New Literature Bibliography and Result Summarization



Annotated Bibliography

Results of Extracorporeal Shockwave Therapy Peer Reviewed Research

Basic Science Articles using Animal models to demonstrate Cause and Effect

Summary: Application of extracorporeal shockwaves to tissue or bone does create a cellular change to promote healing.

1. Wang CJ, Wang FS, Yang KD, Weng LH, Hsu CC, Huang CS, Yang LC. Shockwave Therapy Induces Neovascularization at the Tendon-bone Junction: A Study in Rabbits. Journal of Orthopaedic Research. 21:984-989, 2003.

Results: Animal study with 50 rabbits receiving high-dose shock wave therapy. A microscopic exam of the areas of treatment confirmed that ESWT induces the in-growth of neovascularization associated with early release of angiogenesis-related proteins in the area of shock wave treatment.

2. Wang, CJ, et al. “Effect of Shock Wave Therapy on Acute Fractures of the Tibia. A Study in a Dog Model.” Clinical Orthopaedics and Related Research. Number 387, pp.112-118, 2001.

Results: Animal study with 8 adult dogs. Radiographic findings at 12 weeks statistically showed more callus formations in the treated group. In histologic examinations, there was significantly more cortical bone formation in the treated group at 12 weeks and the bone tissues were thicker, denser, and heavier.

Articles addressing Success of High Energy ESWT

Summary: High-energy shockwave therapy is effective, and is more effective when compared to Low energy shockwave therapy. Substantial improvement in the symptoms occurred between 6-12 weeks after treatment and the improvement continued beyond 24 weeks. Mobility is immediate, and no side effects were reported.

3. Malay, D. Scot, et al., “Extracorporeal Shockwave Tehrapy Versus Placebo for the Treatment of Chronic Proximal Plantar Fasciitis: Results of a Randomized, Placebo-Controlled, Double Blinded, Multicenter Intervention Trial.” The Journal of Foot & Ankle Surgery Volume 45 Number 4, July/August 2006, 196-210.

Study Type: Randomized, placebo controlled, double blinded, multicenter (OrthoSpec)

Results: 3 months success defined as > 50% improvement with a VAS score < 4cm

ESWT: 43%

Placebo: 20%

Sufficiently high energy levels > level 4 for the device tested [or > .21 mJ/mm2 (17-18 kV)] is required to have a therapeutic response.

4. Kudo, P, et al., “Randomized, placebo-controlled, double-blind clinical trial evaluating the

treatment of plantar fasciitis with an extracoporeal shockwave therapy

(ESWT) device: a North American confirmatory study.” J Orthop Res 2006 Feb;24(2):11-23.

Study Type: RCT double-blind, placebo controlled (Dornier Epos Ultra)

Results: 3 months success defined as >60% improvement on VAS

ESWT: 47%

Placebo: 23%

5. Chen, Han-Shiang, et al., “Treatment of Painful Heel Syndrome with Shock Waves.” Clinical Orthopaedics and Related Research. June 2001. No. 387, 41-46.

Study Type: Prospective Clinical Study

Results: 6 week Success: 39% (complaint free and significantly better)

12 week Success: 73% (complaint free and significantly better)

27 week Success: 87% (complaint free and significantly better)

Substantial improvement in the symptoms occurred between 6-12 weeks after treatment and the improvement continued beyond 24 weeks.

6. Theodore, George, et al., “Extracorporeal Shock Wave Therapy for the Treatment of Plantar Fasciitis.” Foot and Ankle International. May 2004. Vol. 25, No. 5, 290-297.

Study Type: Multi-center, randomized, placebo-controlled, prospective, double blind

Results: 3 month Success: 62%

12 month Success: 94%

ESWT has several advantages over surgery. 1) Noninvasive technology without the obvious complications associated with surgery. 2) Relatively limited recovery time during which the patient may return to employment and normal activities the day following treatment. 3) Success rates comparable to surgery and even to other conventional therapies for plantar fasciitis

7. Gerdesmeyer, L, et al. “ Extracorporeal Shock Wave Therapy for the Treatment of Chronic Calcifying Tendonitis of the Rotator Cuff.” JAMA, November 19, 2003, vol 290, No. 19, 2573-2580.

Study Type: Double Blind Randomized Placebo Controlled Study

Results: 12 month Success: 94% High Energy

45% Low Energy

22% Placebo

Both high-energy and low energy ESWT appeared to provide a beneficial effect on shoulder function, as well as on self-rated pain and diminished size of calcifications, compared with placebo. Furthermore, high-energy ESWT appeared to be superior to low energy ESWT.

8. Ko, Jih-Yang, et al., “Treatment of Lateral Epicondylitis of the Elbow with Shock Waves.” Clinical Orthopaedics and Related Research, June 2001 No 387, 60-67.

Study Type: Prospective Clinical Study

Results: 6 week Success: 37% (excellent or good).

12 week Success: 58% (excellent or good).

24 week Success: 73% (excellent or good).

Substantial improvement in the symptoms occurred between 6-12 weeks after treatment and the improvement continued beyond 24 weeks.

9. Strash, W, Perez, R. “Extracorporeal Shockwave Therapy for Chronic Proximal Plantar Fasciitis.” Clinics in Podiatric Medicine and Surgery, 19 (2002) 467-476.

Study Type: Retrospective Study

Results: High Energy 12 month Success: 80-90%

Articles addressing Elbow Low-Mid Energy ESWT Results

Summary: ESWT is a conservative treatment with success that is effective for patients who have failed multiple other conservative treatments.

10. Rompe, Jan, et al., “Analgesic Effect of Extracorporeal Shockwave Therapy on Chronic tennis Elbow” The Journal of Bone and Joint Surgery. Vol. 78-B, No 2 March 1996 233-237.

Study Type: Prospective with control group

Results: Treated group 24 week Success: 48% Excellent/good; 42% Acceptable

Control group 24 week Results: 6% Excellent/good; 24% Acceptable

Following failure of conservative therapy, patients were treated with shockwave therapy. The treated group success may be attributed to hyperstimulation of the affected area. The intense stimulation activates fibers of small diameter which project to cells in the periaqueductal grey area causing the activation of the serotonergic system which modulates the inhibitory control of transmission of pain.

11. Hammer, Dietrich, et al., “Extracorporeal shockwave therapy in patients with tennis elbow and painful heel.” Arch Orthop Trauma Surg, (2000) 120: 304-307.

Study Type: Prospective

Results: Tennis elbow 5 month Success: 63%

Painful heel 6 month Success: 70%

Following failure of conservative treatments ESWT is a useful conservative treatment.

12. Rompe, J.D., et al., “Low-energy extracorporeal shockwave therapy for persistent tennis elbow.” International Orthopaedics, (1996) 20: 23-27.

Study Type: Randomized study with control

Results: Success Rate at 12 weeks: 56%

Following failure of conservative treatments (including at least one steroid injection), patients who were referred for surgical treatment were randomized into one of two ESWT treated groups. The group which received a full treatment at full strength had significant relief of pain and improvement of function.

Articles & Studies addressing Long Term sustainability of Results

13. Wang, CJ et al., “Long-term results of extracorporeal shockwave treatment for plantar

fasciitis.” Am J Sports Med (2006) Apr;34(4):592-6.

Study Type: RCT with non-placebo control group with conservative treatment

Results: Mean F/U interval: OssaTron 64 months; Control 40 months

69.1% excellent, 13.6% good, 6.2% fair, and 11.1% poor for ESWT group

0% excellent, 55% good, 36% fair, and 9% poor for the control group

The recurrence rate was 11% (9/81 heels) for the ESWT group

versus 55% (43/78 heels) for the control group (P < .001).

14. Hammer DS, Adam F, Kreutz A, Kohn D, Seil R “Extracorporeal Shock Wave Therapy (ESWT) in Patients with Chronic Proximal Plantar Fasciitis: A 2-Year Follow-up.” Foot & Ankle International 24(11) 823-828, 2003.

Study Type: Prospective randomized clinical study with cross over

Results: At 12 weeks’ follow-up after high dose ESWT treatment, the treated group had 63% improvement. The second, non-treated group was unchanged after continuation of non-surgical treatment. The second group then received ESWT and both groups were followed to 2 years with 94% improvement in the first and 90% improvement in the second. Over this period of time, the first group had not deteriorated and the second group approached the first group’s results. Therefore, both groups had significant clinical improvement following high-dose ESWT. These improvements were maintained at 2 years of follow-up.

15. Wang, Ching-Jen, et al., “Shock Wave Therapy for Patients with Lateral Epicondylitis of the Elbow – A One to Two Year Follow-up Study.” The American Journal of Sports Medicine, 2002, Vol 30, No. 3, 422-425.

Study Type: One to Two Year Follow-up Study to a Blinded Prospective Controlled Study

Results: High Energy Success Rate 90.9%

16. Ogden, John, et al., “Electrohydraulic High-Energy Shock-Wave treatment for Chronic Plantar Fasciitis. ”The Journal of Bone and Joint Surgery, 2004, Vol86-A, No. 10, 2216-2228.

Study Type: Randomized, placebo controlled, multi blinded, multi-center

One to Five Year follow-up study to a blinded randomized high energy controlled study

Results: High Energy sustained success, of non-randomized patients, at five years was 95% (n=20). High Energy sustained success at one year, of blinded patients with three month success was 97% (n= 67). High energy sustained success at one year of blinded patients who were retreated and had success at three months was 82% (n=22).

Data supports the use of high energy ESW treatment before consideration of any open or endoscopic surgical treatment.

17. HealthTronics: FDA Chronic Lateral Epicondylitis Final Report.

Study Type: Double Blind, Multi-Center, Randomized Controlled Study

Results: Treatment success evident by 8 weeks for patients with chronic lateral epicondylitis post treatment was maintained 100% of the randomized subjects treated with a single ESW treatment and followed to 12 months post treatment.

18. HealthTronics: FDA Chronic Plantar Fasciitis Final Report.

Study Type: Double Blind, Multi-Center, Randomized Controlled Study

Results: Treatment success evident by 8 weeks for patients with chronic plantar fasciitis post treatment was maintained 96% of the randomized subjects treated with a single ESW treatment and followed to 12 months post treatment.

Articles addressing Predictive Success of ESWT based upon duration of condition

Summary: Traditional conservative methods of treating plantar fasciitis (e.g. Orthotics, physical therapy, modification of shoes, NSAIDS, steroid injections etc) should be prescribed first. Following failure of conservative methods and continued duration of symptoms, indicating a chronic condition versus an acute condition, ESWT appears to have greater success.

19. Helbig, K., et al., “Correlations Between the Duration of pain and the Success of Shock Wave Therapy.” Clinical Orthopaedics and Related Research, June 2001, No.387, 68-71.

Study Type: Retrospective Study

Results: Shock wave treatment is more successful for the chronic condition than for the more recent acute complaint.

20. Alvarez RG, Ogden JA, Jaakkola J, Cross GL. “Symptom Duration of Plantar Fasciitis and the Effectiveness of Orthotripsy.” Foot & Ankle International. 24(12): 916-921, 2003.

Study Type: Randomized prospective study with Cross over

Results: Randomized prospective study with cross over demonstrated that the longevity of symptoms of chronic proximal plantar fasciopathy had a minimal effect on the likelihood of a positive response to high-dose shock wave therapy. Even patients who had had symptoms for 15 plus years could have complete symptom relief.

ESWT Literature Review Article

Summary: Shock wave therapy is safe and effective. Shock wave therapy should be considered before invasive surgery.

21. Younger, Alastair. “Shock Wave Therapy for Treatment of Foot and Ankle Conditions.” Techniques in Foot and Ankle Surgery; 5(1): 60-65, 2006.

Study Type: Review

Conclusion: Outcome studies in general have supported a positive outcome. Shock wave therapy should be offered as a second line of treatment to patients with plantar fasciitis, possibly before steroid injection, as the complication rates may be lower and the therapeutic effect higher. Shock wave therapy may have better outcomes than surgery for plantar fasciitis.

22. Ogden, John A., et al. “Shockwave Therapy for Chronic Proximal Plantar Fasciitis: A Meta Analysis.” Foot & Ankle International; Vol. 23, No. 4/ April 2002.

Study Type: Meta Analysis

Conclusion: Directed application of shockwaves to the enthesis of the plantar fascia at the inferior calcaneus is a safe and effective non-surgical method for treating chronic, recalcitrant heel pain syndrome that has been refractory to other commonly used non-operative therapies. The results suggest that this therapeutic procedure should be considered before any surgical intervention, and may be preferable prior to cortisone injection, which has a recognized risk of rupture of the plantar fascia and a frequent recurrence of symptoms.

23. Sems, A, Dimeff, R, and Iannotti, J. “Extracorporeal Shockwave Therapy in the Treatment of Chronic Tendonopathies.” JAAOS; 14(4): 195-204.

Study Type: Review

Conclusion: There is sufficient information to conclude that shockwave therapy is an appropriate treatment, in the right circumstances, for calcific tendonosis and plantar fasciitis that have failed non-surgical management.

24. Chung, B, Wiley, J. Preston. “Extracorporeal Shockwave Therapy, A Review.” Sports Medicine; 32(13): 851-865.

Study Type: Review article of 48 published articles, reviewing shoulder, elbow and heel applications.

Conclusion: There is an increasing body of literature that suggests that ESWT can be an effective therapy for patients who have had repeated conservative treatment failures ESWT is effective. No reports of significant adverse effects. Highest strength of evidence coming from randomized controlled studies.

Articles addressing Outcomes and Complications related to surgery for Plantar Fasciitis

Summary: A full or partial fasciotomy (3rd Party Payor covered procedures) require cutting a portion or all, of the fascia, which affects the biomechanics of the plantar fascia and its function in the foot. This can contribute to long term negative effects on the foot such as nerve entrapment, decrease in arch height, leg strain, stress fractures, lateral column syndrome due to loss of stability in the arch as well as dorsal strain, which can lead to metatarsalgia. Recovery from these procedures can be prolonged. Therefore, aggressive conservative treatment available should be attempted prior to surgical release.

25. Baxter, D, Thigpen, C.M. “Heel Pain—Operative Results.” Foot and Ankle, 1984, vol. 5, No. 1, 16-25.

Study Type: Retrospective Study, no control

Inclusion Criteria: Treated Symptoms for > 6 months, failed NSAIDS, orthoses, > 2 steroid injections, heel spur presence, and nerve entrapment of the abductor digiti quinti freedom

Results: 12 months Success: 94 %

Recovery: 2 weeks limited ambulation, Suture removal 2-3 weeks post procedure, normal mobility 4-6 weeks

26. Daly, P., et al. “Plantar Fasciotomy for Intractable Plantar Fasciitis: Clinical Results and Biomechanical Evaluation.” Foot and Ankle. May 1992, Vol. 13, No. 4, 188-195.

Study Type: Retrospective Study, no control

Results: 4.5-15 years Success: 71% with prolonged recovery period, detrimental effect on function may occur requiring additional treatment. Persistence of abnormalities such as flattening of the longitudinal arch post fasciotomy.

Side Effects following surgery: 36% heel tenderness, 29% limp, 100% limited ankle and subtalar motion.

Additional Treatment required following surgery: 50%

Recovery Period: 10.5 months recovery (vs. 6 month recovery reported by others).

27. Kitaoka, Harold, et al., “Mechanical Behavior of the Foot and Ankle after Plantar Fascia Release in the Unstable Foot.” Foot and Ankle International, January 1997, Vol 18, No. 1, 8-15.

Study Type: Cadaver Study

Purpose: Fasciotomy has a greater effect in unstable feet. The change in position of the bones of the foot may lead to unstable or destabilized feet and further deformity.

Results: Joint rotation and arch displacement occurs in all feet to a measurable point. Deformity occurs in unstable feet with pre-existing arch instability.

28. Murphy, G. Andrew, et al., “ Biomechanical Consequences of Sequential Plantar Fascia Release.” Foot and Ankle International, March 1998, Vol 19, No 3, 149-152.

Study Type: Cadaver Study

Purpose: Determination of the extent of plantar fascia release that can be performed without seriously altering the biomechanics of the foot.

Results: The arch height drops 18% after the partial fascial release and 29% after complete release. Aggressive conservative treatment of plantar fasciitis should therefore be tried before surgical release is considered because of the adverse biomechanical changes in the foot after such surgery.

29. Sammarco, G. James, Idusuyi, Osaretin, “Stress Fracture of the Base of the Third Metatarsal after an Endoscopic Plantar Fasciotomy: A Case Report” Foot and Ankle International, March 1998, Vol. 19, No 3, 157-159.

Study Type: Case Study-

Purpose: Case report of side effects following endoscopic plantar fasciotomy

Results: Release of the plantar fascia results in excessive strain in the lateral side of the foot from loss of the stress relieving function of the plantar fascia. Fracture of the base of the third metatarsal was the result of increase forces produce by the endoscopic plantar fasciotomy.

30. Sharkey, Neil, et al., “Biomechanical Consequences of Plantar Fascial Release or Rupture During Gait: Part I – Disruptions in Longitudinal Arch Conformation.” Foot and Ankle. December 1998, Vol. 19, No. 12, 812-820.

Study Type: Cadaver Study

Purpose: To determine the consequences of fasciotomy.

Results: Significant collapse of the arch in the sagittal plane post complete fasciotomy or plantar fascial rupture. A change occurs in arch, even with partial release of the plantar fascia and increases strain on the tibialis posterior muscle.

Side Effects following surgery: Plantar fascial division (possibly even division of only the central band) or rupture may lead to long-term complications elsewhere in the foot. The changes in conformation of the arch caused by partial fasciotomy are small, which perhaps accounts for the favorable outcomes reported in short-term studies. Surgically compromised plantar fascia my lead to progressive pes planus caused by the added stress placed upon the tibilias posterior muscle and secondary ligamentous restraints. Any change form normal may be sufficient to precipitate a cascade of events eventually leading to pes planus with accompanying pain.

31. Sharkey, Neil, et al., “Biomechanical Consequences of Plantar Fascial Release or Rupture During Gait: Part II – Alterations in Forefoot Loading.” Foot and Ankle. February 1999, Vol. 20, No. 2, 86-96.

Study Type: Cadaver Study

Purpose: Delineation of the effects of plantar fasciotomy on forefoot or metatarsal loading.

Results: Complete fasciotomy or plantar fascia rupture increased the magnitude of strain in the dorsal aspect of the second metatarsal by more than 80%.

Side Effects following surgery: Strains increase the rate of accumulation of damage in the bone, possibly leading to metatarsalgia. If damage caused by increased strain or increased frequency of loading accumulates faster than can be repaired by remodeling, it may escalate to stress fracture.

Articles addressing Outcomes and Complications related to surgery for Lateral Extensor Release

Summary: Surgical success was regarded as 76%. Complications included the development of infection, temporary loss of extension compared to normal, and recuperation away from work of a minimum of six weeks for 100% of the patients.

32. Verhaar, Jan, et al., “Lateral Extensor release for Tennis Elbow.” The Journal of Bone and Joint Surgery, Vol 75-A. No. 7 July 1993, 1034-1043.

Study type: Prospective Study

Purpose: Review of surgical release success

Results: Surgical success was regarded as 76%. Complications included the development of infection, temporary loss of extension compared to normal, and recuperation away from work of a minimum of six weeks for 100% of the patients.

Articles addressing Issues related to Non-Surgical Treatment for Plantar Fasciitis

Summary: Most treatments (many covered by Medicare) were found to be unpredictable or minimally effective. The ineffectiveness was especially true of steroid injections.

33. Gill, Lowell, Kiebzak, Gary. “Outcome of Non-surgical Treatment for Plantar Fasciitis.” Foot & Ankle International, September 1996, Vol. 17, No 9, 527-532.

Study type: Prospective Study, no control, n=411 patients

Purpose: Ranking of effectiveness of various non-surgical treatment modalities

Results: Most treatments were found to be unpredictable or minimally effective. The ineffectiveness of non-surgical treatments is at variance with most published clinical studies

Joint Policy Statement

34. American Podiatric Medical Association and the American College of Foot and Ankle Surgeons

Statement: Based on a thorough review of the literature ESWT appears to be an efficacious, FDA approved non-surgical option in the treatment of chronic proximal plantar fasciitis

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