Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Posted by Jan R. on 10/20/04 at 02:44 (161824)
Here is my Letter to the Editor (http://www.ejbjs.org/cgi/eletters/86/10/2216):
I read with great interest the article 'Electrohydraulic high-energy shock-wave treatment for chronic plantar fasciitis' by John Ogden and co- workers (JBJS 2004; 86-A:2216). I congratulate them for reporting the results of the FDA trial, which, to a vast amount, had been published earlier (1,2).
Some points remain open for discussion.
(1) The alleged efficacy of this single dosed, high-energy, anaesthetically based treatment has already been discussed in an exhaustive way by Buchbinder et al.(3)in 2002: Regarding the HealthTronics sponsored FDA tria1,(4) Buchbinder critizised that the presence of plantar fasciitis was determined solely on clinical grounds. It was uncertain whether the 2 groups in the trial were comparable at baseline. Ogden et al.(1)had defined overall success of treatment at 12 weeks if all 4 of the following criteria were fulfilled: (1st) minimum 50% improvement over baseline in investigator assessment of pain (by dolorimeter), with a VAS score of 4cm or less; (2nd) minimum 50% improvement over pre-treatment baseline in subject´s self assessment of pain on first walking in the morning and VAS score of 4 cm or less; (3rd) minimum 1 point or greater improvement on a 5-point scale of distance walked without heel pain, or maintenance of baseline assessments of no pain or minimal pain; (4th) and no prescription of analgesics for heel pain int the treated heel between 10 and 12 weeks after treatment. While success in the 3 criteria other than investigator assessment of pain also favored the active treatment, none was statistically significant (subject´s self-assessment of pain criterion: 59.7% in ESWT group vs. 48.2% in placebo group, p= 0.08; subject´s self assessment of activity level: 71.4% in ESWT group vs. 67.2% in placebo group, p= 0.49; and use of pain medications: 69.7% in ESWT group vs. 67% in placebo group, p=0.41).
I wonder why Ogden, who quoted the Buchbinder paper in his article, did not specifically respond to these objections.
How is it possible that suddenly significant differences are calculated at 3-month follow-up while in the original FDA paper,(4) no statistically significant difference had been observed at the same follow-up?
(2) In their paper, Ogden et al. report active shock wave treatment with an energy flux density of 0.22 mJ/mm² to be high-energy? In a recent article, Rompe et al.(5)treated patients an energy flux density of 0.18 mJ/mm², calling this low-energy? I therefore question the labelling of Ogden´s concept as high-energy. I would like to know whether the authors are aware of any consensus as to how to define low-energy vs. high-energy treatment.
(3) I find it interesting to read that 47% of patients in the placebo group, having received 3 1-mL subcutaneous injections of lidocaine, reported greater than 50% improvement of morning heel pain at the 3-month follow-up. In an upcoming study(6) 86 patients with chronic plantar fasciitis had been randomly assigned to receive either low-energy ESWT without local anesthesia, given weekly for three weeks or identical ESWT with local anesthesia to the insertion of the plantar fascia. Significantly more patients achieved greater than 50% reduction of pain of first steps in the morning after ESWT without local anesthesia than after ESWT with local anesthesia (67% vs. 29%). Local anesthesia applied prior treatment reduced the efficiency of low-energy ESWT in this setup. I wonder what explanation Ogden and co-workers have for the surprisingly high rate of satisfied patients after local anesthesia only in their experimental design? With their close to 50% success rate in recalcitrant patients regarding morning pain, should subcutaneous injections of lidocaine not be given priority before shock-wave treatment?
(4) I agree with Ogden, that the mechanism of shock wave action in soft tissues is still under investigation. When discussing a possible working mechanism of shock wave application it is important to focus not only on differences of shock wave devices in clinical use. There are also different pathways for the effects of high- versus low-energy shock waves. It is important to know that the current literature(7-10) indicates that shock waves may selectively lead to dysfunction of peripheral sensory unmyelinated nerve fibers without affecting nerve fibers responsible for motor function (large myelinated fibers). For 'high-energy' treatment with 0.9 mJ/mm², this selective destruction of unmyelinated sensory nerve fibers within the focal zone of ESWT may contribute to clinically evident long-term analgesia.(7) For 'low-energy' application with 0.1 mJ/mm² analgesia may be a result of a shock wave-induced release of neuropeptides, such as CGRP, resulting in a local neurogenic inflammation in the focal area with subsequent prevention of sensory nerve endings from reinnervating this area.(8,9) A second application accentuated these inflammatory changes and therefore prevented reinnervation.(10) Centrally, the common findings of a reduction in the number of neurons immunoreactive to CGRP and substance P without a reduction of the total number of neurons within the lower lumbar DRG probably are a secondary effect following the (primarily induced) decrease of the number of sensory nerve fibers in the focal zone of shock wave application.9 So the peripheral and central nervous system may both play a pivotal role in mediating shock wave induced long-term analgesia. Recently, Wang(11) showed that shock wave application of 0.12 mJ/mm² resulted in increased neovascularization at the tendon-bone junction in rabbits. Chen(12) treated rats with a collagenease-induced Achilles tendinitis with a single shock wave treatment with 0, 200, 500 and 1000 impulses of 0.16 mJ/mm². Shock wave application with 200 impulses restored biomechanical and biochemical characteristics of healing tendons 12 weeks after treatment. However, shock wave treatments with 500 and 1000 impulses elicited inhibitory effects on tendinitis repair. Together, low-energy shock wave effectively promoted tendon healing. In my view it is clear from these experimental data that with increasing energy applied there is a chance of side effects that my well harm an already diseased fascia or tendon. It is also clear that even 'low-energy' shock waves may induce a positive local reaction regarding down-regulation of pain transmitters, and up-regulation of cell proliferation factors. The clinical results reported by Ogden and co-workers, using an energy flux density of 0.22 mJ/mm², probably are due to these effects.
(5) I agree with Ogden and co-workers and with Speed(13) that some regimes of ESWT are a potentially helpful addition to the options for the management of soft-tissue conditions such as chronic plantar fasciitis. I support Ogden and co-workers that contrary to the opinion of Buchbinder(14) these regimes of ESWT - producing virtually no complications, allowing immediate full weight bearing without splints - should therefore be given priority before surgery.(15)
Jan D. Rompe, MD
1. Ogden JA et al. Shock wave therapy for chronic proximal plantar fasciitis.Clin Orthop 387: 47-59, 2001.
2. Ogden JA. Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial. Br J Sports Med 38: 382, 2004.
3. Buchbinder R et al. Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis: a randomized controlled trial. JAMA 288:1364-1372, 2002.
4. U.S. Food and Drug Administration. Summary of safety and effectiveness data. http://www.fda.gov/cdrh/pdf/p990086.html
5. Rompe JD et al. Shock wave application for chronic plantar fasciitis in running athletes – a prospective, randomized, placebo- controlled trial. Am J Sports Med 31:268-275, 2003.
6. Rompe JD, Meurer A, Nafe B, Hofmann A, Gerdesmeyer L. Low-energy shock wave application without local anesthesia is more efficient than low -energy extracorporeal shock wave application with local anesthesia in the treatment of chronic plantar fasciitis. J Orthop Res, in press.
7. Maier M et al. Substance P and prostaglandin E2 release after shock wave application to the rabbit femur. Clin Orthop 406:237-245, 2003.
8. Ohtori S et al. Shock wave application to rat skin induces degeneration and reinnervation of sensory nerve fibres. Neurosci Lett 315:57-60, 2001.
9. Takahashi N et al. Application of shock waves to rat skin decreases calcitonin gene-related peptide immunoreactivity in dorsal root ganglion neurons. Auton Neurosci 107:81-84, 2003.
10. Takahashi N et al. The mechanism of pain relief in extracorporeal shock wave therapy. Poster # 448, AAOS Annual Meeting San Francisco, 2004. http://www.aaos.org/wordhtml/anmt2004/poster/p448.htm .
11. Wang CJ. Shock wave therapy induces neovascularization at the tendon-bone junction. A study in rabbits. J Orthop Res 21:984-989, 2003.
12. Chen YJ et al. Extracorporeal shock waves promote healing of collagenase-induced Achilles tendinitis and increase TGF-beta1 and IGF-I expression. J Orthop Res 22:854-861, 2004.
13. Speed CA. Extracorporeal shock-wave therapy in the management of chronic soft-tissue conditions. JBJS 86-B:165-171, 2004.
14. Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med 350:2159-2166, 2004.
15. Rompe J. Plantar fasciitis. N Engl J Med. 351:834, 2004.
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Tina H on 10/20/04 at 07:11 (161826)
Dr. Rompe- Thank you for posting your thoughtful and informative letter. As someone who initially had a very adverse reaction in the weeks immediately following ESWT, and who has seen others come to this site with similar post-ESWT trauma, it's clear that the therapeutic mechanism needs to be futher elucidated. Although I'm a lay person and know very little about ESWT, I'm beginning to think that in my situation, perhaps I received too many mJoules during my high energy treatment. I remember the doctor and tech saying that they were able to give me the maximum shocking rate for almost the full 18minutes. Additionally, I had a cortisone shot 4.5weeks prior to ESWT, maybe this compromised the fascia as well making it more vulnerable to ESWT. I think this situation should be looked at, because many people try cortisone shots as a last ditch effort prior to having ESWT. Thanks again for helping us understand more about this procedure. Tina H
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Lynn F. on 10/20/04 at 13:42 (161840)
Does this mean that those of us who receieved high energy ESWT are basically screwed? (ugh!!)
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228supertwin on 10/20/04 at 13:57 (161841)
Yes, I'm asking myself the same question, Lynn. Also, I have wondered if the 20 day course of steroids (prednisone) I completed 3 weeks before high energy ESWT has something to do with my experience of such inflammation and swelling in both tissue and bone. My doctor knew of my taking the steroids, and did not say he was concerned (?).
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Dr. Z on 10/20/04 at 15:57 (161843)
IF you had ESWT with the dornier the amount of total energy is 1300mj/mm2. This is something that is automatic. This is no guessing. It is a read out on the control panel. On another note you should avoid the use of steriods and or local injections. Some say up two months. It is dependent on the type of local steriod injections. There is literature where local steriods were given at the time of treatment with no adverse effects, however I am of the opinion that you should avoid the use of steriod at least two weeks before ESWT
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Tina H on 10/20/04 at 16:23 (161848)
Thanks Dr. Z, I did have the Dornier machine, but the energy level was adjusted the first few minutes to make sure the local was working okay and that I wasn't in too much pain. The power was gradually increased over the first few minutes. Is this how you do it as well? When you say total energy, it it over the course of application or are the units actually mj/mm/sec? Tina ps. Hope you don't think I'm being argumentative - just trying to fiqure out how all of this works and what the link might be for those of us who were in more pain after. Thanks for all you do for everyone here!!!
Re: Re:For supertwin and LynnTina H on 10/20/04 at 16:45 (161850)
Supertwin and Lynn, I'm not sure you are screwed. High energy ESWT works for the vast majority of people, if any of the many articles I've researched are correct. I was really bad for the first several weeks after ESWT, so bad that I used to crawl up the stairs at the end of the night to go to bed and I kept crutches next to my bed in case I had to get up in the middle of the night. Now I am a lot better but that really didn't seem to happen until 8 weeks after. I'm so much better that now, I can take a shower in my bare feet!!! How's that for progress? So, hang in there and don't despair just yet, maybe if at 12 weeks you're still like this....
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Ed Davis, DPM on 10/20/04 at 17:52 (161855)
Thank you again for bringing your expertise to this site. The advantage of machinery with the ability to vary energy levels will be more obvious as the number of regions of the body treated via ESWT increases. Achilles tendinosis is a rarer yet more difficult to treat condition than PF for which I have had considerable success with low energy ESWT although my numbers are too small to publish at this time. We view achilles tendinosis as a 'pre-rupture' condition and, as such, need to be cautious about the energy level applied.
Some options to local anesthesia that may be helpful include use of nitrous oxide (classified in the US as an analgesic as opposed to an anesthetic) thus available for widespread office use. Occasionally patients may be offered tylenol with hydrocodeine about 45 minutes before a procedure if they have a ride home and are 'squeamish' about the procedure.
Ed Davis, DPM
Re: Re:For supertwin and Lynnsupertwin on 10/20/04 at 18:14 (161856)
Tina, I'm so happy for your progress - that's so great to hear, as I remember reading your posts right after I had mine done Sept. 10th, and being a little scared for both of us. Now I'm only hoping for, at the very least, pre-ESWT conditions for myself - and that I won't have to go back to work until I'm certain I'm not causing further damage/delay in my own healing. This is an experience, for sure. Can't imagine anything else being this hard, or making me tougher.
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Dr. Z on 10/20/04 at 19:04 (161861)
It is the Total amount of energy. Yes we follow the FDA protocol as I believe you are describing.
I have heard about patients being in more pain with both low and energy eswt treatments from this site. The link I am not sure of at this time. Maybe Sunny from Pain Free ESWT or Dr. Rompe could add some light to this situation.
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Dr. Z on 10/20/04 at 19:08 (161862)
I agree with the use of low energy for Achilles tendinosis. I still use a regional block without any local infiltration in patients. We treat the pain epicenter, ultrasound pictures. I have an option for the rare squeamish patient. Once I see how it works I will let you know the formula.
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Pauline on 10/20/04 at 20:01 (161866)
Thanks for posting your letter to the Editor and all the work that you do with ESWT.
I know Elliott a former poster would appreciate seeing your recent letter. I hope that he gets a chance to read it.
When you send letters to the Editor do responses usually follow in the next issue? If so would you also consider posting them. Thank you.
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Lynn F. on 10/21/04 at 12:04 (161895)
Tina - You really do give me hope! I'm 3 weeks post and so very sore. Though when I read some other posts, I realize it could be worse! Thanks!
Re: Re:For supertwin and LynnLynn F. on 10/21/04 at 12:16 (161896)
Supertwin - I've read some of your previous posts and my heart goes out to you. I do hope you get some relief real soon. In hindsight.. I probably didn't need to read something (Dr. R's letter) that seems to undermine everything I've put my hopes into! Good luck.
Re: Ogden JA: J Bone Joint Surg Am. 2004 ; 86-A:2216-2228Dr. Z on 10/21/04 at 18:40 (161932)
I am looking forward to the response