Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: randomised double blinded multi-arm study.

OBJECTIVE: To compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder. DESIGN: Pragmatic, three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months. SETTING: Six hospitals in Norway and Sweden. PARTICIPANTS: 220 adults with calcific tendinopathy of the shoulder, persistent for at least three months. INTERVENTIONS: Ultrasound guided deposit lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (lavage+steroid); sham lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (sham lavage+steroid); or sham lavage plus subacromial injection of 10 mL 1% lidocaine hydrochloride (sham). All patients received a physiotherapeutic treatment regimen consisting of four home exercises. MAIN OUTCOME MEASURES: The primary outcome was the result on the 48 point scale (0=worst; 48=best) of the Oxford Shoulder Score (OSS) at four month follow-up. Secondary outcomes included measurements on the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and of pain intensity up to 24 months. The influence of the size of the deposit at baseline and of the persistence or disappearance of the deposit was investigated. RESULTS: Data from 218 (99%) participants were included in the primary analysis. Differences between groups on the OSS at four months were not significant: lavage+steroid versus sham 0.2 (95% confidence interval -2.3 to 2.8; P=1.0); sham lavage+steroid versus sham 2.0 (-0.5 to 4.6; P=0.35); lavage+steroid versus sham lavage+steroid -1.8 (-4.3 to 0.7; P=0.47). After four months, 143 patients with insufficient treatment effect received supplementary treatment. At 24 months, none of the study procedures was superior to sham. No serious adverse events were reported. CONCLUSIONS: This study found no benefit for ultrasound guided lavage with a corticosteroid injection or for sham lavage with a corticosteroid injection compared with sham treatment in patients with calcific rotator cuff tendinopathy of the shoulder. TRIAL REGISTRATION: NCT02419040EudraCT 2015-002343-34; Ethical committee Norway 2015-002343-34; Ethical committee Sweden 2015/79-31; Clinicaltrials.gov NCT02419040.

Feasibility of the SINEX program for patients with traumatic anterior shoulder instability.

BACKGROUND: An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed for patients with TASI, but has not yet been tested in patients eligible for surgery. The purpose of this study was to investigate and evaluate the feasibility and safety of the SINEX program for patients diagnosed with TASI and eligible for surgery. METHODS: A feasibility study with an experimental, longitudinal design using both quantitative and qualitative research methods. A total of seven participants underwent the SINEX program, a 12-week exercise program including physiotherapist-supervised sessions. Feasibility data on recruitment, retention, compliance, acceptability and safety was collected through observation and individual semi-structured interviews. Clinical tests and self-report questionnaires were completed at baseline and 12 weeks follow-up. Clinical assessments included apprehension and relocation tests, shoulder joint position sense (SJPS), shoulder sensorimotor control measured by center of pressure path length (COPL) on a force platform, isometric strength measured by Constant Score-Isometric Maximal Voluntary Contraction (CS-iMVC), self-report questionnaires including Western Ontario Shoulder Instability Index (WOSI), Tampa Scale of Kinesiophobia (TSK) and Global Perceived Effect questionnaire (GPE). RESULTS: With one participant recruited every 2 weeks, the recruitment rate was 50% lower than expected. Two of seven participants achieved compliance, defined as at least 66% completion of the scheduled home exercises and at least 50% attendance for the physiotherapist supervised sessions. Barriers for successful compliance were (1) inability to take along exercise equipment when travelling, (2) sick leave, (3) holidays and (4) lack of time/busy days. Four adverse events occurred, one of which was related to the intervention (patellar redislocation). All participants expressed satisfaction with the intervention and felt safe during the exercises. All participants improved in the GPE. Change greater than minimal detectable change (MDC) was reported in four participants in some of the outcome assessments. One of the seven participants declined surgery. CONCLUSION: Further assessment is required on several areas before performing an RCT evaluating the efficacy of the SINEX program for patients with TASI considered eligible for surgery. No adverse events suggest that the program is safe, but patients with general hypermobility may need additional adjustments to prevent adverse events in other areas of the body. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04152304, retrospectively registered.

KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study.

BACKGROUND: For the treatment of calcific tendinitis of the shoulder a variety of treatment regimes exist. Commonly used treatment measures include medication with oral analgesics, corticosteroid injections, extracorporeal shockwave therapy, ultrasound guided needling and lavage, and surgical treatment. Earlier cohort studies suggest that patients may benefit from these treatments, but there are few randomized studies and conflicting evidence about the effectiveness of the various treatments. In the present study we aim to compare the effectiveness of ultrasound guided needling and lavage (barbotage) together with a steroid injection to sham barbotage with and without an additional steroid injection. METHODS: The study will be performed in six secondary-care institutions in Norway and Sweden. It is designed as a pragmatic, randomized, three-arm, parallel group, double-blinded, sham-controlled clinical trial with a 2-year follow-up. It will be performed on 210 patients, aged 30 years or older, presenting with painful arc, positive impingement sign and a calcium deposit > 5 mm. Randomization to one of the three treatment options will be performed by using an online central randomization system. The three treatment groups are barbotage together with a subacromial steroid injection (the barbotage group), sham barbotage together with a subacromial steroid injection (the steroid group) or sham barbotage without a subacromial steroid injection (the placebo group). In the placebo group the steroid injection will be replaced by a short-acting local anaesthetic. Standardized home-based post-treatment physiotherapy will be performed by all patients for 8 weeks. Follow-ups are at 2 and 6 weeks, 4, 8, 12 and 24 months after treatment was given and will be performed with the patients and the outcome assessors blinded for group assignment. Primary outcome will be the Oxford shoulder score at 4 month follow-up. Secondary outcome measures are the QuickDASH upper extremity score, the EQ-5D-5L general health score and visual analogue scales for pain at rest, during activity, and at night. DISCUSSION: The scientific evidence from this placebo-controlled trial will be of importance for future treatment recommendations in patients with calcific tendinitis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02419040 , registered 10 April 2015 EudraCT: 2015-002343-34, registered 23 September 2015 (retrospectively registered).

Shoulder instability surgery in Norway: the first report from a multicenter register, with 1-year follow-up.

BACKGROUND AND PURPOSE: In January 2008, we established the Norwegian Register for Shoulder Instability Surgery. We report on the establishment, the baseline data, and the results at 1-year follow-up. METHODS: Primary and revision shoulder stabilization is reported by the surgeon on a 1-page paper form containing the patient's history of shoulder injury, clinical findings, and perioperative findings. The WOSI questionnaire for self-assessment of shoulder function is completed at baseline and at follow-up after 1, 2, and 5 years. To evaluate the completeness of registration, we compared our data with those in the Norwegian Patient Registry (NPR). RESULTS: The NPR reported 39 hospitals performing shoulder stabilizations. 20 of these started to report to our register during 2009, and 464 procedures (404 primary, 59 revisions) were included up to December 31, 2009, which represented 54% of the procedures reported to NPR. Of the 404 primary procedures, 83% were operations due to anterior instability, 10% were operations due to posterior instability, and 7% were operations due to multidirectional instability. Arthroscopic soft tissue techniques were used in 88% of the patients treated for primary anterior instability and open coracoid transfer was used in 10% of such patients. At 1-year follow-up of 213 patients, we found a statistically significantly improved WOSI score in all types of instability. 10% of the patients treated with arthroscopic anterior labral repair and 16% treated with arthroscopic posterior labral repair reported recurrent instability. No statistically significant difference in functional improvement or rate of recurrence was found between these groups. INTERPRETATION: The functional results are in accordance with those in previous studies. However, the incidence of recurrent instability 1 year after arthroscopic labral repair is higher than expected.

Are inflatable nails an alternative to interlocked nails in tibial fractures?

Recently developed inflatable nails avoid reaming and interlocking screws in tibial fractures and reflect a new principle for stabilization of long bone fractures. We asked if the bending stiffness, rotational rigidity, or play (looseness of rotation) differed between an inflatable versus large-diameter reamed interlocked nails, and whether the maximal torque to failure of the two bone-implant constructs differed. In a cadaveric model, we compared the biomechanical properties with those of an interlocked nail in eight pairs of fractured tibial bones. Bending stiffness, rotational rigidity, play (looseness in rotation), and torsional strength within 20 degrees rotation were investigated using a biaxial servohydraulic testing system. For all biomechanical variables, we found a large interindividual variance between the pairs attributable to bone quality (osteoporosis) for both fixation methods. The inflatable nail had a higher bending stiffness, with a mean difference of 58 N/mm, and a lower torsional strength, with a mean difference of 13.5 Nm, compared with the locked nail. During torsional testing we noted slippage between the inflatable nail and bone. We observed no differences in play or rotational rigidity. Given the lower torsional strength we recommend caution with weightbearing until there are signs of fracture consolidation.