Dataset Information

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

ABSTRACT:

Background

Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery.

Methods

We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design.

Discussion

Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing.

Trial registration

ClinicalTrials.gov, NCT02909920 . 14 September 2016.

SUBMITTER: Pastora-Bernal JM

PROVIDER: S-EPMC5324280 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

Pastora-Bernal Jose-Manuel JM Martín-Valero Rocío R Barón-López Francisco Javier FJ García-Gómez Oscar O

Trials 20170223 1

<h4>Background</h4>Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle s ...[more]

PMID: 28231815

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Project description:BACKGROUND:Subacromial impingement syndrome (SIS) is a painful, and often long lasting, shoulder condition affecting patient function and quality of life. In a recent study, we observed major strength impairments in shoulder external rotation and abduction (~30%) in a population of patients with pronounced and long-lasting SIS. However, the current rehabilitation of such strength impairments may be inadequate, with novel rehabilitation programmes including exercise therapy only improving external rotation strength by 4-13%. As these previous studies are the basis of current practice, this suggests that the strengthening component could be inadequate in the rehabilitation of these patients, and it seems likely that more emphasis should be placed on intensifying this part of the rehabilitation. The purpose of this study is to investigate the effectiveness of a programme consisting of progressive home-based resistance training using an elastic band, aimed at improving shoulder external rotation and abduction strength, added to usual care and initiated shortly after diagnosis has been established. METHODS:A pragmatic randomised controlled superiority trial will be conducted, including 200 patients with pronounced and long-lasting SIS, diagnosed using predefined criteria. Participants will be randomised to receive either an add-on intervention of progressive home-based resistance training using an elastic band in addition to usual care or usual care alone in a 1:1 allocation ratio. The randomisation sequence is computer generated, with permuted blocks of random sizes. The primary outcome will be change in Shoulder Pain And Disability Index (SPADI) score from baseline to 16 weeks follow-up. Outcome assessors are blinded to group allocation. Intervention receivers will be kept blind to treatment allocation through minimal information about the content of the add-on intervention and control condition until group allocation is final. Analyses are performed by blinded data analysts. DISCUSSION:If effective, the simple shoulder strengthening exercise programme investigated in this trial could easily be added to usual care. The usefulness of the trial is further supported by the magnitude of the problem, the information gained from the study and the pragmatism, patient centeredness and transparency of the trial. TRIAL REGISTRATION:The trial is pre-registered at ClinicalTrials.gov with the ID NCT02747251 on April 19, 2016.

Project description:IntroductionShoulder lesions rank among the top 15 diagnoses accounting for days of incapacity to work. Inpatient or full-day outpatient rehabilitation are some of the standard therapies. For sustainable rehabilitation, continuation of rehabilitation after discharge from a rehabilitation centre is vital. Besides medical exercise therapy (MET), home-based physical exercise programmes are used. To monitor exercise quantity and quality, AGT-Reha, a health-enabling technology for home rehabilitation, has been developed and evaluated in a pilot study for technical feasibility and acceptance. To integrate the digital therapeutic AGT-Reha into regular healthcare processes, an efficacy evaluation is required.Methods and analysisAGT-Reha-WK is a prospective, monocentric, non-randomised, unblinded non-inferiority trial. Primary objective is to investigate whether AGT-Reha enhanced home-based exercise training is non-inferior to MET as standard aftercare. Secondary objective is to compare the costs of both therapies. Efficacy as medical success (primary outcome) is examined with regard to ability to work, return to work and sustainability of training (secondary outcomes). The outcome measure for non-inferiority is shoulder function (pain and disability) assessed by the standardised Shoulder Pain and Disability Index (SPADI). The non-inferiority margin is set to 10 points on SPADI score using a 95% CI. Subjects will be recruited at the Rehabilitation Center Bad Pyrmont, Germany. The total number of subjects should be 84 (42 per group). Treatment takes 6 months per patient. Subjects will be assessed at four time points: pre-baseline (admission to rehabilitation centre), baseline (discharge from rehabilitation centre), post-therapy and follow-up (3 months post-therapy).Ethics and disseminationEthics approval was granted by the Ethics Committee of Hannover Medical School (ethics approval no: 7313). Results of the trial are planned to be published in a peer-reviewed journal.Trial registration numberGerman Clinical Trials Register DRKS00011596. Registered 2 June 2017. Recruitment started on 3 March 2017, and it is expected to continue until December 2020.Protocol versionV2.0, 23 May 2018, Amendment 01: improved risk analysis, clarification of exclusion criteria to increase reproducibility, additional documentation with OpenClinica; these changes have no effect on structural equality.

Project description:BackgroundShoulder impingement is one of the most common nontraumatic upper limb causes of disability in adults. Our aim was to evaluate the efficacy of surgical intervention in comparison with nonoperative or sham treatments in patients with shoulder impingement in terms of both pain and functional outcomes.MethodsWe conducted a systematic review and meta-analysis of randomized controlled trials. Two reviewers independently screened MEDLINE, Embase, PubMed and Cochrane databases for randomized controlled trials published from 1946 to July 19, 2018. A risk-of-bias assessment was conducted for all included studies, and outcomes were pooled using a random effects model. The primary outcome was improvement in pain up to 2 years. Secondary outcomes were functional outcome scores reported in the short term (≤ 1 yr) and long term (≥ 2 yr). Heterogeneity was assessed using the I 2 statistic. Functional outcome scores were presented along with minimal clinically important differences to provide clinical context for findings.ResultsThirteen randomized controlled trials (n = 1062 patients) were included in this review. Eligible patients had a mean age of 48 (standard deviation ± 4) years and 45% were men. The pooled treatment effect of surgical intervention for shoulder impingement did not demonstrate any benefit to surgery with respect to pain relief (mean difference -0.07, 95% CI -0.40 to 0.26) or short-term functional outcomes (standardized mean difference -0.09, 95% confidence interval [CI] -0.27 to 0.08). Surgical intervention did result in a small statistically significant but clinically unimportant improvement in long-term functional outcomes (standardized mean difference 0.23, 95% CI 0.06 to 0.41).InterpretationEvidence suggests surgical intervention has little, if any, benefit for impingement pathology in the middle-aged patient. Further research is required to identify those patients who will reliably benefit from surgical intervention as well as optimal conservative treatment strategies.

Project description:ObjectiveTo assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting.DesignMulticentre, three group, randomised, double blind, sham controlled trial.SettingOrthopaedic departments at three public hospitals in Finland.Participants210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.InterventionsASD, diagnostic arthroscopy (placebo control), and exercise therapy.Main outcome measuresShoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15.ResultsIn the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -4.6 (95% confidence interval -11.3 to 2.1) points (P=0.18) at rest and -9.0 (-18.1 to 0.2) points (P=0.054) on arm activity. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (-7.5, -14.0 to -1.0, points; P=0.023) and VAS on arm activity (-12.0, -20.9 to -3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group.ConclusionsIn this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months.Trial registrationClinicaltrials.gov NCT00428870.

Project description:PurposeTo describe the clinical features, treatment, and outcomes in patients with complex region pain syndrome (CRPS) following shoulder surgeries.MethodsThree patients were diagnosed with CRPS according to the Budapest criteria. Patients were followed up prospectively at regular intervals for a minimum of 2 years. Demographic data, clinical symptoms, physical examination findings, treatment received, and outcomes were collected and reported.ResultsThe minimum time interval between surgery and diagnosis was 3 weeks (average, 8 weeks). The index procedures included 2 arthroscopic rotator cuff repairs and 1 open Latarjet. Neurologic pain, muscle spasms, hand and wrist swelling, and joint stiffness were seen in the shoulder, wrist, and hand, but the elbow was spared in all patients. Despite the use of multimodal treatment modalities, the symptoms were refractory to treatment for prolonged periods (range, 6-12 months). Hand and wrist symptoms took an average of 4 months longer than shoulder symptoms to improve. At the latest follow-up (range, 24-26 months), varying degrees of residual hand dysfunction, pain, and inability to make a fist or fully extend the fingers were noted in all 3 patients.ConclusionsCPRS type 1 following shoulder surgery is a disabling condition with a long-protracted clinical course. CRPS can present as early as few weeks after shoulder surgery, with symptoms of neuropathic pain, spasm, and stiffness affecting the entire upper-extremity joints except the elbow. CRPS symptoms resolve earlier in the shoulder compared with the wrist and hand, with pain improving first, followed by recovery of motion and function. Residual stiffness affecting grip function is last to recover and can present up to 2 years after onset of symptoms. Although prompt recognition and multimodal approach are considered the mainstay of treatment, there is no gold standard treatment modality that can reproducibly alter the natural history of CRPS.Level of evidenceIV, therapeutic case series.

Project description:A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day) urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day) urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service.This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT) comparing the new proposed short-term (7 day) urethral catheterization to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site.If no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia.ClinicalTrials.gov Identifier NCT01428830.

Project description:To assess cost-effectiveness and cost utility of telerehabilitation (TR) versus standard rehabilitation (SR) after total knee replacement (TKR).Markov decision modelling of cost-effectiveness and cost-utility analysis based on patient-level and secondary data sources employing Italian National Health Service (NHS; Ita-NHS) and Society perspectives.Primary care units (PCUs) in Italy.Patients discharged after TKR.Mixed SR-TR service (10 face-to-face sessions and 10 telesessions) versus SR (20 face-to-face sessions)The incremental cost per additional knee flexion range of motion (ROM) and per QALY gained by SR-TR compared with SR. Second, we considered the probability of being cost-effective and the probability of being more effective and less expensive.TR appears to be the cost-effective in the base case and in all of the considered scenarios, but is no longer more effective and less expensive if transportation costs are excluded. Comparing SR-TR with SR, the incremental cost-effectiveness ratio (ICER) adopting the Ita-NHS perspective for the base case was -€117/ROM gained. The cost-effectiveness probability for SR-TR was 0.98 (ceiling ratio: €50/ROM), while the joint probability of being more effective and less expensive was 0.87. Assuming that TR would increase health-related quality of life (HRQOL) utilities by 2.5%, the ICER adopting Ita-NHS perspective is -€960/QALY (cost-effectiveness probability: 1; ceiling ratio: €30 000/QALY). All the performed sensitivity analyses did not change the conclusions, but if transportation costs were excluded, the probability for SR-TR of being more clinically effective and less expensive reduced to 0.56.The analysis suggested SR-TR to be cost-effective, even less expensive and more effective if the PCUs provide ambulance transportations. However, the uncertainty related to TR costs, HRQOL and long-term clinical outcomes raises important topics for future research, which should be addressed to confirm our estimates.ISRCTN45837371.

Dataset Information

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

Background

Methods

Discussion

Trial registration

Publications

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

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