3 August 2012
“Patients have described living with tendon pain has similar to having constant excruciating toothache,” explains Gayle Maffulli, “it is a persistent pain that doesn’t go away when you rest or move around. Many sufferers experience the pain constantly.”
Gayle Maffulli is based at QM’s Centre for Sports and Exercise Medicine, and together with Professor Nicola Maffulli, is part of a team who have been using Spectrum Technology Ltd’s Extracorporeal Shockwave Therapy (ESWT) to treat tendon injuries for some time.
“Clinicians have reported that some people experience significant relief after a course of ESWT,” says Gayle. “It lessened their pain, and even more importantly, the results were long-lasting. This has been the case even for a number of patients who had suffered with chronic tendon pain for many years.”
Despite these good results, Spectrum Technology UK Ltd’s ESWT treatment is not currently supported by large-scale, consistent clinical data in support of its use. Studies to date have used a range of different outcome measures. What’s more, treatments have not been standardised. Some patients receive one treatment, while others have a series of three. They may also receive varying ‘doses’ in terms of the electric voltage used.
This ImpactQM project set out to research and document the effectiveness of the ESWT treatment using consistent outcome measures and treatment plans in a large-scale research study. Not only will this work help to establish a benchmark for effective treatment, but it will also lay the groundwork for greater take-up across the UK and Europe.
“[ESWT] is typically used to treat Achilles tendinopathy, plantar fasciitis, tennis elbow, calcific tendinopathy of the shoulder, golfers/tennis elbow, trochanteric bursitis, patella tendinopathy and shin splints.” (www.spectrumtechnologyuk.com)
Hundreds of patients have been enrolled in QM’s study, drawn from 98 centres across the UK. These range from NHS orthopaedic outpatient departments to state-of-the-art sports medicine clinics. Patients have been selected according to consistent entry criteria. For many of them, the ESWT treatment is a ‘last resort’ alternative to surgery. All patients have received the same three-session treatment procedure.
For the purposes of the study, treating clinicians are collecting outcomes data over a two-year period and adding it to a UK-wide database. The data will be supported by some qualitative research in the shape of interviews. Patients will be invited to describe what it was like having the treatment and how the ESWT treatment has affected them.
“Anecdotally, some patients have reported that 'the results have been very positive' whilst completing their follow-up,” says Gayle. “In some cases, they have reported that the treatment has been quite literally life-changing.”
ESWT is administered using a small handheld device, Spectrum Technology’s Swiss DolorClast. When placed on the surface of the skin, the device sends out a shock wave that “spreads inside the injured part of the body as an aspherical ‘radial' wave. [This] initiates an inflammation-like response in the injured tissue that is being treated.”
“This prompts the body to respond naturally by increasing blood circulation, the number of blood vessels and therefore metabolism in the injured tissue. This accelerates the body's natural healing process by increasing cell generation and dissolving calcium deposits.” (www.spectrumtechnologyuk.com)
A second phase of the ImpactQM project is focused on exploring the science behind the treatment’s effectiveness. The QM team is conducting microdialysis of the treated tendon that makes it possible to ‘see’ exactly what happens during a treatment.
The ImpactQM funding supported both phase one and two of the research, including two full-time post-doctoral research posts. Stephannie Hemmings and Gayle Maffulli (part-time) are managing the clinical outcomes database, and the Charlie Waugh (part-time) is leading the microdialysis side of things.
The QM team act as key coordinators between Spectrum technology Ltd and the medical professionals and patients enrolled on the study. They produce a quarterly newsletter that ensures everyone is kept up to date with developments as they happen.
“We’ve established a very good working relationship with Spectrum Technology Ltd,” says Gayle. “It’s been really useful for the company to have direct access to the people who are using their products in a live clinical setting.”
Spectrum Technology Ltd will finance a small amount of QM’s research activity into the use of their products after the ImpactQM funding ends. This will ensure the study completes satisfactorily.
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