CIGNA HEALTHCARE COVERAGE POSITION

Subject: Plantar Fasciitis Treatments

Coverage Position...............................................1

General Background...........................................2

Coding/Billing Information...................................5

References..........................................................6

INSTRUCTIONS FOR USE

Coverage Positions are intended to supplement certain standard CIGNA HealthCare benefit plans. Please note, the terms of a participant’s particular benefit plan document [Group Service Agreement (GSA), Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Positions are based. For example, a participant’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Position. In the event of a conflict, a participant’s benefit plan document always supercedes the information in the Coverage Positions. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable group benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Positions and; 4) the specific facts of the particular situation. ©2004 CIGNA Health Corporation

Coverage Position

CIGNA HealthCare considers the following medically necessary for the initial treatment of plantar fasciitis:

• non-steroidal anti-inflammatory medication

• pre-fabricated foot orthoses (orthoses and other items available over the counter are generally not covered under CIGNA HealthCare benefit plans)

• arch taping

• iontophoresis

If initial treatment fails after two months, the following therapies are considered medically necessary:

• steroid injection

• night splinting

• short-leg walking cast

If all conservative therapy fails after six months, open or endoscopic plantar fasciotomy is considered medically necessary.

CIGNA HealthCare does not cover the following because they are considered not medically necessary or of unproven benefit (this list may not be all-inclusive):

• acupuncture

• custom-molded foot orthoses

• electron-generating devices

• extracorporeal shock wave therapy

• laser therapy

• microwave diathermy

• orthoses with magnetic foil

• radiotherapy

• stereotactic radiofrequency thermal lesioning

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• trigger-point needling and infiltration

General Background

Plantar fasciitis is an overuse injury resulting in inflammation of the plantar fascia, which connects the heel to the toes. It is a common cause of heel pain in adults. Symptoms usually start gradually with mild pain at the heel, pain after exercise and pain with standing first thing in the morning. On physical examination, firm pressure will elicit a tender spot over the medial tubercule of the calcaneus. Risk factors for plantar fasciitis may include obesity, age, being female, limited dorsiflexion of the ankle joint, prolonged weight bearing and an increase in the amount of walking or running. Heel spurs are not necessarily associated with plantar fasciitis; heel spurs may be found in asymptomatic patients. Early treatment generally results in a shorter duration of symptoms.

First Line Treatment

The mainstay of non-surgical treatment and the standard of care for initial treatment is a program of stretching exercises, ice, activity modification, weight-loss in overweight patients, recommendations for appropriate footwear, arch taping, nonsteroidal anti-inflammatory medications and shock absorbing shoe inserts or orthoses. Off-the-shelf silicone, rubber or felt heel cushions are as effective as custom-made orthoses (Fink, Mizel, 2001; Pfeffer, et al., 1999). These therapies are more likely to be effective if treatment is started early. About 90% of people with plantar fasciitis improve significantly after two months of initial treatment (American Orthopaedic Foot & Ankle Society, 2001).

Iontophoresis is also a widely accepted non-invasive therapy for plantar fasciitis. Iontophoresis is the use of electric impulses from a low-voltage galvanic current stimulation unit to drive topical corticosteroids into soft tissue structures. A randomized, double-blind, placebo-controlled study was conducted by Gudeman, et al. (1997) comparing traditional modalities alone to traditional modalities with iontophoresis. Iontophoresis combined with traditional modalities resulted in significantly-improved, immediate pain-relief but no difference in outcome at one month after completion of treatment. Iontophoresis may be tried as part of a first-line physical therapy program.

Second Line Treatment

In the event early treatment fails, night splints, steroidal anti-inflammatory injections or a walking cast are the next level of the standard of care.

The evidence for night splinting is limited. Crawford and Thomson (2003) conducted a systematic review of the literature for randomized and quasi-randomized controlled trials on the effectiveness of night splints in reducing pain in patients with plantar fasciitis. A cross-over trial of night splints reported improvements in patients’ heel pain during the two treatment phases (Powell, 1998). A randomized clinical trial by Batt, et al. (1996) found tension night-splinting to be significantly more effective than standard therapy alone. Several retrospective studies support the efficacy of night splints (Barry, et al., 2002; Berlet, et al., 2002).

Crawford and Thomson (2003) conducted a systematic review of the literature for randomized and quasi-randomized controlled trials on the effectiveness of steroid injections in reducing pain in patients with plantar fasciitis. The studies that compare steroid injections with placebo substances show initial significant improvement; however, studies that include follow up after one month show no difference in outcome at that time. This suggests that the effectiveness of steroid injections is short term. Risks of steroid injection into the heel include rupture of the plantar fascia and fat pad atrophy.

The use of a short-leg walking cast for several weeks is a standard of care as a final conservative step in the treatment of plantar fasciitis. In one study by Gill and Kiebzak (1996), a short-leg cast worn for a minimum of three weeks was found to be an effective form of treatment for chronic plantar heel pain.

Surgical Intervention

Surgical intervention should be considered only for intractable pain which has not responded to 6-12 months of proper conservative treatment. Plantar fasciotomy can be conducted using open or endoscopic

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techniques. Surgical interventions can include surgical removal or release of the fascia, and removal of bone spurs. Spurs are usually resected, but no study has demonstrated that this makes a difference to the result. Risks of surgical intervention include flattening of the longitudinal arch (which may cause lateral hindfoot and forefoot pain), heel hypoesthesia, rupture of the plantar fascia and complications related to anesthesia. Davies, et al. (1999) conducted a prospective study of 43 patients with 47 painful heels who underwent partial plantar fascia release and nerve decompression and were followed for an average of 31 months. Only 49% of the patients were satisfied with their outcome.

Endoscopic plantar fasciotomy is a less invasive technique requiring an incision of less than one-half inch in length and utilizing an arthroscope to visualize and release the fascia. It has been proposed as an improvement over open plantar fasciotomy, resulting in less trauma and improved recovery times. The only study to compare open with endoscopic techniques is that of Kinley, et al. (1993), who compared 66 endoscopic with 26 open procedures and found significantly less postoperative pain, earlier return to work and fewer complications in the patients undergoing endoscopic surgery. The study is limited by lack of randomization.

There are a substantial number of retrospective studies supporting the use of endoscopic plantar fasciotomy. The largest case series (n=652) documented the outcomes associated with endoscopic plantar fasciotomy (Barrett, et al., 1995). Six hundred thirty-three of the operations (97%) were a success, as measured by relief in heel pain. Several smaller studies were conducted with case populations ranging from 17 to 69 cases, documenting improvement by patient satisfaction scores and/or foot scores (Boyle and Slater, 2003; O’Malley, et al., 2000; Lundeen, et al., 2000; Benton-Weil, et al., 1998). Based on the large number of reports of relief of heel pain, endoscopic plantar fasciotomy appears effective in the treatment of plantar fasciitis.

Unproven/ Investigational Therapies

There are many therapies that have been suggested for treatment of plantar fasciitis that are not proven in the literature and not accepted as standard of care.

Acupuncture

Acupuncture is a method of producing analgesia or treating disease by stimulating anatomical locations on the skin by the penetration of needles. There are no studies specific to its efficacy in the treatment of plantar fasciitis. The overall body of evidence in general is of poor quality consisting of numerous uncontrolled studies, case series and case reports. There is no evidence that supports the efficacy of acupuncture for the treatment of plantar fasciitis.

Electron-Generating Devices

There is no evidence to support the use of electron generating devices in the treatment of plantar fasciitis (Watt, 2003; Crawford and Thomson, 2003).

Extracorporeal Shock Wave Therapy

Extracorporeal shock wave therapy (ESWT), also called orthotripsy, is a noninvasive treatment that involves delivery of 1000 to 3000 shock waves to the painful heel region, and has been introduced as an alternative to surgery for patients with chronic plantar fasciitis that has not responded to medical therapy. The mechanism by which ESWT might work to relieve pain associated with plantar fasciitis is unknown. It has been hypothesized that the shock waves may reduce transmission of pain signals from sensory nerves in the plantar fascia, and /or stimulate healing (Huang, et al., 2000).

Buchbinder, et al.(2002) conducted a randomized controlled study (n=160) and found no evidence to support a beneficial effect on pain, function and quality of life of ultrasound-guided ESWT over placebo in patients with ultrasound-proven plantar fasciitis up to 12 weeks following treatment.

Haake, et al.(2003) stated that ESWT was no better than sham therapy for heel pain as result of randomized, double-blind, controlled trial (n=135). Statistically similar success rates for improvement were found in treated and placebo group at 12 weeks and one-year follow-up.

A meta-analysis (Crawford, Cochrane Review, 2003) found some indirect evidence that patients’ heel pain improves spontaneously. Patients with heel pain in all trial arms improved spontaneously regardless

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of their treatment allocation, demonstrating that the condition is self-limiting in some patients. ESWT was evaluated in five randomized controlled trials using different doses, with no consensus reached regarding variation of range of energy (high versus low), number of pulses, or number of treatment sessions (Rompe, et al., 1996; Rompe, et al., 2002, Krischek, et al., 1998; Ogden, et al., 2001; Buchbinder, et al., 2002). The results of the meta-analysis found that the effectiveness of ESWT for plantar fasciitis was unclear.

Insoles with Magnetic Foil

The theory behind magnet therapy is that magnetic fields create an electrical current that interrupts the transmission of pain signals in the central nervous system as well as increasing blood flow to an area, boosting the flow of oxygen and other nutrients, ultimately reducing pain and swelling. Two randomized clinical trials comparing magnetic versus sham insoles for reducing pain have demonstrated that there is no difference between the therapies in patients with plantar fasciitis (Caselli, et al., 1997; Winemiller, et al., 2003). There is no evidence to support the use of magnetic insoles in the treatment of plantar fasciitis.

Laser Therapy

Laser therapy, also called low-level laser therapy (LLLT) is a form of phototherapy which involves the application of low-power monochromatic and coherent light to injuries and lesions to stimulate healing. LLLT is used to increase the speed, quality and tensile strength of tissue repair, resolve inflammation, and give pain relief. Basford, et al. (1998) conducted a randomized, double-blinded, placebo-controlled clinical study of 32 subjects comparing dummy versus active laser therapy over four weeks using relief of pain as the endpoint. No significant differences were found between the groups in pain scores either during treatment or at one month follow-up. There is no evidence that laser therapy is effective in the treatment of plantar fasciitis.

Microwave Diathermy

Microwave diathermy uses microwave radiation to create heat within the tissues. There is no evidence supporting the efficacy of this modality in the treatment of plantar fasciitis (Watt, 2003; Crawford and Thomson, 2003).

Radiotherapy

Radiotherapy for plantar fasciitis treatment has been well established in Germany for about 100 years. The exact radiobiologic mechanisms of the effect of ionizing radiation on plantar fasciitis have been incompletely investigated and understood. In 2001, the Patterns of Care Study in Benign Diseases Panel of the German Society for Radiation Oncology distributed a standardized questionnaire to all radiotherapy departments in Germany to determine their experience with radiotherapy for plantar fasciitis (Micke, et al., 2004). The records of 7,947 patients were prospectively evaluated over a median follow-up period of 28 months for reduction in pain scores. Several different types of equipment and doses of radiation were utilized among the centers. No dose-response relationship could be established. Complete relief of pain for more than three months was reported in a median of 70% of all treated patients and pain relief lasting a minimum of 12 months was reported in 65% of patients. No statistical analysis of the significance of these percentages was reported. Further research is needed to demonstrate the safety and efficacy of this therapy.

Stereotactic Radiofrequency Thermal Lesioning

Stereotactic radiofrequency thermal lesioning, or radiofrequency lesioning, is a minimally invasive procedure, in which a probe the size of a needle is placed through the skin in the heel in the area of pain. While the patient is under IV sedation, the tip of the probe heats up to 87 degrees Celsius (189 degrees Fahrenheit), and is kept there for 90 seconds. The proposed mechanism of action is desensitization of the nerve endings. In a retrospective study of 39 patients, Sollitto, et al. (1997) found that 92% of patients experience resolution of symptoms. This study is limited by the lack of a control group and randomization; a more rigorous design is needed.

Trigger-Point Needling and Infiltration

Trigger-point needling for plantar fasciitis is the needling and infiltration of anesthetic into the myofascial trigger points at the proximal portion of the medial gastrocnemius muscle. Imamura, et al. (2003) conducted a randomized, controlled study of 64 subjects comparing conventional physical therapy to physical therapy plus injection of one percent lidocaine to the taut band at the proximal portion of the

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medial gastrocnemius muscle of the involved limb. Statistically significant reduction of pain and improvement in function were found in both groups without difference between them. However, the time required to achieve the same improvement was significantly less in the injected group than in the control group. Post-injection soreness and local hematoma were found in 30% of the patients receiving trigger-point needling. Additional studies are needed to support the effectiveness of this therapy.

Ultrasound

Therapeutic ultrasound is assumed to have thermal and mechanical effects on the target tissue, resulting in an increased local metabolism, circulation, extensibility of connective tissue and tissue regeneration. Crawford and Snaith (1996) conducted a randomized clinical trial evaluating the efficacy of ultrasound compared to placebo ultrasound. Both groups showed a reduction in pain, but there was no signficant difference in pain between the two groups. Ultrasound has not been shown to be effective in the treatment of plantar fasciitis.

Coding/Billing Information

Note: This list of codes may not be all-inclusive.

Covered when medically necessary:

Experimental/Investigational/Unproven/Not Covered:

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*Current Procedural Terminology (CPT^®) ^© 2003 American Medical Association: Chicago, IL.

References

1. American Orthopaedic Foot & Ankle Society. Plantar Fasciitis. Updated April 2001. Accessed Apr 1, 2004. Available at URL address: http//:www.orthoinfo.aaos.org/fact/thr_report.cfm?Thread_ID=144&topcategory=Foot.

2. Barrett SL, Day SV, Pignetti TT, Robinson LB. Endoscopic plantar fasciotomy: a multi-surgeon prospective analysis of 652 cases [abstract]. J Foot Ankle Surg 1995 Jul-Aug;34(4):400-406.

3. Barry LD, Barry AN, Chen Y. A retrospective study of standing gastrocnemius-soleus stretching versus night splinting in the treatment of plantar fasciitis [abstract]. J Foot ankle Surg 2002 Jul-Aug;41(4):221-227.

4. Basford JR, Malanga GA, Krause DA, Harmse WS. A randomized controlled evaluation of low-intensity laser therapy: plantar fasciitis [abstract]. Arch Phys Med Rehab 1998 Mar;79(3):49-254.

5. Batt ME, Tanji EL, Skattum N. Plantar fasciitis: a prospective randomized clinical trial of the tension night splint [abstract]. Clin J Sport Med 1996 Jul;6(3):158-162.

6. Benton-Weil W, Borrelli AH, Weil LS Jr, Weil LS Sr. Percutaneous plantar fasciotomy: a minimally invasive procedure for recalcitrant plantar fasciitis [abstract]. J Foot Ankle Surg 1998 Jul-Aug;37(4):269-272.

7. Berlet GC, Anderson RB, Davis H, Kiebzak GM. A prospective trial of night splinting in the treatment of recalcitrant plantar fasciitis: the Ankle Dorsiflexion Dynasplint [abstract]. Orthopedics 2002 Nov;25(11):1273-1275.

8. Boyle RA, Slater GL. Endoscopic plantar fascia release: a case series [abstract]. Foot Ankle Int 2003 Feb;24(2):176-179.

9. Buchbinder R. Plantar fasciitis. NEJM 2004 May 20;350(21):2159-2166.

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10. Buchbinder R, Ptaszik, Gordon J, Buchman J, Prabaharan V, Forbes A. Ultrasound-guided Extracorporeal shock wave therapy for plantar fasciitis. JAMA 2002;288(11):1364-1372.

11. Caselli MA, Clark N, Lazarus S, Velez Z, Venegas L. Evaluation of magnetic foil and PPT Insoles in the treatment of heel pain [abstract]. J Am Podiatr Med Assoc 1997 Jan;87(1):1-16.

12. Crawford F, Snaith M. How effective is therapeutic ultrasound in the treatment of heel pain? Ann Rheum Dis 1996 Apr;55(4):265-267.

13. Crawford F, Thomson C. Interventions for treating plantar heel pain. The Cochrane Database of Systematic Reviews 2004 (1).

14. Davies MS, Weiss GA, Saxby TS. Plantar fasciitis: how successful is surgical intervention?[abstract]. Foot Ankle Int 1999;20:803-807.

15. Digiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GD, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients’ with chronic heel pain: a prospective, randomized study. J Bone Joint Surg Am 2003 July;85-A(7):1270-1277.

16. Fink B, Mizel M. What’s new in foot and ankle surgery. J Bone Joint Surg Am 2001;83-A(5):791-796.

17. Gill LH, Kiebzak GM. Outcome of nonsurgical treatment for plantar fasciitis [abstract]. Foot Ankle Int 1996 Sep;17(9):527-532.

18. Gudeman SD, Eisele SA, Heidt RS Jr, Colosimo AJ, Stroupe AL. Treatment of plantar fasciitis by Iontophoresis of 0.4% dexamethasone. A randomized, double-blind, placebo-controlled study [abstract]. Am J Sports Med 1997 May-June;25(3):312-316.

19. Haake M, Buch M, Shoellner C. Extracorporeal shock wave therapy for plantar fasciitis: randomized controlled multicenter trial. BMJ.2003;327(7406):75.

20. HAYES Medical Technology Directory™. Extracorporeal Shock Wave Lithotripsy for Chronic Plantar Fasciitis. 2003 May. Lansdale, PA: HAYES Inc; ^©Winifred S. Hayes, Inc. Update 2003.

21. Huang HH, Oureshi AA, Biundo JJ Jr. Sports and other soft tissue injuries, tendonitis, bursitis, and occupation-related syndromes. Curr Opin Rheumatol 2000;12:150-154.

22. Imamura M, Imamura S, De Carvalho AE Jr, Mazagao RA, Casisus DA, Fischer AA. Plantar fasciitis: A new treatment approach [abstract]. Arch Phys Med 2003 Sep;84(9):E4.

23. Jupiter J, Ring D. Approach to minor orthopedic problems of the foot and ankle. In: Goroll A, editor. Primary care medicine. Lippincott Williams & Wilkins; 2003.

24. Kinley S, Frascone S, Calderone D, Wertheimer SJ, Squire MA, Wiseman FA. Endoscopic plantar fasciotomy versus traditional heel spur surgery: a prospective study [abstract]. J Foot Ankle Surg 1993 Nov-Dec;32(6):595-603.

25. Krischek O, Rompe JD, Herbsthofer B, Nafe B. Symptomatic low-energy shockwave therapy in heel pain and radiologically detected plantar heel spur. Orthop Ihre Grenzgeb 1998 Mar-Apr;136(2):169-174.

26. Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation [abstract]. J Am Podiatr Med Assoc 2003 May-Jun;93(3):234-237.

27. Lundeen RO, Aziz S, Burks JB, Rose JM. Endoscopic plantar fasciotomy; a retrospective analysis of results in 53 patients [abstract]. J Foot Ankle Surg 2000 Jul-Aug;39(4):208-217.

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28. Maier M, Steinborn M, Schmitz C, Stabler A, Kohler S, Pfahler M. Extracorporeal shock wave application for chronic plantar fasciitis associated with heel spurs: prediction of outcome by magnetic resonance imaging. J Rheumatol 2000;27:2455-2462.

29. Micke O, Seegenschmiedt MH. Radiotherapy in painful heel spurs (plantar fasciitis): results of a national patterns of care study. Int J Radiation Oncology Biol Phys 2004;58(3):828-843.

30. Ogden JA, Alvarez R, Levitt R, Cross GL, Marlow M. Shock wave therapy for chronic proximal plantar fasciitis. Clin Orthop Rel Res 2001;387:47-59.

31. O’Malley J|MJ, Page A, Cook R. Endoscopic plantar fasciotomy for chronic heel pain [abstract]. Foot Ankle Int 2000 Jun;21(6):505-510.

32. Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W. et al. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis [abstract]. Foot Ankle Int. 1999 Apr;20(4):214-221.

33. Podiatry Associates of Belleville, P.C. Stereotactic radiofrequency thermal lesioning. Updated 2001-2002. Accessed Apr 7, 2004. Available at URL address: http//www.drfoot.tv/html/technology-2.html.

34. Powell M, Post WR, Keener J, Wearden S. Effective treatment of chronic plantar fasciitis with dorsiflexion night splints: a crossover prospective randomized outcome study [abstract]. Foot Ankle Int 1998 Jan;19(1):10-18.

35. Probe RA, Baca M, Adams R, Preece C. Night splint treatment for plantar fasciitis. Clinical Orthopaedics and Related Research 1999;368:190-195.

36. Riddle D, Pulisic M, Pidcoe P, Johnson R. Risk factors for plantar fasciitis: a matched case-control study. J Bone Joint Surg Am 2003;85-A(5):872-877.

37. Rompe JD, Hopf C, Nafe B, Burger R. Low-energy extracorporeal shock wave therapy for painful heel: a prospective controlled single-blind study. Orthop Trauma Surg 1996;115(2):75-79.

38. Rompe JD, Schoellner, Carsten MD, Nafe B. Evaluation of Low-Energy Extracorporeal Shock Wave Application for Treatment of Chronic Plantar Fasciitis. J Bone Joint Surg Am Mar 2002;84-A (3):335-341.

39. Singh D, Angel J, Bentley G, Trevino S. Fortnightly review: plantar fasciitis. BMJ 1997;315(7101):172-175.

40. Sollitto RJ, Plotkin EL, Klein PG, Mullin P. Early clinical results of the use of radiofrequency lesioning in the treatment of plantar fasciitis [abstract]. J Foot Ankle Surg 1997 May-Jun;36(3):215-219.

41. Stephens MB. Clinical inquiries. J Fam Pract 2003;52(9):714-717.

42. Thordarson DB, Kumar PJ, Hedman TP, Ebramzadeh E. Effect of partial versus complete plantar fasciotomy on the windlass mechanism [abstract]. Foot Ankle Int 1997 Jan;18(1):16-20.

43. Torpy J. Plantar fasciitis. JAMA 2003;290(11):1542.

44. Watt J. Plantar fasciitis. Nzfp;30(1):53-57.

45. Winemiller MH, Billow RG, Laskowski ER, Harmsen WS. Effect of magnetic vs sham-magnetic insoles on plantar heel pain. JAMA 2003 Sep 17;290(11):1474-1479.

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46. Young C, Rutherford D, Niedfeldt M. Treatment of plantar fasciitis. Am Fam Physician 2001;63(3):467-474.

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