Plantar Fasciitis by Cigna
LEEDer provides Night Splints and Multi Podus boots: KYDEX-PRO for the treatment of Plantar Fasciitis
LEEDer Group comment: 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 are considered not medically necessary or of unproven benefit (this list may not be all-inclusive). Plantar Fasciitis Night Splints work.
- Whereas, Night Splints are recommended
After reviewing the following CIGNA Policy Bulletin below
- The Night Splint that Works! by LEEDer Group. It’s Guaranteed and Doctor Approved
CIGNA HEALTHCARE COVERAGE POSITION
Subject: Plantar Fasciitis Treatments
Coverage Position Number: 0097
Effective Date: 6/15/2004
Table of Contents:
- Extracorporeal Shock Wave Therapy for Musculoskeletal Conditions
- Physical Therapy
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
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
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):
- custom-molded foot orthoses
- electron-generating devices
- extracorporeal shock wave therapy
- laser therapy
- microwave diathermy
- orthoses with magnetic foil
- stereotactic radiofrequency thermal lesioning
- trigger-point needling and infiltration
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 TreatmentIn the event early treatment fails, night splints, steroidal anti-inflammatory injections or a walking cast are the next level of the standard of care.
- Order Night Splint that Works! Click/ORDER Night splints
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 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 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 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.
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 patient’s 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, 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 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 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.
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.
Note: This list of codes may not be all-inclusive.
Covered when medically necessary:
Fasciotomy, foot and/or toe
Application of short leg cast (below knee to toes); walking or ambulatory type
Application of short leg splint (calf to foot)
Endoscopic plantar fasciotomy
Application of a modality to one or more areas; iontophoresis, each 15 minutes
Orthotics fitting and training, upper and/or lower extremities, each 15 minutes
Checkout for orthotic/prosthetic use, established patient, each 15 minutes
Cast supplies (e.g., plaster)
Special casting material (e.g., fiberglass)
Ankle-foot orthoses (AFO); spring wire, dorsiflexion assist calf band, custom fabricated
Ankle foot orthoses; plastic or other material, prefabricated, includes fitting and adjustment
Ankle foot orthoses; plastic or other material, custom-fabricated
Ankle foot orthoses; plastic or other material, prefabricated, includes fitting and adjustment
Cast supplies, short leg splint, adult (11 years +), plaster
Cast supplies, short leg splint, adult (11 years +), fiberglass
Extracorporeal shock wave therapy; involving plantar fascia
Injection(s); single or multiple trigger point(s), one or two muscle(s)
Injection(s); single or multiple trigger point(s), three or more muscle(s)
Application of a modality to one or more areas; microwave
Acupuncture, one or more needles; without electrical stimulation
Acupuncture, one or more needles; with electrical stimulation
Foot, insert, removable, molded to patient model; UCB type; Berkeley Shell, each
Foot, insert, removable, molded to patient model; Spenco, each
Foot, insert, removable, molded to patient model; plastazote or equal, each
Foot, insert, removable molded to patient model; silicone gel, each
Foot, insert, removable, formed to patient foot, each
*Current Procedural Terminology (CPT®) © 2003 American Medical Association: Chicago, IL.
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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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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.
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