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Assessment of the methodological, recommendation and reporting quality of global guidelines for neck pain and synthesis of evidence and recommendations: a systematic review protocol

Por: Li · J. · Ou · J. · Liu · Y. · Shen · C. · Chen · X. · Li · Y. · Zhao · J. · Xu · J. · Zhang · Y. · Wang · L.
Introduction

Neck pain is a global health problem that can cause severe disability and a huge medical burden. Clinical practice guideline (CPG) is an important basis for clinical diagnosis and treatment. A high-quality CPG plays a significant role in clinical practice. However, the quality of the CPGs for neck pain lacks comprehensive assessment. This protocol aims to evaluate the methodological, recommendation, reporting quality of global CPGs for neck pain and identify key recommendations and gaps that limit evidence-based practice.

Method

CPGs from January 2013 to November 2023 will be identified through a systematic search on 13 scientific databases (PubMed, Cochrane Library, Embase, etc) and 7 online guideline repositories. Six reviewers will independently evaluate the quality of CPGs for neck pain by using the Appraisal of Guidelines for Research and Evaluation, the Appraisal of Guidelines Research and Evaluation-Recommendations Excellence and the Reporting Items for Practice Guidelines in Healthcare tools. Intraclass correlation coefficient will be used to test the consistency of the assessment. We will identify the distribution of evidence and recommendations in each evidence-based CPGs for neck pain and regrade the level of evidence and strength of recommendations by adopting the commonly used Grading of Recommendations, Assessment, Development and Evaluations system. The key recommendations based on high-quality evidence will be summarised. In addition, we will categorise CPGs by different characteristics and conduct a subgroup analysis of the results of assessment.

Ethics and dissemination

No subjects will be involved in this systematic review, so there is no need for ethical approval. The finding of this review will be summarised as a paper for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023417717.

Evidence-informed and consensus-based statements about SAFEty of Physical Agent Modalities Practice in physiotherapy and rehabilitation medicine (SAFE PAMP): a national Delphi of healthcare scientific societies

Por: Gianola · S. · Bargeri · S. · Pellicciari · L. · Gambazza · S. · Rossettini · G. · Fulvio · A. · Genovese · V. · Benedini · M. · Proverbio · E. · Cecchetto · S. · Castellini · G. · Turolla · A. · SAFE PAMP Collaborators · Torresetti · Masturzo · Berliri · Roselli · Vercelli · Scorcu
Objective

A shared consensus on the safety about physical agent modalities (PAMs) practice in physiotherapy and rehabilitation is lacking. We aimed to develop evidence-informed and consensus-based statements about the safety of PAMs.

Study design and setting

A RAND-modified Delphi Rounds’ survey was used to reach a consensus. We established a steering committee of the Italian Association of Physiotherapy (Associazione Italiana di Fisioterapia) to identify areas and questions for developing statements about the safety of the most commonly used PAMs in physiotherapy and rehabilitation. We invited 28 National Scientific and Technical Societies, including forensics and lay members, as a multidisciplinary and multiprofessional panel of experts to evaluate the nine proposed statements and formulate additional inputs. The level of agreement was measured using a 9-point Likert scale, with consensus in the Delphi Rounds assessed using the rating proportion with a threshold of 75%.

Results

Overall, 17 (61%) out of 28 scientific and technical societies participated, involving their most representative members. The panel of experts mainly consisted of clinicians (88%) with expertise in musculoskeletal (47%), pelvic floor (24%), neurological (18%) and lymphatic (6%) disorders with a median experience of 30 years (IQR=17–36). Two Delphi rounds were necessary to reach a consensus. The final approved criteria list comprised nine statements about the safety of nine PAMs (ie, electrical stimulation neuromodulation, extracorporeal shock wave therapy, laser therapy, electromagnetic therapy, diathermy, hot thermal agents, cryotherapy and therapeutic ultrasound) in adult patients with a general note about populations subgroups.

Conclusions

The resulting consensus-based statements inform patients, healthcare professionals and policy-makers regarding the safe application of PAMs in physiotherapy and rehabilitation practice. Future research is needed to extend this consensus on paediatric and frail populations, such as immunocompromised patients.

IMproving psYchosocial adjustment to Traumatic Brain Injury from acute to chronic injury through development and evaluation of the myTBI online psychoeducation platform: protocol for a mixed-methods study

Por: Troeung · L. · Sarunga Raja · T. L. · Mann · G. · Wagland · J. · MacLeod · C. · Martini · A.
Introduction

This protocol describes the myTBI study which aims to: (1) develop an online psychoeducation platform for people with traumatic brain injury (TBI), their family members/caregivers, and healthcare staff to improve psychosocial adjustment to TBI across different phases of injury (acute, postacute, and chronic), and (2) undertake an evaluation of efficacy, acceptability, and feasibility.

Methods and analysis

A three-stage mixed-methods research design will be used. The study will be undertaken across four postacute community-based neurorehabilitation and disability support services in Western Australia. Stage 1 (interviews and surveys) will use consumer-driven qualitative methodology to: (1) understand the recovery experiences and psychosocial challenges of people with TBI over key stages (acute, postacute, and chronic), and (2) identify required areas of psychosocial support to inform the psychoeducation platform development. Stage 2 (development) will use a Delphi expert consensus method to: (1) determine the final psychoeducation modules, and (2) perform acceptance testing of the myTBI platform. Finally, stage 3 (evaluation) will be a randomised stepped-wedge trial to evaluate efficacy, acceptability, and feasibility. Outcomes will be measured at baseline, postintervention, follow-up, and at final discharge from services. Change in outcomes will be analysed using multilevel mixed-effects modelling. Follow-up surveys will be conducted to evaluate acceptability and feasibility.

Ethics and dissemination

Ethics approval was granted by North Metropolitan Health Service Mental Health Research Ethics and Governance Office (RGS0000005877). Study findings will be relevant to clinicians, researchers, and organisations who are seeking a cost-effective solution to deliver ongoing psychoeducation and support to individuals with TBI across the recovery journey.

Trial registration number

ACTRN12623000990628.

IMPROVE study protocol, investigating post-stroke local muscle vibrations to promote cerebral plasticity and functional recovery: a single-blind randomised controlled trial

Por: Julliand · S. · Papaxanthis · C. · Delphin · C. · Mock · A. · Raumel · M.-A. · Gueugnon · M. · Ornetti · P. · Laroche · D.
Introduction

Spasticity is a frequent disabling consequence following a stroke. Local muscle vibrations (LMVs) have been proposed as a treatment to address this problem. However, little is known about their clinical and neurophysiological impacts when used repeatedly during the subacute phase post-stroke. This project aims to evaluate the effects of a 6-week LMV protocol on the paretic limb on spasticity development in a post-stroke subacute population.

Methods and analysis

This is an interventional, controlled, randomised, single-blind (patient) trial. 100 participants over 18 years old will be recruited, within 6 weeks following a first stroke with hemiparesis or hemiplegia. All participants will receive a conventional rehabilitation programme, plus 18 sessions of LMV (ie, continuously for 30 min) on relaxed wrist and elbow flexors: either (1) at 80 Hz for the interventional group or (2) at 40 Hz plus a foam band between the skin and the device for the control group.

Participants will be evaluated at baseline, at 3 weeks and 6 weeks, and at 6 months after the end of the intervention. Spasticity will be measured by the modified Ashworth scale and with an isokinetic dynamometer. Sensorimotor function will be assessed with the Fugl-Meyer assessment of the upper extremity. Corticospinal and spinal excitabilities will be measured each time.

Ethics and dissemination

This study was recorded in a clinical trial and obtained approval from the institutional review board (Comité de protection des personnes Ile de France IV, 2021-A03219-32). All participants will be required to provide informed consent. The results of this trial will be published in peer-reviewed journals to disseminate information to clinicians and impact their practice for an improved patient’s care.

Trial registration number

Clinical Trial: NCT05315726

Dataset

EUDRAct

Home-based mobile-guided exercise-based cardiac rehabilitation among patients undergoing transcatheter aortic valve replacement (REHAB-TAVR): protocol for a randomised clinical trial

Por: Shen · Z. · Mi · S. · Huang · C. · Zhou · D. · Pan · W. · Xu · X. · Lin · Y. · Zhang · Y.
Introduction

Transcatheter aortic valve replacement (TAVR) is a standard treatment for aortic stenosis, particularly in older adults. Reduced exercise capacity and frailty significantly impact outcomes in TAVR patients, yet current management lacks strategies to address these issues. This study aims to assess the effectiveness of home-based mobile-guided exercise-based cardiac rehabilitation in TAVR patients, led by a multidisciplinary team with clear progression milestones.

Methods and analysis

The study involves 90 patients aged 60–89 in a single centre who will be randomised to a 3-month novel multidomain exercise intervention or routine care. Outcome assessors will be blinded towards group allocation. The primary outcome is the 6-min walk distance at month 3. The secondary outcomes include the 6-min walk distance at month 6, physical function measured by total Short Physical Performance Battery score and exercise adherence measured by the Exercise Adherence Rating Scale at months 3 and 6. Additional outcome measures, including rehospitalisations, death, handgrip strength, frailty (Fried Criteria and Essential Toolset), cognitive function (Mini-Mental State Examination), quality of life (EuroQol 5-Dimension 5-Level), nutritional status (Mini-Nutritional Assessment), anxiety (General Anxiety Disorder-7), depression (Geriatric Depression Scale), sleep (Pittsburgh Sleep Quality Index), functional capacity (Duke Activity Status Index), clinical indices (body mass index, symptoms, signs, left ventricular ejection fraction (LVEF), N-Terminal Pro-Brain Natriuretic Peptide, etc) and social support (Lubben Social Network Scale-6), along with comprehensive cost analysis, enhance the study’s significance. The study’s findings hold crucial implications for crafting an effective exercise-focused cardiac rehabilitation strategy for TAVR patients. Community implementation not only deepens understanding but also fosters the potential integration of exercise-based cardiac rehabilitation into self-care, promising enhanced patient adherence and overall cardiovascular health management.

Ethics and dissemination

Ethical approval was obtained from the Zhongshan Hospital, Fudan University Ethics Committee (B2022-062R). Results will be disseminated to local stakeholders and the research community through publications and conferences.

Trial registration number

NCT05989594

Evaluations of virtual exercise programmes for adults with mobility limitations: a scoping review protocol incorporating an equity lens to inform the development of strategies to optimise participation of under-represented groups

Por: dos Santos · R. B. · Lin · J. · Badwal · A. · Singh · H. · Jaglal · S. B. · Sperling · C. · Salbach · N. M.
Introduction

For individuals with mobility limitations, virtual exercise programmes can address the challenges of in-person participation in community exercise programmes. A synthesis of studies of virtual exercise programmes targeting mobility limitations provided outside of conventional rehabilitation services and strategies used to optimise equitable access and inclusivity in these programmes is lacking. We aim to characterise evaluations of virtual exercise programmes for adults with mobility limitations, and the nature of and extent to which equity, diversity and inclusion considerations are integrated in the research process.

Methods and analysis

A scoping review following a six-stage methodological framework, including a consultation exercise, is proposed. A comprehensive strategy will be used to search Medline, Embase, PEDro, CINAHL and Scopus to identify peer-reviewed studies evaluating virtual exercise programmes for adults with mobility limitations living in the community. Three trained reviewers will select studies independently. Data (eg, study methodology, programme structure and content, participant characteristics) will be extracted using a standardised form, and collated and summarised using quantitative and qualitative methods. The PROGRESS-Plus and International Classification of Functioning, Disability and Health frameworks will be used to classify participant characteristics and study outcomes, respectively. During the consultation exercise, key knowledge users, including exercise participants, programme providers and coordinators, and members of community organisations for persons living with disabilities and under-represented groups, will be asked to provide insights regarding the applicability of review findings. A directed content analysis of data from the consultation exercise will be performed.

Ethics and dissemination

The research ethics board at the University of Toronto approved the consultation exercise. Findings will be disseminated through peer-reviewed publications and conference presentations. Findings will enhance understanding of current research evaluating virtual exercise programmes and inform future research and strategies for promoting equitable access and outcomes for individuals with mobility limitations.

Registration details

https://doi.org/10.17605/OSF.IO/X5JMA.

Factors associated with changes in walking performance in individuals 3 months after stroke or TIA: secondary analyses from a randomised controlled trial of SMS-delivered training instructions in Sweden

Por: Vahlberg · B. M. · Eriksson · S. · Holmbäck · U. · Lundström · E.
Objectives

This study aimed to identify factors related to changes in walking performance in individuals 3 months after a stroke or TIA.

Design

Cross-sectional study with post hoc analysis of a randomised controlled study.

Setting

University Hospital, Sweden.

Participants

79 individuals, 64 (10) years, 37% women, who were acutely hospitalised because of stroke or TIA between November 2016 and December 2018. Inclusion criteria were patients aged 18 or above and the major eligibility criterion was the ability to perform the 6 min walking test.

Intervention

The intervention group received standard care plus daily mobile phone text messages (short message service) with instructions to perform regular outdoor walking and functional leg exercises in combination with step counting and training diaries. The control group received standard care.

Outcome measures

Multivariate analysis was performed and age, sex, group allocation, comorbidity, baseline 6 min walk test, body mass index (BMI), cognition and chair-stand tests were entered as possible determinants for changes in the 6 min walk test.

Results

Multiple regression analyses showed that age (standardised beta –0.33, 95% CI –3.8 to –1.05, p

Conclusions

Post hoc regression analyses indicated that younger age, male sex, lower BMI and shorter 6 min walk test at baseline and possible no comorbidity contributed to improvement in walking performance at 3 months in patients with a recent stroke or TIA. These factors may be important when planning secondary prevention actions.

Trial registration number

NCT02902367.

Experiences of fatigued persons with multiple sclerosis with multimodal agility-based exercise training and the ReFEx study protocol: a qualitative extension of a feasibility study

Por: Wolf · F. · Folkerts · A.-K. · Zimmer · P. · Nielsen · J.
Objectives

(1) To explore experiences of fatigued persons with multiple sclerosis (pwMS) with a new multimodal agility-based exercise training (MAT) framework and (2) to investigate the demands of the Rehabilitation, Fatigue, and Exercise (ReFEx) study protocol, which compares high-frequency MAT and ‘traditional’ strength and endurance training (SET) to identify possible adaptations for a powered randomised controlled trial (RCT).

Design

A qualitative interview study nested within a feasibility RCT, comparing MAT and SET.

Setting

Neurological inpatient rehabilitation centre in Germany.

Participants

Twenty-two pwMS were recruited for the feasibility study. Six were selected from MAT and SET, respectively, for semistructured face-to-face interviews prior to discharge, following a purposive sampling strategy. Participants had low physical disability but were at least moderately fatigued.

Interventions

During inpatient rehabilitation (4–6 weeks) MAT participants attended group-based and manual-based MAT sessions in the gym (5x/week, 30 min) and the pool (3x/week, 30 min). SET participants exercised individually on a cycle ergometer (5x/week, 22 min) and on strength training machines (3x/week, 30 min).

Results

Three key categories emerged from the interviews: (1) facilitators regarding MAT were variety and playfulness, group setting and challenging exercises. Barriers regarding MAT were feeling overburdened, feeling pressured in the group setting and the wish to perform ‘traditional’ strength training (not part of MAT). (2) MAT benefits were of physical and psychological nature, with improved balance stated the most. (3) Demands described the perceived exertion during MAT and SET, reflecting that there is no accumulation of fatigue during the intervention.

Conclusions

MAT is appreciated by pwMS and includes facilitators less attainable with ‘traditional’ SET. Evaluation of MAT in a powered RCT is indicated, if rest breaks postsession, and screening for negative self-evaluation and social comparison are considered. Future (qualitative) research should investigate the important factors of inpatient rehabilitation contributing to fatigue reduction in pwMS.

Trial registration number

DRKS00023943; German Clinical Trials Register.

Development of a Core Outcome Set for Dysphagia Interventions in Parkinsons disease (COS-DIP): study protocol

Por: Hirschwald · J. · Duncan · S. · Warnecke · T. · Boyle · G. · Regan · J. · Walshe · M.
Introduction

Current clinical trials on swallowing disorders (dysphagia) in Parkinson’s disease (PD) apply a high variety of outcomes and different outcome measures making comparative effectiveness research challenging. Furthermore, views of patients and dysphagia clinicians when selecting trial outcomes have not been considered in the past, thus study results may have little importance to them. This study aims to develop an agreed standardised Core Outcome Set for Dysphagia Interventions in Parkinson’s disease (COS-DIP), systematically measured and reported as a minimum for all clinical trials. It will also comprise guidance on outcome definitions, outcome measures and time points of measurement.

Methods and analysis

The COS-DIP development will comprise five stages following established methodology: (1) a recent scoping review on all applied outcomes, their definitions, methods and time points of measurement in clinical trials in dysphagia in PD, (2) online surveys and focus groups with clinicians, patients, caregivers and family members to identify outcomes that are important to them, (3) an identified list of outcomes based on results of stage 1 and 2, (4) three round online Delphi survey with up to 200 key stakeholders to determine core outcomes and (5) two online consensus meetings with up to 40 representative key stakeholders to agree on all outcomes, definitions, methods and time points of measurement in the final COS-DIP.

Ethics and dissemination

Full ethical approval was obtained from the Research Ethics Committee, School of Linguistic, Speech and Communication Sciences, Trinity College Dublin, on 15 May 2023 (HT27). Dissemination of the COS-DIP will be enhanced through presentations at (inter-) national conferences and through peer-reviewed, open access publications of related manuscripts. Lay and professional information sheets and infographics will be circulated through relevant patient and professional organisations and networks.

Trial registration number

The COS-DIP study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database on 24 September 2021 (www.comet-initiative.org/Studies/Details/1942).

Measurement properties of the incremental step test for people with chronic obstructive pulmonary disease: a cross-sectional study

Por: Goncalves · T. · Carlos Winck · J. · Silva · F. · Caneiras · C. · Montes · A. M. · Vilarinho · R.
Objectives

The new incremental step test (IST) is a field test that was developed for people with chronic obstructive pulmonary disease (COPD), based on the characteristics of the incremental shuttle walk test (ISWT); however, its measurement properties still need to be determined. We aimed, first, to assess the construct validity (through the comparison with the ISWT), within-day reliability and measurement error of the IST in people with COPD; and, second, to identify whether the participants have a learning effect in the IST.

Design

Cross-sectional study, conducted according to COnsensus-based Standards for the selection of health status Measurement INstruments guidelines.

Setting

A family health unit in Portugal, April 2022 to June 2023.

Participants and analysis

63 participants (67.5±10.5 years) attended two sessions to perform two IST and two ISWT, separately. Spearman’s correlations were used to compare the best performances between the IST and the ISWT. Intraclass correlation coefficient (ICC2,1) was used for reliability, and the SE of measurement (SEM), minimal detectable change at 95% CI (MDC95) and Bland and Altman 95% limits of agreement (LoA) were used for measurement error. The learning effect was explored with the Wilcoxon signed-rank test.

Results

The IST was significant and strongly correlated with the ISWT (0.722,1 of 0.95 (95% CI 0.92 to 0.97), SEM=11.7 (18.9%), MDC95=32.4 (52.2%) and the LoA were –33.61 to 31.48 for the number of steps. No difference was observed between the number of steps of the two attempts of the IST (p>0.05).

Conclusions

The IST can be suggested as a valid and reliable test to assess exercise capacity in people with COPD, with no learning effect when two IST are performed on the same day. The measurement error of the IST is considered indeterminate.

Trial registration number

NCT04715659.

Priming transcranial direct current stimulation for improving hemiparetic upper limb in patients with subacute stroke: study protocol for a randomised controlled trial

Por: Zhu · F. · Xu · X. · Jin · M. · Chen · J. · Feng · X. · Wang · J. · Yu · D. · Wang · R. · Lian · Y. · Huai · B. · Lou · X. · Shi · X. · He · T. · Lu · J. · Zhang · J. J. · Bai · Z.
Introduction

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates brain states by applying a weak electrical current to the brain cortex. Several studies have shown that anodal stimulation of the ipsilesional primary motor cortex (M1) may promote motor recovery of the affected upper limb in patients with stroke; however, a high-level clinical recommendation cannot be drawn in view of inconsistent findings. A priming brain stimulation protocol has been proposed to induce stable modulatory effects, in which an inhibitory stimulation is applied prior to excitatory stimulation to a brain area. Our recent work showed that priming theta burst magnetic stimulation demonstrated superior effects in improving upper limb motor function and neurophysiological outcomes. However, it remains unknown whether pairing a session of cathodal tDCS with a session of anodal tDCS will also capitalise on its therapeutic effects.

Methods and analysis

This will be a two-arm double-blind randomised controlled trial involving 134 patients 1–6 months after stroke onset. Eligible participants will be randomly allocated to receive 10 sessions of priming tDCS+robotic training, or 10 sessions of non-priming tDCS+robotic training for 2 weeks. The primary outcome is the Fugl-Meyer Assessment-upper extremity, and the secondary outcomes are the Wolf Motor Function Test and Modified Barthel Index. The motor-evoked potentials, regional oxyhaemoglobin level and resting-state functional connectivity between the bilateral M1 will be acquired and analysed to investigate the effects of priming tDCS on neuroplasticity.

Ethics and dissemination

The study has been approved by the Research Ethics Committee of the Shanghai Yangzhi Rehabilitation Center (reference number: Yangzhi2023-022) and will be conducted in accordance with the Declaration of Helsinki of 1964, as revised in 2013.

Trial registration number

ChiCTR2300074681.

Experiences and perspectives related to shared decision-making among outpatients with degenerative joint disease in Taiwan: a qualitative study

Por: Chuang · Y.-H. · Wang · C.-C. · Hsiao · C.-Y. · Lu · C.-Y. · Wu · J.-C. · Hou · W.-H.
Objectives

Various treatment options are available for degenerative joint disease (DJD). During clinical visits, patients and clinicians collaboratively make decisions regarding the optimal treatment for DJD; this is the essence of shared decision-making (SDM). Here, we collated and assessed the SDM-related experiences and perspectives of outpatients with DJD in Taiwan.

Design

In-depth interviews and thematic analysis.

Setting

Primary care clinics of a regional teaching hospital in Taiwan, October 2021–May 2022.

Participants

21 outpatients with at least three visits for DJD and who were aware of SDM.

Results

Four main themes emerged in this study: first, equipping themselves with knowledge: outpatients obtained disease-related and treatment-related knowledge in various ways—seeking relevant information online, discussing with family and friends, learning from their own experiences or learning from professionals. Second, shared or not shared: physicians had different patterns for communicating with patients, particularly when demonstrating authority, performing mutual discussion, respecting patient preferences or responding perfunctorily. Third, seldom saying no to physician-prescribed treatment plans during clinical visits: most patients respected physicians’ professionalism; however, some patients rejected physicians’ recommendations indirectly, whereas some responded depending on their disease prognosis. Fourth, whose call?—participants decided to accept or reject a treatment plan independently or by discussing it with their families or by obeying their physicians’ recommendations.

Conclusions

In general, patients with DJD sought reliable medical information from various sources before visiting doctors; however, when having a conversation with patients, physicians dominated the discussion on treatment options. The patient–physician interaction dynamics during the SDM process determined the final medical decision, which was in accordance with either patients’ original autonomy or physicians’ recommendations. To alleviate medical paternalism and physician dominance, patients should be empowered to engage in medical decision-making and share their opinions or concerns with their physicians. Family members should also be included in SDM.

Staying Active with Multimorbidity In Acute hospital settings (StAMInA) trial: protocol for a feasibility randomised controlled trial of allied health assistant mobility rehabilitation for patients with multimorbidity

Por: Snowdon · D. A. · Wang · Y. T. · Callisaya · M. L. · Collyer · T. A. · Jolliffe · L. · Johns · N. · Vincent · P. · Pragash · N. · Taylor · N. F.
Introduction

Key to improving outcomes for patients with multimorbidity is increasing mobility through prescription of a physical activity programme, but this can be difficult to achieve in acute hospital settings. One approach that would assist physiotherapists to increase levels of physical activity is delegation of rehabilitation to allied health assistants. We aim to conduct a randomised controlled trial to determine the feasibility of an allied health assistant providing daily inpatient mobility rehabilitation for patients with multimorbidity.

Methods and analysis

Using a parallel group randomised controlled design, participants will be allocated to allied health assistant mobility rehabilitation or physiotherapist mobility rehabilitation. Adult inpatients (n=60) in an acute hospital with a diagnosis of multimorbidity who walked independently preadmission will be included. The experimental group will receive routine mobility rehabilitation, including daily mobilisation, from an allied health assistant under the supervision of a physiotherapist. The comparison group will receive routine rehabilitation from a physiotherapist. Feasibility will be determined using the following areas of focus in Bowen’s feasibility framework: Acceptability (patient satisfaction); demand (proportion of patients who participate); implementation (time allied health assistant/physiotherapist spends with participant, occasions of service); and practicality (cost, adverse events). Staff involved in the implementation of allied health assistant rehabilitation will be interviewed to explore their perspectives on feasibility. Secondary outcomes include: Physical activity (daily time spent walking); daily mobilisation (Y/N); discharge destination; hospital readmission; falls; functional activity (Modified Iowa Level of Assistance Scale); and length of stay. Descriptive statistics will be used to describe feasibility. Secondary outcomes will be compared between groups using Poisson or negative binomial regression, Cox proportional hazards regression, survival analysis, linear regression or logistic regression.

Ethics and dissemination

Ethics approval was obtained from Peninsula Health (HREC/97 431/PH-2023). Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number

Australian and New Zealand Clinical Trial Registry ACTRN12623000584639p.

Exercise therapy for knee osteoarthritis pain: how does it work? A study protocol for a randomised controlled trial

Por: Beckwee · D. · Nijs · J. · Bierma-Zeinstra · S. M. A. · Leemans · L. · Leysen · L. · Puts · S. · Rice · D. · Schiphof · D. · Bautmans · I.
Introduction

Muscle strengthening training (MST) and behavioural graded activity (BGA) show comparable effects on knee osteoarthritic (KOA) pain, but the mechanisms of action remain unclear. Both exercise-induced anti-inflammation and central sensitisation are promising pathways for pain relief in response to exercise therapy in patients with KOA: MST has the potential to decrease inflammation and BGA has the potential to decrease central sensitisation. Hence, this study aims to examine inflammation and central sensitisation as mediators for the effect of MST and/or BGA on pain in patients with KOA.

Methods and analysis

The Knee OsteoArthritis PAIN trial started on 10 January 2020 (anticipated end: April 2024). The three-arm clinical trial aims to recruit 90 KOA patients who will be randomly allocated to 12 weeks of (1) MST, (2) BGA or (3) care as usual. Assessments will be performed at baseline, 13 and 52 weeks after finishing the intervention. Outcomes, including pain (Knee injury and Osteoarthritis Outcome Score), were chosen in line with the OARSI recommendations for clinical trials of rehabilitation interventions for OA and the IMMPACT/OMERACT recommendations for the assessment of physical function in chronic pain clinical trials. Inflammation as well as features of central sensitisation (including conditioned pain modulation, offset analgesia, temporal summation of pain and event-related potentials following electrical stimulation), will be considered as treatment mediators. A multiple mediators model will be estimated with a path-analysis using structural equation models. In July 2023, all 90 KOA patients have been included and 42 participants already finished the study.

Ethics and dissemination

This study obtained ethics approval (B.U.N. 143201941843). Unravelling the mechanisms of action of exercise therapy in KOA will not only be extremely valuable for researchers, but also for exercise immunology and pain scientists and clinicians.

Trial registration number

NCT04362618.

Efficacy of a physiotherapy, yoga and patient education programme for patients with breast cancer and hormone therapy-induced pain: a multicentre randomised study protocol (SKYPE 2)

Por: Faravel · K. · Jarlier · M. · Meignant · L. · Thomaso · M. · Del Rio · M. · Jacot · W. · Stoebner · A.
Introduction

Osteoarticular pain is experienced by approximately 50% of patients with breast cancer under hormone therapy and can increase the risk of therapy discontinuation. Among complementary therapies, yoga has shown efficacy regarding reduction of fatigue, anxiety, pain due to hormone therapy and inflammation. Personalised patient education programmes increase engagement and motivation, and induce effective behavioural changes. The SKYPE programme, an integrated intervention combining physiotherapy, yoga and patient education, showed promising efficacy on hormone therapy-induced pain in a previous pilot study. In this study, we hypothesised that using theory-based patient education favour learning and practising 15 min of at-home yoga every day to decrease hormone therapy-induced pain.

Methods and analysis

This multicentre randomised study will assess the efficacy of the SKYPE programme on pain reduction compared with standard care in patients with breast cancer reporting osteoarticular pain due to hormone therapy. Main secondary objectives will describe pain evolution and characteristics, patient adhesion to yoga sessions and home practice, forward flexibility, quality of life, fatigue, anxiety and compliance to hormone therapy. Patients in the intervention group will participate in 1 weekly educational yoga session of 90 min for 6 weeks, supervised by physiotherapists (period 1). They will also perform daily at-home 15 min yoga sessions for 12 weeks, the total duration of the intervention (periods 1 and 2). Pain will be evaluated during physiotherapy check-ups at baseline (T0), at 6 weeks (T1) and at 12 weeks (T2).

Ethics and dissemination

This study was approved by the ethics committee (CPP Ile de France 8 on 22 June 2020). The results will be disseminated to patients and healthcare professionals, and published in a peer-reviewed journal.

Trial registration number

NCT04457895.

Study protocol for the validation of a new pictorial functional scale in patients with knee osteoarthritis: the functional activity scoring tool (FAST)

Por: Tang · Z. Y. · Ng · K. S. · Koh · Y. L. E. · Yeung · M. T.
Background

Patient-reported outcome measures (PROMs) are required for patient-centred care. There are limited PROMs with good psychometric properties, and limitations to any language-based scale are often constrained by the written words or numerals used. Therefore, we developed the Functional Activity Scoring Tool (FAST), a self-reporting pictorial scale. FAST measures the impact of knee osteoarthritis on essential activities of daily living (ADL) and the significant changes in the self-perceived functional status over time.

Objectives

This study aims to (1) develop FAST with adaptation from the Wong-Baker FACES pain rating scale, (2) validate FAST against the Patient-Specific Functional Scale (PSFS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) and (3) establish the reliability, validity and responsiveness of FAST in individuals with knee osteoarthritis.

Methods and analysis

The prospective study protocol investigates the validity, responsiveness and reliability of FAST. The PSFS and KOOS will be gold standard comparisons. Participant recruitment will occur at four public polyclinics that offer physiotherapy outpatient services in Singapore. Onsite physiotherapists familiar with the study eligibilities will refer potential participants to the investigators after the routine physiotherapy assessment. After providing written consent, eligible participants will complete outcome measurements with FAST, the PSFS and KOOS during baseline and follow-up assessments. The Global Rating of Change (GROC) scale will determine how the participant’s knee status was changed compared with the beginning of the physiotherapy intervention.

Ethics and dissemination

SingHealth Centralised Institutional Review Board approved the study (CIRB reference number: 2022/2602). The final results will be published via scientific publication. FAST will benefit the evaluation and management of those who suffer knee osteoarthritis regardless of English proficiency or language barriers.

Trial registration number

NCT05590663

Effect of extracorporeal shock wave combined with Kinesio taping on upper limb function during individuals with biceps brachii tendinopathy:protocol for a double-blind, randomised controlled trial

Por: Liu · K. · Yin · L. · Zhang · Y. · Huang · L. · Liu · G. · Zhu · R. · Fang · P. · Ma · Y. · Ma · Z.
Introduction

Long head of biceps brachii tendinopathy (LHBT) is characterised by persistent pain and disability of shoulder joint, impairing patients’ quality of life. Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment, which promotes tissue regeneration and repair. However, ESWT has a side effect that often causes short-term pain and swelling in the treatment area. It is known that the effects of Kinesio taping (KT) on relieving swelling and pain. Due to insufficient clinical evidence from current limited studies, this randomised controlled study aims to explore the effects of ESWT combined with KT on upper limb function during individuals with LHBT.

Methods and analysis

A 2x2 factorial design, double-blind, randomised controlled trial will be conducted. A total of 144 participants will be randomly allocated into one of four groups (KT+ESWT, KT+sham ESWT, sham KT+ESWT or sham KT+sham ESWT) to participate in a 4-week treatment programme. Measurements will be taken at pretreatment (baseline), immediately after treatment and 6 weeks after treatment. The primary endpoint will be the Constant-Murley score (CMS), the secondary endpoints will include the pain Numerical Rating Scale, range of motion, pressure pain threshold and soft tissue hardness of biceps, speed test and global rating of change. Repeated measures analysis of variance will be used to compare differences among the effects of different interventions.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of the Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. In addition to international conference reports, findings will be disseminated through international publications in peer-reviewed journals.

Trial registration number

ChiCTR2100051324.

Effectiveness of non-surgical management in rotator cuff calcific tendinopathy (the effect trial): protocol for a randomised clinical trial

Por: Caballero · I. · Duenas · L. · Balasch-Bernat · M. · Fernandez-Matias · R. · Breso-Parra · L. · Gallego-Terres · C. · Aroca Navarro · J. E. · Navarro-Bosch · M. · Lewis · J. · Lluch Girbes · E.
Introduction

Rotator cuff calcific tendinopathy (RCCT) involves calcific deposits in the rotator cuff. Non-surgical interventions such as extracorporeal shockwave therapy (ESWT) and ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) are recommended for its early management. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been formally tested in RCCT. The main objective of this study is to compare the effectiveness of an ET programme with ESWT and US-PICT in people with RCCT. As a secondary aim, this study aims to describe the natural history of RCCT.

Methods and analysis

A randomised, single-blinded four-group clinical trial will be conducted. Adults from 30 to 75 years diagnosed with RCCT who accomplish eligibility criteria will be recruited. Participants (n=116) will be randomised into four groups: ET group will receive a 12-week rehabilitation programme; ESWT group will receive four sessions with 1 week rest between sessions during 1 month; US-PICT group will receive two sessions with 3 months of rest between sessions; and (actual) wait-and-see group will not receive any intervention during the 12-month follow-up. The primary outcome will be shoulder pain assessed with the Shoulder Pain and Disability Index at baseline, 2 weeks, 4 months, 6 months and 12 months from baseline. The primary analysis will be performed at 12 months from baseline. Secondary outcomes will include pain, range of motion, patient satisfaction and imaging-related variables. Moreover, the following psychosocial questionnaires with their corresponding outcome measure will be assessed: Central Sensitization Inventory (symptoms related to central sensitization); Pain Catastrophizing Scale (pain catastrophizing); Tampa Scale for Kinesiophobia 11 items (fear of movement); Fear Avoidance Belief Questionnaire (fear avoidance behaviour); Hospital Anxiety and Depression Scale (anxiety and depression); Pittsburgh Sleep Quality Index (sleep quality); and the EuroQol-5D (quality of life). An intention-to-treat analysis will be performed to reduce the risk of bias using a worst-case and best-case scenario analysis.

Ethics and dissemination

Ethics committee approval for this study has been obtained (reference number: 1718862). The results of the main trial will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT05478902.

Effectiveness of CO-OP group intervention for children with developmental coordination disorder: single-case experimental design study protocol

Por: Madieu · E. · Therriault · P.-Y. · Cantin · N. · Baghdadli · A.
Introduction

With the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, children with developmental coordination disorder learn to use a problem-solving strategy to deal with their motor difficulties and perform daily activities of their choice. Therapists use guided discovery to enable children to find their own solutions. Although CO-OP is recommended in a group setting, studies are needed to support its effectiveness.

Methods and analysis

A single-case study design with multiple baselines across participants and four systematic replications will be used. In each of the five groups, four children (aged 8–12 years) will be randomly included at the baseline. The baseline includes 5–8 measurements, and the CO-OP intervention stage is comprised of 10 sessions. The follow-up stage includes five measurements. Prior to baseline, each child in each of the five groups will choose five activities of which three will be carried out during the intervention sessions. Children’s performance in each of these activities will be scored using the Performance Quality Rating Scale (PQRS) as the main measure. Three secondary measures will be collected: perceived activity performance using the Canadian Occupational Performance Measure, quality of life using the Kidscreen-27 and spontaneous motor rhythm using a computerised typing task. Graphed data will be analysed visually at the individual level with the Visual Aid Implying an Objective Rule (VAIOR) protocol which provides a colour code based on the level and trend of two consecutive phases, facilitating an objective visual analysis. Statistics will be performed for PQRS scores at the individual level and at the group level.

Ethics and dissemination

The protocol has been approved by the Comité de protection des personnes Sud-Est I (CPP 2021070) and the Comité d’éthique de la recherche avec les êtres humains de l’Université du Québec à Trois-Rivières (CER-22-294-07.03). Results will be published in a peer-reviewed scientific journal.

Trial registration number

NCT05231486.

Protocol for the PORT study: short-term perioperative rehabilitation to improve outcomes in cardiac valvular surgery - a randomised control trial

Por: Zhou · H. · Liu · F. · Liu · Y. · He · X. · Ma · H. · Xu · M. · Wang · H. · Zhang · G. · Cai · X. · Chen · J.-Y. · Guo · L. · Chen · J.
Introduction

Perioperative rehabilitation (PORT) has shown a positive effect on patients undergoing cardiac surgery. However, there are minimal data on the impact of short-term PORT in cardiac surgery, which is associated with higher postoperative morbidity and mortality. The trial will assess the efficacy of short-term PORT in reducing in-hospital mortality, postoperative pulmonary complications and length of stay, compared with the usual care in cardiac surgical patients.

Methods and analysis

This is a single-centre prospective, randomised, open, controlled trial with a 1:1 ratio. Consecutive 800 adult patients undergoing elective valve surgery will be randomised to either usual care or in-hospital short-term PORT that consists of education, inspiratory muscle training, active cycle of breathing techniques and early mobilisation. The primary outcome of this study will be a composite of in-hospital all-cause mortality, incidence of postoperative pulmonary complications and the ratio of postoperative hospitalisation >7 days.

Ethics and dissemination

The PORT study was granted by the Medical Research Ethics Committee of Guangdong Provincial People’s Hospital in August 2018. Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publication.

Trial registration number

NCT03709511.

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