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Rheumatology Advance Access originally published online on July 26, 2006
Rheumatology 2007 46(2):285-291; doi:10.1093/rheumatology/kel217
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© The Author 2006. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Clinical effectiveness and dose response of image-guided intra-articular corticosteroid injection for hip osteoarthritis

P. Robinson1, A.-M. Keenan2 and P. G. Conaghan2

1Leeds Teaching Hospitals, Radiology and 2University of Leeds, Academic Unit of Musculoskeletal Disease, Leeds, UK

Correspondence to: Dr P. Robinson, Musculoskeletal Centre, X-Ray Department, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. E-mail: p.robinson{at}leedsth.nhs.uk


   Abstract
Top
 Abstract
Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
Objectives. To assess symptomatic change after intra-articular corticosteroid (IAST) injection at 2 doses in hip osteoarthritis (OA), and to examine dose response and predictors of response.

Methods. Patients with hip OA (90 women and 30 men and median age 64 yrs) referred for IAST fluoroscopic injection were included in this longitudinal, clinical trial. WOMAC scores, body mass index (BMI), conventional radiographic grade (Kellgren and Lawrence scoring) and ultrasound measures (including capsular thickness and osteophyte assessments) were recorded at baseline. In the first phase of the study, 75 patients were injected with 40 mg methylprednisolone; another 45 patients were injected with 80 mg in the second phase. Change in WOMAC scores from baseline to weeks 6 and 12 were calculated for each dose and then dose comparisons were made. Clinical responders (>15% reduction in baseline pain score) were identified in order to establish predictors of response.

Results. For the 40 mg dose, there was a statistically significant improvement in pain (P < 0.001) and stiffness (P < 0.001) but not disability at week 6, and only the improvement in stiffness at week 12 was maintained (P = 0.041). For the 80 mg dose, there was significant improvement in pain (P < 0.001), stiffness (P < 0.001) and disability (P < 0.001) at week 6, which was maintained for all domains at week 12 (P = 0.002; P = 0.001; P < 0.001). When the doses were compared, the 80 mg dose demonstrated a significant improvement compared with the 40 mg group for stiffness at week 12 (P = 0.026) and disability at both weeks 6 and 12 (P = 0.026; P = 0.004). Imaging findings did not relate to severity of symptoms or response to IAST.

Conclusions. In these two hip OA cohorts, both the 40 mg and 80 mg IAST doses had a beneficial effect at week 6, while the 80 mg dose maintained this improvement at week 12. Comparison of the two dose groups provided some evidence of a dose response. Randomized controlled trials of IAST for hip OA are now required.

KEY WORDS: Osteoarthritis, Hip, Corticosteroid, Radiography, Ultrasound


   Introduction
Top
 Abstract
 Introduction
Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
Intra-articular corticosteroid (IAST) injection is a commonly recommended pharmacological treatment in the medical management of large joint osteoarthritis (OA) although a specific dose is not advised [1–3]. However, the majority of series evaluating this treatment have addressed its effectiveness in knee OA, which may be because intra-articular injection of this joint can be performed easily and safely in the outpatient clinic [4–6]. There have been relatively few studies in hip OA, where anatomical landmarks are less reliable. Therefore, radiology input is usually required to perform hip injection under image guidance to ensure appropriate intra-articular placement [3, 7–9].

While the majority of studies evaluating IAST for hip OA have measured visual analogue pain scores [7–9], there are no reports using a well-validated OA outcome measure, such as the Western Ontario and McMaster Universities (WOMAC) OA index, which also incorporate assessment of the functional impact of treatment, and have been recommended for use in OA trials [10]. Importantly, clinical or imaging predictors of response to injection have also not been clearly identified [4, 5, 7]. One study has shown that atrophic hip radiograph appearances correlate with a poor response, while other authors believe synovitis or joint effusion should improve the chance of response to injection [3, 4, 7].

The aim of this study was to investigate and compare two cohorts of patients with hip OA referred for image-guided IAST injection. The first cohort of patients was injected with 40 mg of IAST and the second cohort with 80 mg IAST. The study aimed to monitor response by evaluating patient pain, stiffness and disability and also investigate if response was related to dose, imaging or demographic features.


   Materials and methods
Top
 Abstract
 Introduction
 Materials and methods
Results
 Discussion
 Acknowledgements
 References
 
After institutional ethics approval, patients with hip OA underwent image-guided IAST injection. All patients gave informed consent prior to entry into the study and injection treatment. All patients were referred by orthopedic surgeons and rheumatologists with a clinical diagnosis of hip OA and symptoms greater than 4 months duration. Patients with a previous history of inflammatory arthritis or intra-articular injection within the previous 16 weeks were excluded. One hundred and twenty patients were included for analysis (90 female and 30 male, mean age 64, range 22–86 yrs); 75 patients were treated with 40 mg IAST in the first phase of the study and another 45 patients with 80 mg in the second phase.

Imaging assessment
Prior to injection a conventional radiograph was taken and graded 0–4 by an experienced musculoskeletal radiologist using the system of Kellgren–Lawrence (K-L) [11]. An assessment of intra-observer reproducibility was made with a second reading, using a random sample of 30 radiographs, at least 6 months after the original scoring.

Ultrasound (Sonosite 180, Sonosite Inc., Bothell, WA, USA) examination of the hip was also performed, by the same radiologist prior to injection, using a linear transducer (10–5 MHz) with the patient supine and the foot directed anteroposteriorly (to reproduce patient position). The maximal anterior capsular thickness (in millimeters) was measured in the longitudinal plane of the femoral neck from the anterior femoral cortex to the outer margin of the capsule [12]. The capsule was also assessed by colour power Doppler for blood flow (recorded as absent or present) [13].

The presence of a hip effusion was defined as hypoechoic or anechoic fluid along the femoral neck deep to the capsule and was recorded as present or absent. Iliopsoas bursal fluid was defined as fluid associated with the iliopsoas tendon and was recorded as present or absent. An additional semi-quantitative assessment of the degree of capsular thickness and anterior femoral head osteophytes was made and scored as normal (0), mild (1), moderate (2) or severe (3) abnormality (Fig. 1). An assessment of intra-observer reproducibility was made with a second reading, using a random sample of 12 ultrasound images, at least 6 months after the original scoring.


Figure 1
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  		FIG. 1. Ultrasound scoring system for anterior capsular thickness: (a) normal (0); (b) mild (1); (c) moderate (2); (d) severe (3).

 
Intra-articular injection
All patients underwent fluoroscopically guided injection of the hip using an anterior approach and a 22-gauge spinal needle with the patient in a supine position. All patients were blinded to the steroid dose injected. Aspiration was attempted prior to confirmation of intra-articular needle position with 1–2 cc iodinated contrast (Omnipague, Nycomed Inc., Princeton, NJ, USA). Injection of 40 mg (n = 75, first phase of study) or 80 mg (n = 45, post-initial analysis) methylprednisolone acetate (Depo-medrone 40 mg/cc, Pfizer, New York, NY, USA) was then performed. Each steroid dose was mixed with 3–4 cc 0.5% bupivocaine (Marcain, AstraZeneca, Wilmington, DE, USA) to ensure the same volume (5 cc) was always injected.

Primary outcome
Efficacy of the IAST was evaluated using the WOMAC V3.0 (Likert) at baseline prior to injection and then at 6 and 12 weeks following injection by telephone interview. All WOMACs were administered by research assistants who were blinded to steroid dose and imaging assessment.

The WOMAC is disease specific and comprises 24 questions assessing three domains associated with hip OA: pain (5 questions), stiffness (2 questions) and disability (functional ability) (17 questions). WOMAC has been designed for use in knee and hip OA populations [10] and has demonstrated appropriate construct validity [14], reliability [15, 16] and responsiveness to change [14, 17, 18]. It has been commonly used in OA clinical trials [19–22] and has been validated for administration by telephone [23].

Strategy for statistical analysis
Data was explored and evaluated for parametric and non-parametric analysis. Those patients lost to follow-up were recorded but not included in the statistical analysis. Assessment of the intra-observer reliability for the radiographic and ultrasound scoring was undertaken using weighted kappas (w{kappa}) and evidence of systematic error was explored using Wilcoxon signed-rank tests. Standard error of the measurement (SEM, 95% CI) was also calculated for each imaging method. WOMAC raw scores were evaluated for their distribution using visual inspection and statistical testing (Kolmogorov–Smirnov test) and found to be significantly skewed. Change in WOMAC scores for each dose at weeks 6 and 12 were undertaken using Wilcoxon signed-rank tests. In order to explore a possible dose effect, comparison of the 40 mg and 80 mg groups was undertaken using Freidman's chi-square ({chi}2), with post hoc comparisons between the 40 mg and the 80 mg doses evaluated using Mann–Whitney U-test at weeks 6 and 12. Correlations between radiographic, ultrasound and WOMAC scores were explored using Spearman's rho ({rho}).

Response prediction
In order to establish factors that may predict a clinically important response to IAST, patients were identified as ‘responders’ if they achieved a greater than 15% reduction in baseline WOMAC score based on the 9–12% minimal perceptible clinical improvement reported in the literature [17, 25]. Differences between doses were analysed using the chi-square test.

Patients were also categorized into two groups based on conventional radiographic assessment (normal/mild has a K-L score of 0–2 and moderate/severe has a K-L score of 3–4) and compared with WOMAC scores. Patients were also categorized into two groups based on ultrasound capsular thickness grading and compared with WOMAC scores: Normal/mild (0 or 1 on the rating scale) and moderate/severe (2 or 3 on the rating scale). Factors such as age, gender, body mass index (BMI), dose of steroid, ultrasound and radiographic features were then analysed for significance in those who where responders compared with non-responders, using either Students’ t-test, chi-square test or Mann–Whitney U-test according to data composition, with correction for multiple comparisons undertaken using the Bonferonni adjustments. The aim of this strategy was to take factors that were found to be statistically significant in the univariate analyses, or those that had been reported to be of significance in the literature, and then enter these into a forward, stepwise, logistical regression model.


   Results
Top
 Abstract
 Introduction
 Materials and methods
 Results
Discussion
 Acknowledgements
 References
 
The baseline characteristics of subjects from both phases of the study are demonstrated in Table 1. Fourteen patients in the 40 mg group and nine in the 80 mg group were lost to follow-up prior to the 6 week data being recorded and were not included in the analysis. Looking at the combined cohorts, conventional radiograph and ultrasound scores did not correlate with baseline WOMAC scores. No fluid was aspirated from any of the hip joints. Joint effusion, iliopsoas bursa and capsular vascularity on power Doppler were absent in all cases. Assessment of the reproducibility of the radiologist's K-L scoring was found to be very good (w{kappa} = 0.873, 95% CI for the SEM ±0.712; Z =–1.633, P = 0.103). Assessment of the reproducibility of the radiologists rating of the US capsular thickness rating was very good (w{kappa} = 0. 0.928, 95% CI for SEM ±0.418; Z = –1.0, P = 0.317) and excellent for the capsular thickness measurement in mm (w{kappa} = 0.982, 95% CI for SEM ±0.549 mm, Z = –1.2, P = 0.230).


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  		TABLE 1. Baseline characteristics for each treatment group

 
Response to intra-articular injection
A summary of the raw WOMAC scores for the 40 mg and 80 mg doses is presented in Table 2.


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  		TABLE 2. Summary of WOMAC raw scores for the 40 and 80 mg group over the study period

 
40 mg dose
There was a significant improvement in the WOMAC pain scores over the 12-week period for the 40 mg dose ({chi}2 = 11.328, df = 2, P = 0.003). There was an improvement in baseline pain from a median score of 12 to a score of 10 at week 6 (Z = –3.895, P < 0.001), which was not evident at week 12, where the median score had returned to 12. There was a significant improvement in the WOMAC stiffness scores over the 12-week period for the 40 mg with a significant improvement from a median score of 5 down to 4 at week 6 (Z = –4.238, P < 0.001). This was maintained at week 12 (Z = –2.042, P = 0.041). While there was a trend for the 40 mg dose to improve WOMAC disability scores, this did not reach statistical significance.

80 mg dose
For the 80 mg dose, there was a significant improvement in WOMAC pain from a median baseline pain score of 12 ({chi}2 = 19.344, df = 2, P < 0.001) to a score of 8 at week 6 (Z = –4.323, P < 0.001) and again at week 12 to a score of 10 (Z = –3.164, P = 0.002). There was also an improvement in baseline stiffness scores over the 12-weeks ({chi}2 = 29.457, df = 2, P < 0.001), from a median score of 5 at week 6 to a score of 4 (Z = –4.6740, P < 0.001) which was maintained at week 12 (Z = –4.048, P = 0.001). On the disability domain, there was a significant improvement over the 12-week period for the 80 mg dose ({chi}2 = 14.770, df = 2, P = 0.001), with an improvement in baseline disability median score of 39 at week 6 to a score of 31 (Z = –4.338, P = 0.001) and again at week 12 to a score of 34.5 (Z = 3.628, P < 0.001).

Comparison between 40 and 80 mg doses
At baseline participant imaging, demographic and WOMAC characteristics were relatively similar for both groups, with the 40 mg group demonstrating a slightly higher baseline stiffness and disability (Table 1). To account for these differences, dose effects were compared using percentage change from baseline rather than raw scores for the WOMAC domains for the dose–response data.

While both the 40 mg and the 80 mg doses improved WOMAC pain, there were no significant differences in WOMAC pain scores between the dose groups at week 6 or week 12 (Fig. 2; U = 1369, P = 0.084 for week 6 and U = 1365, P = 0.115 of week 12). The median percentage change from baseline to week 6 pain scores was 11.8% for 40 mg and 27.3% for 80 mg dose. For week 12, both the 40 mg and the 80 mg reported a median change of 0% from baseline. While there was an improvement in each group for the stiffness domain at week 6 (Fig. 3), there was no significant difference between the two doses (16.6% improvement compared with 25% improvement; U = 1304, P = 0.102). At week 12, the 80 mg dose demonstrated a greater reduction in stiffness of 6.25% compared with no median change in the 40 mg group at week 12 (U = 1150, P = 0.047). For the disability domain, the 80 mg group reported a median change of 19.05% at week 6 (Fig. 4) compared with 9.05% for the 40 mg group (U = 1257, P = 0.026). At week 12, the 40 mg group demonstrated no median change compared with 12.5% for the 80 mg group (U = 1109, P = 0.004).


Figure 2
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  		FIG. 2. Box plots for percentage change in pain in the WOMAC scores between the 40 mg and 80 mg doses for change from baseline to (a) week 6 and (b) week 12. There were no significant differences between the doses at either time point.

 

Figure 3
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  		FIG. 3. Box plots for percentage change in stiffness scores in the WOMAC scores between the 40 mg and 80 mg doses for change from baseline to (a) week 6 and (b) week 12. There was a significant improvement for the 80 mg dose at week 12 compared with the 40 mg dose.

 

Figure 4
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  		FIG. 4. Box plots for percentage change in disability scores in the WOMAC scores between the 40 mg and 80 mg doses for change from baseline to (a) week 6 and (b) week 12. There was a significant improvement in disability scores at both weeks 6 and 12 for the 80 mg dose compared with the 40 mg dose.

 
Response using the clinical significance definition
Dose effect
Forty three of the 75 (57.5%) patients in the 40 mg IAST were classified as responders at week 6, 29 (38.6%) of whom were still responders at week 12. In the 80 mg group, 32 of the 45 (71.1%) patients were considered to be clinical responders at week 6, 19 of whom were still classified as responders at week 12 (42.2%). There were no significant differences in the number of responders at either time point between the 40 and the 80 mg doses.

Predictors of response
The baseline characteristics of the responders and the non-responders are presented in Table 3. The only difference between responders and non-responders at week 6 was BMI: those with a lower BMI had a greater chance of responding compared with those with a higher BMI (t = 2.224, P = 0.028). However, with Bonferronni corrections, this difference was not considered significant. At week 12, while the non-responders tended to have a higher BMI, this did not reach statistical significance. The only statistically significant difference between responders and non-responders at week 12 was that responders demonstrated less stiffness at baseline (Z = 2.019, P = 0.043). While the responders appeared to have less severe imaging findings (lower K-L score) compared with the non-responders at week 12, this was not statistically significant. Forward logistic regression for predictive factors resulted in a model that was unable to predict more than 25% of the response and this strategy was abandoned.


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  		TABLE 3. Baseline characteristics for responders vs non-responders group

 

   Discussion
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
Acknowledgements
 References
 
This pragmatic, clinical study demonstrated a short-term benefit from IAST injection in OA hip patients, with reductions in symptoms with both the 40 and 80 mg doses. A dose response was demonstrated with a higher dose of methylprednisolone (80 mg) being more effective than a 40 mg dose: there were no differences in WOMAC pain for both doses at week 6 and 12, although benefits were seen in terms of stiffness for both groups at week 12 and disability at week 12 using the 80 mg dose.

While the limitations of this pragmatic, clinical study need to be acknowledged, this study informs an area that has had only limited previous research. Few studies have evaluated IAST in OA hip, especially using a recommended outcome measure such as the WOMAC, and few studies have attempted to measure clinically meaningful response.

Previous studies of IAST injection in knee and hip OA have shown a very limited response in terms of pain reduction [2]. Evaluation of knee OA studies has demonstrated significant reductions in visual analogue pain scores of 3–6 weeks duration [4–6]. Series specifically enrolling hip OA have evaluated a range of steroid preparations and doses (20–80 mg triamcinolone and 80 mg methylprednisolone) [1, 7–9]. One report without a control group showed a significant reduction in visual analogue pain score at 12 weeks that was not present at 26 weeks (dose of 80 mg methylprednisolone) [7], consistent with the findings of the present study. Another study evaluated injection of saline, anesthetic only or steroid and anesthetic (20 mg triamcinolone), and reported that the reduction in pain grading for all patients at 4 weeks was not as ‘apparent’ at 12 weeks. However, statistical evaluation was not presented and there was potential for bias as patients were told they would be fast-tracked for hip replacement surgery if they had a poor response [8]. A recent study of 80 patients randomized to receive steroid (80 mg methylprednisolone) only or anesthetic only showed a significant reduction in visual analogue pain scores up to 12 weeks for the steroid group not seen in the anesthetic group [9]. The current study employed a well validated outcome measure and demonstrated statistically significant reduction in pain for the 80 mg dose at 12 weeks with a significant reduction at 6 weeks for both doses. However, this is the first hip OA IAST study to include the concept of minimal clinically important difference (as distinct from statistical difference), and only the reduction in pain at 6 weeks for the 80 mg dose was clinically significant, suggesting a definite dose response. It is worth noting that ~60% of participants were classified as responders using the criteria for minimal clinical important difference.

There are very few studies evaluating the effect of IAST on hip function. One study that compared steroid and anesthetic injection also assessed hip range of motion (by physiotherapist examination) and function (on a semi-quantitative scale) [9]. Range of movement was only assessed once after injection (3 weeks) but showed a significant improvement in the steroid group compared with baseline. Functional assessment showed a statistically significant improvement in only the steroid group at 3 and 12 weeks [9]. Another study of steroid injection including 27 patients with OA measured hip range of motion (by goniometer) and function (using a self developed questionnaire) [7]. Internal rotation was significantly improved at 2 weeks but was no longer significant at 12 weeks. There was no significant improvement in the function scores at any point. The current study evaluated function by using the WOMAC domain for disability. The 80 mg, but not the 40 mg dose, showed a significant decrease in disability scores compared with baseline at weeks 6 and 12. However, only the reduction at week 6 could be classified as clinically significant (19% below baseline compared with 12% at week 12).

Radiographic severity does not seem to correlate with symptoms or response although atrophic radiographic appearances in the hip may indicate a poor response to injection [5, 7]. A letter reviewing 510 patients with hip OA described a poor response in patients with severe radiographic changes. However, statistical evaluation was not presented and outcome was assessed by the patient stating if the pain had or had not improved 8 weeks after injection [26]. In this current series, radiographic severity did not correlate with the severity of symptoms or with any of the outcome measures evaluated.

Although IAST injection is recommended for both inflammatory and mechanical arthritides, it might seem more intuitive that it should be effective where there is more synovial inflammation [1, 2]. Certainly, synovitis is a common component of the whole-organ damage seen in OA, and steroids have a beneficial effect in reducing this [3, 27, 28]. The fact that previous studies have not defined predictors of response to injection may be due to lack of definition of what constituted response, lack of sustained symptomatic response or the absence of significant inflammation. There are conflicting reports on whether clinical signs of inflammation can predict response to injection [4, 5]. Ultrasound was performed in all patients and evaluated anterior osteophytes, joint effusion and capsular Doppler signal as well as grading and measuring capsular thickness. A previous study showed increased hip capsule vascularity on Doppler correlated with vascularity on histological examination [29]. The patients studied included those with a diagnosis of rheumatoid arthritis, and higher scores were seen in this group. We hypothesized that increased capsular thickness on ultrasound may have been an indicator of chronic synovitis but no effusions or increased vascularity on Doppler were detected in association with this feature. However, anterior capsular thickening and the other ultrasound features which may have indicated cartilage damage (osteophytes) also showed no correlation with response or severity of symptoms.

The result of this study must be considered in light of its limitations. This study was a pragmatic, cohort study, where patients were not randomized to treatment nor was the clinician blinded to the treatment dose. A priori sample size calculations were not undertaken and our initial sample for the 40 mg group was made on an estimation of how many patients could be captured within our specified time frame. We ended the trial pragmatically based on our clinical resources; however, this was prior to any data analysis of the 80 mg group. Certainly, a limitation of this study was the lack of a placebo group; however, this was not considered ethical as the patients would have required fluoroscopic exposure as well as injection to remain truly blinded. While the attrition rate within the two arms of the study was consistent between each of the two groups, we did not attempt to include those lost to follow-up in the analysis. While it is possible to undertake statistical modelling to estimate the profile of such people, we considered this to be inappropriate in an observational study of this size. Clearly the profile of such patients needs further consideration. Indeed, one of the main conclusions to be drawn from this study is that further research, including a double-blinded, randomized control trial is necessary in order to address the limitations associated with this pragmatic trial method. The duration of follow-up in our patient group was relatively short; however, the previous literature had not demonstrated any benefit past 12 weeks. Only one other study has assessed patients for a longer duration but this involved a considerably smaller series (30 patients for 26 weeks) [7]. Another limitation was that image assessment was conducted by a single observer. As well, the ultrasound system employed here had a relatively low flow sensitivity compared with Doppler evaluation by larger systems, and may have been insensitive to low levels of inflammation.

This study has shown a positive effect for IAST injection in OA of the hip. The effect was dose related (80 mg methylprednisolone superior to 40 mg dose) and only showed a clinically significant improvement in all domains at 6 weeks, although pain, stiffness and disability showed a statistically significant improvement up to 12 weeks. No imaging (ultrasound or radiographic) features predicted response. Although many radiologists utilize this treatment in OA, the results of this study provide some evidence for steroid dose selection and provide evidence for the limited duration of response. There is a clear need for randomized trials of IAST for OA hip.


   Acknowledgements
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
References
 
The authors would like to acknowledge the contribution of Patricia Duffin, Martin Hampshire, Emma Smith, Rachel Linfoot and Michael Dew of St James University Hospital in collecting data for this study.

The authors have declared no conflicts of interest.


   References
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 

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Submitted 19 September 2005; revised version accepted 19 May 2006.
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I. Atchia, F. Birrell, and D. Kane
A modular, flexible training strategy to achieve competence in diagnostic and interventional musculoskeletal ultrasound in patients with hip osteoarthritis
Rheumatology, October 1, 2007; 46(10): 1583 - 1586.
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