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A prospective randomized controlled trial comparing extracorporeal shockwave therapy and physiotherapy in the treatment of acute plantar fasciitis
⁎Corresponding author: Samuel Sing Li Ong. samuel.ong.s.l@cgh.com.sg
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Received: ,
Accepted: ,
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.
Abstract
Abstract
We aimed to evaluate whether the addition of early extracorporeal shockwave therapy (ESWT) to physiotherapy improved outcomes in patients with acute plantar fasciitis.
We conducted a randomized controlled trial in a tertiary hospital in Singapore. Eligibility criteria were patients ≥21 years old presenting from April 2017 to November 2019 with untreated plantar fasciitis for <1 month with no prior physiotherapy. Exclusion criteria included history of plantar fasciitis, calcaneal fractures, chronic steroid use, pregnancy, chronic limb injuries and risks for venous thromboembolism. Patients were randomized using a random number generator into either Group A (ESWT + physiotherapy) or Group B (physiotherapy only). Visual Analogue Scale (VAS), 36-Item Short Form Survey (SF-36) and American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score were measured at baseline and 3 months. T-tests were performed for statistical significance.
46 patients were eligible for the trial. 10 were lost to follow up. 15 in Group A and 21 in Group B were treated and assessed. Mean age was 51.6. Baseline VAS scores were Group A (5.5 ± 2.3) and Group B (6.1 ± 2.1) (p = 0.451). There was no significant difference in 3-month VAS scores between Group A (4.7 ± 2.2) and Group B (5.2 ± 2.6) (p = 0.543). Baseline AOFAS scores were Group A (72.7 ± 12.8) and Group B (73.9 ± 14.2) (p = 0.801). There was also no significant difference in 3-month AOFAS scores between Group A (76.7 ± 5.1) and Group B (77.2 ± 13.4) (p = 0.876). No significant difference in SF-36 scores was seen at 3 months between the two groups.
The addition of early ESWT to physiotherapy did not result in better outcomes compared to physiotherapy alone for acute plantar fasciitis.
Keywords
Acute plantar fasciitis
eswt
Extracorporeal shockwave therapy
Physiotherapy
Plantar fasciitis
1 Introduction
Plantar fasciitis is a common cause of plantar heel pain. It approximately affects 10 % of the United States population1 with about 600,000 patients receiving treatment annually in outpatient clinics.2 Diagnosis of plantar fasciitis can be made clinically, and typical symptoms include heel pain on weightbearing upon waking in the morning. Pain from plantar fasciitis is attributed to thickening of the plantar fascia, decreased vascularity, peritendinous inflammation and loss of normal elasticity.3,4
The cause of plantar fasciitis is multifactorial and the most common etiology is biomechanical tension at the insertion of plantar fascia on the calcaneus and causing growth of spur on the area.5 Risk factors such as prolonged weight-bearing, obesity, limited ankle joint dorsiflexion, posterior muscle group tightness and maladaptive patterns of walking or running can produce biomechanical stress on the plantar fascia.6
Plantar fasciitis usually responds to a broad range of treatment options but there is no “gold standard” or universally accepted treatment algorithm for its management.7 Most common treatments are non-surgical options with 90 % of cases resolving with these methods.8 The mainstay of non-surgical treatment includes the use of nonsteroidal anti-inflammatory drugs (NSAIDs), relative rest from aggravating circumstances, physiotherapy and stretching exercises. Other treatment options include the use of orthoses, shoe wear modification, steroid injection, and extracorporeal shock wave therapy (ESWT).
ESWT has been successfully and safely used as a treatment for chronic plantar fasciitis since the 1990s.9 This involves the generation of vibrations through shockwaves from a machine source and transported to tissues via fluid and solid particle interaction. ESWT proponents hypothesize stimulation of healing by the creation of controlled local tissue injury causing neovascularization with associated increased amounts of growth factors.10–12 Alteration of nociceptors thereby inhibiting pain perception has also been theorized as a mechanism of action.12,13
However, the addition of ESWT in acute plantar fasciitis has not been well described in the literature and this is the first randomized controlled trial in this area. This study aimed to evaluate whether the addition of ESWT with physiotherapy results in improved outcomes in patients with acute plantar fasciitis.
2 Materials and methods
This study is an open-label prospective randomized controlled trial conducted in a tertiary hospital in Singapore. We secured approval from SingHealth's Centralized Institutional Review Board (Reference number 2016/3114, 6th December 2016) and conducted the study in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki. Informed consent was obtained from eligible patients in accordance with the Singapore Guideline for Good Clinical Practice.
2.1 Participants
We enrolled 46 eligible patients who presented at our tertiary hospital in Singapore from April 2017 to November 2019. The inclusion criteria include patients who have had (1) untreated plantar fasciitis for less than 1 month; (2) no prior physiotherapy treatment for the plantar fasciitis; (3) ≥21 years of age; and (4) have given written informed consent obtained before undergoing any study-related activities. The diagnosis of plantar fasciitis was based on clinical history and examination. The exclusion criteria were (1) previous history of plantar fasciitis; (2) evidence of existing risk or history of venous thrombo-embolic events; (3) history of calcaneal fractures; (4) pregnant females; (5) those with chronic steroid treatment; and (6) those with chronic limb injuries.
2.2 Randomization
Enrolled patients were then randomized using an automated computerized random number generator into either Treatment Group A (standardized treatment with physiotherapy and ESWT) or Treatment Group B (standardized treatment with physiotherapy).
2.3 Interventions
Treatment Group A received ESWT with standardized physiotherapy. ESWT was performed by Sports Physicians and used Dornier Epos Ultra and gave 2000 shocks under ultrasound guidance, with a gradual increase in the level of energy. Treatment Group B received standardized physiotherapy which involves plantar fascia/gastrocnemius and soleus stretches and strengthening.
2.4 Outcome measures
The Visual Analogue Scale (VAS), 36-Item Short Form Survey (SF-36) and American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score were measured at the initial visit and 3-month visit. A safety questionnaire was used to identify patients who may have developed any adverse effects from the treatment.
2.5 Statistical analysis
Demographic data was summarized in mean with standard deviation (SD) for numerical data and frequency with percentage for categorical data such as gender and smoking status. An Independent T-test was used to detect significant differences between parameters such as age and BMI while a Pearson's chi-square test was used for gender. Outcome measurement scales such as VAS, SF-36, AOFAS scores were presented in mean with SD. An Independent T-test was performed to assess the effect of ESWT on the outcome measured by comparing it to the control group at baseline and 3-month visit. A two-tailed P < 0.05 was considered statistically significant. All statistical analysis was performed using SPSS ver23 (IBP Corp., Armonk, New York, USA).
3 Results
3.1 Patient demographics
We recruited 50 patients to participate in the study. The trial was designed in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 guidelines (Fig. 1). 46 patients were eligible and 4 patients declined to participate. In addition, 10 patients were excluded from the study because of no-shows or out of window. We analyzed 36 patients, 15 from Treatment Group A and 21 from Treatment Group B.
The overall mean age of the patients was 51.6. There was no statistical difference with age in both treatment groups (p = 0.991) (Table 1). There were 10 (27.8 %) males and 26 (72.2 %) females with no statistically significant difference between the groups (p = 0.709) (Table 1). The mean overall BMI was 25.2 with no statistically significant difference between groups (0.258) (Table 1).
| Overall (n = 36) | ESWT + Physiotherapy (n = 15) | Physiotherapy (n = 21) | p-value | |
| Age | 51.6 ± 9.9 | 51.5 ± 8.7 | 51.6 ± 10.9 | 0.991 |
| Gender | ||||
| Male | 10 (27.8) | 5 (33.3) | 5 (23.8) | 0.709 |
| Female | 26 (72.2) | 10 (66.7) | 16 (76.2) | |
| Baseline BMI (kg/m2) | 25.2 ± 4.6 | 24.1 ± 5.0 | 25.9 ± 4.3 | 0.258 |
3.2 VAS, AOFAS and SF-36
The table below shows the mean VAS scores at baseline and 3 months follow-up. VAS scores at baseline showed no statistically significant difference between groups (p = 0.451). At 3 months, mean VAS scores showed no statistically significant difference between groups (p = 0.543) (Table 2).
| ESWT + Physiotherapy Group (n = 15) | Physiotherapy Group (n = 21) | p-value | |
| VAS | |||
| Baseline | 5.5 ± 2.3 | 6.1 ± 2.1 | 0.451 |
| 3 months | 4.7 ± 2.2 | 5.2 ± 2.6 | 0.543 |
| AOFAS | |||
| Baseline | 72.7 ± 12.8 | 73.9 ± 14.2 | 0.801 |
| 3 months | 76.7 ± 5.1 | 77.2 ± 134 | 0.876 |
AOFAS Scores at baseline showed no statistically significant difference between treatment groups (p = 0.801). At 3 months follow-up, AOFAS scores were not statistically significant between groups (p = 0.876) (Table 2).
Comparing the SF-36 scores, all 8 health domains showed no significant difference at 3 months between the two groups (Table 3).
| ESWT + Physiotherapy Group (n = 15) | Physiotherapy Group (n = 21) | p-value | |
| Physical Function | |||
| Baseline | 68.0 ± 17.8 | 72.6 ± 19.0 | 0.466 |
| 3 months | 66.0 ± 22.5 | 65.5 ± 17.7 | 0.938 |
| Role Physical | |||
| Baseline | 46.7 ± 47.1 | 69.0 ± 43.2 | 0.149 |
| 3 months | 53.3 ± 39.9 | 59.5 ± 42.2 | 0.660 |
| Body Pain | |||
| Baseline | 47.5 ± 24.1 | 53.7 ± 23.0 | 0.440 |
| 3 months | 53.4 ± 20.7 | 53.6 ± 21.2 | 0.976 |
| General Health | |||
| Baseline | 57.3 ± 22.7 | 63.3 ± 20.5 | 0.413 |
| 3 months | 61.0 ± 22.6 | 59.4 ± 21.4 | 0.828 |
| Vitality | |||
| Baseline | 53.3 ± 16.0 | 50.7 ± 18.5 | 0.661 |
| 3 months | 58.7 ± 12.9 | 48.8 ± 18.9 | 0.090 |
| Social Functioning | |||
| Baseline | 68.3 ± 26.2 | 77.4 ± 30.0 | 0.355 |
| 3 months | 75.0 ± 23.6 | 76.2 ± 24.3 | 0.884 |
| Role Emotional | |||
| Baseline | 62.2 ± 45.2 | 77.8 ± 41.3 | 0.291 |
| 3 months | 60.0 ± 47.5 | 68.3 ± 42.8 | 0.589 |
| Mental Health | |||
| Baseline | 66.9 ± 24.4 | 72.4 ± 18.0 | 0.446 |
| 3 months | 71.5 ± 19.3 | 71.8 ± 17.5 | 0.956 |
3.3 Adverse events
For both patient groups, there were no reported adverse events during the conduct of this study.
4 Discussion
The mainstay of treatment for plantar fasciitis has generally been non-surgical such as physiotherapy with stretching exercises, use of insoles, intralesional injections and ESWT.8 Although surgical treatment such as endoscopic plantar fasciotomy has been described, systematic reviews and meta-analysis do not support strong evidence.14
Although studies have shown promising results of ESWT in treating chronic plantar fasciitis,15,16 there have been no studies that have evaluated ESWT in the treatment of acute plantar fasciitis. This study investigated the effects of ESWT in addition to physiotherapy for the treatment of acute plantar fasciitis.
At 3 months follow-up, patients receiving ESWT and physiotherapy did not show better outcomes in terms of VAS, SF-36 and AOFAS scores than the patients receiving physiotherapy only.
Previous studies on chronic plantar fasciitis comparing ESWT with other treatment modalities showed improvement in outcomes.17,18 In this study both treatment groups showed improvement of VAS, SF-36 and AOFAS scores, however, no statistically significant difference was seen. The addition of ESWT with physiotherapy seemingly does not improve outcome scores in comparison with physiotherapy alone in acute plantar fasciitis. This is because one of the key concepts of ESWT is it creates a new injury at the site of the chronic condition – returning a chronic condition to its more reactive acute phase, avoiding its chronic inflammatory cascade, and triggering the body's self-repair mechanism.19,20
There have been limited reports in the literature describing ESWT in acute injuries. A systemic review by Zissler et al. revealed that there are benefits of ESWT in acute injuries of the bone and soft tissues, but mainly in accelerating wound healing in acute skin wounds.20 Fleckenstein et al. performed a randomized controlled trial that showed a single administration of focused ESWT on eccentric exercise-induced delayed-onset muscle soreness at the biceps brachii muscle showed clinical improvements in pain, strength and function but these were not statistically significant.21 For lateral epicondylitis, Köksal et al. found out that ESWT was equally effective in treating both acute and chronic cases and he hypothesized that ESWT may prevent acute cases from deteriorating into a chronic condition.19
The natural course of acute plantar fasciitis has not been fully described in the literature, although it has been thought of as self-limiting in nature.22 There is difficulty in distinguishing those patients who recover spontaneously and those who respond to formal treatment. More studies are recommended to further describe the natural course of acute plantar fasciitis.
Limitations of this study include the relatively small sample size due to our strict eligibility criteria of untreated plantar fasciitis for <1 month to delineate its acute phase. However, the majority are initially seen in the primary care setting and may have received some form of treatment before being referred to orthopaedic specialists. The average waiting time for a specialist appointment can also take up to a few months. Another limitation is that the diagnosis of plantar fasciitis was made clinically based on history and examination without any radiological evidence (such as an ultrasound scan or MRI) to confirm or exclude other causes of heel pain. Nonetheless, this is in keeping with our clinical practice. Lastly, despite using 3 different scoring systems combining subjective and objective aspects, we did not include any direct assessment of the plantar fascia itself through imaging.
5 Conclusion
This study shows that the addition of ESWT with physiotherapy did not improve outcomes of acute plantar fasciitis in terms of VAS, SF-36 and AOFAS ankle-hindfoot score at 3 months follow-up. Therefore, we recommend that physiotherapy should remain as the first line of treatment for acute plantar fasciitis which can be managed in the primary care setting. When plantar fasciitis becomes a chronic issue or recalcitrant to physiotherapy, a specialist referral should be made to consider ESWT as an adjunct or alternative treatment option.
CRediT authorship contribution statement
Samuel Sing Li Ong: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Validation, Visualization, Writing – original draft, Writing – review & editing. David Weijia Mao: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Validation, Visualization, Writing – original draft, Writing – review & editing. Raj Kumar Socklingam: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Validation, Visualization, Writing – original draft, Writing – review & editing. Ing How Moo: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing. Charles Kon Kam King: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing.
Guardian/patient's consent
Informed consent was obtained from eligible patients in accordance with the Singapore Guideline for Good Clinical Practice.
Ethical statement
We secured approval from SingHealth's Centralized Institutional Review Board (Reference number 2016/3114, 6th December 2016) and conducted the study in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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