9%) and clinical chemistry and/or hematology lab abnormalities (6.8%). Among the subjects excluded from the trial due to hand pain and lab abnormalities, there were equal proportions of subjects with similar demographic differences and disease characteristics compared to enrolled subjects. However, there were a disproportionate number of younger, male and non-white subjects excluded from the trial due to an absence of hand joint erosions (Table 2). Conclusions: A higher proportion of younger, male and non-white subjects were excluded from the ILLUSTRATE-H trial during the screening process primarily due to an absence of erosions on hand imaging rather than being excluded on the basis of hand pain or other demographic characteristics or disease features. This finding is consistent with our current understanding of the epidemiology of erosive hand OA which is most prevalent in older white women.
Table 1. Baseline Characteristics
Variable
Enrolled (n¼132)
Ineligible (n¼426)
Total (N¼558)
P value
n¼132 Mean ± SD age, y Sex, n (%) Female Male Race, n (%) White Non-white Missing
n¼425 65.8±7.7 n¼132 112 (84.8) 20 (15.2) n¼132 130 (98.5) 2 (1.5) 0
n¼557 63.9±8.3 n¼426 327 (76.8) 99 (23.2) n¼278 253 (91.0) 25 (9.0) 148
64.4±8.2 n¼558 439 (78.7) 119 (21.3) n¼410 383 (93.4) 27 (6.6) 148
0.024* 0.047y
0.004y
*T test. yChi-square.
S353
568 KNEE OSTEOARTHRITIS PAIN IS DIFFERENTIALLY ASSOCIATED WITH TISSUE DEGRADATION AND JOINT INFLAMMATION A.C. Bay-Jensen y, S.B. Abramson z, J. Samuels z, I. Byrjalsen y, S. Krasnokutsky Samuels z, T. Manon-Jensen y, M. Asser Karsdal y, M. Attur z. y Nordic BioSci., Herlev, Denmark; z New York Univ., New York, NY, USA Purpose: Osteoarthritis (OA) is a disease characterized by pain and tissue destruction, in some cases concomitant with inflammation. The link between pain and tissue destruction is yet unknown, and there is a lack objective quantifiable parameters. Collagens are the main structural proteins of the joint extracellular matrix. The degradation of especially type I (connective tissue), II (cartilage), III (synovium) and IV (basement membrane) collagens have been shown to be elevated in OA. So we investigated whether biomarkers reflecting collagen degradation were associated with knee OA representing with different pain and inflammatory phenotypes. Methods: 111 knee OA patients, 62% women, from NYUHJD progression cohort study with varying degree of OA were included: mean (SD) age, 62 (10); mean(SD) BMI, 27(4); NSAID users, 23%; radiographic OA (KL2) 68%; and bilateral knee OA; 87%. Pain was assessed by VAS and WOMAC at baseline (BL) at a 2-year follow-up (FU) visit. Median (IQR) were 39 (13e69) and 37 (13e52) for BL VAS and WOMAC. Four BL serum biomarkers of type I, II, III and IV collagen degradation (C1M, C2M, C3M, C4M), and the two inflammatory biomarkers CRPM and hsCRP, were assessed. Data were log2 transformed. Associations between BL biomarkers, BL pain and change (CHG) pain scores were assessed by multivariate linear model including gender, age, BMI, KL, bilateral knee OA and NSAID use. Patients with cont. mild/moderate pain had a BL VASpain<54 and FU VASpain<30, cont. moderate/severe pain had VASpain>30 at baseline and FU, and transitional severe pain had either VASpain_BL<30 and VASpain_FU>54 or VASpain_BL>54 and VASpain_FU<30. Patients with; low biochemical disease activity index (bDAI) low in CRPM (<12nM) moderate bDAI were high in CRPM but low in hsCRP (<5), and high bDAI (flare) were high in CRPM and hsCRP. Results: BL association between pain and biomarkers C2M (b 17.9, p<0.0001) and KL (b 5.4, p¼0.0031) were significantly associated with WOMAC pain. C2M (b 12.4, p¼0.0033), C3M (b 19.9, p¼0.059), age (b 0.84, p<0.0018), KL (b 8.9, p¼0.0021) and bilateral knee OA (b 12.2, p¼0.087) were associated with VAS. Association between BL biomarkers and CHG pain C2M (b13.3, p¼0.0016), age (b 0.5, p¼0.029) and bilateral OA (b 12.0, p¼0.043) were significantly associated with delta WOMAC. Only age, BMI and NSAID use was associated with CHG VAS. Association between pain phenotypes and BL biomarkers Patients with cont. mild/moderate pain had significantly higher C2M compared patients with transitional severe pain (p¼0.0014) and cont. moderate/ severe pain (p¼0.04). Biomarker, BL pain and CHG pain in patients w. inflammatory OA Patient with low bDAI had lower WOMAC (p<0.05) and VAS (p<0.1). C1M was higher (p<0.05) in the flare group compared to the low and moderate bDAI groups. C3M was higher (p<0.05) in the moderate bDAI group than the low DAI group. Conclusions: Different collagen degradation products are linked differentially to different phenotypes. Cartilage degradation (C2M) was consistently linked to CHG pain phenotypes, whereas it was not associated with an inflammatory phenotype. In contrast, C1M and C3M were linked to inflammatory and flared OA. 569 PATELLOFEMORAL OSTEOARTHRITIS DOES NOT AFFECT TOLERABILITY OF TRADITIONAL THERAPEUTIC EXERCISE IN INDIVIDUALS WITH TIBIOFEMORAL OSTEOARTHRITIS B. Pietrosimone, B. Luc-Harkey, D. Nissman, M. Harkey, H. Davis, T. Blackburn, D. Padua, B. Malay, P. Olmos, M. Laffan, J. Spang. Univ. of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Table 2. Disproportionate Enrollment by Age, Sex, and Race vs Reason for Exclusion
Reason for Exclusion
Mean ± SD age, y
P Value*
Female, n/N (%)
Male, n/N (%)
P Valuey
White, n/N (%)
Non-white, n/N (%)
P Valuey
None (enrolled) Absence of hand erosions BMI out of range Hand pain Clinical chemistry and/or hematology laboratory abnormalities
65.8±7.7 62.9±8.4 63.8±8.1 64.9±7.2 68.1±8.1
e 0.0010 0.1327 0.5069 0.1740
112/132 (84.8) 161/217 (74.2) 41/53 (77.4) 32/42 (76.2) 25/29 (86.2)
20/132 (15.2) 56/217 (25.8) 12/53 (22.6) 10/42 (23.8) 4/29 (13.8)
e 0.0228 0.2819 0.2405 1.0000
130/132 (98.5) 121/131 (92.4) 33/37 (89.2) 34/35 (97.1) 19/20 (95.0)
2/132 (1.5) 10/131 (7.6) 4/37 (10.8) 1/35 (2.9) 1/20 (5.0)
e 0.0194 0.0213 0.5085 0.3471
*Satterthwaite test. yFisher exact test.
S354
Abstracts / Osteoarthritis and Cartilage 25 (2017) S76eS444
Purpose: Traditional land-based therapeutic exercise demonstrates moderate short-term improvements in pain and physical function in those with tibiofemoral osteoarthritis (TFOA). Unfortunately, not all patients with TFOA positively respond to therapeutic exercise interventions and long-term benefits of therapeutic exercise for those with TFOA remains uncertain. Some individuals report exercise-induced pain that limits their ability to tolerate the magnitude of resistance needed to elicit strength gains. Individuals with TFOA and concomitant patellofemoral osteoarthritis (PFOA) may tolerate lower extremity strength training differently than individuals with TFOA only. The patellofemoral joint can be a critical source of pain and tissues associated to the patellofemoral joint may be loaded differently than the tibiofemoral joint during therapeutic exercise. The purpose of this study is to determine if individuals with TFOA and concomitant PFOA (TFOAþPFOA) tolerate a traditional land-based therapeutic exercise intervention differently than those with TFOA only. Methods: Thirty-five individuals who demonstrated moderate to severe TFOA (Kellgren-Lawrence grade 3e4) in at least one limb were included in either the TFOAþPFOA (n¼19; 58% female; 64.2±6.24 years old, 28.60±4.17kg/m2, aggregate Western Ontario and McMaster University Osteoarthritis Index [WOMAC] ¼44.42±10.50) or the TFOA only cohort (n¼16; 38% female; 63.6±5.70 years old, 29.15±4.34kg/m2, aggregate WOMAC¼48.25±17.42). TFOA and PFOA were determined via bilateral standing radiographs conducted in three planes (anterior, lateral, and sunrise view) within 6 months of enrollment. All TFOA and PFOA severity classifications were determined by the same fellowship-trained musculoskeletal radiologist. PFOA severity was classified as ‘none or mild PFOA’ or ‘moderate to severe PFOA’ based on patellofemoral femoral joint space narrowing and osteophyte formation. Individuals with moderate to severe PFOA were classified into the TFOAþPFOA group and individuals with no or mild PFOA were classified into the TFOA only group. All participants were enrolled in a lower extremity strengthening intervention, which included 10 sessions that were progressed in a standardized manner over four weeks by a licensed physical therapist (PT). Therapeutic exercise consisted of lower extremity stretching, as well as closed and open-chain strengthening that was augmented by sensory transcutaneous electrical nerve stimulation in some of the patients. The PTs were blinded to PFOA status during the intervention. At the end of each week patients were instructed to indicate their level of tolerability for the intervention on a 10cm visual analog scale marked by ‘not tolerable at all’ and ‘extremely tolerable’ on the left and right boundaries of the scale. All participants who started the intervention were included in an intention-to-treat analysis and regression imputation was used to populate missing tolerability scores. A 2x4 repeated measures analysis of variance was used to assess tolerability of the therapeutic exercise intervention between the TFOAþPFOA and TFOA only groups at each week over the 4-week therapeutic exercise intervention. Tukey multiple comparisons analyses were performed if a significant interaction or main effect was determined (P 0.05). All within-subject time contrasts were compared to the baseline tolerability score for this analysis. Results: Perceived tolerability of the intervention did not differ between individuals with TFOAþPFOA and TFOA only over time (F1,33¼0.26, P¼ 0.62). All individuals reported greater tolerability of the intervention at the 4-week (TFOAþPFOA 9.14cm 95% Confidence intervals (8.70 - 9.95); TFOA only group 9.92cm [8.69 - 9.64]; P¼0.002), 3-week (TFOAþPFOA 8.97cm [8.34 - 9.60]; TFOA only group 8.88cm [8.19 - 9.57]; P¼0.001), and 2-week time points (TFOAþPFOA 8.51cm [7.70 - 9.33]; TFOA only group 8.12cm [7.23 - 9.00]; P¼0.043) compared to the tolerability of the intervention in the first week (TFOAþPFOA 7.67cm [6.56 - 8.87]; TFOA only group 7.60cm [6.39 - 8.81]). Conclusions: Patients with TFOA tolerated the traditional land-based therapeutic exercise intervention similarly regardless of PFOA status. Even though the intervention was standardized to progressively increased resistance throughout the 4-weeks, all participants reported better tolerability in the 2nd, 3rd, and 4th weeks of the intervention compared to the 1st week. Traditional land-based therapeutic exercise should be considered as a possible treatment for improving disability in those with TFOA regardless of PFOA severity. 570 CORRELATION BETWEEN BODY COMPOSITION MEASURES ASSESSED BY DUAL ENERGY X-RAY ABSORPTIOMETRY (DXA) ON THE FUNCTIONAL PERFORMANCE OF PATIENTS WITH KNEE OSTEOARTHRITIS A.C. Almeida, M. Pedroso, J. Aily, G. Gonçalves, S. Mattiello. Federal Univ. ~o Carlos (UFSCar), Sa ~o Carlos-SP, Brazil of Sa
Purpose: Alterations in body composition, especially the increased of adipose tissue concentration can be considered important risk factors for knee osteoarthritis (KOA) development, as well as contribute to its progression. Muscle loss and fat gain contribute to the disability, pain, and morbidity associated with KOA. Obesity is widely classified by body mass index (BMI). The literature has shown that individuals with higher BMI may present lower functional performance. However, BMI is limited considering the real body composition. Measures such as adiposity index (body fat mass / height2), lean mass index (body lean mass / height2), leg fat mass, and leg lean mass, assessed by Dual Energy X-ray absorptiometry, can provide more appropriate information in order to verify the impact of body composition on KOA. Since most of the activities of daily living such as walking sit and stand up, and going up and down stairs, depends on the performance of lower limbs, the amount of lean and fat mass may influence these functions performance. Thus, it seems pertinent to evaluate the relationship of these indexes, leg fat mass and leg lean mass with functional performance of patients with KOA, and to assess whether functional performance is more influenced by fat mass or lean mass. Methods: Participants of both sexes, aged between 40 and 65 years with KOA were selected based on the American College of Rheumatology criteria (ACR) and classified by the Kellgren and Lawrence scale as grades 2 and 3. Only participants with BMI <30 kg/m2 were included. Body composition was assessed by Dual Energy X-ray absorptiometry (DXA, Hologic A), gold standard for body composition measurements, and assessment of adiposity and lean mass indexes was considered. In addition, participants performed the 30 seconds chair test, stair climbing test, and 40 m fast paced walk test according to OARSI recommendations. 30 seconds chair test: participant performed from the sitting position in the middle of seat with feet shoulder width apart, flat on the floor, arms crossed at chest, stand completely up, then sit completely back down, repeatedly for 30 s. Chair was against a wall. It was counted the total number of complete chair stands (up and down represents one stand) of one trial; stair climbing test: participant ascended and descended flight of nine stairs in a usual manner, and at a safe and comfortable pace. Use of any walking aid and handrail was permitted and recorded. Total time to ascend and descend steps for one trial was recorded in seconds; 40 m fast paced walk test: participant should walk as quickly but as safely as possible to a mark 10 m away, return, and repeat for a total distance of 40 m. Regular walking aid is allowed and recorded. Time of one trial, with turn time excluded, is recorded and expressed as speed m/s by dividing distance (40 m) by time (s). Longer times indicated physical function more compromised. Initially, data were checked for normality by the Shapiro-Wilk test. To analyze the correlation index between the variables, the Spearman’s test was used to correlate fat mass/heigth2, lean mass/heigth2, legs fat mass and lean mass with functional performance tests. For all analyzes was adopted a significance level of 5% (p0.05). Results: Thirty seven participants (mean age of 53.08 ± 5.92 years, 1.65 ± 0.06 m, 72.60 ± 9.34 kg and 26.70 ± 3.00 kg/m2) were included in this study. The results of this study are shown in Table 1. A significant positive correlation was observed for the adiposity index and leg fat mass for stair climbing test and 40 m fast paced test. For leg lean mass a negative significant correlation was observed only for 40 m fast paced walk test. No correlation was found between measures of body composition and the 30 seconds chair test. There was a significant positive correlation between the adiposity index and the stair climbing test, in which higher adiposity index values were associated with longer time to perform the test. Conclusions: From the results of this study, it can be concluded that in patients with KOA, measures of body composition that represent fat mass content, both the distribution of body fat and fat mass in the legs seem to have more influence on functional performance tests than the distribution of lean mass, despite a correlation between lean mass in the legs and the 40 m fast paced walk test. Table 1. Correlation between performance based tests and adipose, lean mass indexes, leg fat mass and leg lean mass Performance based tests
Fat mass/ height2
Lean mass/ height2
Leg fat mass
r
r
r
P
P
Leg lean mass P
r
p
30 seconds 0.337 0.450 0.087 0.616 0.255 0.134 0.083 0.630 chair test Stair climbing 0.486 0.003* 0.030 0.860 0.466 0.004* 0.076 0.661 test 40 m fast paced walk test 0.530 0.001* 0.248 0.144 0.413 0.012* 0.351 0.036* *Significant correlation (p.05).
Purpose: Erosive hand osteoarthritis (OA) is a significant cause of pain and disability that may be associated with functional impairments similar to rheumatoid arthritis. Understanding the characteristics of subjects enrolled in erosive hand OA clinical trials and the reasons that subjects are declared ineligible for these trials is important since it may not only reduce the screen failure rate in future trials but may also better delineate the epidemiology of erosive hand OA and provide insight into optimal use of erosive hand OA therapies in clinical practice. Methods: The ILLUSTRATE-H study (NCT02384538) was a 6 month study in the United States and Western Europe that assessed the symptomatic and structural efficacy of ABT-981 (an anti-IL-1a/b dual variable domain [DVD] immunoglobulin) of erosive hand OA subjects with at least 1 erosion on hand x-ray, clinical signs of inflammation in at least 3 joints, and moderate to severe hand pain 6 on a NRS-11 scale. At baseline screening, 132 subjects were enrolled and 426 subjects were deemed ineligible for the study. The demographic characteristics of subjects (age, sex, and race) enrolled in the study versus those deemed ineligible were compared with t tests for continuous variables and with chi-square tests for dichotomous variables. The frequencies of each inclusion and exclusion criteria for which subjects were deemed ineligible for the study were tabulated. Satterthwaite and Fisher’s exact tests were conducted for continuous and dichotomous data, respectively, to identify demographic differences associated with not satisfying each of the individual inclusion and exclusion criteria. Results: Subjects enrolled in the ILLUSTRATE-H study were more likely to be older (65.8 vs. 63.9; p ¼ 0.024), female (84.8% vs. 76.8%; p ¼ 0.047) and white (98.5 vs. 91.0; p ¼ 0.004) compared to subjects deemed ineligible for the study, respectively (Table 1). The most frequent reasons for screen failure were absence of erosions on hand x-rays (50.9%), BMI out of range (12.4%), hand pain < 6 on a NRS-11 scale (9.9%) and clinical chemistry and/or hematology lab abnormalities (6.8%). Among the subjects excluded from the trial due to hand pain and lab abnormalities, there were equal proportions of subjects with similar demographic differences and disease characteristics compared to enrolled subjects. However, there were a disproportionate number of younger, male and non-white subjects excluded from the trial due to an absence of hand joint erosions (Table 2). Conclusions: A higher proportion of younger, male and non-white subjects were excluded from the ILLUSTRATE-H trial during the screening process primarily due to an absence of erosions on hand imaging rather than being excluded on the basis of hand pain or other demographic characteristics or disease features. This finding is consistent with our current understanding of the epidemiology of erosive hand OA which is most prevalent in older white women.
Table 1. Baseline Characteristics
Variable
Enrolled (n¼132)
Ineligible (n¼426)
Total (N¼558)
P value
n¼132 Mean ± SD age, y Sex, n (%) Female Male Race, n (%) White Non-white Missing
n¼425 65.8±7.7 n¼132 112 (84.8) 20 (15.2) n¼132 130 (98.5) 2 (1.5) 0
n¼557 63.9±8.3 n¼426 327 (76.8) 99 (23.2) n¼278 253 (91.0) 25 (9.0) 148
64.4±8.2 n¼558 439 (78.7) 119 (21.3) n¼410 383 (93.4) 27 (6.6) 148
0.024* 0.047y
0.004y
*T test. yChi-square.
S353
568 KNEE OSTEOARTHRITIS PAIN IS DIFFERENTIALLY ASSOCIATED WITH TISSUE DEGRADATION AND JOINT INFLAMMATION A.C. Bay-Jensen y, S.B. Abramson z, J. Samuels z, I. Byrjalsen y, S. Krasnokutsky Samuels z, T. Manon-Jensen y, M. Asser Karsdal y, M. Attur z. y Nordic BioSci., Herlev, Denmark; z New York Univ., New York, NY, USA Purpose: Osteoarthritis (OA) is a disease characterized by pain and tissue destruction, in some cases concomitant with inflammation. The link between pain and tissue destruction is yet unknown, and there is a lack objective quantifiable parameters. Collagens are the main structural proteins of the joint extracellular matrix. The degradation of especially type I (connective tissue), II (cartilage), III (synovium) and IV (basement membrane) collagens have been shown to be elevated in OA. So we investigated whether biomarkers reflecting collagen degradation were associated with knee OA representing with different pain and inflammatory phenotypes. Methods: 111 knee OA patients, 62% women, from NYUHJD progression cohort study with varying degree of OA were included: mean (SD) age, 62 (10); mean(SD) BMI, 27(4); NSAID users, 23%; radiographic OA (KL2) 68%; and bilateral knee OA; 87%. Pain was assessed by VAS and WOMAC at baseline (BL) at a 2-year follow-up (FU) visit. Median (IQR) were 39 (13e69) and 37 (13e52) for BL VAS and WOMAC. Four BL serum biomarkers of type I, II, III and IV collagen degradation (C1M, C2M, C3M, C4M), and the two inflammatory biomarkers CRPM and hsCRP, were assessed. Data were log2 transformed. Associations between BL biomarkers, BL pain and change (CHG) pain scores were assessed by multivariate linear model including gender, age, BMI, KL, bilateral knee OA and NSAID use. Patients with cont. mild/moderate pain had a BL VASpain<54 and FU VASpain<30, cont. moderate/severe pain had VASpain>30 at baseline and FU, and transitional severe pain had either VASpain_BL<30 and VASpain_FU>54 or VASpain_BL>54 and VASpain_FU<30. Patients with; low biochemical disease activity index (bDAI) low in CRPM (<12nM) moderate bDAI were high in CRPM but low in hsCRP (<5), and high bDAI (flare) were high in CRPM and hsCRP. Results: BL association between pain and biomarkers C2M (b 17.9, p<0.0001) and KL (b 5.4, p¼0.0031) were significantly associated with WOMAC pain. C2M (b 12.4, p¼0.0033), C3M (b 19.9, p¼0.059), age (b 0.84, p<0.0018), KL (b 8.9, p¼0.0021) and bilateral knee OA (b 12.2, p¼0.087) were associated with VAS. Association between BL biomarkers and CHG pain C2M (b13.3, p¼0.0016), age (b 0.5, p¼0.029) and bilateral OA (b 12.0, p¼0.043) were significantly associated with delta WOMAC. Only age, BMI and NSAID use was associated with CHG VAS. Association between pain phenotypes and BL biomarkers Patients with cont. mild/moderate pain had significantly higher C2M compared patients with transitional severe pain (p¼0.0014) and cont. moderate/ severe pain (p¼0.04). Biomarker, BL pain and CHG pain in patients w. inflammatory OA Patient with low bDAI had lower WOMAC (p<0.05) and VAS (p<0.1). C1M was higher (p<0.05) in the flare group compared to the low and moderate bDAI groups. C3M was higher (p<0.05) in the moderate bDAI group than the low DAI group. Conclusions: Different collagen degradation products are linked differentially to different phenotypes. Cartilage degradation (C2M) was consistently linked to CHG pain phenotypes, whereas it was not associated with an inflammatory phenotype. In contrast, C1M and C3M were linked to inflammatory and flared OA. 569 PATELLOFEMORAL OSTEOARTHRITIS DOES NOT AFFECT TOLERABILITY OF TRADITIONAL THERAPEUTIC EXERCISE IN INDIVIDUALS WITH TIBIOFEMORAL OSTEOARTHRITIS B. Pietrosimone, B. Luc-Harkey, D. Nissman, M. Harkey, H. Davis, T. Blackburn, D. Padua, B. Malay, P. Olmos, M. Laffan, J. Spang. Univ. of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Table 2. Disproportionate Enrollment by Age, Sex, and Race vs Reason for Exclusion
Reason for Exclusion
Mean ± SD age, y
P Value*
Female, n/N (%)
Male, n/N (%)
P Valuey
White, n/N (%)
Non-white, n/N (%)
P Valuey
None (enrolled) Absence of hand erosions BMI out of range Hand pain Clinical chemistry and/or hematology laboratory abnormalities
65.8±7.7 62.9±8.4 63.8±8.1 64.9±7.2 68.1±8.1
e 0.0010 0.1327 0.5069 0.1740
112/132 (84.8) 161/217 (74.2) 41/53 (77.4) 32/42 (76.2) 25/29 (86.2)
20/132 (15.2) 56/217 (25.8) 12/53 (22.6) 10/42 (23.8) 4/29 (13.8)
e 0.0228 0.2819 0.2405 1.0000
130/132 (98.5) 121/131 (92.4) 33/37 (89.2) 34/35 (97.1) 19/20 (95.0)
2/132 (1.5) 10/131 (7.6) 4/37 (10.8) 1/35 (2.9) 1/20 (5.0)
e 0.0194 0.0213 0.5085 0.3471
*Satterthwaite test. yFisher exact test.
S354
Abstracts / Osteoarthritis and Cartilage 25 (2017) S76eS444
Purpose: Traditional land-based therapeutic exercise demonstrates moderate short-term improvements in pain and physical function in those with tibiofemoral osteoarthritis (TFOA). Unfortunately, not all patients with TFOA positively respond to therapeutic exercise interventions and long-term benefits of therapeutic exercise for those with TFOA remains uncertain. Some individuals report exercise-induced pain that limits their ability to tolerate the magnitude of resistance needed to elicit strength gains. Individuals with TFOA and concomitant patellofemoral osteoarthritis (PFOA) may tolerate lower extremity strength training differently than individuals with TFOA only. The patellofemoral joint can be a critical source of pain and tissues associated to the patellofemoral joint may be loaded differently than the tibiofemoral joint during therapeutic exercise. The purpose of this study is to determine if individuals with TFOA and concomitant PFOA (TFOAþPFOA) tolerate a traditional land-based therapeutic exercise intervention differently than those with TFOA only. Methods: Thirty-five individuals who demonstrated moderate to severe TFOA (Kellgren-Lawrence grade 3e4) in at least one limb were included in either the TFOAþPFOA (n¼19; 58% female; 64.2±6.24 years old, 28.60±4.17kg/m2, aggregate Western Ontario and McMaster University Osteoarthritis Index [WOMAC] ¼44.42±10.50) or the TFOA only cohort (n¼16; 38% female; 63.6±5.70 years old, 29.15±4.34kg/m2, aggregate WOMAC¼48.25±17.42). TFOA and PFOA were determined via bilateral standing radiographs conducted in three planes (anterior, lateral, and sunrise view) within 6 months of enrollment. All TFOA and PFOA severity classifications were determined by the same fellowship-trained musculoskeletal radiologist. PFOA severity was classified as ‘none or mild PFOA’ or ‘moderate to severe PFOA’ based on patellofemoral femoral joint space narrowing and osteophyte formation. Individuals with moderate to severe PFOA were classified into the TFOAþPFOA group and individuals with no or mild PFOA were classified into the TFOA only group. All participants were enrolled in a lower extremity strengthening intervention, which included 10 sessions that were progressed in a standardized manner over four weeks by a licensed physical therapist (PT). Therapeutic exercise consisted of lower extremity stretching, as well as closed and open-chain strengthening that was augmented by sensory transcutaneous electrical nerve stimulation in some of the patients. The PTs were blinded to PFOA status during the intervention. At the end of each week patients were instructed to indicate their level of tolerability for the intervention on a 10cm visual analog scale marked by ‘not tolerable at all’ and ‘extremely tolerable’ on the left and right boundaries of the scale. All participants who started the intervention were included in an intention-to-treat analysis and regression imputation was used to populate missing tolerability scores. A 2x4 repeated measures analysis of variance was used to assess tolerability of the therapeutic exercise intervention between the TFOAþPFOA and TFOA only groups at each week over the 4-week therapeutic exercise intervention. Tukey multiple comparisons analyses were performed if a significant interaction or main effect was determined (P 0.05). All within-subject time contrasts were compared to the baseline tolerability score for this analysis. Results: Perceived tolerability of the intervention did not differ between individuals with TFOAþPFOA and TFOA only over time (F1,33¼0.26, P¼ 0.62). All individuals reported greater tolerability of the intervention at the 4-week (TFOAþPFOA 9.14cm 95% Confidence intervals (8.70 - 9.95); TFOA only group 9.92cm [8.69 - 9.64]; P¼0.002), 3-week (TFOAþPFOA 8.97cm [8.34 - 9.60]; TFOA only group 8.88cm [8.19 - 9.57]; P¼0.001), and 2-week time points (TFOAþPFOA 8.51cm [7.70 - 9.33]; TFOA only group 8.12cm [7.23 - 9.00]; P¼0.043) compared to the tolerability of the intervention in the first week (TFOAþPFOA 7.67cm [6.56 - 8.87]; TFOA only group 7.60cm [6.39 - 8.81]). Conclusions: Patients with TFOA tolerated the traditional land-based therapeutic exercise intervention similarly regardless of PFOA status. Even though the intervention was standardized to progressively increased resistance throughout the 4-weeks, all participants reported better tolerability in the 2nd, 3rd, and 4th weeks of the intervention compared to the 1st week. Traditional land-based therapeutic exercise should be considered as a possible treatment for improving disability in those with TFOA regardless of PFOA severity. 570 CORRELATION BETWEEN BODY COMPOSITION MEASURES ASSESSED BY DUAL ENERGY X-RAY ABSORPTIOMETRY (DXA) ON THE FUNCTIONAL PERFORMANCE OF PATIENTS WITH KNEE OSTEOARTHRITIS A.C. Almeida, M. Pedroso, J. Aily, G. Gonçalves, S. Mattiello. Federal Univ. ~o Carlos (UFSCar), Sa ~o Carlos-SP, Brazil of Sa
Purpose: Alterations in body composition, especially the increased of adipose tissue concentration can be considered important risk factors for knee osteoarthritis (KOA) development, as well as contribute to its progression. Muscle loss and fat gain contribute to the disability, pain, and morbidity associated with KOA. Obesity is widely classified by body mass index (BMI). The literature has shown that individuals with higher BMI may present lower functional performance. However, BMI is limited considering the real body composition. Measures such as adiposity index (body fat mass / height2), lean mass index (body lean mass / height2), leg fat mass, and leg lean mass, assessed by Dual Energy X-ray absorptiometry, can provide more appropriate information in order to verify the impact of body composition on KOA. Since most of the activities of daily living such as walking sit and stand up, and going up and down stairs, depends on the performance of lower limbs, the amount of lean and fat mass may influence these functions performance. Thus, it seems pertinent to evaluate the relationship of these indexes, leg fat mass and leg lean mass with functional performance of patients with KOA, and to assess whether functional performance is more influenced by fat mass or lean mass. Methods: Participants of both sexes, aged between 40 and 65 years with KOA were selected based on the American College of Rheumatology criteria (ACR) and classified by the Kellgren and Lawrence scale as grades 2 and 3. Only participants with BMI <30 kg/m2 were included. Body composition was assessed by Dual Energy X-ray absorptiometry (DXA, Hologic A), gold standard for body composition measurements, and assessment of adiposity and lean mass indexes was considered. In addition, participants performed the 30 seconds chair test, stair climbing test, and 40 m fast paced walk test according to OARSI recommendations. 30 seconds chair test: participant performed from the sitting position in the middle of seat with feet shoulder width apart, flat on the floor, arms crossed at chest, stand completely up, then sit completely back down, repeatedly for 30 s. Chair was against a wall. It was counted the total number of complete chair stands (up and down represents one stand) of one trial; stair climbing test: participant ascended and descended flight of nine stairs in a usual manner, and at a safe and comfortable pace. Use of any walking aid and handrail was permitted and recorded. Total time to ascend and descend steps for one trial was recorded in seconds; 40 m fast paced walk test: participant should walk as quickly but as safely as possible to a mark 10 m away, return, and repeat for a total distance of 40 m. Regular walking aid is allowed and recorded. Time of one trial, with turn time excluded, is recorded and expressed as speed m/s by dividing distance (40 m) by time (s). Longer times indicated physical function more compromised. Initially, data were checked for normality by the Shapiro-Wilk test. To analyze the correlation index between the variables, the Spearman’s test was used to correlate fat mass/heigth2, lean mass/heigth2, legs fat mass and lean mass with functional performance tests. For all analyzes was adopted a significance level of 5% (p0.05). Results: Thirty seven participants (mean age of 53.08 ± 5.92 years, 1.65 ± 0.06 m, 72.60 ± 9.34 kg and 26.70 ± 3.00 kg/m2) were included in this study. The results of this study are shown in Table 1. A significant positive correlation was observed for the adiposity index and leg fat mass for stair climbing test and 40 m fast paced test. For leg lean mass a negative significant correlation was observed only for 40 m fast paced walk test. No correlation was found between measures of body composition and the 30 seconds chair test. There was a significant positive correlation between the adiposity index and the stair climbing test, in which higher adiposity index values were associated with longer time to perform the test. Conclusions: From the results of this study, it can be concluded that in patients with KOA, measures of body composition that represent fat mass content, both the distribution of body fat and fat mass in the legs seem to have more influence on functional performance tests than the distribution of lean mass, despite a correlation between lean mass in the legs and the 40 m fast paced walk test. Table 1. Correlation between performance based tests and adipose, lean mass indexes, leg fat mass and leg lean mass Performance based tests
Fat mass/ height2
Lean mass/ height2
Leg fat mass
r
r
r
P
P
Leg lean mass P
r
p
30 seconds 0.337 0.450 0.087 0.616 0.255 0.134 0.083 0.630 chair test Stair climbing 0.486 0.003* 0.030 0.860 0.466 0.004* 0.076 0.661 test 40 m fast paced walk test 0.530 0.001* 0.248 0.144 0.413 0.012* 0.351 0.036* *Significant correlation (p.05).