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“Shockwave Treatment in Orthopaedics and Rheumatology, Clinical and Experimental Studies” Dr Moustafa Hafez, MB.BCh, MS (Orth), CASLAT, PhD,Clinical Tutor & Research Consultant Imperial College London,Mr Milad Hanna MB. BCh, FRCS (Glas), FRCS (Ed)Director of the Lithotripsy Unit & Research Consultant Imperial College London,Mr Richard Coombs MA DM MCh FRCS MRCS FRCS (Ed) OrthConsultant Orthopaedic Surgeon, London, UK,Dr Nikki Horwood, PhDKennedy Institute of Rheumatology Research, Imperial College London. The 4thAnnual Meeting of the Egyptian Society of Rheumatology and Orthopedic Surgery, Sheraton Alxandria, Egypt 28-30 April 2011 Egypt.
Introduction: • Historical background for shockwave applications: In the last World War, it was noted that unprotected sailors swimming in the vicinity of depth charges were killed with minimal external trauma, but with deep tissue changes. Their deaths were attributed to the unknown effects of shockwaves. From 1968 to 1970 extensive research in Germany revealed the effects of shockwaves on living organisms.
Historical background for shockwave applications: • Experimental studies were performed on tissues such as muscle, CNS, lung and connective tissues. • Severe damage occurs when lung and central nervous tissues are exposed to shockwaves. It was not until 1980 that an effective use of Shockwaves was first introduced into clinical practice for the treatment of renal stones. • By 1983 the first, commercial lithotripter was available for hospital use. By 1985 shockwave treatment had also been offered to patients with gallstones and pancreatic stones.
Clinical effects of shockwave therapy: • The most common and widespread clinical application of shockwave therapy is for renal stones. Shockwave therapy has now been extended to a variety of orthopaedic conditions, including chronic fracture non-unions, rotator cuff problems, tennis elbow, and plantar fasciitis (Coombs et al, 2000). Coombs et al, 2000, COOMBS R, SCHADEN W, ZHOU, S: “Musculoskeletal Shockwave Therapy”, ed by R Coombs, et al, Greenwich Medical Media, London, 2000.
Clinical effects of shockwave therapy: • Despite being destructive for renal stones, shockwaves may also have a stimulatory effect on the growth and differentiation of cells. When shockwaves are applied to fracture non-unions, the healing process is accelerated (Johannes et al, 1994; Valchanov et al, 1991). • In addition when shockwaves are given to patients with infected chronic un-united fractures, the fractures may unite rapidly, demonstrating a stimulatory effect. Experimental studies have established the effect on stem cells promoting osteogenic activity. The exact mechanism is unclear. • It has also been shown that shockwaves have a neo angiogenic effect, increasing the blood flow to bone and soft tissues and a selective effect on ummyelinated, pain carrying nerve fibers. Johannes EJ, Kaulesar Sukul DM, Matura E (1994). High-energy shock waves for the treatment of nonunions: an experiment on dogs. J Surg Res 57:246–252. Valchanou VD, Michailov P (1991). High energy shock waves in the treatment of delayed and nonunion of fractures. Int Orthop 15:181–184.
Case presentation: • A 32 year old nurse fractured her humerus. • She went on to develop a hypertrophic non-union of the fracture as shown. • It was suggested that operative intervention would be inevitable, with exploration of the fracture and insertion of a plate. • The patient was concerned about the risk of a serious complication which could include a radial nerve palsy or infection. • In addition there was no guarantee that surgery would secure satisfactory union and time away from work was inevitable.
Case presentation: • As an alternative she elected for treatment with four sessions of shockwaves. • The sequence of x-rays is shown.
Case presentation Un-United fracture Scaphoid Before Shockwave treatment After Shockwave treatment
Delayed union of fracture tibia Before Shockwave treatment After Shockwave treatment
Case presentation: • The equipment used at Charing Cross Hospital for our clinical and experimental studies is shown. • We now have experience of approximately 400 patients undergoing shockwave treatment for a variety of indications over a 15 year period for soft tissue problems, chronic non-union, bone cysts and osteochondritis disecans of the knee and talus. • The technique has also been used for reversing stage 1 and 2 MRI positive osteonecrosis of the bone.
Mechanism of Action • The mechanical effect of shock waves on the tissues stimulates the nervous system (memory effect of the central nervous system), distribution of the substance P and the release of nitrogen and other messenger molecules*. • Some of the effects include the activation of ion channels in cell membranes, an increase in metabolism and neoangiogenesis and the release of vascular endothelial growth factors that ultimately lead to pain reduction even for chronic pelvic pain. * O. J. Wess, A neural model for chronic pain and pain relief by extracorporeal shock wave treatment, Urol Res, 36:327 – 334 (2008).
Shockwave treatment for infection: • At the ISMST meeting in Vienna in 2005, Dr Ludger Gerdesmeyer from Munich was the first to suggest that shockwaves might have a bactericidal effect. • Following this meeting we have established that shockwave treatment may be very helpful for deep infections of implants in patients who are not suitable for operative intervention.
Case Presentation: • A 25 year old Afro-Caribbean nurse underwent a massive replacement of the left distal femur for a chondrosarcoma. • Five years later she developed a bacteraemic infection of the implant with chronic sinuses leaking pus from the tibial component
Case Presentation: • Four sessions of shockwave treatment resulted in the complete healing of the infected sinuses. • Since developing sepsis, the patient had experienced extreme difficulty in mobilising because the tibial component appeared to be loose within the bone. • As the sinuses healed the patient found that she could mobilise full weight bearing on her leg for the first time for several years
Case Presentation: • A 55 year old patient, developed chronic osteoarthritis in her right knee. • She underwent an arthroscopy which confirmed severe cartilage loss and a total knee joint replacement was performed.
Case Presentation: • She initially made a good recovery, but then developed severe pain and tenderness over the tibial component. • The inflammatory markers, ESR and CRP were raised and a radioactive white cell labelled scan showed increased activity over the tender zone of the tibia.
Case Presentation: • Three sessions of shockwave treatment were targeted at the tender zone and the bone pain resolved.
Case Presentation: • A 73 year old Greek Cypriot, developed severe pain and discomfort in the right thigh with a discharging sinus. • The infected wound was explored and Septopal beads were inserted into a bony cavity.
Case Presentation: • After four weeks the beads were removed and the cavity was packed with antibiotic impregnated bone substitute. • The infection resolved but five years later he developed severe pain associated with an abscess over the bone.
Case Presentation: A sinogram confirmed the extensive nature of the infection. There was concern that the bone substitute might form a nidus for chronic sepsis
Case Presentation: • Three sessions of shockwave treatment were givento the infected zone. The pain resolved and there was no sign of active infection. • The ESR dropped from 108mm at the time of acute sepsis down to 3-5mm after treatment.
Case Presentation: • We have also treated a patient who suffered some inflammation and infection of an ankle wound • This patient had three sessions of shockwave treatment and the wound infection resolved completely.
Case Presentation: • Normally we avoid treating superficial wound infections in the ankle region, but this patient has achieved a satisfactory long term outcome.
Is it true? & How does it work? • Our clinical experience is anecdotal. • The bacteriology is inconclusive. • All our patients were also treated with antibiotics. • Nevertheless these patients would have been extremely challenging to treat with traditional techniques. • Our clinical experience has inspired scientific studies.
Aim of the study • The objective of our programme has been to study the effects of shockwaves on bacteria, including Gram-negative organisms, Fungi and Staphylococcus aureus, including multi-resistant strains.
Materials and methods: • Our experimental work on Staphylococci including MRSA and Fungi has already been presented. We have now extended our studies to Gram negative organisms.
Methods • Semisolid suspension • Liquid suspension* • Sandwiched as a colony within an agar plug • Sandwiched as a colony within an agar plug within muscle tissue • Sandwiched as a semisolid suspension within a cylinder in tissue *Gerdesmeyer L et al. Ultrasound in Med. & Biol 2005; 31, 115-9
Experimental Design: • Twelve standardised pieces of lamb meat 7 x 5 x 5 cm were cut from fresh ovine leg muscle. • Each piece was partially sliced across approximately 2 cm from the top. A 2 cm cube of muscle was cut from the centre of each sample and was discarded. • A radio-opaque lead marker was placed at the bottom of each cavity and 1 ml of sterile liquid 1.2% Agar maintained at 42 C was added to fill the cube completely. • The top of each sample was then closed by covering with the partially cut slice of meat
The samples have been treated with a STORZ Medical Modulith SLX-F2 Lithotripter Radio-opaque Raytec thread has been used to help target the shockwaves under x-ray control.
Experimental Design • Experimental samples were treated with shockwaves and were compared with untreated controls.
Experimental Design • All samples were diluted with brain heart infusion broth and counts of viable organisms were estimated after incubating the broth. • Serial dilutions were used to assess the bacterial counts. The numbers of viable bacterial colonies were counted in the treated samples and were compared to the untreated controls.
Results • There was a statistically significant kill rate for the MRSA, Fungi and E.coli bacteria. • Some changes were noted in the muscle tissue in the treated samples. • This situation does not reflect the clinical condition. Part of the damage may be related to heat necrosis which would be reduced in the living patient with a normal muscle blood flow. • In the clinical situation, petechial haemorrhages and minor haematomas have been reported in the literature following the treatment of soft tissue problems with shockwaves. • In our own clinical series of nearly 400 patients, we have so far not experienced this complication.
Results • This was an in vitro model in which additional biological factors were not active. • In the biological situation, shockwaves may promote angiogenesis, can stimulate the immune system and may also lead to differentiation of stem cells. Professor Wang, (Kaohsiung Taiwan) and others.
Discussion • We suspect the reason why the changes were more marked in our tissue samples was because this was not living tissue. There was no blood flow taking away toxic kinins. • We suspect that the changes may also be related to a type of thermal necrosis.
Conclusion • The potential for shockwaves in the treatment of deep sepsis seems attractive but the technique requires further experimental work before it can be established as a method of choice.
Thank you We are grateful to the Furlong FoundationFor Financial Support
