Jan D. Rompe

Eccentric Loading, Shock-Wave Treatment, or a Wait-and-See Policy for Tendinopathy of the Main Body of Tendo Achillis A Randomized Controlled Trial

Background Few randomized controlled trials compare different methods of management in chronic tendinopathy of the main body of tendo Achillis. Purpose To compare the effectiveness of 3 management strategies—group 1, eccentric loading; group 2, repetitive low-energy shock-wave therapy (SWT); and group 3, wait and see—in patients with chronic tendinopathy of the main body of tendo Achillis. Study Design Randomized controlled trial; Level of evidence, 1. Methods Seventy-five patients with a chronic recalcitrant (>6 months) noninsertional Achilles tendinopathy were enrolled in a randomized controlled study. All patients had received unsuccessful management for >3 months, including at least (1) peritendinous local injections, (2) nonsteroidal anti-inflammatory drugs, and (3) physiotherapy. A computerized random-number generator was used to draw up an allocation schedule. Analysis was on intention-to-treat basis. Results At 4 months from baseline, the Victorian Institute of Sport Assessment (VISA)-A score increased in all groups, from 51 to 76 points in group 1 (eccentric loading), from 50 to 70 points in group 2 (repetitive low-energy SWT), and from 48 to 55 points in group 3 (wait and see). Pain rating decreased in all groups, from 7 to 4 points in group 1, from 7 to 4 points in group 2, and from 8 to 6 points in group 3. Fifteen of 25 patients in group 1 (60%), 13 of 25 patients in group 2 (52%), and 6 of 25 patients in Group 3 (24%) reported a Likert scale of 1 or 2 points (“completely recovered” or “much improved”). For all outcome measures, groups 1 and 2 did not differ significantly. For all outcome measures, groups 1 and 2 showed significantly better results than group 3. Conclusion At 4-month follow-up, eccentric loading and low-energy SWT showed comparable results. The wait- and-see strategy was ineffective for the management of chronic recalcitrant tendinopathy of the main body of the Achilles tendon.

Low-energy extracorporeal shock wave therapy for painful heel : a prospective controlled single-blind study

The aim of this prospective single-blind pilot study was to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy (ESWT) in painful heel associated with inferior calcaneal spurs. Thirty patients who suffered from persistent symptoms for more than 12 months qualified for low-energy ESWT and were assigned at random to two groups, real or simulated ESWT. Before beginning the treatment, any other therapy was stopped for a period of 6 weeks. The shock waves were applied by an experimental device allowing exact localization through an integrated fluoroscopy unit. Patients were treated three times at weekly intervals. Each time 1000 impulses of 0.06 mJ/mm2 were given around the heel spur. Follow-ups were done after 3, 6, 12 and 24 weeks. Patients of the placebo group who did not improve at the 6-week follow-up were then offered ESWT therapy and were checked at 3, 6, 12 and 24 weeks after the last treatment. Whereas we noticed no significant differences between the groups before ESWT, there was a significant alleviation of pain and improvement of function at all follow-ups in the treatment group.

Eccentric Loading Versus Eccentric Loading Plus Shock-Wave Treatment for Midportion Achilles Tendinopathy A Randomized Controlled Trial

Background Results of a previous randomized controlled trial have shown comparable effectiveness of a standardized eccentric loading training and of repetitive low-energy shock-wave treatment (SWT) in patients suffering from chronic midportion Achilles tendinopathy. No randomized controlled trials have tested whether a combined approach might lead to even better results. Purpose To compare the effectiveness of 2 management strategies—group 1: eccentric loading and group 2: eccentric loading plus repetitive low-energy shock-wave therapy. Study Design Randomized controlled trial; Level of evidence, 1. Methods Sixty-eight patients with a chronic recalcitrant (>6 months) noninsertional Achilles tendinopathy were enrolled in a randomized controlled study. All patients had received unsuccessful management for >3 months, including at least (1) peritendinous local injections, (2) nonsteroidal anti-inflammatory drugs, and (3) physiotherapy. A computerized random-number generator was used to draw up an allocation schedule. Analysis was on an intention-to-treat basis. Results At 4 months from baseline, the VISA-A score increased in both groups, from 50 to 73 points in group 1 (eccentric loading) and from 51 to 87 points in group 2 (eccentric loading plus shock-wave treatment). Pain rating decreased in both groups, from 7 to 4 points in group 1 and from 7 to 2 points in group 2. Nineteen of 34 patients in group 1 (56%) and 28 of 34 patients in group 2 (82%) reported a Likert scale of 1 or 2 points (“completely recovered” or “much improved”). For all outcome measures, groups 1 and 2 differed significantly in favor of the combined approach at the 4-month follow-up. At 1 year from baseline, there was no difference any longer, with 15 failed patients of group 1 opting for having the combined therapy as cross-over and with 6 failed patients of group 2 having undergone surgery. Conclusion At 4-month follow-up, eccentric loading alone was less effective when compared with a combination of eccentric loading and repetitive low-energy shock-wave treatment.

Shock wave therapy versus conventional surgery in the treatment of calcifying tendinitis of the shoulder.

A prospective quasirandomized study was performed to compare the effects of surgical extirpation (Group I, 29 patients) with the outcome after high-energy extracorporeal shock wave therapy (Group II, 50 patients; 3000 impulses of an energy flux density of 0.6 mJ/mm2) in patients with a chronic calcifying tendinitis in the supraspinatus tendon. Symptoms and demographic data of the two groups were comparable. According to the University of California Los Angeles Rating System, the mean score in Group I was 30 points with 75% good or excellent results after 12 months, and 32 points with 90% good or excellent results after 24 months. Radiologically, there was no calcific deposit in 85% of the patients after 1 year. In Group II, the mean score was 28 points with 60% good or excellent results after 12 months, and 29 points with 64% good or excellent results after 2 years. Radiologically, complete elimination of the deposit was observed in 47% of the patients after 1 year. Clinically, according to the University of California Los Angeles score, there was no significant difference between both groups at 1 year. At 2 years, there was a significantly better result in Group II. Both groups then were subdivided into patients who had a homogenous deposit as seen on radiographs and patients who had an inhomogenous deposit before treatment. Surgery was superior compared with high-energy shock wave therapy for patients with homogenous deposits. For patients with inhomogenous deposits, high-energy extracorporeal shock wave therapy was equivalent to surgery and should be given priority because of its noninvasiveness.

Evaluation of low-energy extracorporeal shock-wave application for treatment of chronic plantar fasciitis.

Background: Although the application of low-energy extracorporeal shock waves to treat musculoskeletal disorders is controversial, there has been some limited, short-term evidence of its effectiveness for the treatment of chronic plantar fasciitis.Methods: From 1993 to 1995, a prospective, two-tailed, randomized, controlled, observer-blinded pilot trial was performed to assess whether three applications of 1000 impulses of low-energy shock waves (Group I) led to a superior clinical outcome when compared with three applications of ten impulses of low-energy shock waves (Group II) in patients with intractable plantar heel pain. The sample size was 112. The main outcome measure was patient satisfaction according to a four-step score (excellent, good, acceptable, and poor) at six months. Secondary outcome measures were patient satisfaction according to the four-step score at five years and the severity of pain on manual pressure, at night, and at rest as well as the ability to walk without pain at six months and five years.Results: At six months, the rate of good and excellent outcomes according to the four-step score was significantly (47%) better (p < 0.0001) in Group I than in Group II. As assessed on a visual analog scale, the score for pain caused by manual pressure at six months had decreased to 19 points, from 77 points before treatment, in Group I, whereas in Group II the ratings before treatment and at six months were 79 and 77 points (p < 0.0001 for the difference between groups). In Group I, twenty-five of forty-nine patients were able to walk completely without pain at six months compared with zero of forty-eight patients in Group II (p < 0.0001). By five years, the difference in the rates of good and excellent outcomes according to the four-step score was only 11% in favor of Group I (p = 0.071) because of a high rate of good and excellent results from subsequent surgery in Group II; the score for pain caused by manual pressure had decreased to 9 points in Group I and to 29 points in Group II (p = 0.0006 for the difference between groups). At five years, five (13%) of thirty-eight patients in Group I had undergone an operation of the heel compared with twenty-three (58%) of forty patients in Group II (p < 0.0001).Conclusions: Three treatments with 1000 impulses of low-energy shock waves appear to be an effective therapy for plantar fasciitis and may help the patient to avoid surgery for recalcitrant heel pain. In contrast, three applications of ten impulses did not improve symptoms substantially.

Dose-related effects of shock waves on rabbit tendo Achillis: A sonographic and histological study

We aimed to determine whether extracorporeal shock waves of varying intensity would damage the intact tendo Achillis and paratenon in a rabbit model. We used 42 female New Zealand white rabbits randomly divided into four groups as follows: group a received 1000 shock-wave impulses of an energy flux density of 0.08 mJ/mm2, group b 1000 impulses of 0.28 mJ/mm2, group c 1000 impulses of 0.60 mJ/mm2, and group d was a control group. Sonographic and histological evaluation showed no changes in group a, and transient swelling of the tendon with a minor inflammatory reaction in group b. Group c had formation of paratendinous fluid with a significant increase in the anteroposterior diameter of the tendon. In this group there were marked histological changes with increased eosin staining, fibrinoid necrosis, fibrosis in the paratenon and infiltration of inflammatory cells. We conclude that there are dose-dependent changes in the tendon and paratenon after extracorporeal shock-wave therapy and that energy flux densities of over 0.28 mJ/mm should not be used clinically in the treatment of tendon disorders.

Shock Wave Application for Chronic Plantar Fasciitis in Running Athletes: A Prospective, Randomized, Placebo-Controlled Trial:

Background: Recent articles have reported success with repeated low-energy shock wave application for treatment of chronic plantar fasciitis in runners. Hypothesis: Shock wave treatment for chronic plantar fasciitis is safe and effective. Study Design: Prospective, randomized, placebo-controlled trial. Methods: Forty-five running athletes with intractable plantar heel pain for more than 12 months were enrolled; half were assigned to a treatment group that received three applications of 2100 impulses of low-energy shock waves, and half received sham treatment. Follow-up examinations were performed at 6 months and at 1 year by a blinded observer. Results: After 6 months, self-assessment of pain on first walking in the morning was significantly reduced from an average of 6.9 to 2.1 points on a visual analog scale in the treatment group and from an average of 7.0 to 4.7 points in the sham group. The mean difference between groups was 2.6 points. After 12 months, there was a further reduction of pain in both groups, to an average 1.5 points in the treatment group, and to 4.4 points in the sham group. Conclusion: Three treatments with 2100 impulses of low-energy shock waves were a safe and effective method for treatment of chronic plantar fasciitis in long-distance runners.

Eccentric loading compared with shock wave treatment for chronic insertional achilles tendinopathy. A randomized, controlled trial.

BACKGROUND Nonoperative management of chronic tendinopathy of the Achilles tendon insertion has been poorly studied. With the recently demonstrated effectiveness of eccentric loading and of repetitive low-energy shock wave therapy in patients with midsubstance Achilles tendinopathy, the aim of the present randomized, controlled trial was to verify the effectiveness of both procedures exclusively in patients with insertional Achilles tendinopathy. METHODS Fifty patients with chronic (six months or more) recalcitrant insertional Achilles tendinopathy were enrolled in a randomized, controlled study. All patients had received treatment, including local injections of an anesthetic and/or corticosteroids, a prescription of nonsteroidal anti-inflammatory drugs, and physiotherapy, without success for at least three months. A computerized random-number generator was used to draw up an allocation schedule. Twenty-five patients were allocated to receive eccentric loading (Group 1), and twenty-five patients were allocated to treatment with repetitive low-energy shock wave therapy (Group 2). Analysis was on an intention-to-treat basis. Primary follow-up was at four months, and afterward patients were allowed to cross over. The last follow-up evaluation was at one year after completion of the initial treatment. The patients were assessed for pain, function, and activity with use of a validated questionnaire (the Victorian Institute of Sport Assessment-Achilles [VISA-A] questionnaire). RESULTS At four months from baseline, the mean VISA-A score had increased in both groups, from 53 to 63 points in Group 1 and from 53 to 80 points in Group 2. The mean pain rating decreased from 7 to 5 points in Group 1 and from 7 to 3 points in Group 2. Seven patients (28%) in Group 1 and sixteen patients (64%) in Group 2 reported that they were completely recovered or much improved. For all outcome measures, the group that received shock wave therapy showed significantly more favorable results than the group treated with eccentric loading (p = 0.002 through p = 0.04). At four months, eighteen of the twenty-five patients from Group I had opted to cross over, as did eight of the twenty-five patients from Group 2. The favorable results after shock wave therapy at four months were stable at the one-year follow-up evaluation. CONCLUSIONS Eccentric loading as applied in the present study showed inferior results to low-energy shock wave therapy as applied in patients with chronic recalcitrant tendinopathy of the insertion of the Achilles tendon at four months of follow-up. Further research is warranted to better define the indications for this treatment modality.

High-energy extracorporeal shock wave treatment of nonunions

Forty-three consecutive patients who did not have healing of tibial or femoral diaphyseal and metaphyseal fractures and osteotomies for at least 9 months after injury or surgery were examined prospectively for use of high-energy extracorporeal shock waves. Former treatment modalities (cast, external fixator, plate osteosynthesis, limitation of weightbearing) remained unchanged. In all cases a 99mTechnetium dicarboxyphosphonate regional two-phase bone scintigraphy was performed before one treatment with 3000 impulses of an energy flux density of 0.6 mJ/mm2. Radiologic and clinical followups were done at 4-week intervals starting 8 weeks after shock wave treatment. The success criterion was bridging of all four cortices in the anteroposterior and lateral radiographic views, in oblique views, or by conventional tomography. An independent observer described bony consolidation in 31 of 43 cases (72%) after an average of 4 months (range, 2–7 months). Twenty-nine of 35 (82.9%) patients with a positive bone scan had healing of the pseudarthrosis compared with two of eight (25%) patients with a negative bone scan. Six of these eight patients with negative scans were heavy smokers. No complications were observed. High-energy shock wave therapy seemed to be an effective noninvasive tool for stimulation of bone healing in properly selected patients with a diaphyseal or metaphyseal nonunion of the femur or tibia. Additional controlled studies are mandatory.

Shoulder function after extracorporal shock wave therapy for calcific tendinitis

We report a controlled, prospective study that explored the effect of extracorporal shock waves of low- versus high-energy density in patients with chronic shoulder pain and calcific tendinitis. We assigned at random 100 patients who had had calcific tendinitis for more than 12 months to 2 groups to receive shock wave therapy either of a low- or high-energy density. Group 1 received 1500 impulses of 0.06 mJ/mm2, whereas group 2 received 1500 impulses of 0.28 mJ/mm2. Unlike group 1, in which the shock wave application could be performed without local anesthesia, all patients in group 2 required brachial plexus anesthesia. The patients were reviewed at 6 and 24 weeks. Partial or complete disintegration of the calcareous deposit was observed in 50% of the patients in group 1 and 64% of the patients in group 2 (P < .01). According to the Constant score, ratings increased from 48 to 71 points in group 1 (P < .001) and from 53 to 88 in group 2 (P < .001) (out of a total possible 100 points), the end values of both groups differing significantly (P < .01). After 24 weeks, 52% of the patients in group 1 rated the results of treatment as good or excellent, compared with 68% in group 2 (P < .01). No improvement was reported by 24% versus 10%, respectively, at the 24-week follow-up.