Dataset Information

A Historical Analysis of Randomized Controlled Trials in the Management of Pain in Rotator Cuff Tears.

ABSTRACT: The aim of this analysis was to assess the quality of reporting of randomized controlled trials (RCTs) relating to pain management in rotator cuff (RC) tears. This review evaluated the quality of the studies in the literature regarding this topic through the use of some factors and trends. The online databases used to search all RCTs on the topic of RC surgery were Medline, Scopus, CINAHL, EMBASE, and CENTRAL. This research was completed in September 2020. To assess the quality of reports, the Consolidated Standards of Reporting Trials (CONSORT) and the modified Coleman methodology score (MCMS) were used. From the research, 262 articles emerged. Finally, 79 studies were included in this historical analysis. There were no statistically significant changes in MCMS across trials that included or did not include a CONSORT diagram (p = 0.10). A statistically significant difference in MCMS was discovered between papers produced prior to 2009 and publications produced after 2015 (p = 0.03). There was no association between the number of checklist items for each article and the Coleman score. During the years there has been a significant increase in both quantity and quality of RCTs relating to pain in RC tears.

SUBMITTER: Berton A

PROVIDER: S-EPMC8470804 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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A Historical Analysis of Randomized Controlled Trials in the Management of Pain in Rotator Cuff Tears.

Berton Alessandra A Longo Umile Giuseppe UG De Salvatore Sergio S Sciotti Gaia G Santamaria Giulia G Piergentili Ilaria I De Marinis Maria Grazia MG Denaro Vincenzo V

Journal of clinical medicine 20210909 18

The aim of this analysis was to assess the quality of reporting of randomized controlled trials (RCTs) relating to pain management in rotator cuff (RC) tears. This review evaluated the quality of the studies in the literature regarding this topic through the use of some factors and trends. The online databases used to search all RCTs on the topic of RC surgery were Medline, Scopus, CINAHL, EMBASE, and CENTRAL. This research was completed in September 2020. To assess the quality of reports, the C ...[more]

PMID: 34575180

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Project description:BackgroundRotator cuff-related shoulder pain (RCRSP) is a common and disabling musculoskeletal condition. Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes.ObjectiveThe primary aim of this pilot randomized controlled trial was to assess the feasibility of a 12-week internet-delivered intervention for RCRSP comparing advice only, recommended care, and recommended care with group-based telerehabilitation.MethodsReporting was in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot and feasibility trials. People with a primary complaint of RCRSP for 3 months or longer were identified via a paid Facebook strategy. Screening involved an online questionnaire followed by a 20-minute telehealth assessment. Participants were randomly allocated (via a Zelen design) to receive (1) advice only, (2) recommended care (internet-delivered evidence-based exercise and education), or (3) recommended care and telerehabilitation (including a weekly group teleconference session). Progression criteria for a full-scale trial included (1) recruitment of 20% or greater of eligible participants, (2) acceptable adherence (two or more of the three prescribed weekly sessions) among 70% or greater of participants, (3) 80% or greater retention of participants, (4) absence of intervention-related serious adverse events, and (5) 80% or greater response rates to questionnaires. Secondary clinical and patient knowledge outcomes were collected (via email or text) at baseline, six weeks, and 12 weeks (for clinical and patient knowledge), and within-group change was reported descriptively.ResultsWe enrolled 36 of 38 (95%) eligible participants and all participants were recruited within a 3-week period. Of the 36 participants, 12 participants were allocated to each of the three trial arms. The mean age of participants was between 51 and 56 years, and 83% (10/12) to 92% (11/12) were female. Retention at the 12-week endpoint was 94% (34/36) and response to email questionnaires at other time points was 83% or greater. We found acceptable adherence (defined as greater than 70% of participants performing exercise 2 or 3 times/week) in the recommended care group with telerehabilitation but not in the recommended care group without telerehabilitation. There was a total of 24 adverse events over 108 person-months of observation. All adverse events were mild or moderate (mainly muscle and shoulder symptoms), with the exception of one instance of elective surgery (unrelated to the person's shoulder condition).ConclusionsOur prespecified success criteria were met or exceeded, but there was a gender imbalance toward women. It is feasible to progress to a fully powered trial, but strategies to address the gender imbalance need to be implemented.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12620000248965); https://tinyurl.com/yy6eztf5.

Project description:ImportanceRotator cuff disorders remain the most common cause of shoulder pain and are among the most common reasons for patients to seek care in primary and specialty settings. Although operative and nonoperative treatments are offered to patients with atraumatic rotator cuff tears, there is a lack of evidence to support operative vs nonoperative treatment. This paucity of evidence has been highlighted by several professional agencies and experts.ObjectiveTo perform a pragmatic randomized clinical trial, the Arthroscopic Rotator Cuff trial, comparing pain and functional outcomes in patients undergoing operative vs nonoperative treatment for atraumatic rotator cuff tears, and assessing heterogeneity of treatment effects by age and tear size.Design, setting, and participantsTrial protocol of the Arthroscopic Rotator Cuff trial. This pragmatic randomized clinical trial of an estimated 700 patients is adequately powered to accomplish its aims with 488 patients. Primary analysis will be conducted on an intent-to-treat population in the context of a mixed model. The multicenter trial started recruitment in 2018 with a 1-year follow-up duration. Patients aged 50 years or older to younger than 85 years with magnetic resonance imaging-confirmed atraumatic rotator cuff tears that are suitable for either operative or nonoperative treatment will be enrolled. Block randomization will be performed and stratified by site, age, and tear size.InterventionNonoperative treatment consists of an approximately 3-month standardized physical therapy program, whereas operative treatment consists of rotator cuff surgery followed by approximately 4 months of postoperative rehabilitation.Main outcomes and measuresThe primary outcome is patient-reported Shoulder Pain and Disability Index score, and the secondary outcome is American Shoulder and Elbow Surgeons Standardized Shoulder Form score measured at 1 year of follow-up.DiscussionThe Arthroscopic Rotator Cuff trial is ongoing, and 12 sites with more than 40 physicians are currently recruiting patients. Although there is variation by site, as of May 2, 2019, 13% of all patients screened (787 of 6293) were eligible for the trial, and 9% of eligible patients (74 of 787) were recruited. Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears.Trial registrationClinicalTrials.gov identifier: NCT03295994.

Project description:It has been indicated that rotator cuff tears, especially large or massive ones, can cause suprascapular neuropathy. When such a diagnosis has been established, it is still unknown whether an arthroscopic release of the superior transverse scapular ligament during cuff repair can change the course of this neuropathy.This is a single-center, double-blinded randomized controlled trial for which 42 patients with large or massive repairable rotator cuff tears and suprascapular neuropathy will be recruited and followed up at 6 and 12 months. Nerve function will be measured by nerve conduction and electromyography studies preoperatively and at the selected follow-up periods. Patients will be randomly divided into equally numbered groups, the first one being the control group. Patients of this group will undergo arthroscopic repair of the rotator cuff without combined arthroscopic release of the superior transverse scapular ligament; in the second group the ligament will be released. The primary objective is to test the null hypothesis that arthroscopic repair of large/massive rotator cuff tears in patients with combined suprascapular neuropathy provides equivalent outcomes to one-stage arthroscopic cuff repair where the superior suprascapular ligament is additionally released. The secondary objective is to search for a relation between rotator cuff tear size and degree of suprascapular nerve recovery. The tertiary objective is to demonstrate any relation between rotator cuff muscle fatty infiltration grade and degree of suprascapular nerve function. Patients, clinicians during follow-up clinics and the neurologist will be blinded to the type of surgery performed.To the best of our knowledge, we are unaware of any prospective, randomized double-blinded studies with similar objectives. So far, the evidence suggests a positive correlation between massive rotator cuff tears and suprascapular neuropathy. However, there is mixed evidence suggesting that neuropathy can be effectively treated with rotator cuff repair with or without release of the superior transverse scapular ligament.ClinicalTrials.gov registration number NCT02318381 ; date of initial release: 5 December 2014.

Dataset Information

A Historical Analysis of Randomized Controlled Trials in the Management of Pain in Rotator Cuff Tears.

Publications

A Historical Analysis of Randomized Controlled Trials in the Management of Pain in Rotator Cuff Tears.

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