Clinical Outcomes

 

The Swiss DolorClast, manufactured by Electro Medical Systems (EMS) in Switzerland, is supported by more clinical trial data between levels 1 and 2 than any other Extracorporeal Shockwave Therapy device in the world.

We work with some of the world's leading clinicians to conduct comprehensive clinical trials that test the effectiveness of the Swiss DolorClast under a number of conditions.

Here is a summary of some of our clinical evidence:


Plantar Fasciitis - randomised, double blind, multi-centered placebo controlled trial.

Level 1 clinical evidence.

Authors: Gerdesmeyer L, Frey C, Vester J, Maier M, Weil L Jr, Weil L Sr, Russlies M, Stienstra J, Scurran B, Fedder K, Diehl P, Lohrer H, Henne M, Gollwitzer H - 2008.

Hypothesis: There is no difference in effectiveness between Extracorporeal Shockwave Therapy (ESWT) and placebo in the treatment of chronic Plantar Fasciitis?

Methods: The effects of three interventions of ESWT were studied and compared in 245 patients with chronic Plantar Fasciitis. Primary endpoints were changes in visual analog scale composite score from baseline to 12 weeks' follow up, overall success rates and success rates of the single visual analog scale scores. Secondary endpoints were single visual analog scale scores, success rates, Roles and Maudsley score,
SF-36, and the global judgement of success by patients and investigators after 12 weeks and 12 months.

Results: ESWT proved significantly superior to placebo with a reduction of the visual analog scale composite score of 72.1% compared with 44.7% and an overall success rate of 61.0% compared with 42.2% in the placebo group at 12 weeks. Superiority was even more pronounced at 12 months with all secondary outcome measurements supporting ESWT to be significantly superior to placebo. No relevant side effects were observed during the treatment.

Conclusion: ESWT significantly improves pain, function, and quality of life compared with placebo in patients with recalcitrant Plantar Fasciitis.


Achilles Tendonopathy - randomised controlled trial.

Level 1 clinical evidence.

Authors: Rompe JD, Furia J, Maffulli N - 2009.

Trial brief: To compare the effectiveness of two management strategies for Achilles Tendonopathy. Group 1 will undergo eccentric loading treatment, while group 2 will undergo eccentric loading and ESWT treatment.

Methods: A total of 68 patients with a chronic recalcitrant non-insertional Achilles Tendonopathy were enrolled in the trial. All patients had received unsuccessful management for more than three months beforehand, including a) peritendinous local injections, 2) non-steroidal anti-inflammatory drugs, and 3) physiotherapy. An allocation schedule was generated using a computerized random-number generator and analysis was on an intention-to-treat basis.

Results: At four months from baseline, the VISA-A score increased in both groups from 50 to 73 in group 1 and from 51 to 87 in group 2. Plain rating decreased in both groups from 7 to 4 points in group 1 and from 7 to 4 points in group 2. Nineteen of the 34 patients in group 1 and 28 of the 34 patients in group 2 reported a ‘completely recovered' or ‘much improved' result.
For all outcome measures, groups 1 and 2 differed significantly in favour of the combined treatment approach at four-month follow-up. A year after baseline, there was no difference, with 15 failed patients in group 1 opting to have the combined therapy as cross-over and with 6 failed patients in group 2 undergoing surgery.

Conclusion: After four months, eccentric loading alone was less effective when compared with a combination of eccentric loading and ESWT treatment.


Chronic insertional Achilles Tendonopathy - randomised prospective controlled trial.

Level 1 clinical evidence.

Authors: Rompe JD, Furia J and Maffulli N (published in the British Journal of Bone and Joint Surgery, January 2008).

Hypothesis: Compare eccentric loading with ESWT treatment by the Swiss Dolorclast device for chronic insertional Achilles Tendonopathy.

Methods: Fifty patients with chronic recalcitrant insertional Achilles Tendonopathy were enrolled in a peer-reviewed, randomised controlled trial. All patients had previously received other treatment, without success, for at least three months. The population was randomised into two groups: 25 patients received eccentric loading physiotherapy (group 1) and 25 patients (group 2) had treatment with repetitive
low-energy shockwave therapy. Primary follow up was at four months and the last evaluation was carried out at one year using the VISA-A rating scale.

Results: Using the VISA-A scoring system, the patients that received eccentric loading physiotherapy (group 1) showed a drop from 7 to 5 VISA-A scoring and the patients that received low-energy shockwave therapy treatment (group 2) showed a fall from 7 to 3. Seven patients (28%) in group 1 and 16 patients (64%), in group 2 reported they were completely recovered or much improved. For all outcome measures, the group that received the shockwave therapy showed significantly more favourable results than the group treated with eccentric loading physiotherapy.

Conclusion: Eccentric loading physiotherapy showed inferior results to low-energy shockwave therapy treatment at four months follow-up.


Use of anaesthesia during low-energy shockwave therapy treatment - randomised, single centre, parallel treatment study with a blinded independent observer.

Authors: Auersperg V, Labek G, Ziernhoeld M, Poulios N, Rompe JD, and Boehler N (published in the British Journal of Bone and Joint Surgery - Vol 86-B, Issue SUPP_III, 365. 2004).

Hypothesis: Simultaneous local anaesthesia deteriorates the clinical outcome for repetitive low energy shockwave therapy for chronic Plantar Fasciitis.
Methods: Forty eight patients suffering with chronic Plantar Fasciitis were enrolled. The 24 patients in group 1 received low-energy shockwave therapy treatment with anaesthesia, while the 24 patients in group 2 received low-energy shockwave therapy treatment without local anaesthesia.

Results: The heels of sixteen out of the 24 patients in group 1 (67%) reached a good or excellent result, while in group 2, the heels of seven out of the 24 patients showed a good or excellent result at three-month follow-up.

Conclusion: The author concluded that use of local anaesthesia has a negative influence on repetitive low-energy shockwave therapy for Plantar Fasciitis.


Home training, local corticosteroid injection or radial shockwave therapy for Greater Trochanter Pain Syndrome - randomised controlled trial.

Level 2 clinical evidence.

Authors: Rompe JD et al - 2009

Hypothesis: Does local corticosteroid injection, home training and repetitive low-energy radial shockwave therapy produce equivalent outcomes four months from baseline?

Methods: A group of 229 patients with refractory unilateral greater trochanter pain syndrome were assigned to a home training programme, a single corticosteroid injection or a repetitive low-energy radial shockwave treatment. Subjects underwent outcome assessments at baseline and then at 1, 4 and 15-month intervals. Primary outcome measures were degree of recovery (measured on a 6-point Likert scale) and severity of pain during the past week (0-10 points) at 4-month follow up.

Results: One month from baseline, results after corticosteroid injection (success rate 75% and pain rating 2.2 points) were significantly better than those after home training (7% and 5.9 points) or shockwave therapy (13% and 5.6 points). At 4 months, radial shockwave therapy led to significantly better results (68% and 3.1 points) than home training (41% and 5.2 points) and corticosteroid injection (51% and 4.5 points). At 15 months from baseline, radial shockwave therapy (74% and 2.4 points) and home training (80% and 2.7 points) were significantly more successful than was corticosteroid injection (48% and 5.3 points).

Conclusion: The significant short-term superiority of a single corticosteroid injection over home training and shockwave therapy declined after one month. Both corticosteroid injection and home training were significantly less successful than shockwave therapy at 4-month follow-up. Corticosteroid injection was significantly less successful than home training or shock wave therapy at 15-month follow up.


Repetitive low-energy radial shockwave therapy without local anaesthetic is more efficient than without in the treatment of chronic plantar fasciitis - randomised controlled trial.

Level 2 clinical evidence.

Authors: Rompe JD et al - 2004

Hypothesis: To evaluate the effect of local anesthesia on the clinical outcome after repetitive low-energy ESWT for chronic plantar fasciitis

Methods: A group of 86 patients with chronic plantar fasciitis were randomly assigned to receive either low-energy radial ESWT without local anaesthesia, given weekly for three weeks, or identical radial ESWT with local anaesthesia. The primary outcome measure was reduction of pain from baseline to month 3 post-treatment in a pain numeric rating scale (0-10 points) during first steps in the morning. Calculations were based on intention-to-treat.

Results: No difference was found between the groups at baseline. At 3 months the average pain score for patients without local anaesthesia was 2.2 ± 2.0 points, while those with local anaesthesia scored 4.1 ± 1.5 points. Patients in the group without local anaesthesia achieved 50% reduction of pain compared to those with local anaesthesia.

Conclusion: ESWT as applied should be done without local anaesthesia in patients suffering from chronic heel pain. Local anaesthesia applied prior to treatment reduced the efficiency of low-energy ESWT.


Greater Trochanteric Pain Syndrome - randomised controlled trial.

Level 2 clinical evidence.

Authors: Rompe JD, Segal NA, Cacchio A, Furia JP, Morral A, Maffulli N - 2009.

Hypothesis: Local corticosteroid injection, home training, and repetitive low-energy ESWT treatment produce equivalent outcomes four months from baseline?

Methods: A total of 229 patients with refractory unilateral Greater Trochanter Pain Syndrome were given either a home training programme, a single corticosteroid injection or a course of low-energy ESWT treatment. Each patient was assessed at baseline, one month, four months, and 15 months. The primary outcome measures were degree of recovery - measured on a six-point Likert scale - and severity of pain during the last week (0 to 10 points) at the four-month follow-up.

Results: After one month from baseline, results after the corticosteroid injection (75% success rate and 2.2 points pain rating) were significantly better than those after home training (7% success rate and 5.9 points pain rating) and ESWT treatment (13% success rate and 5.6 points pain rating). When considering treatment success at four months, ESWT achieved significantly better results (68% success rate and 3.1 points pain rating), compared with home training (41% success rate and 5.2 points pain rating) and corticosteroid injection (51% success rate and 4.5 points pain rating). At 15 months from baseline, ESWT (74% success rate and 2.4 points pain rating) and home training (80% success rate and 2.7 points pain rating) were significantly more successful than the corticosteroid injection (48% success rate and 5.3 points pain rating).

Conclusion: The role of the corticosteroid injection for the treatment of Greater Trochanter Pain Syndrome needs to be reconsidered. The significant short-term superiority of a single corticosteroid injection over home training and ESWT treatment declined after one month, while the corticosteroid injection and home training were both significantly less successful than ESWT treatment at four-month follow-up. The corticosteroid injection was again significantly less successful than home training or ESWT treatment at 15-month follow-up.


Greater Trochanteric Pain Syndrome - case controlled study.

Level 3 clinical evidence.

Authors: Furia JP, Rompe JD, Maffulli N - 2009

Hypothesis: Extracorporeal shockwave therapy is an effective treatment for chronic Trochanteric Pain Syndrome?

Methods: A group of 33 patients with Greater Trochanteric Pain Syndrome received a low-energy course of ESWT treatment. Another group of 33 patients did not receive the same ESWT treatment but were given additional non-operative forms of therapy (‘control'). All ESWT treatment was performed without anaesthetic. Evaluation was measured by change in visual analog score, Harris hip score and Roles and Maudsley score.

Results: The mean pre-treatment visual analog scores for the ‘control' and ESWT groups were 7.6 and 5.1, 7 and 3.7, 6.3 and 2.7 respectively. After one month, four months, and 12 months after treatment the mean visual analog scores for the ‘control' and ESWT groups were 7.6 and 5.1, 7 and 3.7, 6.3 and 2.7 respectively. After one month, four months, and 12 months after treatment, the mean Hip scores for the ‘control' and ESWT groups were 54.4 and 69.8, 56.9 and 74.8, and 57.6 and 79.9 respectively. At final follow-up, the number of excellent, good, fair and poor results for the ESWT and ‘control' groups were 10 and 0, 16 and 12, 4 and 13, and 3 and 8 respectively. Chi-square analysis showed the percentage of patients with excellent (1) or good (2) Roles and Maudsley scores 12 months after treatment was statistically greater in the ESWT group, as opposed to the ‘control' group.

Conclusion: Extracorporeal shockwave therapy is an effective treatment for Greater Trochanteric Pain Syndrome.


Medial Tibial Stress Syndrome - case controlled study.

Level 3 clinical evidence.

Authors: Rompe JD, Caccio A, Furia JP, Maffulli N.

Hypothesis: Extracorporeal shockwave therapy is an effective treatment for Chronic Medial Tibial Stress Syndrome (MTSS)?

Methods: A group of 47 patients underwent a standardised home training program and received repetitive low-energy ESWT without any local anaesthesia (‘treatment group'). A separate group of 47 patients underwent a standardized home training program without any ESWT (‘control group'). Success was evaluated by a change in numeric rating scale. The degree of recovery was measured on a six-point Likert scale. Patients with a rating of ‘completely recovered' or ‘much improved' were rated as treatment success.

Results: At one month, four months, and 15 months from baseline, success rates for the ‘control' and ‘treatment groups' according to the Likert scale were 13% and 30%, 30% and 64%, and 37% and 76% respectively. At one month, four months, and 15 months from baseline, the mean numeric rating scale for the ‘control' and ‘treatment' groups were 7.3 and 5.8, 6.9 and 3.8, and 5.3 and 2.7 respectively. Finally, at 15 months from baseline, 40 of the 47 patients in the treatment group had been able to return to their preferred sport at their pre-injury level, as had 22 of the 47 control patients.

Conclusion: ESWT as applied was an effective treatment for Medial Tibial Stress Syndrome.