Plantar fasciopathy (PF) is a common cause of heel pain involving the plantar fascia and accounts for approximately one million patient visits in the United States.1 Because the disorder is likely to be degenerative rather than inflammatory in nature, “fasciopathy” may be more precise than the commonly used term, “plantar fasciitis.”2 Plantar fasciopathy is a self-limiting disease that usually resolves within 10 mos.3 Stretching exercises of the plantar fascia and calf muscles, heel silicon insoles, night splints, and extracorporeal shock wave therapy of the plantar fascia are among the noninterventional treatments.4 However, previous studies have shown that these treatments have diverse outcomes; approximately 10% of patients do not benefit from them at all and progress to chronic status.4
Corticosteroid (CS) injection into the plantar fascia results in rapid pain relief and is therefore commonly used to treat patients with PF.5 However, its effect is short, with an efficacy of between 4 and 12 wks.5 In addition, its potential complications, including heel pad atrophy and plantar fascia rupture, raise further concerns regarding this treatment method, limiting its use.6
Although the etiology of PF is not clear, it is considered to be multifactorial. One important factor may be myxoid degeneration with fragmentation and chronic inflammatory changes in the plantar fascia.7 This supports the proposed theory that the tensile load over the plantar fascia leads to recurrent microtrauma, resulting in a degenerative process at the origin of the plantar fascia over the medial tuberosity of the calcaneus.
Considering the degenerative nature of PF, autologous blood-derived products (ABPs), including whole blood (WB) and platelet-rich plasma (PRP), may be beneficial for PF patients. These products carry bioactive molecules to the lesion site and modulate processes such as inflammation, angiogenesis, cell migration, and metabolism.8
Whole blood is autologous blood that contains platelets, which can release platelet-derived growth factors to promote the healing process. However, the effect of these growth factors may be influenced by other blood cell types in WB, such as red blood cells and leukocytes.9 Platelet-rich plasma is autologous plasma with concentrated platelets centrifuged from autologous blood. It promotes the release of a variety of growth factors and enhances tissue healing.10 Although ABP has been shown to improve PF outcomes,11 the relative efficacy of PRP versus WB is controversial.
Platelet-rich plasma induces cellular anabolism and regeneration through cytokines, as well as growth factors that are involved in chemotaxis, cell proliferation and maturation, and modulation of inflammatory molecules, thus promoting wound healing.8 Different PRP preparation methods may affect the quality of PRP and concentration of blood components, thus influencing the treatment outcome. The initial separation technique divides the red blood cells, whereas the subsequent separation concentrates the platelets and other components. The platelet and leukocyte concentrations of the one-step separation procedure are generally lower than those in the two-step procedure,10 which may be beneficial.12 However, the optimal injected volume of PRP, efficacy of injecting local anesthetic with PRP, and platelet and leukocyte concentrations to treat PF remain uncertain. Moreover, the efficacy of commercial PRP preparation systems has not been compared with that of a self-prepared PRP preparation technique.
This meta-analysis aimed to compare the efficacy of ABP (including WB and PRP) to CS by comparing refractory PF-related pain relief and functional improvement at chronic stage.
This systematic review and meta-analysis were conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (see Checklist, Supplemental Digital Content 1, http://links.lww.com/PHM/A691).13 All analyses were based on previous studies; therefore, no ethical approval and informed consent were required. PubMed, Scopus, Cochrane Central Register of Controlled Trials, Cochrane database, Embase, and ClinicalTrial.gov were systematically searched to identify relevant articles up to June 26, 2018. The search strategy is listed in Appendix 1. The bibliographies of identified studies, meta-analyses, and reviews were also manually reviewed for additional references. The title and abstracts were screened, and the full text of potentially related articles was downloaded for further review. Randomized controlled trials (RCTs) and quasi-experimental studies that compared the efficacy of ABP and CS were included according to the following criteria: (1) population: patients diagnosed with PF who did not respond to noninterventional treatments, with a symptom duration of more than 2 mos, i.e., nonacute onset PF; (2) intervention: injection of WB or PRP into the plantar fascia; (3) comparison: injection of CS into the plantar fascia; and (4) outcome: visual analog scale (VAS) pain score or American Orthopedic Foot and Ankle Society (AOFAS) hindfoot score. The VAS pain score assigns pain intensity a value between 0 and 10. The AOFAS score includes the following three categories: pain (40 points), function (50 points), and alignment (10 points).14 Studies were excluded if the patients received a local ABP or CS injection within 1 mo, received oral steroid or nonsteroidal anti-inflammatory drugs within 1 wk, or had had previous surgical intervention in the heel or ankle or a previous calcaneal fracture. Studies were also excluded if the outcome data could not be extracted. The following key terms were used in different combinations: “heel pain,” “plantar fasciitis,” “plantar fasciosis,” “plantar fasciopathy,” “plantar fasc*,” “corticosteroid,” “steroid,” “whole blood,” “PRP,” “platelet-rich plasma,” “autologous blood,” and “injection.”
Two authors independently conducted the search, screened the titles and abstracts, evaluated eligibility, and identified articles. Discrepancies were solved through discussion and consensus. The following data were extracted: first author, year of publication, number of patients, patient characteristics, details of treatment regimens (including preparation method of PRP), outcome measures, and adverse events. If there were missing data or any query regarding the relevant article, the authors of this review contacted the authors via e-mail to obtain further information.
Risk of Bias Assessment and Sensitivity Analysis
The quality of the included trials was independently appraised with the Jadad scale and Newcastle–Ottawa Scale by two authors. The Jadad scale15 was used to assess the likelihood of bias of the selected RCTs; the total score ranged between 0 and 5 points, and trials with scores of less than 3 were considered to have a lower methodologic quality. The Newcastle-Ottawa Scale,16 which includes aspects of selection, comparability, and outcome, was used for quasi-experimental studies; the maximum score was 9 points, and total scores of less than 4 points were considered to indicate a low-quality study. A sensitivity analysis was conducted to determine the representativeness of the actual effect. Discrepancies between authors were solved through discussion and consensus.
Data Synthesis and Analysis
To evaluate pain reduction and improvement in foot function in patients with PF, the standardized mean differences (SMDs) with 95% confidence interval (CI) of the VAS pain score and AOFAS hindfoot score between the baseline and posttreatment were calculated, and the outcome pooled. Random-effect models were used for the meta-analyses because of the variations of patient characteristics and details of treatment regimens. I2 and Cochran's Q test were used to evaluate heterogeneity. A P value ≤0.1 was considered statistically significant. Heterogeneity was considered low, moderate, high, and very high when the I2 value was less than 25%, between 25% and 50%, between 50% and 75%, and more than 75%, respectively. A subgroup analysis was performed based on: (1) the steps of PRP separation (one-step vs. two-step separation); (2) the types of PRP preparation systems (commercial PRP kit vs. self-prepared PRP); (3) activators versus nonactivators of PRP; (4) volume of the injected PRP; (5) PRP with versus without anesthetics; and (6) study design (RCTs vs. quasi-experimental studies). The small study bias was assessed using a funnel plot and Egger's test. All statistical analyses were conducted using the statistical software package Stata (Version 15; College Station, TX). Two-sided P values <0.05 were considered to indicate statistical significance.
A total of 296 studies were identified in the initial search. After evaluation of the titles and abstracts, 20 full-text articles were assessed for eligibility. After a review of the full-text articles, 16 studies were included in the meta-analysis.17–32Figure 1 illustrates the literature search and reasons for exclusion.
Features of Included Studies
The characteristics of the included studies are summarized in Table 1. These studies were published between 2006 and 2018. Five of the eligible studies, all of which were RCTs, compared WB and CS. Eleven of the eligible studies, including seven RCTs and four quasi-experimental studies, compared PRP and CS. In studies with more than two arms,17,19,20,29 data from the PRP, WB, and CS groups were extracted. None of the included studies reported significant adverse events after injection.
The studies had between 24 and 61 participants, with 214 patients for WB versus CS, and 506 patients for PRP versus CS. Platelet-rich plasma, WB, and CS were injected as a single dose in all studies. The mean age of the patients ranged between 30 and 55 yrs. The length of follow-up ranged between 2 wks and 12 mos.
Risk of Bias Assessment
The Jadad scale was used to assess the risk of bias in RCTs, whereas Newcastle–Ottawa Scale was applied to evaluate quasi-experimental studies. The total score of the quality assessment is shown in Table 1, and the scores of each domain are in Appendices 2 and 3 (Supplemental Digital Content 2 and 3, http://links.lww.com/PHM/A692, http://links.lww.com/PHM/A693). Based on the obtained scores, seven RCTs and four quasi-experimental studies were found to be of good quality.
Visual Analog Scale Pain Scores
Autologous Blood-Derived Product Versus CS
No significant difference was found between ABP and CS groups at 1.5, 3, or 6 mos (SMD = 0.09, 95% CI = −0.37 to 0.55, I2 = 87.3%; SMD = −0.08, 95% CI = −0.59 to 0.42, I2 = 88%; and SMD = −0.38, 95% CI = −0.89 to 0.13, I2 = 87.6%, respectively) (Fig. 2A).
White Blood Versus CS
The VAS pain score significantly improved in the CS group relative to the WB group at 1.5 and 3 mos (SMD = 0.69, 95% CI = 0.40 to 0.98, I2 = 0%; and SMD = 0.56, 95% CI = 0.22 to 0.89, I2 = 0%); however, no difference was apparent at 6 mos (SMD = 0.31, 95% CI = −0.06 to 0.69, I2 = 42.7%) (Fig. 2B).
Platelet-Rich Plasma Versus CS
The VAS pain score significantly improved in the PRP group relative to the CS group at 6 mos (SMD = −0.83, 95% CI = −1.51 to −0.15, I2 = 88.3%); however, no difference was apparent at 1.5 and 3 mos (SMD = −0.19, 95% CI = −0.79 to 0.41, I2 = 89%; and SMD = −0.29, 95% CI = −0.91 to 0.33, I2 = 89%) (Fig. 2C).
American Orthopedic Foot and Ankle Society
Autologous Blood-Derived Product Versus CS
No significant difference was found between the ABP and CS groups at 1.5, 3, or 6 mos (SMD = −0.21, 95% CI = −0.84 to 0.42, I2 = 79.3%; SMD = −0.08, 95% CI = −1.01 to 0.84, I2 = 92.2%; and SMD = −0.29, 95% CI = −0.86 to 0.27, I2 = 74.3%, respectively) (Fig. 3A).
White Blood Versus CS
White blood versus CS was not analyzed as only one study17 used the AOFAS score to compare the efficacy of WB and CS.
Platelet-Rich Plasma Versus CS
No significant difference was found between the PRP and CS groups at 1.5, 3, or 6 mos (SMD = −0.21, 95% CI = −0.84 to 0.42, I2 = 79.3%; SMD = −0.08, 95% CI = −1.01 to 0.84, I2 = 92.2%; and SMD = −0.48, 95% CI = −1.08 to 0.13, I2 = 74.2%, respectively) (Fig. 3B).
Sensitivity analysis revealed that one study had obvious variance. However, removing this study from the analysis did not dramatically alter the pooled result for pain reduction due to PRP compared with CS at 6 mos (Appendix 4, Supplemental Digital Content 4, http://links.lww.com/PHM/A694).
A subgroup analysis was performed for reductions in the VAS pain score at 6 mos. Results of the subgroup analysis found that PRP led to greater pain reduction than CS at 6 mos for self-prepared PRP, one-step separation PRP (Table 2),23,25,26,29 larger volume of injected PRP (≥3 ml), PRP without local anesthetic, and RCT study design (Fig. 4). Another subgroup analysis was performed to determine whether activators influence pain reduction between the PRP and CS groups at 6 mos; no significant difference was identified. The injected WB were all venous blood without further preparation, and all studies that compared WB and CS were RCTs. Therefore, no subgroup analysis was performed for the comparison between WB and CS.
Small Study Bias
Small study bias refers to the larger treatment effects from smaller studies, which is necessary for smaller studies to be statistically significant.33 Appendices 5 and 6 (Supplemental Digital Content 5 and 6, http://links.lww.com/PHM/A695, http://links.lww.com/PHM/A696) demonstrate the funnel plots and Egger's test of the VAS pain scores at different time points to investigate small study bias. Asymmetry was observed in the funnel plot of PRP versus CS, based on the effect sizes of improvement in the VAS pain scores. Asymmetric funnel plots may indicate potential small study bias. In Egger's test, small study bias was identified for the PRP versus CS groups at 6 mos' postinjection (P = 0.046). No small study bias was found in the PRP versus CS groups at 1.5 (P = 0.999) and 3 mos' (P = 0.870) postinjection.
This meta-analysis compared the efficacy of ABP versus CS to treat patients with PF. Although not achieving statistical difference, a trend favoring ABP over CS for relieving pain was noted within 1.5 to 6 mos' postinjection. In addition, because the ABP used in the literature contains two major blood products, i.e., PRP and WB, the differences between the products were further analyzed. Corticosteroid provided greater pain reduction than WB within 1.5 and at 3 mos. Notably, the superiority of CS to WB disappeared at 6 mos. Compared with CS, PRP is significantly more effective in reducing pain at 6 mos' postinjection. However, there was no difference in the AOFAS functional scores between CS and PRP at 1.5, 3, or 6 mos. Compared with CS, self-prepared PRP, one-step separated PRP, injected PRP volume of more than 3 ml, and PRP without local analgesics significantly reduced pain at 6 mos. This effect was stronger in RCTs than quasi-experimental studies.
Platelet-rich plasma has been used widely in patients with soft tissue injuries. It is beneficial as platelets that are activated by thrombin-release cytokines to enhance tendon proliferation.34 Furthermore, the growth factors present in PRP, such as transforming growth factor beta, vascular endothelial growth factor, and platelet-derived growth factor, stimulate tissue regeneration from mesenchymal cells, thus promoting cell replication and differentiation.8 Several meta-analyses have compared the efficacy of ABP and CS in PF treatment.11,35 Hsiao et al.11 performed a meta-analysis that comprised three RCTs and three quasi-experimental studies comparing ABP with CS, and they concluded that ABP provided better pain relief than CS at 3 and 6 mos, while PRP appeared to increase the efficacy of treatment. Another meta-analysis35 indicated that PRP was associated with better improvements in pain and functional scores than CS at 3 mos, whereas no difference was noted at 1, 6, and 12 mos' follow-up. However, the previously mentioned meta-analyses had inconsistent results. The inconsistency regarding the effect of PRP may be due to insufficiency of the included literature, lack of functional evaluation, and absence of a separate comparison for PRP and WB. Jain et al.26 reported that PRP tended to lead to greater pain reduction than CS at 6 mos and patients who were administered PRP showed significantly better VAS and AOFAS scores until 12 mos' postinjection, compared with those who were given CS, implying the late-onset and long-term effect of PRP in relieving pain and improving function in patients with PF. To clarify the efficacy of ABP (including WB and PRP) in patients with PF, ABP and CS were compared; WB and CS, as well as PRP and CS, were further compared separately in terms of pain relief and functional improvement. Although WB and PRP are commonly categorized as ABPs, the results of this study revealed that WB and PRP possess different effects in the treatment of PF. Therefore, WB and PRP should be discussed separately.
While the VAS pain score may indicate the treatment efficacy, functional aspects such as gait and motion are also crucial to improve quality of life. The AOFAS hindfoot score measures function, alignment, and pain and has been shown to be associated with quality of life.14 Therefore, it has been widely used to evaluate the functional outcome of the foot. A previous meta-analysis35 suggested that PRP injection was associated with better AOFAS score than CS at midterm follow-up, although no difference was found between the groups at short- and long-term follow-up. Notably, only one high-quality study was included in a long-term follow-up analysis. The current study demonstrated that there was no difference in the AOFAS hindfoot score for ABP versus CS and PRP versus CS at 1.5, 3, and 6 mos. There are two possible reasons for this result: (1) the included studies were subject to high heterogeneity, even with a random-effect model, and (2) one study36 demonstrated that there was significantly better AOFAS scores among patients who received PRP at 6 mos' follow-up than those who received CS. However, it provided only the mean and range values of the AOFAS score, which are insufficient for analysis. On the other hand, only one study17 used the AOFAS score to compare the efficacy of WB and CS; it found no significant difference between the groups. A further study to evaluate functional improvement in different subdomains may clarify the effect of PRP in patients with PF. Because of limitations of the relevant literature, further studies should evaluate whether there are differences in WB and PRP compared with CS in terms of functional improvement of the foot.
Different preparation techniques may influence the components of PRP and therefore influence the efficacy of treatment. The subgroup analysis of this study revealed that one-step separation PRP was significantly superior to CS for pain relief at 6 mos, whereas no significant difference was found between two-step separation PRP and CS. Although none of the studies provided data regarding the leukocyte counts of PRP, one-step separation PRP preparation systems mostly yield leukocyte-poor PRP (LP-PRP)10; our results may therefore indicate that LP-PRP provides significantly greater pain reduction than CS. Leukocytes release high levels of toxic reactive oxygen substances that may be detrimental to the surrounding tissue, increase catabolic cytokine concentrations, and possibly decrease growth factor levels.10,37 One recent study revealed that leukocyte-rich PRP had a detrimental effect on rabbit tendon stem cells and was associated with increased apoptosis.37 Yan et al.12 also found that LP-PRP had a better effect on tendon healing than leukocyte-rich PRP because of its anabolic effects. However, these findings concerning the effect of leukocyte concentration in PRP for PF treatment require further investigation, with quantification of the actual leukocyte count of PRP.
Differences in PRP composition may also result from discrepancies between self-preparation and commercial kit techniques. This study demonstrated that patients treated with self-prepared PRP had greater pain reduction than those treated with CS at 6 mos' postinjection. However, substantial heterogeneity was noted and limited the value of this finding. In addition, different PRP preparation techniques and compositions were not analyzed in most studies. Because PRP composition was found to have an effect on outcomes, further research is certainly warranted.
The volume of injected PRP and whether local analgesics were co-administered may affect the treatment efficacy. Our study revealed that patients with PF who were injected with more than 3 ml of PRP had greater pain reduction at 6 mos' postinjection. The effect of PRP on tissue healing is associated with platelet count and concentration of growth factors.38 Therefore, a higher volume of PRP may improve tissue healing and thus lead to better pain relief. In addition, PRP injection without local analgesics is associated with better efficacy in pain reduction at 6 mos. Although analgesics may reduce pain transiently, a previous study has shown that analgesics such as lidocaine and bupivacaine attenuate tenocyte proliferation and cell viability.39 Our study also suggests that PRP injection without local analgesics is associated with better long-term pain relief in PF.
The design of the studies may have also influenced the outcome. Quasi-experimental designs do not randomly assign patients and have less internal validation, giving them less standing to posit causal relationships. In contrast, RCTs render the groups comparable and are regarded as the criterion standard to evaluate the efficacy of interventions.40 Therefore, subgroup analysis was conducted to determine whether PRP and CS are significantly different in both RCTs and quasi-experimental studies. Theoretically, quasi-experimental studies are more likely to have statistically significant results because of potentially higher risks and confounded causal inference than RCTs. However, this study revealed that there was a significant reduction in pain in patients who participated in RCTs. The result further strengthens the finding that PRP provides better pain relief than CS at 6 mos in patients with refractory PF. Another possible reason is that all the RCT-designed studies examined had more than 3 ml of PRP injected without local analgesics, factors that have been shown to be associated with better pain relief. Notably, a greater pain difference was identified in the CS group at 6 mos in one study,30 which may have caused a marked effect size.
Strengths and Limitations
This study has several limitations. First, the included studies had substantial heterogeneity in terms of injection regimens (PRP preparation, CS dosage, and WB volume), length of follow-up period, and patient characteristics (age, duration of symptoms, and body mass index). A meta-regression may be beneficial, but it was not performed because of a limited number of studies. However, the statistical significance of our results indicates that they have a possible clinical value. A further study with long-term follow-up is required to investigate the effect of different PRP regimens and components. Second, four of the 16 included studies were quasi-experimental in nature, a design that is of lower quality than RCT and may thus limit the current study findings. Third, PRP subgroup analyses of the leukocyte count and mean platelet concentration were not performed because of incomplete data. Fourth, an analysis of each AOFAS score domain was not performed, also because of incomplete data. Fifth, comparison between WB and CS using the AOFAS hindfoot score was not performed because of the limited number of studies. Sixth, in this study, we did not directly compare WB with PRP, because only one previous study had made this comparison.41 Significant improvement in pain, function, and plantar fascia thickness were demonstrated in both groups at 1 or 3 mos, although between-group differences were not apparent.41
This meta-analysis demonstrated that CS provided greater pain reduction than WB at 1.5 and 3 mos' postinjection, whereas the effect was diminished at 6 mos. Platelet-rich plasma was significantly more effective in reducing pain at 6 mos' postinjection. The subgroup analysis indicated that self-prepared PRP, PRP of more than 3 ml, PRP without local analgesics, and one-step separation PRP are associated with greater pain reduction at 6 mos of follow-up than other factors. In addition, RCTs demonstrated a greater effect than quasi-experimental studies. The results of this meta-analysis suggest that PRP may provide a long-term, beneficial effect in relieving pain in patients with PF.
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Autologous Blood; Corticosteroid; Pain Relief; Plantar Fasciopathy; Platelet Rich Plasma; Whole Blood
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