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Shall We Inject Superficial or Deep to the Plantar Fascia? An Ultrasound Study of the Treatment of Chronic Plantar Fasciitis
The Journal of Foot & Ankle Surgery 56 (2017) 783–787
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Shall We Inject Superficial or Deep to the Plantar Fascia? An Ultrasound Study of the Treatment of Chronic Plantar Fasciitis Eda Gurcay, MD 1, Murat Kara, MD 2, Ozgur Zeliha Karaahmet, MD 3, Ays¸e Merve Ata, MD 4, € ¸ akar, MD 6 S¸ule S¸ahin Onat, MD 5, Levent Ozc 1
Associate Professor, Department of Physical and Rehabilitation Medicine, Ankara Dıs¸kapı Yıldırım Beyazıt Education and Research Hospital, Ankara, Turkey Associate Professor, Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey Specialist, Department of Physical and Rehabilitation Medicine, Ankara Dıs¸kapı Yıldırım Beyazıt Education and Research Hospital, Ankara, Turkey 4 Specialist, Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey 5 Associate Professor, Ankara Physical and Rehabilitation Medicine Training and Research Hospital, Ankara, Turkey 6 Professor, Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey 2 3
a r t i c l e i n f o
a b s t r a c t
Level of Clinical Evidence: 2
We compared the effectiveness of ultrasound (US)-guided corticosteroid, injected superficial or deep to the fascia, in patients with plantar fasciitis. Thirty patients (24 females [75%] and 6 males [25%]) with unilateral chronic plantar fasciitis were divided into 2 groups according to the corticosteroid injection site: superficial (n ¼ 15) or deep (n ¼ 15) to the plantar fascia. Patient heel pain was measured using a Likert pain scale and the Foot Ankle Outcome Scale (FAOS) for foot disability, evaluated at baseline and repeated in the first and sixth weeks. The plantar fascia and heel pad thicknesses were assessed on US scans at baseline and the sixth week. The groups were similar in age, gender, and body mass index (p > .05 for all). Compared with the baseline values, the Likert pain scale (p < .001 for all) and FAOS subscale (p < .01 for all) scores had improved at the first and sixth week follow-up visits in both groups. Although the plantar fascia thickness had decreased significantly in both groups at the sixth week (p < .001 for both), the heel pad thickness remained unchanged (p > .05 for both). The difference in the FAOS subscales (pain, p ¼ .002; activities of daily living, p ¼ .003; sports/recreational activities, p ¼ .008; quality of life, p ¼ .009) and plantar fascia thickness (p ¼ .049) showed better improvement in the deep than in the superficial injection group. US-guided corticosteroid injections are safe and effective in the short-term therapeutic outcome of chronic plantar fasciitis. Additionally, injection of corticosteroid deep to the fascia might result in greater reduction in plantar fascia thickness, pain, and disability and improved foot-related quality of life. Ó 2017 by the American College of Foot and Ankle Surgeons. All rights reserved.
Keywords: pain plantar fasciitis steroid injection ultrasonography
Plantar fasciitis is a common cause of heel pain with mild to severe limitations in activities of daily living (ADL) and work (1). Its treatment is mainly conservative and includes pain medication, rest, activity modification, physical therapy, stretching exercises, and the use of heel pads or customized orthotics. Regardless of the treatment type, spontaneous resolution of the symptoms usually occurs within 12 months; however, about 10% of the patients will develop chronic plantar fasciitis. Because of their low cost and complexity and provision of rapid pain relief, local injections have also proved effective, in particular, for refractory cases (2–5). Although palpation-guided injections are in use, considering the relevant complications (e.g., heel
pad atrophy and/or fascial rupture [6]), ultrasound (US) guidance has been recently and effectively used during the procedure (7,8). Despite the variety of applied injectables (i.e., corticosteroids, local anesthetics, hyperosmolar solutions, or even botulinum toxin), the pertinent data lack the answer to the question of where exactly to inject. Accordingly, in the present prospective randomized study, we aimed to compare the effectiveness of US-guided corticosteroid injection administered superficial and deep to the deep plantar fascia in patients with unilateral chronic plantar fasciitis. Moreover, US imaging was used, not only for guidance during the injections, but also for the diagnosis and assessment of the thickness of the symptomatic plantar fasciitis. Patients and Methods
Financial Disclosure: None reported. Conflict of Interest: None reported. Address correspondence to: Ays¸e Merve Ata, MD, Hacettepe University Faculty of Medicine, Department of Physical and Rehabilitation Medicine, Sıhhiye, 06100, Ankara, Turkey. E-mail address: [email protected] (A.M. Ata).
Study Population Subjects who were seen in the outpatient clinic for inferior heel pain from March 2015 to May 2016 were assessed for eligibility. The inclusion criteria were a history of unilateral heel pain with tenderness on the medial side of the calcaneus for 3 months
1067-2516/$ - see front matter Ó 2017 by the American College of Foot and Ankle Surgeons. All rights reserved. http://dx.doi.org/10.1053/j.jfas.2017.03.004
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and persistent symptoms, despite 4 weeks of conservative treatment (nonsteroidal anti-inflammatory drugs and heel pad use) and increased thickness of the plantar fascia (>4 mm) measured on the US scan. The exclusion criteria were a diagnosis of systemic inflammatory disease, previous heel trauma or surgery, and local corticosteroid injection within the previous 12 weeks. The ethics committee of Hacettepe University Medical School (Ankara, Turkey) provided ethical approval for the present study. The patients who met the criteria were enrolled in the present study. The patients were informed about the procedures and consented to participate. A randomized procedure was used in which 2 treatment protocols were distributed evenly in an equal number of sealed envelopes that were opened immediately before injection (i.e., after the patient agreed to participate in the study). The patients were then divided into 2 groups according to the injection site: superficial (n ¼ 15) or deep (n ¼ 15) to the plantar fascia. The demographic data age, gender, and body mass index (BMI) were recorded.
wrapped in a towel was applied for 10 to 15 minutes. The patients were instructed to use the heel pad and not to bear weight on the injected region for 48 hours. Endpoints
The figures and tables were composed by 2 of us (A.M.A., S¸.S¸.O.).
The primary outcome measures were patient self-assessment of heel pain (at rest, in the morning, and during activities) using the categorical Likert pain scale (LPS) with an incremental range of values. The participants were instructed to mark a designated interval, from 0 to 100, in 10-point intervals, with 0 indicating no pain and 100 indicating the worst pain (14–16). The validated Turkish version of the Foot Ankle Outcome Score (FAOS) was used to assess foot disability (17,18). The FAOS consists of 42 items with 5 subscales: pain, other symptoms (e.g., stiffness, swelling, and range of motion), ADL, sport and recreational activities, and foot and ankle-related quality of life. For each question, 5 Likert boxes are used (no, mild, moderate, severe, and extreme), and all items are scored from 0 to 4. Each of the 5 subscale scores is calculated as the sum of the items included. The raw scores are then transformed to 0 to 100 (worst to best). A higher FAOS score indicates an improved condition compared with a lower score. These 2 outcome assessments were performed at baseline and repeated on the first and sixth week follow-up visits by a physician who was unaware of the patient details. The secondary outcome measures included the baseline and sixth week follow-up plantar fascia and heel pad thickness measurements. The patients were followed up for possible complications, including fascial rupture and heel pad atrophy.
Intervention
Statistical Analysis
For US measurement, a 7- to 12-MHz linear probe (Logiq P5; GE Medical Systems, Port Washington, NY) was used. The patients were assessed in the supine position with their ankles in 90 of dorsiflexion. The plantar fasciae were scanned in both short- and long-axis views (Fig.). A thickness of >4 mm (at the calcaneal insertion) was considered abnormal (5,7,8). To support the diagnosis, the presence of abnormal US findings, including fascial hypoechogenicity, power Doppler activity in the fascia, and calcaneal spur and/or calcaneal cortical irregularity were recorded (9–12). The heel pad thickness was also measured at the same reference point to monitor heel pad atrophy after the injections. All injections to the plantar fascia were performed using a medial approach by the same physiatrist (E.G.) with 4 years of experience in injection techniques. Although US guidance enables accurate localization of the injected material, we preferred the medial approach because access to the plantar fascia is easier and less painful compared with the plantar approach (13). A combination of 0.5 mL of betamethasone dipropionate (6.43 mg/mL), betamethasone sodium phosphate (2.63 mg/mL), and 0.5 mL of prilocaine hydrochloride (20 mg/mL) was injected, either superficial or deep to the fascia, using an US-guided direct in-plane approach (Fig.). However, the injection of corticosteroids, together with local anesthetics, decreases the postinjection flare and rapidly relieves pain. Furthermore, local anesthetics also add volume to the injectate and help to distribute the corticosteroid within the area. Thereafter, for pain relief, an ice pack
The data were analyzed using the Statistical Package for the Social Sciences, version 21.0, software (IBM Corp, Armonk, NY). The clinical and US findings were compared within and between the 2 groups. The normality of the distribution was assessed using the Kolmogorov-Smirnov test. For descriptive statistics, the data are presented as the mean standard deviation or median and range for continuous variables, and as the number of cases for nominal variables. The Pearson or Spearman test was selected for correlation analysis between the US measurements of plantar fascia thickness and the other clinical findings. The Student t test (for numerical variables) or chi-square or Fisher’s exact test (for categorical variables) was used to compare the demographic and baseline US findings. Continuous variables were compared using a paired t test or Kruskal-Wallis test within the groups, as appropriate. A post hoc Bonferroni test was used to identify the significant changes in the Kruskal-Wallis test. Delta (D) analyses were also performed using Student’s t test to compare the differences (baseline to follow-up) between the groups. When investigating the effect of treatment, analysis of covariance was used to adjust for differences in baseline values between the groups. A p value .05 was accepted as statistically significant.
Assessors and Other Members of Investigational Team € Patient enrollment and data collection were performed by 2 of us (O.Z.K., E.G.). All US examinations and injection procedures were performed by a single physiatrist (E.G.) € with >4 years of experience in musculoskeletal US. Three of us (E.G., O.Z.K., A.M.A.) served as the outcome assessors. The data analyses were performed by 1 of us (M.K.). € The study design was planned and the report was written by 3 of us (E.G., M.K., L.O.).
Fig. Long axis, plantar image (Left) demonstrating swollen fascia at the calcaneal (cal) attachment site. Longitudinal image of plantar fasciitis with cursor markers indicating the thickness of fascia (short arrow) and heel pad (long arrow). Also note the epin calcanei (asterisk) with an abrupt acoustic shadowing (arrowhead). During the interventions (Right), the injectate was given either superficial (A) or deep (B) to the fascia.
Results Overall, 32 patients were enrolled; however, 2 patients (6%) could not complete the present study (because of transport problems). Thus, 30 patients (24 females [80%] and 6 males [20%]) were included in the analyses. No serious complication, such as heel fat pad atrophy or plantar fascia rupture, was encountered during the study follow-up period. The demographic and US findings of the groups are listed in Table 1. The 2 groups were similar regarding age, gender, BMI, and presence of any abnormal US findings at baseline, except for the presence of Doppler activity. Overall, the plantar fascia thickness correlated positively only with the LPS morning scores (r ¼ 0.384; p ¼ .036). The clinical assessments, including LPS scores and FAOS subscale scores, are summarized in Tables 2 and 3. When the LPS (at rest, morning, and activity) and FAOS scores were compared within groups, statistically significant differences were found (LPS, p < .001 for all; FAOS subscale, p < .01 for all) in both groups. The post hoc Bonferroni tests revealed significant differences between the baseline values and the other assessments. The latter 2 assessments were similar (p > .05 for all). Although the plantar fascia thickness had decreased significantly in both groups at the sixth week (p < .001 for both). The heel pad thickness remained unchanged (p > .05 for both; Table 4). In both groups, the plantar fascia thickness in 6 patients had decreased to 4 mm at the sixth week (p > .05). The results of the delta (D) analyses are also listed in Tables 2–4. The difference in the FAOS subscales (pain, p ¼ .002; ADL, p ¼ .003; sport/recreational activities, p ¼ .008; quality of life, p ¼ .009; plantar
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Table 1 Demographic and baseline ultrasound findings
Age (y) Female gender BMI (kg/m2) Abnormal US findings Fascial hypoechogenicity Doppler activity Cortical irregularity Calcaneal spur
Superficial Group (n ¼ 15)
Deep Group (n ¼ 15)
p Value
52.5 12.2 10 (67) 31.1 3.5 13 (87) 10 (67) 5 (33) 3 (20) 9 (60)
46.2 7.6 14 (93) 33.5 4.6 10 (67) 7 (47) 0 (0) 7 (47) 4 (27)
.103 .169 .125 .390 .269 .042* .121 .065
fascia thickness, p ¼ .049) showed greater improvement in the deep than in the superficial injection group (Tables 3 and 4).
Discussion The present study has revealed that US-guided corticosteroid injections provide safe and effective therapeutic outcomes (improving plantar fascia thickness, pain, disability, and quality of life) in chronic plantar fasciitis and that injections deep to the fascia might provide better improvement in these parameters. The main problem in the pathogenesis of plantar fasciitis is thought to ensue at the attachment site and to be more predominant on the deep aspect of the fascia (19–24). Abnormal thickening occurs because of increased secretion of ground substance proteins such as proteoglycans and proliferation of fibroblasts, subsequent tissue edema, and enthesopathy (often associated with adjacent bony edema and new bone formation) (25). In addition, some evidence has shown that therapeutic intervention is more likely to be successful when bone edema is also present (15,23,24). In that sense, corticosteroids have been reported to reduce plantar fascia thickness and decrease edema (26). Furthermore, it has been suggested that proximal tendinopathy of the flexor digitorum brevis muscle (which is Table 2 Likert pain scale score changes within groups and delta (D) changes (baseline to sixth week) between groups LPS LPS - Rest Baseline First week Sixth week p value D change LPS - Morning Baseline First week Sixth week p value D change LPS - Activity Baseline First week Sixth week p value D change
Superficial Group (n ¼ 15)
Deep Group (n ¼ 15)
p Value
20 (0–90)* 0 (0–80) 0 (0–60)y <.001z 20 (0–50)
30 (0–80)* 0 (0–60)y 0 (0–50)y <.001z 30 (0–70)
.891 .456 .251
90 (60–100)* 50 (10–80) 40 (10–80) <.001z 50 (10–90)
90 (40–100)* 30 (0–80) 30 (0–60) <.001z 60 (30–80)
*
80 (50–90) 40 (10–80) 20 (0–60) <.001z 60 (0–80)
75 (40–90) 20 (0–60) 20 (0–50) <.001z 50 (20–70)
.522
*
Table 3 Foot and Ankle Outcome Scale score changes within the groups and delta (D) changes (baseline to sixth week) between groups FAOS*
Abbreviations: BMI, body mass index; US, ultrasound. Data presented as n (%) or mean standard deviation. * Statistically significant difference.
.949 .038z .196 .228 .186 .004z .189 .799
Abbreviation: LPS, Likert pain scale. Data presented as median (range). * Significant difference occurred from the baseline assessment among the three measurements. y Data were not normally distributed. z Statistically significant difference.
785
Superficial Group (n ¼ 15)
Pain Baseline 51.5 8.1y First week 66.5 11.7 Sixth week 70.0 13.1 p value <.001z D change 18.5 14.9 Other symptoms Baseline 90.3 10.1y First week 94.2 7.7 Sixth week 94.2 7.8 p value .001z D change 4.3 4.7 ADL Baseline 50.6 12.6y First week 65.3 14.3 Sixth week 67.2 14.1 p value <.001z D change 16.6 11.1 Sports/recreational activities Baseline 36.0 19.3y First week 44.0 10.4 Sixth week 46.3 10.4 p value .006z D change 10.3 20.1 QOL Baseline 34.6 17.3y First week 53.8 14.3 Sixth week 56.7 14.5 p value <.001z D change 22.1 21.8
Deep Group (n ¼ 15) 45.2 80.2 81.9 <.001z 36.7 90.5 92.9 93.3 .002z 2.8
p Value
12.1y 11.5 7.6
.104 .003z .006z
15.0
.002z
11.7y 9.5 9.3
.951 .651 .704
3.6
.354 y
47.1 74.9 77.5 <.001z 30.4
10.3 10.0 8.6 12.5
.003z
26.7 63.3 55.9 <.001z 29.3
16.0y 17.5 21.7
.160 .008z .105
16.4
.008z
31.3 71.7 74.4 <.001z 43.2
15.0y 15.6 10.9
.577 .003z .001z
19.5
.009z
.407 .041z .023z
Abbreviations: ADL, activities of daily living; FAOS, Foot and Ankle Outcome Scale; QOL, quality of life. Data presented as mean standard deviation. * A higher FAOS score indicates an improved condition compared with a lower score. y A statistically significant difference occurred from the baseline assessment among the 3 measurements. z Statistically significant difference.
deep to the plantar fascia) is implicated in the pathology of plantar fasciitis (27). The best location for the injectate is as yet unclear; thus, the relevant published studies lack data regarding whether injecting superficial or deep to the fascia results in any difference. Moreover, in some studies, corticosteroid, platelet-rich plasma, or botulinum toxin injections were even administered directly into the fascial substance (8–10,26,28–30). Superficial plantar fascia injections have been
Table 4 Comparison of ultrasound measurements and delta (D) changes between groups Thickness (mm) Plantar fascia Baseline Sixth week p value D change ANCOVAy Heel pad Baseline Sixth week p value D change ANCOVA
Superficial Group (n ¼ 15)
Deep Group (n ¼ 15)
p Value
5.1 0.6 4.3 0.5 <.001* 0.8 0.3
5.3 0.6 4.2 0.4 <.001* 1.1 0.5
.475 .431
1.5 0.4 1.4 0.4 .163 0.1 0.2
1.1 0.2 1.1 0.2 .468 0.0 0.1
.052 .049* .002* .012* .113 .452
Abbreviation: ANCOVA, analysis of covariance. Data presented as mean standard deviation. * Statistically significant difference. y Used to adjust for differences in baseline values between groups to investigate the treatment effect.
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advocated by some investigators such that the injectate is placed between the superficial plantar fascia and the overlying heel pad using US guidance (11,31). McNally and Shetty (32) recently advocated an US-guided deep plantar fascia injection technique in which the needle is advanced adjacent to the deep side of the plantar fascia. In our study, we performed the injections either superficial or deep to the fascial borders but never directly into the fascia. Our results showed a reduction in plantar fascia thickening that was more predominant with the deep approach. We consider this finding to be quite consistent with the cited suggestion that the deep part of the fascia is the actual and/or initial area of the inflammatory process. It has been explained in the published data that a high BMI causes an increase in vertical forces, leading to plantar pressure and repetitive microtears and subsequent inflammation (33). Additionally, patients usually describe first step heel pain in the morning (6,34). Likewise, our findings of increased pain in foot disability with higher BMI values and increased first step pain with thicker plantar fascia seem to support this idea. The US examination of the heel is very sensitive and specific in the diagnosis of plantar fasciitis (34); thus, it is also very convenient for serial follow-up examinations. Hypoechoic and swollen fascia (7,10,29,31), often accompanied by calcaneal spurs (35–37), is the most commonly encountered finding, and our results were in accordance with previous studies. The hypoechoic echotexture with loss of the fibrillar pattern and blurring of the superficial and deep borders of the fascia reflect the presence of fascial edema. In 40% of patients affected by acute plantar fasciitis, Doppler imaging can reveal hyperemia in the fascia. Often, a calcaneal spur is found on the inferior aspect of the calcaneus related to a phenomenon reactive to increased tensile forces at the enthesis (38). Furthermore, US guidance can also be useful to help avoid the occurrence of relevant complications. If corticosteroid is injected into the superficial fascia, some can remain in the subcutaneous fat and can lead to heel pad atrophy. The most commonly reported US-guided plantar fascia injection technique is intrafascial, which carry a risk of plantar fascia rupture. However, injecting corticosteroid close to the plantar fascia insertion, deep to the superficial fascia, the corticosteroid will largely remain in the deep compartment and would simultaneously minimize the potential adverse effects of fat pad atrophy (30). In our study, none of these complications were observed. Therefore, our results seem to appear to favor the use of US guidance with these injections. Injection of corticosteroid usually results in short-term pain relief, lasting 4 to 12 (average 6) weeks in duration (39). Therefore, we have taken 6 weeks as the primary efficacy endpoint. Some reports have also reported that facial rupture or plantar fat pad atrophy ensues 3 months after a corticosteroid injection (40). Accordingly, 1 of the limitations of our study was that the treatment outcome was assessed only at a 6-week follow-up visit. As such, we had no data regarding the long-term benefits or side effects of the treatments. Another issue was the use of FAOS scores to assess foot and ankle disability, which includes standardized answers in 5 Likert boxes. Because it is not an analog scale, it might predispose the results to a type 2 statistical error. Our use of a Likert-type pain scale and small sample size also could have limited our ability to identify a statistically significant difference in pain relief between the treatment groups. Nonetheless, we believe that our prospective randomized study describes a novel perspective regarding how to perform steroid injections precisely to the plantar fascia. In conclusion, we believe that our first and preliminary results show that US-guided corticosteroid injections are safe and effective in the short-term therapeutic outcomes of chronic plantar fasciitis. Additionally, injections deep to the fascia might result in better improvement in pain, disability, and fascia thickness. Finally, studies
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Shall We Inject Superficial or Deep to the Plantar Fascia? An Ultrasound Study of the Treatment of Chronic Plantar Fasciitis Eda Gurcay, MD 1, Murat Kara, MD 2, Ozgur Zeliha Karaahmet, MD 3, Ays¸e Merve Ata, MD 4, € ¸ akar, MD 6 S¸ule S¸ahin Onat, MD 5, Levent Ozc 1
Associate Professor, Department of Physical and Rehabilitation Medicine, Ankara Dıs¸kapı Yıldırım Beyazıt Education and Research Hospital, Ankara, Turkey Associate Professor, Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey Specialist, Department of Physical and Rehabilitation Medicine, Ankara Dıs¸kapı Yıldırım Beyazıt Education and Research Hospital, Ankara, Turkey 4 Specialist, Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey 5 Associate Professor, Ankara Physical and Rehabilitation Medicine Training and Research Hospital, Ankara, Turkey 6 Professor, Department of Physical and Rehabilitation Medicine, Hacettepe University Medical School, Ankara, Turkey 2 3
a r t i c l e i n f o
a b s t r a c t
Level of Clinical Evidence: 2
We compared the effectiveness of ultrasound (US)-guided corticosteroid, injected superficial or deep to the fascia, in patients with plantar fasciitis. Thirty patients (24 females [75%] and 6 males [25%]) with unilateral chronic plantar fasciitis were divided into 2 groups according to the corticosteroid injection site: superficial (n ¼ 15) or deep (n ¼ 15) to the plantar fascia. Patient heel pain was measured using a Likert pain scale and the Foot Ankle Outcome Scale (FAOS) for foot disability, evaluated at baseline and repeated in the first and sixth weeks. The plantar fascia and heel pad thicknesses were assessed on US scans at baseline and the sixth week. The groups were similar in age, gender, and body mass index (p > .05 for all). Compared with the baseline values, the Likert pain scale (p < .001 for all) and FAOS subscale (p < .01 for all) scores had improved at the first and sixth week follow-up visits in both groups. Although the plantar fascia thickness had decreased significantly in both groups at the sixth week (p < .001 for both), the heel pad thickness remained unchanged (p > .05 for both). The difference in the FAOS subscales (pain, p ¼ .002; activities of daily living, p ¼ .003; sports/recreational activities, p ¼ .008; quality of life, p ¼ .009) and plantar fascia thickness (p ¼ .049) showed better improvement in the deep than in the superficial injection group. US-guided corticosteroid injections are safe and effective in the short-term therapeutic outcome of chronic plantar fasciitis. Additionally, injection of corticosteroid deep to the fascia might result in greater reduction in plantar fascia thickness, pain, and disability and improved foot-related quality of life. Ó 2017 by the American College of Foot and Ankle Surgeons. All rights reserved.
Keywords: pain plantar fasciitis steroid injection ultrasonography
Plantar fasciitis is a common cause of heel pain with mild to severe limitations in activities of daily living (ADL) and work (1). Its treatment is mainly conservative and includes pain medication, rest, activity modification, physical therapy, stretching exercises, and the use of heel pads or customized orthotics. Regardless of the treatment type, spontaneous resolution of the symptoms usually occurs within 12 months; however, about 10% of the patients will develop chronic plantar fasciitis. Because of their low cost and complexity and provision of rapid pain relief, local injections have also proved effective, in particular, for refractory cases (2–5). Although palpation-guided injections are in use, considering the relevant complications (e.g., heel
pad atrophy and/or fascial rupture [6]), ultrasound (US) guidance has been recently and effectively used during the procedure (7,8). Despite the variety of applied injectables (i.e., corticosteroids, local anesthetics, hyperosmolar solutions, or even botulinum toxin), the pertinent data lack the answer to the question of where exactly to inject. Accordingly, in the present prospective randomized study, we aimed to compare the effectiveness of US-guided corticosteroid injection administered superficial and deep to the deep plantar fascia in patients with unilateral chronic plantar fasciitis. Moreover, US imaging was used, not only for guidance during the injections, but also for the diagnosis and assessment of the thickness of the symptomatic plantar fasciitis. Patients and Methods
Financial Disclosure: None reported. Conflict of Interest: None reported. Address correspondence to: Ays¸e Merve Ata, MD, Hacettepe University Faculty of Medicine, Department of Physical and Rehabilitation Medicine, Sıhhiye, 06100, Ankara, Turkey. E-mail address: [email protected] (A.M. Ata).
Study Population Subjects who were seen in the outpatient clinic for inferior heel pain from March 2015 to May 2016 were assessed for eligibility. The inclusion criteria were a history of unilateral heel pain with tenderness on the medial side of the calcaneus for 3 months
1067-2516/$ - see front matter Ó 2017 by the American College of Foot and Ankle Surgeons. All rights reserved. http://dx.doi.org/10.1053/j.jfas.2017.03.004
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and persistent symptoms, despite 4 weeks of conservative treatment (nonsteroidal anti-inflammatory drugs and heel pad use) and increased thickness of the plantar fascia (>4 mm) measured on the US scan. The exclusion criteria were a diagnosis of systemic inflammatory disease, previous heel trauma or surgery, and local corticosteroid injection within the previous 12 weeks. The ethics committee of Hacettepe University Medical School (Ankara, Turkey) provided ethical approval for the present study. The patients who met the criteria were enrolled in the present study. The patients were informed about the procedures and consented to participate. A randomized procedure was used in which 2 treatment protocols were distributed evenly in an equal number of sealed envelopes that were opened immediately before injection (i.e., after the patient agreed to participate in the study). The patients were then divided into 2 groups according to the injection site: superficial (n ¼ 15) or deep (n ¼ 15) to the plantar fascia. The demographic data age, gender, and body mass index (BMI) were recorded.
wrapped in a towel was applied for 10 to 15 minutes. The patients were instructed to use the heel pad and not to bear weight on the injected region for 48 hours. Endpoints
The figures and tables were composed by 2 of us (A.M.A., S¸.S¸.O.).
The primary outcome measures were patient self-assessment of heel pain (at rest, in the morning, and during activities) using the categorical Likert pain scale (LPS) with an incremental range of values. The participants were instructed to mark a designated interval, from 0 to 100, in 10-point intervals, with 0 indicating no pain and 100 indicating the worst pain (14–16). The validated Turkish version of the Foot Ankle Outcome Score (FAOS) was used to assess foot disability (17,18). The FAOS consists of 42 items with 5 subscales: pain, other symptoms (e.g., stiffness, swelling, and range of motion), ADL, sport and recreational activities, and foot and ankle-related quality of life. For each question, 5 Likert boxes are used (no, mild, moderate, severe, and extreme), and all items are scored from 0 to 4. Each of the 5 subscale scores is calculated as the sum of the items included. The raw scores are then transformed to 0 to 100 (worst to best). A higher FAOS score indicates an improved condition compared with a lower score. These 2 outcome assessments were performed at baseline and repeated on the first and sixth week follow-up visits by a physician who was unaware of the patient details. The secondary outcome measures included the baseline and sixth week follow-up plantar fascia and heel pad thickness measurements. The patients were followed up for possible complications, including fascial rupture and heel pad atrophy.
Intervention
Statistical Analysis
For US measurement, a 7- to 12-MHz linear probe (Logiq P5; GE Medical Systems, Port Washington, NY) was used. The patients were assessed in the supine position with their ankles in 90 of dorsiflexion. The plantar fasciae were scanned in both short- and long-axis views (Fig.). A thickness of >4 mm (at the calcaneal insertion) was considered abnormal (5,7,8). To support the diagnosis, the presence of abnormal US findings, including fascial hypoechogenicity, power Doppler activity in the fascia, and calcaneal spur and/or calcaneal cortical irregularity were recorded (9–12). The heel pad thickness was also measured at the same reference point to monitor heel pad atrophy after the injections. All injections to the plantar fascia were performed using a medial approach by the same physiatrist (E.G.) with 4 years of experience in injection techniques. Although US guidance enables accurate localization of the injected material, we preferred the medial approach because access to the plantar fascia is easier and less painful compared with the plantar approach (13). A combination of 0.5 mL of betamethasone dipropionate (6.43 mg/mL), betamethasone sodium phosphate (2.63 mg/mL), and 0.5 mL of prilocaine hydrochloride (20 mg/mL) was injected, either superficial or deep to the fascia, using an US-guided direct in-plane approach (Fig.). However, the injection of corticosteroids, together with local anesthetics, decreases the postinjection flare and rapidly relieves pain. Furthermore, local anesthetics also add volume to the injectate and help to distribute the corticosteroid within the area. Thereafter, for pain relief, an ice pack
The data were analyzed using the Statistical Package for the Social Sciences, version 21.0, software (IBM Corp, Armonk, NY). The clinical and US findings were compared within and between the 2 groups. The normality of the distribution was assessed using the Kolmogorov-Smirnov test. For descriptive statistics, the data are presented as the mean standard deviation or median and range for continuous variables, and as the number of cases for nominal variables. The Pearson or Spearman test was selected for correlation analysis between the US measurements of plantar fascia thickness and the other clinical findings. The Student t test (for numerical variables) or chi-square or Fisher’s exact test (for categorical variables) was used to compare the demographic and baseline US findings. Continuous variables were compared using a paired t test or Kruskal-Wallis test within the groups, as appropriate. A post hoc Bonferroni test was used to identify the significant changes in the Kruskal-Wallis test. Delta (D) analyses were also performed using Student’s t test to compare the differences (baseline to follow-up) between the groups. When investigating the effect of treatment, analysis of covariance was used to adjust for differences in baseline values between the groups. A p value .05 was accepted as statistically significant.
Assessors and Other Members of Investigational Team € Patient enrollment and data collection were performed by 2 of us (O.Z.K., E.G.). All US examinations and injection procedures were performed by a single physiatrist (E.G.) € with >4 years of experience in musculoskeletal US. Three of us (E.G., O.Z.K., A.M.A.) served as the outcome assessors. The data analyses were performed by 1 of us (M.K.). € The study design was planned and the report was written by 3 of us (E.G., M.K., L.O.).
Fig. Long axis, plantar image (Left) demonstrating swollen fascia at the calcaneal (cal) attachment site. Longitudinal image of plantar fasciitis with cursor markers indicating the thickness of fascia (short arrow) and heel pad (long arrow). Also note the epin calcanei (asterisk) with an abrupt acoustic shadowing (arrowhead). During the interventions (Right), the injectate was given either superficial (A) or deep (B) to the fascia.
Results Overall, 32 patients were enrolled; however, 2 patients (6%) could not complete the present study (because of transport problems). Thus, 30 patients (24 females [80%] and 6 males [20%]) were included in the analyses. No serious complication, such as heel fat pad atrophy or plantar fascia rupture, was encountered during the study follow-up period. The demographic and US findings of the groups are listed in Table 1. The 2 groups were similar regarding age, gender, BMI, and presence of any abnormal US findings at baseline, except for the presence of Doppler activity. Overall, the plantar fascia thickness correlated positively only with the LPS morning scores (r ¼ 0.384; p ¼ .036). The clinical assessments, including LPS scores and FAOS subscale scores, are summarized in Tables 2 and 3. When the LPS (at rest, morning, and activity) and FAOS scores were compared within groups, statistically significant differences were found (LPS, p < .001 for all; FAOS subscale, p < .01 for all) in both groups. The post hoc Bonferroni tests revealed significant differences between the baseline values and the other assessments. The latter 2 assessments were similar (p > .05 for all). Although the plantar fascia thickness had decreased significantly in both groups at the sixth week (p < .001 for both). The heel pad thickness remained unchanged (p > .05 for both; Table 4). In both groups, the plantar fascia thickness in 6 patients had decreased to 4 mm at the sixth week (p > .05). The results of the delta (D) analyses are also listed in Tables 2–4. The difference in the FAOS subscales (pain, p ¼ .002; ADL, p ¼ .003; sport/recreational activities, p ¼ .008; quality of life, p ¼ .009; plantar
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Table 1 Demographic and baseline ultrasound findings
Age (y) Female gender BMI (kg/m2) Abnormal US findings Fascial hypoechogenicity Doppler activity Cortical irregularity Calcaneal spur
Superficial Group (n ¼ 15)
Deep Group (n ¼ 15)
p Value
52.5 12.2 10 (67) 31.1 3.5 13 (87) 10 (67) 5 (33) 3 (20) 9 (60)
46.2 7.6 14 (93) 33.5 4.6 10 (67) 7 (47) 0 (0) 7 (47) 4 (27)
.103 .169 .125 .390 .269 .042* .121 .065
fascia thickness, p ¼ .049) showed greater improvement in the deep than in the superficial injection group (Tables 3 and 4).
Discussion The present study has revealed that US-guided corticosteroid injections provide safe and effective therapeutic outcomes (improving plantar fascia thickness, pain, disability, and quality of life) in chronic plantar fasciitis and that injections deep to the fascia might provide better improvement in these parameters. The main problem in the pathogenesis of plantar fasciitis is thought to ensue at the attachment site and to be more predominant on the deep aspect of the fascia (19–24). Abnormal thickening occurs because of increased secretion of ground substance proteins such as proteoglycans and proliferation of fibroblasts, subsequent tissue edema, and enthesopathy (often associated with adjacent bony edema and new bone formation) (25). In addition, some evidence has shown that therapeutic intervention is more likely to be successful when bone edema is also present (15,23,24). In that sense, corticosteroids have been reported to reduce plantar fascia thickness and decrease edema (26). Furthermore, it has been suggested that proximal tendinopathy of the flexor digitorum brevis muscle (which is Table 2 Likert pain scale score changes within groups and delta (D) changes (baseline to sixth week) between groups LPS LPS - Rest Baseline First week Sixth week p value D change LPS - Morning Baseline First week Sixth week p value D change LPS - Activity Baseline First week Sixth week p value D change
Superficial Group (n ¼ 15)
Deep Group (n ¼ 15)
p Value
20 (0–90)* 0 (0–80) 0 (0–60)y <.001z 20 (0–50)
30 (0–80)* 0 (0–60)y 0 (0–50)y <.001z 30 (0–70)
.891 .456 .251
90 (60–100)* 50 (10–80) 40 (10–80) <.001z 50 (10–90)
90 (40–100)* 30 (0–80) 30 (0–60) <.001z 60 (30–80)
*
80 (50–90) 40 (10–80) 20 (0–60) <.001z 60 (0–80)
75 (40–90) 20 (0–60) 20 (0–50) <.001z 50 (20–70)
.522
*
Table 3 Foot and Ankle Outcome Scale score changes within the groups and delta (D) changes (baseline to sixth week) between groups FAOS*
Abbreviations: BMI, body mass index; US, ultrasound. Data presented as n (%) or mean standard deviation. * Statistically significant difference.
.949 .038z .196 .228 .186 .004z .189 .799
Abbreviation: LPS, Likert pain scale. Data presented as median (range). * Significant difference occurred from the baseline assessment among the three measurements. y Data were not normally distributed. z Statistically significant difference.
785
Superficial Group (n ¼ 15)
Pain Baseline 51.5 8.1y First week 66.5 11.7 Sixth week 70.0 13.1 p value <.001z D change 18.5 14.9 Other symptoms Baseline 90.3 10.1y First week 94.2 7.7 Sixth week 94.2 7.8 p value .001z D change 4.3 4.7 ADL Baseline 50.6 12.6y First week 65.3 14.3 Sixth week 67.2 14.1 p value <.001z D change 16.6 11.1 Sports/recreational activities Baseline 36.0 19.3y First week 44.0 10.4 Sixth week 46.3 10.4 p value .006z D change 10.3 20.1 QOL Baseline 34.6 17.3y First week 53.8 14.3 Sixth week 56.7 14.5 p value <.001z D change 22.1 21.8
Deep Group (n ¼ 15) 45.2 80.2 81.9 <.001z 36.7 90.5 92.9 93.3 .002z 2.8
p Value
12.1y 11.5 7.6
.104 .003z .006z
15.0
.002z
11.7y 9.5 9.3
.951 .651 .704
3.6
.354 y
47.1 74.9 77.5 <.001z 30.4
10.3 10.0 8.6 12.5
.003z
26.7 63.3 55.9 <.001z 29.3
16.0y 17.5 21.7
.160 .008z .105
16.4
.008z
31.3 71.7 74.4 <.001z 43.2
15.0y 15.6 10.9
.577 .003z .001z
19.5
.009z
.407 .041z .023z
Abbreviations: ADL, activities of daily living; FAOS, Foot and Ankle Outcome Scale; QOL, quality of life. Data presented as mean standard deviation. * A higher FAOS score indicates an improved condition compared with a lower score. y A statistically significant difference occurred from the baseline assessment among the 3 measurements. z Statistically significant difference.
deep to the plantar fascia) is implicated in the pathology of plantar fasciitis (27). The best location for the injectate is as yet unclear; thus, the relevant published studies lack data regarding whether injecting superficial or deep to the fascia results in any difference. Moreover, in some studies, corticosteroid, platelet-rich plasma, or botulinum toxin injections were even administered directly into the fascial substance (8–10,26,28–30). Superficial plantar fascia injections have been
Table 4 Comparison of ultrasound measurements and delta (D) changes between groups Thickness (mm) Plantar fascia Baseline Sixth week p value D change ANCOVAy Heel pad Baseline Sixth week p value D change ANCOVA
Superficial Group (n ¼ 15)
Deep Group (n ¼ 15)
p Value
5.1 0.6 4.3 0.5 <.001* 0.8 0.3
5.3 0.6 4.2 0.4 <.001* 1.1 0.5
.475 .431
1.5 0.4 1.4 0.4 .163 0.1 0.2
1.1 0.2 1.1 0.2 .468 0.0 0.1
.052 .049* .002* .012* .113 .452
Abbreviation: ANCOVA, analysis of covariance. Data presented as mean standard deviation. * Statistically significant difference. y Used to adjust for differences in baseline values between groups to investigate the treatment effect.
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advocated by some investigators such that the injectate is placed between the superficial plantar fascia and the overlying heel pad using US guidance (11,31). McNally and Shetty (32) recently advocated an US-guided deep plantar fascia injection technique in which the needle is advanced adjacent to the deep side of the plantar fascia. In our study, we performed the injections either superficial or deep to the fascial borders but never directly into the fascia. Our results showed a reduction in plantar fascia thickening that was more predominant with the deep approach. We consider this finding to be quite consistent with the cited suggestion that the deep part of the fascia is the actual and/or initial area of the inflammatory process. It has been explained in the published data that a high BMI causes an increase in vertical forces, leading to plantar pressure and repetitive microtears and subsequent inflammation (33). Additionally, patients usually describe first step heel pain in the morning (6,34). Likewise, our findings of increased pain in foot disability with higher BMI values and increased first step pain with thicker plantar fascia seem to support this idea. The US examination of the heel is very sensitive and specific in the diagnosis of plantar fasciitis (34); thus, it is also very convenient for serial follow-up examinations. Hypoechoic and swollen fascia (7,10,29,31), often accompanied by calcaneal spurs (35–37), is the most commonly encountered finding, and our results were in accordance with previous studies. The hypoechoic echotexture with loss of the fibrillar pattern and blurring of the superficial and deep borders of the fascia reflect the presence of fascial edema. In 40% of patients affected by acute plantar fasciitis, Doppler imaging can reveal hyperemia in the fascia. Often, a calcaneal spur is found on the inferior aspect of the calcaneus related to a phenomenon reactive to increased tensile forces at the enthesis (38). Furthermore, US guidance can also be useful to help avoid the occurrence of relevant complications. If corticosteroid is injected into the superficial fascia, some can remain in the subcutaneous fat and can lead to heel pad atrophy. The most commonly reported US-guided plantar fascia injection technique is intrafascial, which carry a risk of plantar fascia rupture. However, injecting corticosteroid close to the plantar fascia insertion, deep to the superficial fascia, the corticosteroid will largely remain in the deep compartment and would simultaneously minimize the potential adverse effects of fat pad atrophy (30). In our study, none of these complications were observed. Therefore, our results seem to appear to favor the use of US guidance with these injections. Injection of corticosteroid usually results in short-term pain relief, lasting 4 to 12 (average 6) weeks in duration (39). Therefore, we have taken 6 weeks as the primary efficacy endpoint. Some reports have also reported that facial rupture or plantar fat pad atrophy ensues 3 months after a corticosteroid injection (40). Accordingly, 1 of the limitations of our study was that the treatment outcome was assessed only at a 6-week follow-up visit. As such, we had no data regarding the long-term benefits or side effects of the treatments. Another issue was the use of FAOS scores to assess foot and ankle disability, which includes standardized answers in 5 Likert boxes. Because it is not an analog scale, it might predispose the results to a type 2 statistical error. Our use of a Likert-type pain scale and small sample size also could have limited our ability to identify a statistically significant difference in pain relief between the treatment groups. Nonetheless, we believe that our prospective randomized study describes a novel perspective regarding how to perform steroid injections precisely to the plantar fascia. In conclusion, we believe that our first and preliminary results show that US-guided corticosteroid injections are safe and effective in the short-term therapeutic outcomes of chronic plantar fasciitis. Additionally, injections deep to the fascia might result in better improvement in pain, disability, and fascia thickness. Finally, studies
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