Abstract
Background
Plantar fasciitis is a known degenerative pathology and is a common cause of heel pain. We intend to evaluate the efficacy between locally injected Corticosteroids and autologous PRP in the management of chronic plantar fasciitis patients.
Materials and methods
In this prospective randomized controlled study, 70 chronic plantar fasciitis with failed conservative management for 3 months were randomly selected into 2 groups of 35 patients each. Group A received a local autologous platelet rich plasma injection of 3 ml and group B received a local corticosteroid injection of 2 ml. The Visual Analogue Scale (VAS) and American Orthopaedic Foot and Ankle Society (AOFAS) scores were compared between the groups at 15 days, 1 month, 3 months and 6 months.
Results
No improvement in pain between autologous PRP and corticosteroids study subjects was noted in the initial period up to 15 days whereas after 1 month, 3 months and 6 months duration, it is seen that autologous PRP injected study subjects showed significant relief in pain compared to corticosteroids.
Conclusion
PRP was more effective in chronic plantar fasciitis patients compared to corticosteroids with pain relief coming after first 1st, 3rd and 6th month of the injection.
Level of evidence
Level 2.
Keywords: Plantar fasciitis, Autologous PRP, Corticosteroid, Visual analogue scale (VAS), American orthopaedic foot and ankle society (AOFAS) score
What this study adds
We compared VAS & AOFAS outcome between autologous PRP and corticosteroids treatment during the 15th day, 1st month, 3rd month, 6thmonth post-instillation. We compared VAS & AOFAS scoring qualitatively in terms of pain such as mild/moderate/severe, the literature on which we believe is scarce.
1. Introduction
Plantar fasciitis is the most common disorders of the foot1,2 It is an overuse syndrome and is characterized by an insidious onset of sharp pain along the medial aspect of the heel that is worse with the first step taken in the morning and the pain improves with warm up.3
The most common treatment modality is nonsurgical as most commonly plantar fasciitis resolves spontaneously with or without treatment4,5 In chronic plantar fasciitis patients, after failure of conservative non-invasive interventions, corticosteroid & PRP injections are employed to reduce the heel pain6
However, conflicting reports are given by studies & authors in using PRP & Corticosteroids as some authors state that PRP treatment is superior12, 13, 14,17, 18, 19 & some quote PRP results are comparable to corticosteroid15,16,20,21 in regards to clinical & functional outcome. So in our study, we compared subjective outcome between the two groups using the Visual Analogue Scale (VAS) and American Orthopaedic Foot and Ankle Society (AOFAS) scoring for better understanding.
2. Material and methods
SAMPLE SIZE: This prospective Randomized Controlled Trial was carried out in a Tertiary care centre in North India after clearance from the Ethics committee in 70 chronic plantar fasciitis patients.
3. Participants
| Inclusion criteria | Exclusion criteria |
|---|---|
| MRI/USG confirmed patients of plantar fasciitis patients aged 20–60 years with failure of conservative treatment with physiotherapy and analgesics for 3 months |
|
A total of 150 patients were screened and 70 patients were selected according.
RANDOMIZATION: After taking informed consent, the target population was selected by randomization. The process adopted for randomization was Random Number Table.
ALLOCATION & IMPLEMENTATION: The patients were allocated into two groups i.e. Group A and group B of 35 patients each with similar baseline characteristics were formed.
Preparation of PRP: 20 ccs of the patient's blood was collected from the antecubital vein under aseptic conditions into four 5 cc vials. Each 5 cc vacutainer was containing Acid Citrate Dextrose (ACD). After 2 cycles of centrifugation in a centrifuge machine (1st Spin-centrifuged at 1300 rpm for 10 min & 2nd Spin-centrifuged again at 3500 rpm for 10 min) results in 3 cc of supernatant platelet-rich fraction of plasma.
INTERVENTIONS: The PRP group & Corticosteroid group patients were given 3 cc of freshly prepared PRP injection & 1 cc (40 mg) of methylprednisolone acetate with 1 cc of 2% lidocaine respectively, under strict aseptic precautions in the most tender point of heel with a medial approach using USG guidance with the patient in a prone position and ankle in a relaxed position using a peppering technique (a single skin portal and 4–5 penetrations of the plantar fascia).
OBJECTIVES: The follow up at the interval of 15th day, 1st month, 3rd month and 6th month were done to assess the outcomes. Any adverse effects due to the injections were recorded.
OUTCOMES: Assessment was done using -
-
1.
Visual Analogue Scale (VAS)
-
2.
American Orthopaedic Foot and Ankle Society (AOFAS) score.
4. Statistical analysis
Categorical variables were presented in number and percentage (%) and continuous variables were presented as mean ± SD and median. The normality of data was tested by the Kolmogorov-Smirnov test. If the normality was rejected then a non-parametric test was used. Quantitative variables were compared using independent t-test between the two groups. Qualitative variables were compared using Fisher's Exact test. A p-value of <0.05 was considered statistically significant. The data was entered in MS EXCEL spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) version 21.0. Categorical variables were presented in number and percentage (%) and continuous variables was presented as Mean SD.
5. Observation & result
The comparison was done between local injection of autologous PRP (Group 1) and corticosteroids (group 2). No adverse reactions or complications were recorded in both the groups. After the intervention, all the patients were followed up regularly for a minimum period of 6 months.
5.1. VAS comparison
Pre-instillation & 15th day post-instillation mean VAS between PRP and Corticosteroid group were 7.66 ± 1.0 and 7.03 ± 0.79 & 7.49 ± 1.2 and 7.09 ± 0.98 respectively, which shows both are statistically insignificant.
The 1st Month, 3rd & 6th month post-instillation mean VAS between PRP and Corticosteroid group were 6.26 ± 0.70, 5.37 ± 0.69, 3.71 ± 0.67 & 6.69 ± 0.87, 6.20 ± 0.72, 5.40 ± 0.65 respectively, all of which are statistically significant. (p-0.026) (p-0.0001) (p-0.0001) (see Table 1 & Fig. 1).
Table 1.
VAS comparison (quantitatively).
| Visual analogue scale(VAS) | Platelet rich plasma (n = 35) Group A | Corticosteroids (n = 35) Group B | P value | Test performed |
|---|---|---|---|---|
| Pre- instillation | ||||
| Mean ± Std deviation | 7.66 ± 1 | 7.49 ± 1.2 | 0.518 | Independent t-test; table value = 1.811 |
| 15th day Post-instillation | ||||
| Mean ± Std deviation | 7.03 ± 0.79 | 7.09 ± 0.98 | 0.789 | Independent t-test; table value = = 0.947 |
| 1st month Post-instillation | ||||
| Mean ± Std deviation | 6.26 ± 0.7 | 6.69 ± 0.87 | 0.026 | Independent t-test; table value = 2.181 |
| 3rd month Post-instillation | ||||
| Mean ± Std deviation | 5.37 ± 0.69 | 6.2 ± 0.72 | <.0001 | Independent t-test; table value = 0.21 |
| 6th month Post-instillation | ||||
| Mean ± Std deviation | 3.71 ± 0.67 | 5.4 ± 0.65 | <.0001 | Independent t-test; table value = 0.001 |
Fig. 1.
VAS Comparison (Quantitatively).
VAS score ⩽3.4 cm corresponds to mild pain, a score of 3.5–6.4 represents moderate pain and a score ⩾6.5 corresponds to severe pain.
The Pre-instillation mean VAS between Group A in terms of moderate pain (17.14%) & severe pain (82.86%) and Group B in terms of moderate pain (22.86%) & severe pain (77.14%) respectively, which shows an insignificant difference.
The 15th Day post-instillation mean VAS between Group A in terms of moderate pain (28.57%) & severe pain (71.43%) and Group B in terms of moderate pain (25.71%) & severe pain (74.29%) respectively, which shows an insignificant difference.
The 1st Month post-instillation mean VAS between Group A in terms of moderate pain (65.71%) & severe pain (34.29%) and Group B in terms of moderate pain (40%) & severe pain (60%) respectively, which was statistically significant (p-0.031).
The 3rd Month post-instillation mean VAS between Group A in terms of moderate pain (94.29%) & severe pain (5.71%) and Group B in terms of moderate pain (62.86%) & severe pain (37.14%) respectively, which was statistically significant (p-0.003).
The 6th Month post-instillation mean VAS between Group A in terms of mild pain (40%), moderate pain (60%) & severe pain (0%) and Group B in terms of mild pain (0%), moderate pain (97.14%) & severe pain (2.86%) respectively, which was statistically significant (p - 0.0001) (see Table 2 & Fig. 2).
Table 2.
VAS comparison (qualitatively).
| VAS | PRP (n = 35) | Corticosteroids (n = 35) | Total | P value | Test performed |
|---|---|---|---|---|---|
| Pre- instillation | |||||
| Moderate pain | 6 (17.14%) | 8 (22.86%) | 14 (20%) | 0.55 | Fisher Exact test |
| Severe pain | 29 (82.86%) | 27 (77.14%) | 56 (80%) | ||
| 15th day Post - instillation | |||||
| Moderate pain | 10 (28.57%) | 9 (25.71%) | 19 (27.14%) | 0.788 | Fisher Exact test |
| Severe pain | 25 (71.43%) | 26 (74.29%) | 51 (72.86%) | ||
| 1st month Post - instillation | |||||
| Moderate pain | 23 (65.71%) | 14 (40%) | 37 (52.86%) | 0.031 | Fisher Exact test |
| Severe pain | 12 (34.29%) | 21 (60%) | 33 (47.14%) | ||
| 3rd month Post - instillation | |||||
| Moderate pain | 33 (94.29%) | 22 (62.86%) | 55 (78.57%) | 0.003 | Fisher Exact test |
| Severe pain | 2 (5.71%) | 13 (37.14%) | 15 (21.43%) | ||
| 6th month Post - instillation | |||||
| Mild pain | 14 (40%) | 0 (0%) | 14 (20%) | 0.0001 | Fisher Exact test |
| Moderate pain | 21 (60%) | 34 (97.14%) | 55 (78.57%) | ||
| Severe pain | 0 (0%) | 1 (2.86%) | 1 (1.43%) | ||
Fig. 2.
Vas comparison (qualitatively).
5.2. AOFAS comparison
Pre-instillation & 15th day post-instillation mean AOFAS between PRP and Corticosteroid group were 62.86 ± 7.1 and 65.71 ± 9.17 & 64 ± 8.12 and 65.14 ± 8.87 respectively, which shows both are statistically insignificant.
Alternatively, the 1st Month, 3rd & 6th month post-instillation mean AOFAS between PRP and Corticosteroid patients were 72.57 ± 9.80, 79.43 ± 3.38, 84 ± 4.97 & 68 ± 9.94, 72.57 ± 9.8, 79.43 ± 3.38 respectively, all of which are statistically significant (p-0.057) (p-0.001) (p-0.0002) (see Table 3 & Fig. 3).
Table 3.
AOFAS comparison (quantitatively).
| AOFAS | PRP (n = 35) Group A | Corticosteroids (n = 35) Group B | P value | Test performed |
|---|---|---|---|---|
| Pre- instillation | ||||
| Mean ± Std deviation | 62.86 ± 7.1 | 64 ± 8.12 | 0.533 | Independent t-test; table value = 1.597 |
| 15th day Post-instillation | ||||
| Mean ± Std deviation | 65.71 ± 9.17 | 65.14 ± 8.87 | 0.792 | Independent t-test; table value = 0.281 |
| 1st month Post-instillation | ||||
| Mean ± Std deviation | 72.57 ± 9.8 | 68 ± 9.94 | 0.057 | Independent t-test; table value = 0.232 |
| 3rd month Post-instillation | ||||
| Mean ± Std deviation | 79.43 ± 3.38 | 72.57 ± 9.8 | 0.001 | Independent t-test; table value = 143.483 |
| 6thmonth Post-instillation | ||||
| Mean ± Std deviation | 84 ± 4.97 | 79.43 ± 3.38 | 0.0002 | Independent t-test; table value = 42.744 |
Fig. 3.
Aofas comparison (quantitatively).
The Pre-instillation mean AOFAS between Group A in terms of moderate pain (14.29%) & severe pain (85.71%) and Group B in terms of moderate pain (20%) & severe pain (80%) respectively, which shows an insignificant difference.
The 15th Day post-instillation mean AOFAS between Group A in terms of moderate pain (28.57%) & severe pain (71.43%) and Group B in terms of moderate pain (25.71%) & severe pain (74.29%) respectively, which shows an insignificant difference.
The 1st Month post-instillation mean AOFAS between Group A in terms of moderate pain (62.86%) & severe pain (37.14%) and Group B in terms of moderate pain (40%) & severe pain (60%) respectively, which was statistically significant (p-0.056).
The 3rd Month post-instillation mean AOFAS between Group A in terms of moderate pain (97.14%) & severe pain (2.86%) and Group B in terms of moderate pain (62.86%) & severe pain (37.14%) respectively, which was statistically significant (p-0.0006).
The 6th Month post-instillation mean AOFAS between Group A in terms of mild pain (40%), moderate pain (60%) & severe pain (0%) and Group B in terms of mild pain (0%), moderate pain (97.14%) & severe pain (2.86%) respectively, which was statistically significant (p-0.0001) (see Table 4 & Fig. 4).
Table 4.
AOFAS comparison (qualitatively).
| AOFAS | Platelet rich plasma (n = 35) Group A | Corticosteroids (n = 35) Group B | Total | P value | Test performed |
|---|---|---|---|---|---|
| Pre-Instillation | |||||
| Moderate pain | 4(14.29%) | 8 (20%) | 12 (17.14%) | 0.57 | Fisher Exact test |
| Severe pain | 31(85.71%) | 27 (80%) | 58 (82.85%) | ||
| 15th day Post-Instillation | |||||
| Moderate pain | 10 (28.57%) | 9 (25.71%) | 19 (27.14%) | 0.788 | Fisher Exact test |
| Severe pain | 25 (71.43%) | 26 (74.29%) | 51 (72.86%) | ||
| 1st month Post-Instillation | |||||
| Moderate pain | 22 (62.86%) | 14 (40%) | 36 (52.86%) | 0.056 | Fisher Exact test |
| Severe pain | 13 (37.14%) | 21 (60%) | 34 (47.14%) | ||
| 3rd month Post-Instillation | |||||
| Moderate pain | 34 (97.14%) | 22 (62.86%) | 56 (80%) | 0.0006 | Fisher Exact test |
| Severe pain | 1 (2.86%) | 13 (37.14%) | 14 (20%) | ||
| 6th month Post-Instillation | |||||
| Mild pain | 14 (40%) | 0 (0%) | 14 (20%) | 0.0001 | Fisher Exact test |
| Moderate pain | 21 (60%) | 34 (97.14%) | 55 (78.57%) | ||
| Severe pain | 0 (0%) | 1 (2.86%) | 1 (1.43%) | ||
Fig. 4.
Aofas comparison (qualitatively).
6. Discussion
Our study compared the clinical & functional outcomes of chronic plantar fasciitis patients managed with local autologous PRP and Corticosteroid injection. The potent anti-inflammatory effect of corticosteroids diminishes the inflammation & thus resulting in pain relief.7 However, complications such as rupture of the plantar fascia, infection, change in skin pigmentation, peripheral nerve injury, muscle damage, post-injection flare, and fat pad atrophy are reported with the employment of local corticosteroids injection for the management of plantar fasciitis.8, 9, 10
Autologous platelet-rich plasma, a therapeutic alternative to corticosteroid, is a source of anabolic growth factors, helps in curtailing the time of tendon and ligament healing & potentially alleviates pain without any complications that are associated with local steroid injection that we know of.11
A single 3 cc injection of autologous PRP was superior to the corticosteroid injection in terms of pain and functional results during various phases of follow-up in our chronic plantar fasciitis patients in our study.
Pre-instillation & 15th day post-instillation mean VAS between Group A and Group B were 7.66 and 7.03 & 7.49 and 7.09 respectively, which shows both are statistically insignificant. Alternatively, the 1st Month, 3rd & 6th month post-instillation mean VAS between Group A and Group B were 6.26, 5.37, 3.71 & 6.69, 6.20, 5.40 respectively, all of which were statistically significant.
An outstanding improvement in the mean VAS score & AOFAS scores was recorded in a study conducted by Mahindra et al12 before injection and 3rd weeks & 3rd months following the injection in the PRP group & concluded that PRP injection is superior to the corticosteroid injection in the management of chronic plantar fasciitis.
A recently published study in 80 patients with chronic plantar fasciitis by Vijay Shetty et al (2014)13 studied using VAS, the Foot & Ankle Disability Index (FADI) and American Foot and Ankle Score (AFAS) found that there was a significant clinical improvement in PRP group at three months after the injection in the treatment compared to steroid injection. Similarly, Pankaj Varshney et al (2022)14 found a remarkable reduction in the mean VAS score at 4 weeks, 8 weeks and 3 months in the corticosteroid group, however at 6 months, there was a significant reduction in the VAS score in the PRP group compared to corticosteroid group.
However, Sumit Pal Singh et al (2O22)15 state that an insignificant difference was observed between the two groups at the 1, 3 and 6month using VAS & AOFAS scores. Shetty et al (2018)16 from their study in 50 patients, states that at 3 weeks and at 6 weeks VAS was diminished in the PRP group. However, VAS was improved in the corticosteroid group but with no statistical significance.
In our study, the Pre-instillation & 15th day post-instillation mean AOFAS between Group A and Group B were 62.86 and 65.71 & 64 and 65.14 respectively, which shows both are statistically insignificant. Alternatively, the 1st Month, 3rd & 6th month post-instillation mean VAS between Group A and Group B were 72.57, 79.43, 84 & 68, 72.57, 79.43 respectively, all of which are statistically significant.
A study by Ankit K et al (2020)17 state that the autologous PRP injection was equated with a superior AOFAS score at 6 months & the difference was more pronounced at 6 months follow-up compared to steroid injection. Soraganvi P et al (2018)18 asserted that the mean AOFAS score in the PRP group improved more than in the steroid group at 6th month follow-up and the difference is of statistical significance.
Xing Fei et al (2021)19 has observed that the PRP group AOFAS scores were significantly higher than that of the steroid group at 1-year follow-up in his systematic review of 12 randomized control trials.
Jain et al (2018)20 state that there was significant improvement in VAS, FAI and AOFAS scores in both the groups but with an insignificant difference in improvement between the 2 groups. Similarly, Prashant Singh et al (2016)21 stated the VAS score or AOFAS scores were similar at 6 months between the groups & there was similar pain and functional score at one, six- or 12-month follow-up.
We compared AOFAS & VAS scoring qualitatively in terms of pain such as mild/moderate/severe intensity during pre-instillation & post-instillation follow-up period, the findings of which are significant during 1st, 3rd & 6th month of post-instillation follow-up, the literature on which we believe is scarce & seldom done. This qualitative aspect of AOFAS scoring needs further research & study. Limited number of patients and shorter duration of follow-up are the limitations of our study.
7. Conclusion
Initially, there was no improvement in pain between PRP and corticosteroids study subjects during pre-instillation &15th days, whereas during 1st month, 3rd month and 6th month it is seen that the autologous PRP group showed much relief in pain & functional outcome compared to steroid group. We conclude that PRP was effective in the management of patients with plantar fasciitis compared to corticosteroids. Hence we can steer clear of reported complications of steroid injections compared to relatively fewer/no complications of PRP as the literature states.
A longer period of follow up & higher number of patients are necessary to evaluate whether the beneficial effects of PRP are sustained over a period of time.
Funding acknowledgement
No funding or grant was received for our study.
Declaration of competing interest
None.
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