BACKGROUND: A number of surgical techniques for managing tennis elbow have been described. One of the most frequently performed involves excising the affected portion of the extensor carpi radialis brevis (ECRB). The results of this technique, as well as most other described surgical techniques for this condition, have been reported as excellent, yet none have been compared with placebo surgery. Hypothesis: The surgical excision of the degenerative portion of the ECRB offers no additional benefit over and above placebo surgery for the management of chronic tennis elbow. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: This study investigated surgical excision of the macroscopically degenerated portion of the ECRB (surgery; n = 13) as compared with skin incision and exposure of the ECRB alone (sham; n = 13) to treat patients who had tennis elbow for >6 months and had failed at least 2 nonsurgical modalities. The primary outcome measure was defined as patient-rated frequency of elbow pain with activity at 6 months after surgery. Secondary outcome measures included patient-rated pain and functional outcomes, range of motion, epicondyle tenderness, and strength at 6 months and 2.5 years. All outcome measures up to and including the 6-month follow-up were measured in person; the longer-term questionnaire was conducted in person or over the phone. RESULTS: The 2 groups, surgery and sham, were similar for age, sex, hand dominance, and duration of symptoms. Both procedures improved patient-rated pain frequency and severity, elbow stiffness, difficulty with picking up objects, difficulty with twisting motions, and overall elbow rating >6 months and at 2.5 years (P < .01). Both procedures also improved epicondyle tenderness, pronation-supination range, grip strength, and modified Orthopaedic Research Institute–Tennis Elbow Testing System at 6 months (P < .05). No significant difference was observed between the groups in any parameter at any stage. No side effects or complications were reported. The study was stopped before the calculated number of patients were enrolled (40 per group); yet, a post hoc futility analysis was conducted that showed, based on the magnitude of the differences between the groups, >6500 patients would need to be recruited per group to see a significant difference between the groups at 26 weeks in the primary outcome (patient-rated frequency of elbow pain with activity). CONCLUSION: With the number of available participants, this study failed to show additional benefit of the surgical excision of the degenerative portion of the ECRB over placebo surgery for the management of chronic tennis elbow.
<b>BACKGROUND: </b>Arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression.<b>METHODS: </b>We did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011.<b>FINDINGS: </b>Between Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference -1·3 points (95% CI -3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5-5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8-6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group).<b>INTERPRETATION: </b>Surgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process.<b>Funding: </b>Arthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).
<b>PURPOSE: </b>To compare the results two to three years after intervention, using either surgical or non-operative treatment.<b>METHODS: </b>Eighty-seven patients with subacromial impingement syndrome (SAIS) were randomised into open acromioplasty (OS group), arthroscopic acromioplasty (AS group) or physiotherapy (PT group) treatment. The assessments comprised the Constant score, the Watson and Sonnabend score, the SF-36 evaluation and a clinical examination performed by an independent observer. Fifty-five patients attended the clinical follow-up.<b>RESULTS: </b>The groups were comparable at baseline in terms of demographics and clinical assessments. No significant differences in terms of the clinical assessments or health-related quality of life (QoL) were found between the study groups at follow-up. The Constant score had improved significantly at follow-up in both the OS group and the AS group (p = 0.003 and 0.008, respectively). At follow-up, the OS group revealed improved strength compared with before intervention (p = 0.012). All groups revealed a significantly improved internal rotation (OSG p = 0.01, ASG p = 0.005, PTG p = 0.004). The SF-36 was significantly improved in some scales within all three groups. The Watson and Sonnabend score was significantly improved in 12/14 questions for the OS group, in 5/14 questions for the AS group and in 6/14 for the PT group (p < 0.02 OS group vs. AS group, p < 0.05 OS group vs. PT group).<b>CONCLUSION: </b>In this randomised study, the Constant score, other clinical assessments and subjective health-related QoL revealed no significant differences between the 3 groups two to three years after intervention in patients with SAIS. The OS group showed a greater improvement over time.<b>LEVEL OF EVIDENCE: </b>CT with low follow-up rate, Level II.
OBJECTIVES: To report the five-year results of a randomised controlled trial examining the effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome.
METHODS: A total of 140 patients were randomly divided into two groups: 1) supervised exercise programme (n = 70, exercise group); and 2) arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group).
RESULTS: The main outcome measure was self-reported pain as measured on a visual analogue scale. At the five-year assessment a total of 109 patients were examined (52 in the exercise group and 57 in the combined treatment group). There was a significant decrease in mean self-reported pain on the VAS between baseline and the five-year follow-up in both the exercise group (from 6.5 (1 to 10) to 2.2 (0 to 8); p < 0.001) and the combined treatment group (from 6.4 (2 to 10) to 1.9 (0 to 8); p < 0.001). The same trend was seen in the secondary outcome measures (disability, working ability, pain at night, Shoulder Disability Questionnaire and reported painful days). An intention-to-treat analysis showed statistically significant improvements in both groups at five years compared with baseline. Further, improvement continued between the two- and five-year timepoints. No statistically significant differences were found in the patient-centred primary and secondary parameters between the two treatment groups.
CONCLUSIONS: Differences in the patient-centred primary and secondary parameters between the two treatment groups were not statistically significant, suggesting that acromioplasty is not cost-effective. Structured exercise treatment seems to be the treatment of choice for shoulder impingement syndrome.
Fifty-six patients who suffered from chronic persistent tennis elbow of more than six months duration were randomly assigned to two active treatment groups. Group 1 (n = 29) received high-energy extracorporeal shock wave treatment (ESWT; 1,500 shocks) at 18 kV (0.22 mJ/mm(2)) without local anaesthesia; group 2 (n = 27) underwent percutaneous tenotomy of the common extensor origin. Both groups achieved improvement from the base line at three weeks, six weeks, 12 weeks and 12 months post-intervention. The success rate (Roles and Maudsley score: excellent and good) at three months in the ESWT group was 65.5% and in the tenotomy group was 74.1%. ESWT appeared to be a useful noninvasive treatment method that reduced the necessity for surgical procedures.
Sclerosing polidocanol injections targeting the area with vasculo/neural ingrowth on the ventral side of the tendon have previously been demonstrated to give good clinical results in patients with chronic painful midportion Achilles tendinosis. In this study, 20 consecutive patients (9 men and 11 women, mean age 46 years) with chronic painful midportion Achilles tendinosis were treated with either sclerosing polidocanol injections (Group A) or open surgical revision of the area with vasculo/neural ingrowth on the ventral side of the Achilles tendon (Group B). Before treatment, all patients had structural tendon changes and increased blood flow-neovascularisation demonstrated with US and colour Doppler. Under US and colour Doppler-guidance, both the injections and the surgical revision targeted the area with neovessels just outside the ventral part of the tendon. A maximum of two sclerosing injection treatments, with 6-8 weeks in-between, were given. For evaluation, the patients recorded the severity of Achilles tendon pain during tendon loading activity (their recreational or sport activity), before and after treatment, on a VAS. Patient global satisfaction with treatment was also assessed. At the 3 months follow-up 6/9 (one patient was excluded) patients in Group A, and 8/10 patients in Group B, were satisfied with the treatment and had a significantly reduced level of tendon pain (Group A VAS from 76 to 24, P < 0.05, Group B VAS from 75 to 21, P < 0.05). There was one deep infection in Group B. At the 6 months follow-up, 6/9 patients in Group A, and 10/10 patients in Group B were satisfied. In summary, both treatment with sclerosing polidocanol injections and open surgical revision outside the ventral Achilles midportion show promising short-term clinical results.
BACKGROUND: Although the surgical treatment of patellar tendinopathy (jumper's knee) is a common procedure, there have been no randomized, controlled trials comparing this treatment with forms of nonoperative treatment. The purpose of the present study was to compare the outcome of open patellar tenotomy with that of eccentric strength training in patients with patellar tendinopathy.
METHODS: Thirty-five patients (forty knees) who had been referred for the treatment of grade-IIIB patellar tendinopathy were randomized to surgical treatment (twenty knees) or eccentric strength training (twenty knees). The eccentric training group performed squats on a 25 degrees decline board as a home exercise program (with three sets of fifteen repetitions being performed twice daily) for a twelve-week intervention period. In the surgical treatment group, the abnormal tissue was removed by means of a wedge-shaped full-thickness excision, followed by a structured rehabilitation program with gradual progression to eccentric training. The primary outcome measure was the VISA (Victorian Institute of Sport Assessment) score (possible range, 0 to 100), which was calculated on the basis of answers to a symptom-based questionnaire that was developed specifically for patellar tendinopathy. The patients were evaluated after three, six, and twelve months of follow-up.
RESULTS: There was no difference between the groups with regard to the VISA score during the twelve-month follow-up period, but both groups had improvement (p < 0.001). The mean combined VISA score for the two groups increased from 30 (95% confidence interval, 25 to 35) before the start of treatment to 49 (95% confidence interval, 42 to 55) at three months, 58 (95% confidence interval, 51 to 65) at six months, and 70 (95% confidence interval, 62 to 78) at twelve months. In the surgical treatment group, five knees had no symptoms, twelve had improvement but were still symptomatic, two were unchanged, and one was worse after twelve months (p = 0.49 compared with the eccentric training group). In the eccentric training group, five knees did not respond to treatment and underwent secondary surgery after three to six months. Of the remaining fifteen knees in the eccentric training group, seven had no symptoms and eight had improvement but were still symptomatic after twelve months.
CONCLUSIONS: No advantage was demonstrated for surgical treatment compared with eccentric strength training. Eccentric training should be tried for twelve weeks before open tenotomy is considered for the treatment of patellar tendinopathy.
OBJECTIVES: To compare the effect of graded physiotherapeutic training of the rotator cuff versus arthroscopic subacromial decompression in patients with subacromial impingement. METHODS: Randomised controlled trial with 12 months' follow up in a hospital setting. Ninety consecutive patients aged 18 to 55 years were enrolled. Symptom duration was between six months and three years. All fulfilled a set of diagnostic criteria for rotator cuff disease, including a positive impingement sign. Patients were randomised either to arthroscopic subacromial decompression, or to physiotherapy with exercises aiming at strengthening the stabilisers and decompressors of the shoulder. Outcome was shoulder function as measured by the Constant score and a pain and dysfunction score. "Intention to treat" analysis was used, with comparison of means and control of confounding variables by general equation estimation analysis. RESULTS: Of 90 patients enrolled, 84 completed follow up (41 in the surgery group, 43 in the training group). The mean Constant score at baseline was 34.8 in the training group and 33.7 in the surgery group. After 12 months the mean scores improved to 57.0 and 52.7, respectively, the difference being non-significant. No group differences in mean pain and dysfunction score improvement were found. CONCLUSIONS: Surgical treatment of rotator cuff syndrome with subacromial impingement was not superior to physiotherapy with training. Further studies are needed to qualify treatment choice decisions, and it is recommended that samples are stratified according to disability level.
Surgical treatment is considered the last option for chronic tennis elbow. The purpose of this pilot study was to compare treatment with botulinum toxin infiltration of the wrist extensor, a less invasive method, with a surgical wrist extensor release (Hohmann operation). Forty patients were included in the prospective randomized study; one group of patients had surgery (n = 20), the other group of patients was treated with botulinum toxin (n = 20). The results of evaluations after 3, 6, 12, and 24 months are presented. One year after treatment 13 (65%) patients in the botulinum toxin group and 15 (75%) patients in the operative group had good to excellent results. Two years after treatment 15 patients in the botulinum toxin group (75%) had good to excellent results; four patients had been operated on after initial treatment with botulinum toxin Type A. Seventeen patients in the operative group scored good to excellent (85%) at 2 years. When analyzed with an overall scoring system, no differences were found between the two forms of treatment. Botulinum toxin infiltration, a less invasive technique, may be an alternative for surgical treatment of tennis elbow.
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; 3,000 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.
A number of surgical techniques for managing tennis elbow have been described. One of the most frequently performed involves excising the affected portion of the extensor carpi radialis brevis (ECRB). The results of this technique, as well as most other described surgical techniques for this condition, have been reported as excellent, yet none have been compared with placebo surgery. Hypothesis: The surgical excision of the degenerative portion of the ECRB offers no additional benefit over and above placebo surgery for the management of chronic tennis elbow.
STUDY DESIGN:
Randomized controlled trial; Level of evidence, 2.
METHODS:
This study investigated surgical excision of the macroscopically degenerated portion of the ECRB (surgery; n = 13) as compared with skin incision and exposure of the ECRB alone (sham; n = 13) to treat patients who had tennis elbow for >6 months and had failed at least 2 nonsurgical modalities. The primary outcome measure was defined as patient-rated frequency of elbow pain with activity at 6 months after surgery. Secondary outcome measures included patient-rated pain and functional outcomes, range of motion, epicondyle tenderness, and strength at 6 months and 2.5 years. All outcome measures up to and including the 6-month follow-up were measured in person; the longer-term questionnaire was conducted in person or over the phone.
RESULTS:
The 2 groups, surgery and sham, were similar for age, sex, hand dominance, and duration of symptoms. Both procedures improved patient-rated pain frequency and severity, elbow stiffness, difficulty with picking up objects, difficulty with twisting motions, and overall elbow rating >6 months and at 2.5 years (P < .01). Both procedures also improved epicondyle tenderness, pronation-supination range, grip strength, and modified Orthopaedic Research Institute–Tennis Elbow Testing System at 6 months (P < .05). No significant difference was observed between the groups in any parameter at any stage. No side effects or complications were reported. The study was stopped before the calculated number of patients were enrolled (40 per group); yet, a post hoc futility analysis was conducted that showed, based on the magnitude of the differences between the groups, >6500 patients would need to be recruited per group to see a significant difference between the groups at 26 weeks in the primary outcome (patient-rated frequency of elbow pain with activity).
CONCLUSION:
With the number of available participants, this study failed to show additional benefit of the surgical excision of the degenerative portion of the ECRB over placebo surgery for the management of chronic tennis elbow.
