• View in gallery

    A, Medial portal incision. B, Arthroscope insertion into the cannula from the lateral portal and No. 11 scalpel from the medial portal. C, The plantar fascia and guide needle visualized through the cannula. D, Complete partial medial plantar fasciotomy.

  • View in gallery

    A and B, Cryosurgery unit and cryoprobe. C, Insertion of the probe on the medial plantar aspect of the heel. D, Fluoroscopic image of the probe.

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Endoscopic Plantar Fascia Release versus Cryosurgery for the Treatment of Chronic Plantar Fasciitis: A Prospective Randomized Study

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Background

In a prospective randomized study, we compared two different surgical techniques used in plantar fasciitis surgery.

Methods

Forty-eight patients diagnosed as having plantar fasciitis and treated for at least 6 months with no response to conservative modalities were included in this study. The patients were randomly assigned to receive endoscopic plantar fascia release (EPFR) or cryosurgery (CS). Patients were evaluated using the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHS) as a primary outcome measurement at baseline and 3 weeks and 3, 6, and 12 months after surgery. At the final follow-up visit, the Roles-Maudsley score was used to determine patient satisfaction.

Results

Five patients did not complete the 1-year follow-up examination (one in the EPFR group and four in the CS group). Thus, the study group included 43 patients. Although both groups showed significant improvement at the final evaluation, the patients in the EPFR group had significantly better AOFAS-AHS scores at 3 months. The success rate (Roles-Maudsley scores of excellent and good) in the EPFR group at 12 months was 87% and in the CS group was 65%.

Conclusions

Both EPFR and CS were associated with statistically significant improvements at 1-year follow-up. At 3-month follow-up, EPFR was associated with better results and a higher patient satisfaction rate compared with CS.

Background

In a prospective randomized study, we compared two different surgical techniques used in plantar fasciitis surgery.

Methods

Forty-eight patients diagnosed as having plantar fasciitis and treated for at least 6 months with no response to conservative modalities were included in this study. The patients were randomly assigned to receive endoscopic plantar fascia release (EPFR) or cryosurgery (CS). Patients were evaluated using the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHS) as a primary outcome measurement at baseline and 3 weeks and 3, 6, and 12 months after surgery. At the final follow-up visit, the Roles-Maudsley score was used to determine patient satisfaction.

Results

Five patients did not complete the 1-year follow-up examination (one in the EPFR group and four in the CS group). Thus, the study group included 43 patients. Although both groups showed significant improvement at the final evaluation, the patients in the EPFR group had significantly better AOFAS-AHS scores at 3 months. The success rate (Roles-Maudsley scores of excellent and good) in the EPFR group at 12 months was 87% and in the CS group was 65%.

Conclusions

Both EPFR and CS were associated with statistically significant improvements at 1-year follow-up. At 3-month follow-up, EPFR was associated with better results and a higher patient satisfaction rate compared with CS.

Plantar fasciitis is the most common cause of heel pain and affects approximately 10% of the population.1-3 The etiology of this condition is multifactorial, and it is generally characterized as an overuse syndrome. Repetitive trauma over the calcaneal medial tubercle can lead to degenerative painful changes at the origin of the plantar fascia.4 Up to 90% of patients with plantar fasciitis can be treated conservatively with foot strapping, nonsteroidal anti-inflammatory drugs, corticosteroid injections, platelet-rich plasma injection, botulinum toxin injection, orthotic devices, heel cups, night splints, extracorporeal shockwave therapy, and other forms of noninvasive therapy.5-13 However, the remaining 10% of patients with no improvement in symptoms after 6 months of conservative therapy often undergo surgical intervention for pain relief.14-16

The most common surgical intervention used for the treatment of recalcitrant plantar fasciitis is plantar fasciotomy. Open, endoscopic, and percutaneous plantar fasciotomy techniques have all been used with high patient satisfaction rates.17,18 In addition to these traditional surgical procedures, some innovative minimally invasive techniques, such as radiofrequency ablation and cryosurgery (CS), have also been used. The results of clinical trials of these new methods show encouraging results in the surgical management of plantar fasciitis.19-24

Cryosurgery can be broadly defined as the destruction of pathologic tissues and nerve endings with cold. The analgesic effect of cold has been known for a long time. Hippocrates and Napoleon's surgeons general reported the benefits of ice and snow on painful tissue.25-27 Cryosurgery is frequently used today in various medical specialties for painful conditions such as peripheral neuromas, pain after tonsillectomy, trigeminal neuralgia, biomechanical spine pain, and recalcitrant plantar fasciitis.23,24,28-31

Endoscopic plantar fascia release (EPFR) is still the most popular surgical procedure used in the treatment of recalcitrant plantar fasciitis among foot and ankle surgeons. To our knowledge, no published studies have compared clinical outcomes between the EPFR and CS methods. The present prospective randomized study was designed to assess the effectiveness of EPFR and CS for recalcitrant plantar fasciitis and to compare their clinical outcomes. The main hypothesis was that no difference in treatment outcomes would be found between the methods.

Patients and Methods

Patients

After receiving approval from the Muğla Sıtkı Koçman University Medical Ethics Committee, we initiated the prospective randomized study protocol. Between November 1, 2013, and September 30, 2016, 48 patients (31 women and 17 men) with chronic plantar fasciitis were included in the study. Patients diagnosed as having plantar fasciitis and treated conservatively for at least 6 months without a response to at least three conservative treatment modalities were included. Conservative treatment included nonsteroidal anti-inflammatory drugs, corticosteroid injections, physical therapy, an exercise program (Achilles tendon and plantar fascia stretching exercises), and orthotic devices (heel cup, molded shoe insert, night splint, or cast). Patients with inflammatory diseases, neuromuscular disorders, anatomical deformities, previous heel surgery, or painful heel due to other systemic or local causes were excluded. Patients lost during follow-up were also excluded from the study. All of the patients were informed in detail via oral presentation of the procedures and gave informed consent to join the study. Pretreatment heel radiographs and magnetic resonance images were obtained to exclude the presence of intraosseous lesions, such as a calcaneal cyst, subtalar arthritis, or fracture, and to confirm the diagnosis of plantar fasciitis. At enrollment, a single foot and ankle surgeon (B.C.) clinically confirmed the diagnosis by palpation to reveal the characteristic location of pain and tenderness in the hindfoot. The patients were randomly allocated to the EPFR or CS group using a computer-generated randomization list. Five patients did not complete the 1-year follow-up examination (one in the EPFR group and four in the CS group). Thus, the study group included 43 patients.

EPFR Technique

The procedure was performed in all of the patients using medial and lateral portals under general or spinal anesthesia with the patient in the supine position. A pneumatic tourniquet was applied to the thigh and inflated to a pressure of 250 mm Hg. The first medial portal was formed using a 7-mm incision at the intersection between the vertical line drawn from the posterior border of the medial malleolus and the plantar skin line (Fig. 1A). After blunt dissection, a path was created using a trocar from medial to lateral under the fascia, perpendicular to the plantar axis of the foot. The tip of the trocar was palpated from the lateral heel skin, and the lateral portal was created using another 7-mm skin incision. A slotted cannula was passed from lateral to medial through the trocar. An arthroscope was inserted into the cannula from the lateral portal, with water flow provided by gravity (Fig. 1B). Soft tissue inside the cannula was removed with a shaver to improve visualization. The medial half of the plantar fascia was cut using a No. 11 scalpel, careful not to damage the flexor digitorum brevis muscle fibers (Fig. 1 C and D). Portal incisions were closed using No. 3 polypropylene sutures. All of the EPFR procedures were performed by the same surgeon (B.C.).

Figure 1.
Figure 1.

A, Medial portal incision. B, Arthroscope insertion into the cannula from the lateral portal and No. 11 scalpel from the medial portal. C, The plantar fascia and guide needle visualized through the cannula. D, Complete partial medial plantar fasciotomy.

Citation: Journal of the American Podiatric Medical Association 110, 5; 10.7547/18-082

CS Technique

All of the patients were prepared in a prone position. The area of maximal tenderness was carefully identified before surgery. The most common site for this palpable tenderness was the origin of the plantar fascia at the medial calcaneal tubercle medial band of the plantar fascia origin, near the calcaneal tubercle. Next, the tibial nerve was anesthetized at the site of the inferior border of the medial malleolus with 7 mL of 5% bupivacaine. Then, a 5-mm incision was made for the cryoprobe (Cryo-Line; Optikon Corp Ltd, Kitchener, ON, Canada) (Fig. 2 A and B) at the intersection between the area of maximal tenderness and the plantar skin line (Fig. 2C). The accuracy of the cryoprobe placement was confirmed using fluoroscopy (Fig. 2D). The procedure includes 3 min of freezing, 30 sec of thawing, and another 3 min of freezing. The surgical site was irrigated with saline solution, and the dressing was applied without suturing the incision. All of the CS procedures were performed by the same surgeon (A.B.)

Figure 2.
Figure 2.

A and B, Cryosurgery unit and cryoprobe. C, Insertion of the probe on the medial plantar aspect of the heel. D, Fluoroscopic image of the probe.

Citation: Journal of the American Podiatric Medical Association 110, 5; 10.7547/18-082

Postoperative Care

The same postoperative follow-up protocol was used for both groups. Active range-of-motion exercises of the foot and ankle were started the day after surgery. Patients were allowed to start weightbearing as tolerated. Patients were encouraged to perform plantar fascia stretching exercises at home and were not allowed to participate in sports activities or excessive walking before 2 weeks.

Follow-up Protocol

At enrollment the patients' demographic data (age, sex, duration of symptoms, and body mass index) were recorded. The American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHS)32,33 score (primary outcome measure; range, 0–100) was determined before surgery and 3 weeks and 3, 6, and 12 months after surgery. Patient satisfaction was determined using Roles-Maudsley (R-M) scores at the final follow-up visit.34 According to the R-M score, “excellent” and “good” were considered satisfactory outcomes and “fair” and “poor” were considered unsatisfactory outcomes. The assessor (R.G.U.) performed all of the assessments twice in 1 day. The mean value of each score was used in the statistical analysis. Early complications, which developed immediately after the procedure, and delayed complications, which developed during follow-up, were also recorded. Persistent heel pain after the procedures was determined to be a complication.

Statistical Analysis

SPSS Statistics for Windows, Version 15.0 (SPSS Inc, Chicago, Illinois) was used for statistical analysis. G-Power software was used for sample size estimation. A sample size of 42 individuals (21 per arm) is proposed. This would give 80% power to detect an effect size of 0.8 (one-tailed) between groups for continuous outcome variables of the study. Normality was tested using the Kolmogorov-Smirnov test. Intragroup and intergroup comparisons of normally distributed continuous variables were performed using paired-samples and independent-samples t tests, whereas Wilcoxon rank and Mann-Whitney U tests were used for intragroup and intergroup comparisons of continuous variables without normal distribution. Categorical variables were compared using the χ2 test. When comparing the groups regarding clinical outcomes (AOFAS-AHS scores), the null hypothesis was the absence of a difference in mean scores. A P < .05 was considered statistically significant.

Results

The EPFR group included nine men and 14 women with an average age of 53.5 years (range, 39–67 years). Symptoms averaged 22.3 months (range, 10–34 months) in duration before treatment. The CS group included six men and 14 women with an average age of 46.9 years (range, 32–60 years). Symptoms averaged 20.7 months (range, 6–48 months) in duration before treatment. There was no significant difference between groups with respect to sex, body mass index, duration of symptoms, and baseline AOFAS-AHS score (P > .05). The mean age of the patients was higher in the EPFR group (P = .01). Baseline characteristics of patients in each group are summarized in Table 1.

Table 1.

Baseline Characteristics of Patients in Each Group

Table 1.

The EPFR group had an average AOFAS-AHS score of 51 (range, 38–72) before treatment, which initially improved to 84.6 (range, 60–95) 12 months after surgery. The CS group had a baseline average AOFAS-AHS score of 53.9 (range, 31–76), which initially improved to 73.5 (range, 39–92) at 12 months. There was a significant increase in AOFAS-AHS scores in both groups at 12-month follow-up (P < .001). The difference between the postoperative AOFAS-AHS scoring results of the EPFR and CS groups was significant at the 6- and 12-month follow-up evaluations (P = .006 and P = .005, respectively) (Table 2).

Table 2.

Summary of Study Results

Table 2.

When the intragroup evaluation was performed by follow-up period, it was seen that the AOFAS-AHS scores in the EPFR group increased significantly over time. However, there was no significant intragroup improvement in AOFAS-AHS scores in CS group after 3 months. Intragroup evaluation of AOFAS-AHS scores by time is summarized in Table 3.

Table 3.

Intragroup Evaluation of AOFAS-AHS Scores and Statistical Data

Table 3.

Using the R-M scoring system, the patient satisfaction rate was 87% for the EPFR group and 65% for the CS group at 12 months. The patient satisfaction rate was significantly higher in the EPFR group at the final evaluation (P = .029).

Two patients in the CS group experienced persistent heel pain on the medial calcaneal tubercle at the final evaluation. No complications were recorded in the EPFR group. The difference in the incidence of complications between the two groups was deemed significant (P = .48).

Discussion

It is a well-known fact that more than 90% of patients with plantar fasciitis respond to conservative treatment modalities. However, the remaining minority of patients do not improve with conservative treatment and may be candidates for surgical treatment. This study focuses on the latter group of patients.

Endoscopic plantar fascia release is a very commonly used method in plantar fasciitis surgery. Although the endoscopic approach to plantar fasciotomy was previously compared with the open approach, extracorporeal shockwave therapy, or radiofrequency microtenotomy, it was never compared with CS.35-38 In this study, we compared treatment outcomes between EPFR and CS. The study results showed that patients undergoing endoscopic plantar fasciotomy had significantly better functional outcomes, less pain, and higher satisfaction rates at the final evaluation.

Cryosurgery uses extremely cold temperatures to selectively destroy nerve endings and create a block that stops the conduction of pain. The cycle of freezing, thawing, and refreezing causes the axons and cellular elements to rupture, altering the pain pathway. Two major mechanisms are theorized to cause nerve injury and denervation: the first is the direct injury to cells caused by ice crystal formation during the freezing cycle. The second mechanism is microcirculatory failure, which occurs during the thawing phase.39,40 The main purpose of CS for recalcitrant plantar fasciitis is to obtain pain relief by destroying pathologic tissue and nerve endings at the medial insertion site of the plantar fascia. Allen et al23 investigated the efficacy of CS on painful plantar fasciitis. In their prospective study, they showed significant pain decrease after the procedure at 1-year follow-up.23 In a retrospective study, Cavazos et al24 analyzed 137 feet over a 24-month period after CS. They reported a 77.4% success rate and also stated that CS was successful in resolving both short- and long-term heel pain. In the present study, we found similar results in the CS group as in literature. The preoperative mean AOFAS-AHS score of 53.9 had increased to 73.5 at 12 months after surgery. The results of the present prospective study show that CS gives satisfactory outcomes for chronic plantar fasciitis.

The goal of partial plantar fasciotomy is to reduce the mechanical overload in the affected area. Endoscopic plantar fascia release is a minimally invasive procedure for partial plantar fasciotomy. The procedure significantly minimizes surgical trauma and allows patients to return to regular daily activities faster with less pain and discomfort compared with traditional open techniques.41 In the present study, the EPFR group mean preoperative AOFAS-AHS score of 51 was increased to 84.6 at 12 months. This improvement of 33.6 points (range, 12–48 points) in the present study is compatible with previous studies reporting an increase of 18 to 44 points in mean AOFAS-AHS scores.42-45 The present results are in accordance with those from previous studies and show that the results of EPFR are encouraging.

When the EPFR and CS groups were compared, although no difference was noted in the early postoperative phase, higher AOFAS-AHS scores at 6- and 12-month follow-up were found in the EPFR group. Another difference was found in the patient satisfaction rate at the final evaluation (87% in the EPFR group versus 65% in the CS group; P = .029). In the early phase of follow-up, both group results were similar, but the EPFR group showed better results with time. In addition, according to intragroup evaluation, the EPFR group AOFAS-AHS scores continued to increase with time, whereas there was no significant change seen in the CS group after 3 months. These results can be explained by several reasons. First, it is well-known that plantar fasciitis is a result of repeated microtrauma and mechanical overload at the medial process of the calcaneal tubercle.46,47 When these two techniques were compared, only EPFR eliminated mechanical overload by partial plantar fasciotomy at the medial insertion site. In CS, pain relief is achieved by denervation, and the integrity of the plantar fascia remains intact. The better results after 3 months in the EPFR group can be explained by the continuation of repeated microtrauma in the CS group. Second, in the EPFR group there is direct visualization of the plantar fascia, and, thus, partial plantar fasciotomy can be performed without damaging other tissues in anatomical proximity. However, CS was defined as a percutaneous technique in the treatment of plantar fasciitis.23,24 Allen et al23 stated that the cryoprobe is used to destroy the branches of the medial calcaneal nerve that innervate the fascia and register pain. The placement depth of the probe in the percutaneous technique may be affected by several variables, including skin thickness and soft-tissue swelling present at the time of the procedure. Moreover, there is a certain risk that the tissue in anatomical proximity, such as the first branch of the lateral plantar nerve or flexor digitorum brevis muscle, can be damaged by percutaneous CS. This might be another reason for the better results in the EPFR group at the final evaluation.

This study had some limitations. First, we did not use a blinding method for the patients and the assessor to avoid detection bias. Another limitation of this study was the relatively small sample size and the modest follow-up of 1 year. The relatively small sample size made the statistical analysis of the data difficult, and we were unable to evaluate the effect of patient characteristics on the outcomes. Finally, the AOFAS-AHS score was used as an outcome measure. Although the AOFAS scale is the most widely used and accepted outcome measure in the foot and ankle literature, the AOFAS score has not been validated, and translation has not been cross-culturally adapted.

In conclusion, we found that both EPFR and CS were associated with statistically significant improvements in postoperative outcome measures at 1-year follow-up, but after 3 months, EPFR was associated with better results and higher patient satisfaction rates compared with CS.

Financial Disclosure: None reported.

Conflict of Interest: None reported.

References

  • 1. 

    Riddle DL, Pulsic M & Pidcoe P et al.: Risk factors for plantar fasciitis: a matched case-control study. J Bone Joint Surg Am 85 : 872, 2003.

  • 2. 

    Riddle DL & Shappert SM: Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int 25 : 303, 2004.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3. 

    Scher DL, Belmont PJ Jr, & Bear R et al.: The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am 91 : 2867, 2009.

  • 4. 

    Lapidus PW & Guidotti FP: Painful heel: report of 323 patients with 364 painful heels. Clin Orthop Relat Res 39 : 178, 1965.

  • 5. 

    Martinelli N, Bonifacini C & Romeo G: Current therapeutic approaches for plantar fasciitis. Orthop Res Rev 6 : 33, 2014.

  • 6. 

    Young CC, Rutherford DS & Niedfeldt MW: Treatment of plantar fasciitis. Am Fam Physician 63 : 467, 2001.

  • 7. 

    Lynch DM, Goforth WP & Martin JE et al.: Conservative treatment of plantar fasciitis: a prospective study. JAPMA 88 : 375, 1998.

  • 8. 

    Kıter E, Çelikbaş E & Akkaya S et al.: Comparison of injection modalities in the treatment of plantar heel pain: a randomized controlled trial. JAPMA 96 : 293, 2006.

    • Search Google Scholar
    • Export Citation
  • 9. 

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Department of Orthopedic Surgery, Medipol University Medical School and Koşuyolu Hospital, Kadıköy/İstanbul, Turkey.

Department of Orthopedic Surgery, Çanakkale Onsekiz Mart University Medical School, Çanakkale, Turkey.

Department of Orthopedic Surgery, Kafkas University Medical School, Kars, Turkey.

Corresponding author: Bilgehan Çatal, MD, Department of Orthopedic Surgery, Medipol University Medical School, Koşuyolu Hospital, Koşuyolu Lambacı Sokak no.1, Kadıköy/İstanbul, Turkey. (E-mail: drbilgehancatal@yahoo.com)