Effectiveness of Four Different Treatment Modalities in the Treatment of Chronic Plantar Fasciitis
Effectiveness of Four Different Treatment Modalities in the Treatment of Chronic Plantar Fasciitis During a 36-Month Follow-Up Period: A Randomized Controlled Trial RSS Download PDF
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Effectiveness of Four Different Treatment Modalities in the Treatment of Chronic Plantar Fasciitis During a 36-Month Follow-Up Period: A Randomized Controlled Trial Download PDF
Journal of Foot and Ankle Surgery, The, 2018-09-01, Volume 57, Issue 5, Pages 913-918, Copyright © 2018 The American College of Foot and Ankle Surgeons
Abstract
No consensus has been reached about the best treatment method of plantar fasciitis and the results of the treatment methods have been inconsistent. The objective of the present study was to compare the therapeutic effects of extracorporeal shock wave therapy, platelet-rich plasma injection, local corticosteroid injection, and prolotherapy for the treatment of chronic plantar fasciitis using a randomized, controlled, prospective study. We performed a randomized controlled prospective clinical study of 4 groups. The first group received extracorporeal shock wave therapy, the second group received prolotherapy, the third group received platelet-rich plasma injection, and the fourth group received a local corticosteroid injection. The study included 158 consecutive patients with a diagnosis of chronic plantar fasciitis with a symptomatic heel spur. The clinical outcomes were assessed using the visual analog scale and Revised Foot Function Index. At the end of the follow-up period, the mean visual analog scale scores for all 4 groups were similar to the mean visual analog scale scores before treatment. At the end of the follow-up period, no significant improvement was noted in the Revised Foot Function Index score in any of the groups. The corticosteroid injection was more effective in the first 3 months and extracorporeal shock wave therapy was an effective treatment method in the first 6 months in regard to pain. The corticosteroid injection lost its effectiveness during the follow-up period. The effect of prolotherapy and platelet-rich plasma was seen within 3 to 12 months; however, at the 36-month follow-up point, no differences were found among the 4 treatments.
Plantar fasciitis (PF) is a common cause of heel pain and has been defined as a tensile overload of the plantar fascia at its origin on the medial tubercle of the calcaneus . The pain is usually caused by collagen degeneration at the origin of the plantar fascia . The cause of degeneration is repetitive microtears of the plantar fascia at the calcaneal enthesis and is thought to be caused by biomechanical overuse from prolonged standing or running . Soft tissue ossification can also be present as a heel spur at the origin of the plantar fascia . The prevalence of heel spur has ranged from 30% to 70% in patients with heel pain .
Nonoperative treatment options of PF includes plantar fascia and gastrocnemius–soleus muscle stretching, nonsteroidal antiinflammatory drugs (NSAIDs), local corticosteroid (CS) injections, heel cups, arch supports, night splints, electrotherapy, lidocaine needling, prolotherapy (proliferation therapy), autologous blood injection, platelet-rich plasma (PRP) injection, and extracorporeal shock wave therapy (ESWT) . No concensus has been reached regarding the best treatment method for PF, and the results of the different treatments have been inconsistent . CS injections reduce the inflammation and swelling of the soft tissue around the plantar fascia . ESWT is a noninvasive procedure that uses single-pulse acoustic waves generated outside the body to a specific site in the body . Although the mechanism of ESWT is not completely understood, direct stimulation of healing, neovascularization, direct suppressive effects on nociceptors, and an hyperstimulation mechanism that would block the gate-control mechanism have been described in explaining its effects . Prolotherapy works by improving ligament mechanics and decreasing pain through an inflammatory mechanism . PRP is hypothesized to release high concentrations of platelet-derived growth factors that enhance tendon healing, because growth factors are released after platelets become activated to initiate the tissue healing response .
The aim of the present study was to compare the therapeutic effects of ESWT, PRP, local CS injection, and prolotherapy during a 36-month follow-up period for the treatment of chronic proximal PF (CPPF) with a duration of ≥12 months, using a randomized controlled prospective study. To the best of our knowledge, no reported studies have investigated and compared the effectiveness of these 4 treatment modalities.
Patients and Methods
We performed a randomized controlled prospective clinical study of 158 consecutive patients with a diagnosis of CPPF with a symptomatic heel spur with a duration of ≥12 months from December 2010 to February 2013. The patients were randomized into 4 groups, with the first group receiving ESWT, the second, prolotherapy, the third, PRP injection, and the fourth, a local CS injection.
All the patients joined the present study voluntarily without any monetary offering. All the patients were informed about the procedure and possible complications and the objectives of the present study. All patients provided written informed consent before participating in the study. The institutional review board approved the study. All cases were evaluated according to the inclusion and exclusion criteria ( Tables 1 and 2 ). All the patients had unilateral symptoms.
Table 1
Inclusion criteria of the study
| Inclusion criteria |
|---|
| Age ≥18 y |
| Pain on palpation of plantar medial calcaneal tubercle for ≥6 months |
| Body mass index <30 kg/m 2 |
| Visual analog scale score for pain intensity >5 for participant's self-assessment of pain on first few minutes of walking in morning |
| Pain worse on waking up in the morning or after a period of rest |
| Heel spur on lateral radiograph of the foot |
| Failure to respond to treatment modalities, including plantar fascia and muscle stretching, nonsteroidal antiinflammtory drugs, heel cups, arch supports, and night splints within 4 wk |
Table 2
Exclusion criteria for the study
| Exclusion Criteria |
|---|
| Pregnancy or lactation |
| Bilateral plantar fasciitis |
| Body mass index >30 kg/m 2 |
| Previous surgery for plantar fasciitis |
| Any previous injection (corticosteroid, platelet-rich plasma, prolotherapy, lidocaine needling), treatment, or surgery to plantar fascia |
| History of epilepsy, type 1 or 2 diabetes mellitus, or hematologic disease |
| Previous calcaneus fracture |
| Arthritis of the foot or ankle joint |
| History of gout arthritis |
| History of systemic inflammatory, autoimmune, or peripheral vascular disease, such as deep venous thrombosis or bleeding disorders |
| Effusion around the ankle joint |
| History of tarsal tunnel syndrome or achilles tendinopathy |
| Calcaneal bone tumor or cyst |
| Radiculopathy or peripheral neuropathy around the ankle joint such as nerve entrapment or tarsal tunnel syndrome |
| Cardiac, liver, or renal failure |
| Osteoporosis |
| Osteomyelitis of the affected limb |
| Tuberculosis infection |
| Joint, bone, or skin infection in the affected foot |
| Spondyloarthritis |
| Fat pad atrophy |
| Proximal plantar fibroma |
| Complex regional pain syndrome |
| Cardiac pacemaker |
| Clubfoot, pes cavus, or pes calcaneovalgus |
| Abnormal erythrocyte sedimentation rate or C-reactive protein level |
| Known sensitivity or allergic reaction to bupivacaine or acetaminophen |
| History of foot or ankle injury after plantar fasciitis treatment had started through the 36-month follow-up point |
The diagnosis of CPPF was determined from the patients' history of plantar heel pain during the initial steps after a period of inactivity or the first steps in the morning, pain after prolonged weightbearing, physical examination findings (heel pain with palpation of the proximal insertion of the plantar fascia), positive windlass test, positive dorsiflexion–eversion test, and ultrasound (US) evaluation findings. All patients first underwent conservative treatment such as plantar fascia and gastrocnemius–soleus muscle stretching, NSAIDs, heel cups, and night splints for 6 months. The patients who did not experience benefit from these conservative methods at the end of the 6-month follow-up period were allocated to the 4 study groups. The pretreatment and post-treatment collected data included the patients' self-assessments of heel pain, activity, and function level, use of analgesics, radiographic evaluation findings, US evaluation findings, adverse events, and complication data.
The pretreatment assessments included a complete history, physical examination, and laboratory tests, including complete blood cell and platelet counts, erythrocyte sedimentation rate, C-reactive protein level, prothrombin time, partial thromboplastin time, blood urea nitrogen, creatinine level, and electrolyte level analysis.
The patients who were allocated to the study were advised to avoid using any other conservative treatment, such as plantar fascia and muscle stretching, NSAIDs, heel cups, arch supports, night splints, electrotherapy, and lidocaine needling during their participation in the present study. All the patients were randomly allocated to US-guided ESWT, prolotherapy, PRP, or local CS injection. A randomization schedule was created by a computer program using block randomization of 10 patients. Of the 158 patients, 39 were assigned to the ESWT group, 40 to the prolotherapy group, 39 to the PRP group, and 40 to the local CS injection group. The demographic data of the subjects are summarized inTable 3 . The severity of the pain, before and after the injections and ESWT, during the last 24 hours at rest, at the first step in the morning, and during daily activities at the area of plantar fascia origin on the medial tubercle was recorded using a visual analog scale (VAS), ranging from 0 to 10, with 0 indicating no pain and 10 indicating severe pain. The long form of the Revised Foot Function Index (FFI-R), which consists of 68 questions, was used to evaluate overall foot function, foot health, and quality of life before and after the injections and ESWT . The 4 subscales of FFI-R are pain and stiffness (19 questions), social and emotional outcomes (19 questions), disability (20 questions), and activity limitation (10 questions) .
Table 3
Demographic patient data
| Variable | ESWT | Prolotherapy | PRP Injection | Corticosteroid Injection |
|---|---|---|---|---|
| Gender (n) | ||||
| Male | 22 | 21 | 19 | 17 |
| Female | 17 | 19 | 20 | 23 |
| Affected foot (n) | ||||
| Right | 18 | 22 | 23 | 20 |
| Left | 21 | 18 | 16 | 20 |
| Age (y) | ||||
| Mean | 39.2 | 37.5 | 38.4 | 40.1 |
| Range | 21 to 49 | 25 to 62 | 19 to 58 | 21 to 56 |
| BMI (kg/m 2 ) | ||||
| Mean | 27.1 | 26.7 | 26.6 | 27.3 |
| Range | 24.3 to 29.4 | 22.2 to 29.7 | 19.6 to 29.1 | 21.5 to 29.3 |
| Symptom duration (mo) | ||||
| Mean | 15.7 | 13.2 | 13.9 | 14.5 |
| Range | 14 to 18 | 12 to 14 | 12 to 15 | 13 to 16 |
| Follow-up period (mo) | ||||
| Mean | 35.7 | 36.1 | 36.0 | 36.2 |
| Range | 34 to 38 | 34 to 38 | 34 to 38 | 34 to 38 |
Abbreviations: BMI, body mass index; ESWT, extracorporeal shock wave therapy; PRP, platelet-rich plasma.
The patients received 3 injections in the local CS injection, prolotherapy, and PRP groups once each week or 3 ESWT sessions in the ESWT group at the plantar fascia, with an interval of 7 days between the sessions. All the patients in ESWT group received the same dose of ESWT per protocol (6 Hz, 2000 pulse, 4.0 bar energy density) using a Chattanooga Intelect ® RPW shockwave radial device (Chattanooga, Surrey, UK) under US guidance. All the injections (local CS, prolotherapy, PRP) and ESWT sessions were performed using real-time US guidance with a linear array transducer. The US evaluation was performed by measurement of the medial, lateral, and central bands of the plantar fascia of the affected foot and nonaffected foot for comparison before ESWT or the injections. The heels were marked with a marker to detect the plantar fascia insertion into the calcaneus. All US examinations of the patients' symptomatic plantar heel and injection procedures were performed by the same radiologist from the medial side, as described by Cyriax and Cyriax .
The Arthrex ® ACP Double Syringe System™ (Arthrex ® , Naples, FL) was used to obtain the PRP. This system includes a 10-mL syringe and another 5-mL syringe connected to the 10-mL syringe. After the blood has been taken from the patient using the 10-mL syringe and centrifuged for 5 minutes at 1500 rpm in the Arthrex ® centrifuge (Rotofix), under aseptic conditions, the PRP was transferred from the 10-mL syringe to the 5-mL syringe.
Under US guidance, 1 mL of betamethasone 40 mg/mL and 2 mL of bupivacaine 5 mg/mL were injected into the site of maximal tenderness in the local CS injection group. Using US guidance, 1 mL of bupivacaine 5 mg/mL, 3 mL of 5% dextrose, and 6 mL of 0.9% physiologic sodium chloride solution were injected in the prolotherapy group. No bupivacaine was administered to the patients in ESWT group. A “peppering” technique was not used during the injections.
All the patients were advised to apply local ice to their heel and to take 500-mg acetaminophen tablets 3 times daily to relieve pain for 3 days. No activity or weightbearing limitation was advised to the patients.
To realize a change from the pretreatment heel pain to post-treatment heel pain with a 2.2 standard deviation and allowing for a 5% loss to follow-up, a total of 158 patients were required to provide 80% power to detect a difference of 1.0 at the 5% level of significance.
The primary efficacy endpoint for our study was the change in heel pain in the last 24 hours at rest, first step in the morning, and with daily activities at the area of plantar fascia origin on the medial tubercle in patients with CPPF from before treatment to 36 months after treatment. All randomized patients who were periodically followed up and evaluated for this outcome were included in the primary analysis of efficacy. The patients without a posttreatment assessment available, for whatever reason and at any month that had been previously scheduled, were excluded from the present study.
The primary clinical outcomes were assessed using VAS score and FFI-R score. Statistical analyses were performed using SPSS software, version 15 (IBN, Armonk, NY). The variables were investigated using analytical methods (Kolmogorov-Smirnov and Shapiro-Wilk tests) to determine whether they were normally distributed. Descriptive analyses are reported using the mean ± standard deviation for normally distributed data, including age, body mass index, and symptom duration. One-way analysis of variance was used to compare these parameters among the treatment (ESWT, CS, PRP, and prolotherapy injection) groups. The Levene test was used to assess the homogeneity of the variances. An overall p value of < .05 was considered to show a statistically significant result. When significance was observed, pairwise post hoc tests were performed using Tukey's test.
Results
A total of 158 patients were randomly assigned to the ESWT, PRP, prolotherapy, or CS injection group. No patients had missing data or withdrew from the study. The patients were evaluated before treatment and at the 1-, 3-, 6-, 12-, 24-, and 36-month visits. The baseline demographic data of the groups were similar to each other, including gender, age, affected foot, body mass index, and symptom duration ( p< .05; Table 3 ). The mean follow-up period for the groups is summarized in Table 3 . All the laboratory parameters for all the patients were within the normal range.
The mean VAS scores at the first step in the morning for all groups are summarized in Table 4 . The mean VAS scores of all the groups did not differ before treatment ( p > .05). In the ESWT group, the mean VAS score had significantly improved until 12 months after treatment ( p< .05). In contrast, it increased after 12 months ( p < .05; Table 4 ). In the prolotherapy and PRP groups, the mean VAS score had significantly decreased at 3 months until 12 months ( p < .05; ( Table 4 ). In the CS group, the mean VAS score had improved at 1 month ( p < .05) but increased afterward ( p < .05; Table 4 ). At the end of the follow-up period, the mean VAS scores for all the groups were much the same as the mean VAS scores before treatment ( p < .05; Table 4 ).
Table 4
Mean visual analog scale scores at first step in the morning
| Before treatment | 1 stmonth | 3 rdmonth | 6 thmonth | 12 th month | 24 th month | 36 th month | |
|---|---|---|---|---|---|---|---|
| ESWT (n = 39) | 7.6 ± 6.4 | 3.1 ± 2.5 | 2.5 ± 2.9 | 2.3 ± 1.4 | 5.4 ± 3.7 | 7.2 ± 6.6 | 7.4 ± 5.7 |
| Prolotherapy (n = 40) | 7.0 ± 6.4 | 6.9 ± 6.5 | 2.8 ± 2.3 | 3.0 ± 2.4 | 6.5 ± 6.4 | 7.6 ± 6.5 | 7.5 ± 7.4 |
| PRP (n = 39) | 7.9 ± 7.6 | 7.8 ± 6.5 | 2.7 ± 0.3 | 2.6 ± 0.3 | 5.6 ± 4.4 | 7.5 ± 6.5 | 7.7 ± 5.5 |
| Steroid (n = 40) | 7.4 ± 5.5 | 3.2 ± 2.4 | 4.4 ± 3.5 | 5.2 ± 3.6 | 6.8 ± 4.4 | 7.4 ± 5.4 | 7.5 ± 6.4 |
Abbreviations: ESWT, extracorporeal shock wave therapy; PRP, platelet-rich plasma.
At the end of the follow-up period, no significant improvement was noted in the cumulative FFI-R score in all 4 groups ( p > .05). The ESWT group had a better mean FFI-R score at the first 12 months and the PRP and prolotherapy groups at the 3- and 12-month intervals ( p < .05). Although the FFI-R score for the CS injection group was improved at 1 month, it then worsened progressively afterward ( p < .05; Table 5 ). No complications were noted after the injections or ESWT sessions.
Table 5
Foot Function Index-Revised of the groups. (Group 1: ESWT, Group 2: prolotherapy, Group 3: PRP, Group 4: local CS)
| Before treatment | 1 st month | |||||||
|---|---|---|---|---|---|---|---|---|
| Group | ESWT (n = 39) | PLT (n = 40) | PRP (n = 39) | CS (n = 40) | ESWT (n = 39) | PLT (n = 40) | PRP (n = 39) | CS (n = 40) |
| Pain | 32.1 ± 25.1 | 30.8 ± 29.3 | 33.6 ± 29.1 | 31.7 ± 27.9 | 13.1 ± 10.1 | 30.1 ± 26.9 | 33.4 ± 29.9 | 12.7 ± 9.4 |
| Stiffness | 12.1 ± 9.6 | 10.3 ± 8.8 | 11.3 ± 8.6 | 11.1 ± 9.4 | 9.3 ± 8.5 | 10.2 ± 9.1 | 11.1 ± 8.7 | 8.9 ± 7,8 |
| Difficulty | 42.7 ± 36.6 | 42.8 ± 35.9 | 43.2 ± 35.7 | 44.2 ± 40.1 | 33.1 ± 27.2 | 42.2 ± 36.9 | 42.7 ± 38.3 | 33.5 ± 28.7 |
| Activity score | 16.0 ± 14.9 | 15.6 ± 15.1 | 15.9 ± 14.8 | 16.1 ± 14.9 | 10.0 ± 9.6 | 15.4 ± 14.0 | 16.2 ± 14.7 | 10.3 ± 8.9 |
| Social issues | 43.9 ± 41.2 | 40.8 ± 39.6 | 41.5 ± 40.8 | 43.4 ± 41.1 | 23.3 ± 21.6 | 40.7 ± 38.7 | 41.3 ± 38.9 | 24.7 ± 22.5 |
| Cumulative | 146.8 ± 127.4 | 140.3 ± 128.7 | 145.5 ± 129.0 | 146.5 ± 133.4 | 88.8 ± 77.0 | 138.6 ± 125.6 | 144.7 ± 130.5 | 90.1 ± 77.3 |
| 3 rd month | 6 th month | |||||||
|---|---|---|---|---|---|---|---|---|
| Group | ESWT (n = 39) | PLT (n = 40) | PRP (n = 39) | CS (n = 40) | ESWT (n = 39) | PLT (n = 40) | PRP (n = 39) | CS (n = 40) |
| Pain | 12.5 ± 8.9 | 13.0 ± 10.8 | 12.9 ± 11.1 | 26.1 ± 24.2 | 10.8 ± 8.1 | 13.3 ± 11.7 | 12.8 ± 11.6 | 24.4 ± 23.9 |
| Stiffness | 8.9 ± 7.9 | 9.2 ± 8.2 | 9.0 ± 8.0 | 9.0 ± 8.1 | 8.8 ± 7.8 | 9.3 ± 9.0 | 9.0 ± 8.8 | 8.9 ± 7.3 |
| Difficulty | 29.9 ± 27.1 | 27.4 ± 25.3 | 27.4 ± 22.4 | 33.4 ± 29.7 | 27.2 ± 26.5 | 27.3 ± 26.1 | 27.3 ± 26.3 | 36.8 ± 34.7 |
| Activity score | 9.8 ± 9.0 | 9.8 ± 8.8 | 9.6 ± 8.7 | 11.6 ± 10.5 | 9.7 ± 8.8 | 9.9 ± 8.6 | 9.8 ± 9.0 | 12.1 ± 9.8 |
| Social issues | 23.3 ± 20.9 | 22.0 ± 19.3 | 21.9 ± 18.6 | 27.8 ± 25.1 | 22.1 ± 20.1 | 22.2 ± 19.7 | 22.1 ± 21.3 | 38.3 ± 37.6 |
| Cumulative | 84.4 ± 73.8 | 81.4 ± 72.4 | 80.8 ± 68.8 | 107.9 ± 97.6 | 78.6 ± 71.3 | 82.0 ± 75.1 | 81.0 ± 77.0 | 120.5 ± 113.3 |
| 12 th month | 24 th month | |||||||
|---|---|---|---|---|---|---|---|---|
| Group | ESWT (n = 39) | PLT (n = 40) | PRP (n = 39) | CS (n = 40) | ESWT (n = 39) | PLT (n = 40) | PRP (n = 39) | CS (n = 40) |
| Pain | 24.7 ± 23.4 | 19.2 ± 18.5 | 24.8 ± 22.9 | 30.8 ± 29.9 | 28.5 ± 28.0 | 29.1 ± 27.8 | 29.3 ± 28.4 | 30.2 ± 29.0 |
| Stiffness | 10.3 ± 9.6 | 9.6 ± 9.1 | 9.8 ± 9.1 | 10.1 ± 8.8 | 10.9 ± 9.5 | 9.6 ± 8.7 | 9.9 ± 8.9 | 9.8 ± 9.2 |
| Difficulty | 37.0 ± 35.3 | 40.4 ± 38.2 | 37.2 ± 36.6 | 43.2 ± 40.8 | 41.4 ± 39.6 | 43.3 ± 39.8 | 40.3 ± 38.4 | 43.4 ± 41.3 |
| Activity score | 12.9 ± 10.1 | 13.4 ± 9.9 | 13.1 ±1 11.5 | 13.3 ± 11.2 | 15.1 ± 14.5 | 13.7 ± 13.0 | 13.6 ± 11.2 | 13.9 ± 13.1 |
| Social issues | 38.8 ± 38.4 | 29.3 ± 28.5 | 39.0 ± 36.2 | 39.5 ± 36.8 | 41.4 ± 39.6 | 39.7 ± 38.1 | 39.5 ± 37.7 | 40.3 ± 37.5 |
| Cumulative | 123.7 ± 116.8 | 111.9 ± 104.2 | 123.9 ± 116.3 | 136.9 ± 127.5 | 137.3 ± 131.2 | 135.4 ± 127.4 | 132.6 ± 124.6 | 137.6 ± 130.1 |
| 36 th month | ||||||||
|---|---|---|---|---|---|---|---|---|
| Group | ESWT (n = 39) | PLT (n = 40) | PRP (n = 39) | CS (n = 40) | ||||
| Pain | 31.1 ± 29.9 | 31.2 ± 29.8 | 32.2 ± 30.9 | 32.0 ± 30.8 | ||||
| Stiffness | 11.8 ± 10.3 | 10.4 ± 8.9 | 11.8 ± 10.5 | 10.8 ± 9.2 | ||||
| Difficulty | 43.4 ± 40.8 | 43.1 ± 42.1 | 41.6 ± 39.9 | 44.4 ± 43.2 | ||||
| Activity score | 15.6 ± 13.9 | 15.9 ± 13.7 | 15.7 ± 13.6 | 15.9 ± 14.4 | ||||
| Social issues | 44.2 ± 43.6 | 44.2 ± 41.7 | 44.2 ± 40.9 | 44.2 ± 43.4 | ||||
| Cumulative | 146.1 ± 138.5 | 144.8 ± 136.2 | 145.5 ± 135.8 | 147.3 ± 141.0 | ||||
Abbreviations: CS, corticosteroid injection; ESWT, extracorporeal shock wave therapy; PLT, prolotherapy; PRP, platelet-rich plasma injection.
Discussion
ESWT, prolotherapy, local CS injection, and PRP injection therapies have received attention for the treatment of CPPF. To the best of our knowledge, the present study is the first to compare 4 treatment modalities of CPPF for a single condition. Our aim was to compare the effectiveness of the 4 treatment methods in a single study with an average follow-up period of 36 months. Plantar fasciitis usually presents as a chronic condition, with the duration of pain >1 year before treatment . Two different retrospective cohort studies reported the mean duration of symptoms ranged from 13.3 to 14.1 months . Our study included patients who had not benefited from conservative methods, with a mean duration of symptoms ranging from 13.2 to 15.6 months ( Table 3 ).
No diagnostic test for CPPF has been accepted. Although the plain radiographs will show the heel spurs, US findings support the diagnosis when the plantar fascia is thickened (>4 to 4.5 mm) and hypoechoic . US scanning is a noninvasive, low-cost, and radiation-free method with quick performance, large availability, and a high sensitivity for the diagnosis . According to Ball et al , US evaluations can detect the subtle signs of inflammatory enthesopathy. US-guided injections have been suggested by some investigators . In our study, we used US scanning with all the patients for the diagnosis of PF and to standardize the injection site of the plantar fascia and ESWT application site (to establish the area where ESWT would be applied and for guidance to avoid misinjection into the fat pad).
Several studies have demonstrated 48% to 88% success rates with ESWT , and significant improvement in VAS scores and activity scores for CPPF . It has been suggested that ESWT is safer than CS injections . The therapeutic benefits of ESWT starts 2 weeks after the ESWT application . In contrast, several studies have shown the early effects of shock waves on tenocytes in animal-derived primary cultures . According to Kudo et al , ESWT offers an additional benefit to pain and activity levels for ≥3 months after treatment.
Some placebo-controlled studies of ESWT have been reported. In 1 of these studies, Speed et al reported no beneficial effects for ESWT compared with placebo during a 6-month period. Buchbinder et al reported no statistically significant differences in the degree of improvement between the ESWT and placebo groups. In contrast to their study, Haake et al reported better results with ESWT for CPPF in a placebo-controlled multicenter trial. Ogden et al reported successful results for 56% of 302 patients in a placebo-controlled study. Buch et alfollowed up 150 patients for 12 weeks and reported success for 61.6% of the ESWT group and 40% of the placebo group. Malay et al reported that in the absence of a calcaneal spur on radiographs, the reduction in heel pain in the ESWT group was statistically significant compared with that in the placebo group but that in the presence of a calcaneal spur, the reduction in heel pain was not statistically significant between the 2 groups. Theodore et al reported successful results for 56% of patients after ESWT in a placebo-controlled trial. Rompe et al reported a significant improvement in 67% of the ESWT patients versus 27% of the placebo patients after 6 weeks, 56% versus 16% after 12 weeks, and 88% versus 34% after 1 year, respectively. In another study, Rompe et al reported a significant improvement in pain and function in ESWT group at the 3-month follow-up point in a single-blind randomized controlled study.
Melegati et al separated their patients into 2 groups and gave 3 sessions of ESWT to both groups. Group A consisted of 38 patients without a history of previous CS injections and group B consisted of 26 patients with a history of previous CS injections. At 2 months, 31.6% of the patients in group A and 11.5% in group B were pain free. At 10 months after EWST, 39.5% of patients in group A were pain free. However, in group B, none of the patients were pain free . Hammer et al demonstrated that ESWT is a long-lasting pain-reducing method for treating PF. Ragab and Othman reported their results with ESWT in runners with a symptomatic heel spur. At the end of the 24-month follow-up period, the VAS scores had significantly improved . Saxena et al reported that ESWT is an effective treatment for ≥12 months after treatment. Thompson et al performed a meta-analysis of 6 randomized controlled trials and reported that ESWT was not significantly effective statistically for plantar heel pain. In our study, the ESWT group had better VAS and FFI-R scores at the first year, but these results worsened subsequently.
Tsai et al and Kane et al both reported a therapeutic benefit of 80% to 90% for CS injections. Tsai et al reported that the effectiveness of CS injection could last for 1 year. Porter and Shadbolt compared CS injections and ESWT. Their study demonstrated that although CS injection results in a significant improvement in pain at 3 months relative to ESWT, at 12 months, the pain levels in the CS injection group were similar to those of the ESWT group. According to Crawford and Thompson , CS injection can be useful in the short term. Similarly, Ball et al reported significant benefits with CS injection in the short and medium term. However, CS injection has high frequency of relapse and recurrence of pain after 6 months . In contrast, Kalaci et al and Genc et al reported long-term positive effects with CS injection. The results of 2 systematic reviews failed to find any clinical benefit from CS injections for the treatment of heel pain in PF . However, Crawford et al reported that CS injections could achieve short-term effects. Coombes et al showed strong evidence that CS injection can be effective in the treatment of tendinopathies in the short term but is less effective than prolotherapy and PRP in the long term. According to their review, PRP was less effective than CS injection in the short term but superior to relieving pain for tendinopathies in the long term . Although the FFI-R and VAS scores had improved at 1 month after treatment in the CS injection group in our study, the results became worse after this time until 36 months after treatment.
PRP is a hot topic in the field of orthopedic medicine and has been reported as an effective treatment option for PF . A prospective, randomized controlled study compared autologous blood injections and CS injections in the treatment of PF. In that study, at 6 weeks and 3 months of the treatment, the CS injection group had significantly lower VAS scores than those of the autologous blood injection group. However, no significant difference was found at the 6-month follow-up point. The tenderness threshold scores were greater in the CS group at 6 weeks, 3 months, and 6 months after treatment. They suggested using autologous blood injections when first-line noninvasive treatment had failed to decrease pain levels and when CS injections had failed or were contraindicated . Monto emphasized that PRP is more effective than CS injection at the 2-year follow-up examination. Martinelli et al treated 14 patients with PRP and reported that the VAS scores had decreased from 7.1 before treatment to 1.9 at the end of the 12-month follow-up period. Ragab and Othman reported complete resolution of pain with PRP in 88% of their patients at the end of their 10.3-month follow-up period. Some studies have shown that no recurrence of tendonitis develops after treatment with PRP . In contrast to these studies, Shetty et al found no significant differences between PRP and CS injections in a 6-month follow-up period. Akşahin et al compared CS and PRP injections in 60 patients. Although they expected more satisfactory results in the PRP group, because PF is believed to be a regenerative process rather than an inflammatory reaction, at the sixth month of the treatment, only 4 patients had poor results, and they found no significant differences in the VAS scores or clinical outcomes . Mahindra et al compared PRP and CS injections in a placebo-controlled study and found no significant differences between the 2 at 3 weeks and 3 months after treatment; however, the results were better than placebo. Our patients in the PRP group experienced resolution of their pain from 1 month to 1 year; however, after the first year, the pain returned and the cumulative FFI-R scores became worse.
In a pilot study, Ryan et al reported good and excellent results at the end of an 11.8-month follow-up period for 16 of 20 patients treated with US-guided prolotherapy for chronic PF. Our findings are not in agreement with their findings. To the best of our knowledge, in the English data, no studies have reported on the duration of resolution or the incidence of relapse after prolotherapy for PF. In our study, the VAS and FFI-R scores from prolotherapy group improved between the third and sixth months after treatment.
To the best of our knowledge, ours is the first study designed to compare the use of ESWT and CS, PRP, and prolotherapy injections for the treatment of CPPF. However, the present study did have some limitations. First, we had a small number of patients, which resulted from the inclusion and exclusion criteria for our study. Additionally, we did not include a placebo control group in our study. The US outcomes were not evaluated using a blinded method. An ideal study would include a prospective, randomized, placebo-controlled, double-blind sample of patients. Nonetheless, the primary aim of our study was to compare the 4 treatment modalities, not to show their individual effects. Also, we did not assess the changes using pretreatment and posttreatment US imaging, magnetic resonance imaging, or scintigraphy. Although limited by many factors, the results of our series have shown that no improvement occurred between the pretreatment and posttreatment VAS and FFI-R scores for all our patients at the end of the follow-up period. The increase in activity level of the patients, changes in lifestyle, weight gain, and shoe changes could have affected the results. These factors could be possible causes for why the results failed over time. Thus, another important limitation of our study was the difficulty in controlling for all these changes in 158 patients at the 36-month follow-up period. Therefore, more prospective, randomized, placebo-controlled, double-blind studies are needed. The strengths of our study included the mean 36-month comprehensive assessment of the outcomes. The present trial provides valuable information for future treatment trials of CPPF.
In conclusion, once chronic plantar fasciopathy has persisted, CS injection will be more effective in the first 3 months, and ESWT is a safe, effective method in the first 6 months with regard to pain. CS injection loses its effectiveness over time. The effect of prolotherapy and PRP will be seen within 3 to 12 months; however, at the 36-month follow-up point, we found no differences among the 4 treatments.
Financial Disclosure: None reported.
Conflict of Interest: None reported.
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