ESWT For Plantar Fasciitis: What Do The Long-Term Results Reveal?

Offering a closer look at the role of extracorporeal shockwave therapy (ESWT) in the armamentarium for chronic plantar fasciitis, this author reviews long-term research from randomized controlled trials, offers a compelling case study and assesses the cost-effectiveness of ESWT in comparison to surgical alternatives.

   Heel pain is the number one reason why patients seek medical attention from a foot and ankle specialist. Conservative care alternatives and successes are well known if not well validated in the literature. It is commonly accepted that between 70 and 90 percent of patients will undergo successful treatment via those conservative measures.
However, no study has looked at the timeframe necessary for those conservative alternatives to be successful or the cost involved with those measures. Additionally, 20 to 30 percent of those patients will progress to a chronic condition for which response to conservative treatment becomes less predictable, more costly and has a higher rate of recurrence.

   Tong and Furia looked at the total cost for treating heel pain/plantar fasciitis in their 2010 study.1 They found that at any given time, 5 million Americans were undergoing treatment for heel pain/plantar fasciitis. The 2007 national economic burden of plantar fasciitis was an estimated $284 million annually (a range of $192 million to $376 million) with 80 percent of those costs associated with medications and 14 percent to office visits (physician or physical therapist).

   This economic calculation did not incorporate lost work, lost wages, societal burden and personal psychological burden.1 In fact, no study has looked at those indirect effects of plantar fasciitis as they pertain to patient outcomes and economics. It stands to reason that any therapy that returns patients back to a normal daily lifestyle quickly and in a cost-effective manner should be attractive.

   In 2000, extracorporeal shockwave therapy (ESWT) entered the United States medical landscape as an alternative for treating chronic plantar fasciitis, trailing Europe by at least a decade. There was a great deal of controversy and posturing between manufacturers of ESWT technologies. Each company was determined to create an exclusive market at the expense of their competition. One of the most common targets for criticism was the level of energy of shockwave technology. In my own experience, high-energy ESWT is the most effective modality for the musculoskeletal system and one should consider those devices that fail to reach high energy to be inferior.

   Interestingly, there was no standard by which energy levels were measured so comparisons were not valid. When physicists who were experts in ESWT were questioned as to which modalities were high energy and which modalities were low energy, they usually were unable to answer the question because of the lack of standardization.

A Closer Look At The Research

Many different studies in peer-reviewed journals were published on the success or failure of ESWT. Nearly every study that involved a retrospective analysis of ESWT on plantar fasciitis found success in the 80 to 88 percent range in substantially reducing heel pain.2,3 These statistics were nearly identical to those of retrospective studies on surgical procedures for plantar fasciitis.

   My colleagues and I published a study comparing surgical success with that of ESWT and found the success rates of both treatments to be equivalent.4 The study consisted of 40 feet treated with ESWT. We used electrohydraulic shockwave with a mean of 20.6 kV in combination with a mean of 2,506 pulses.

   We reviewed outcomes after a mean follow-up time of 8.4 months and compared the results to those of patients who had a percutaneous plantar fasciotomy. Eighty-two percent of the patients treated with ESWT were successfully treated in comparison to 83 percent with a percutaneous plantar fasciotomy. On the Visual Analogue Scale (VAS) of 0 to 10, the mean score for satisfied patients in the ESWT group was 7.9 preoperatively and 2.95 within seven days postoperatively. After three months, the mean VAS in the ESWT group was 4.2 or 50 percent of the preoperative value after a mean of 8.4 months following treatment. The VAS improvement of the surgical group we had previously studied was identical. However, our study noted that the ESWT group returned to work and activities of daily life nearly immediately following the procedures without complications. This was much different than the surgical group.

   There have been other prospective randomized placebo controlled trials (RCTs) on ESWT. Some showed good results and others did not show a difference between the treatment and the placebo groups. Some studies showed no difference between treated and non-treated groups. These studies received more attention from the media, insurance companies and public (physicians included).

   Rarely does anyone point out that no surgical procedure is under the same scientific scrutiny as ESWT as placebo controlled studies would be unethical in a surgical setting. Therefore, ESWT has always been held to a higher scientific burden than surgical procedures that have equivalent retrospective success. There are far more studies published on the successes of shockwave than on its lack of success and now it is commonly accepted as an appropriate and evidenced-based alternative for the treatment of chronic plantar fasciitis.

   In an attempt to quantify the long-term success of ESWT, we recently performed a study looking at the patients who underwent ESWT at the Weil Foot and Ankle Institute from 2000 to 2002.5 We presented our results at the 2010 International Society for Medical Shockwave Treatment Annual Congress and at the 2010 American College of Foot and Ankle Surgeons Annual Scientific Congress. My colleagues and I have also submitted the study results for publication in a peer-reviewed journal.

   The study included 75 patients and 87.5 percent of the patients were either satisfied or very satisfied with their ESWT experience at an average of nine years after treatment with a mean pain score of 1.2 on the VAS scale of 0 to 10. Twenty-four percent of patients were able to discontinue all aspects of maintenance treatment including orthotics, medications, supportive devices or shoes and physical therapy type activities. In addition, 24 percent of patients maintained 95.8 percent improvement with a pain rating of 0.67. The remaining 76 percent of patients continued their heel pain maintenance treatment(s)and had a 79.9 percent improvement with an average pain score of 2.07.

Case Study: Achieving Results For A Patient Who Had Three Years Of Unilateral Heel Pain

As a good example of the early and long-term success of ESWT, consider a 48-year-old woman who presented to my clinic in October of 2000. At the time, she had suffered with unilateral heel pain for nearly three years. She was a primary school teacher who was finding it difficult to complete her normal day of work due to the pain she was suffering. Very typically, she had pain when getting out of bed in the morning. Her drive to work took approximately 45 minutes and getting out of the car was very painful. Additionally, every time she rose from her seat in the classroom, the pain stopped her and she felt the pain was affecting her classroom behavior. Furthermore, because of her heel pain, she had been unable to exercise to her desires and had gained 40 pounds during that three-year span.

   The patient previously had seen three different podiatrists for treatment. She received three different pairs of orthotics, shoe gear changes, a reduction in physical activities, five cortisone injections, a variety of over the counter and prescription anti-inflammatory medications, several rounds of physical therapy, immobilization with a walking boot and cast, and a night splint. Her VAS pain at the time of initial presentation was 8 out of 10 at its worst on a daily basis.

   Two weeks after her initial consultation, she was treated with high-energy ESWT under sedation. At her first follow-up visit two weeks after her procedure, she noted a 50 percent reduction in pain. At her visit three months after the ESWT procedure, she felt that 90 percent of her symptoms were resolved and was anxious to return to all activities including the use of a treadmill.

   When we called patients back for our long-term study, she was insistent about having a long conversation with me. She wanted to help the study in any way she could because she felt that ESWT had “given her life back.” She related that her current condition was terrific. She has had no heel pain since six months following the original ESWT procedure. She had returned to all aspects of life including exercise and stated that not only had she lost the 40 pounds that she had gained during the plantar fascia problem but lost an additional 10 pounds. She told me she was running regularly and had completed two marathons in the previous five years. Her story, more detailed than most, was very common during our long-term study evaluations.

How Does ESWT Compare With Other Treatments In Cost And Efficacy?

The alternative to ESWT for chronic plantar fasciitis (plantar fasciosis) is often surgical intervention and more recently platelet rich plasma (PRP). Platelet-rich plasma is the use of autologous blood products to stimulate healing of bone, tendons, ligaments and cartilage. At this moment, there are no published prospective RCTs on PRP for plantar fasciitis or any other pathology that PRP treats in an ambulatory, injectable, soft tissue healing situation. There are several anecdotal reports on success but they are only that.

   Furthermore, PRP is constantly evolving, much in the same way the way that ESWT did in the early 2000s with different companies jockeying for positioning and stating their system is superior to others. The cost of PRP may be higher than ESWT and ranges from $500 to $1,500 per treatment with some advocating two or three treatments for a given condition.6

   Comparing the costs of surgical intervention (open, percutaneous or endoscopic) to ESWT will significantly favor ESWT. According to Tong and Furia, the median cost of surgical procedures for plantar fasciitis in 2008 was $1,347 for surgeon reimbursement and ranged from $4,352 to $9,500 for hospital or surgery center reimbursement.1

   The indirect costs associated with surgical intervention include the chance of significant complications requiring some intervention (2 to 5 percent) and the resultant expense of care needed for those complications. Other indirect costs associated with open surgery include lost time from work and changes in activities of daily living. It is not uncommon for postoperative plantar fasciitis patients to miss work for two to six weeks due to immobilization and partial weightbearing. It is difficult to accurately determine the overall cost of someone being away from work as this is different from person to person based on the job. It is even more difficult to put a number on the cost of interference in activities of daily life. Without doubt, there are tangible dollars and social costs that are significant with both.

   With low-energy ESWT, the typical costs range from $900 to $1,500 total for three treatments, based on my experience and talking to people around the country, and recognizing what insurance covers when ESWT is covered. There is no facility fee or anesthesia fee. There are no complications associated with low-energy ESWT that would create any additional expenses. There is virtually no loss of work with the exception of the time spent to have the procedure performed. Social costs are also reduced as patients can return to almost all activities of daily life without restrictions.

   High-energy shockwave does have higher costs associated with it in comparison to low-energy ESWT and can range from $1,000 to $3,000 total. However, treatment with high-energy ESWT does have the advantage of one-time treatment.

   Extracorporeal shockwave therapy, high energy or low energy, exhibits strong cost benefits in both absolute dollars and less tangible but equally important work and social costs. The Journal of Bone and Joint Surgery states that long-term studies must be those that have been performed at least five years following the original study. We initially reported our early results in 2002 in the Journal of Foot and Ankle Surgery and now have reported our long-term results, which, as far as we know, is the only long-term study on ESWT and plantar fasciitis.4,5

Final Notes

Extracorporeal shockwave therapy has gone through the trials and tribulations of being a new and expensive technology. These include inconsistent information to consumers, conflicting results of research on the efficacy of the technology and the relative inaccessibility to physicians and patients. However, years of clinical success and proper research have proved the validity of ESWT.

   Plantar fasciitis continues to be a burden on our healthcare system, economy and society. It is incumbent on all medical providers to find the most proven and cost-effective treatments for their patients to return to life and work. While there are many treatments employed for plantar fasciitis, most have not been proven and we have pointed out their costs. Others have been studied but their costs are quite substantial and their complications are notable.

   Extracorporeal shockwave therapy has proven to be a cost effective treatment for plantar fasciitis while showing long-term success that other treatments cannot boast. Not only should one consider ESWT a mainstay of treatment for more chronic cases of plantar fasciitis, it should now be an option earlier in the treatment regimen and possibly supplant other treatments that have not been validated. The future may show that combining treatments such as ESWT and PRP will provide the fastest and safest recovery but until PRP is better studied, it will still take a back seat to ESWT.

   Dr. Weil is the Research and Fellowship Director for the Weil Foot and Ankle Institute, which has various office locations in Illinois. He is the Editor of Foot and Ankle Specialist, and is a Past President of the International Society for Medical Shockwave Treatment.

References

1. Tong KB, Furia J. Economic burden of plantar fasciitis treatment in the United States. Am J Orthop. 2010; 39(5):227-31.
2. Hammer DS, Rupp S, Kreutz A, Pape D, Kohn D, Seil R. Extracorporeal shockwave therapy (ESWT) in patients with chronic proximal plantar fasciitis. Foot Ankle Int. 2002; 23(4):309-13.
3. Ogden JA, Alvarez RG, Marlow M. Shockwave therapy for chronic proximal plantar fasciitis: a meta-analysis. Foot Ankle Int. 2002; 23(4):301-8.
4. Weil LS Jr., Roukis TS, Weil LS Sr., Borrelli AH. Extracorporeal shock wave therapy for the treatment of chronic plantar fasciitis: indications, protocol, intermediate results, and a comparison of results to fasciotomy, J Foot Ankle Surg. 2002 May-Jun;41(3):166-72.
5. Weil L Jr., et al. Long-term results of extracorporeal shockwave treatment for chronic plantar fasciitis. Presented at the International Society for Medical Shockwave Treatment Annual Meeting, Chicago, June 2010.
6. Taylor DW, Petrera M, Hendry M, Theodoropoulos JS. A systematic review of the use of platelet-rich plasma in sports medicine as a new treatment for tendon and ligament injuries. Clin J Sport Med. 2011; 21(4):344-52.