Internet and Telerehabilitation-Delivered Management of Rotator Cuff–Related Shoulder Pain (INTEL Trial): Randomized Controlled Pilot and Feasibility Trial

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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

Highlights

  • Rotator cuff–related shoulder pain (RCRSP) is a common and disabling musculoskeletal condition

  • We found acceptable adherence in the recommended care group with telerehabilitation but not in the recommended care group without telerehabilitation

  • The estimated point prevalence of shoulder pain among adults is between 15% and 27% [1], and RCRSP is regarded as the most common cause, accounting for 70% of cases [2]

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Rotator cuff–related shoulder pain (RCRSP) is a common and disabling musculoskeletal condition. The estimated annual cost of managing shoulder pain is US $5,234.54 per person in 2009, and this is heavily influenced by sick leave and surgical costs [4]. One in 6 GPs would refer for surgical opinion [9] These imaging and surgical referral practices involve significant costs and, in some cases, unnecessary surgery [10], and may partly explain the doubling of rotator cuff–related surgeries and tripling of associated costs in Western Australia in just over a decade (2001-2013) [11]. Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes

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ReferencesShowing 10 of 72 papers
  • Cite Count Icon 229
  • 10.1016/j.msksp.2020.102193
Telehealth for musculoskeletal physiotherapy
  • May 30, 2020
  • Musculoskeletal Science and Practice
  • Michelle A Cottrell + 1 more

  • Open Access Icon
  • Cite Count Icon 274
  • 10.1016/j.math.2016.03.009
Rotator cuff related shoulder pain: Assessment, management and uncertainties
  • Mar 26, 2016
  • Manual Therapy
  • Jeremy Lewis

  • Open Access Icon
  • Cite Count Icon 54
  • 10.1016/j.physio.2013.06.001
Self-managed loaded exercise versus usual physiotherapy treatment for rotator cuff tendinopathy: a pilot randomised controlled trial
  • Aug 15, 2013
  • Physiotherapy
  • Chris Littlewood + 4 more

  • Cite Count Icon 9
  • 10.1016/j.pmn.2016.12.004
Development of a Guided Internet-based Psycho-education Intervention Using Cognitive Behavioral Therapy and Self-Management for Individuals with Chronic Pain
  • Mar 2, 2017
  • Pain Management Nursing
  • Jennifer Perry + 3 more

  • Open Access Icon
  • Cite Count Icon 253
  • 10.1136/bmj.e787
Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study
  • Feb 20, 2012
  • The BMJ
  • Theresa Holmgren + 4 more

  • Open Access Icon
  • Cite Count Icon 319
  • 10.3109/17453674.2014.920991
Guideline for diagnosis and treatment of subacromial pain syndrome
  • Jun 1, 2014
  • Acta Orthopaedica
  • Ron Diercks + 8 more

  • Open Access Icon
  • Cite Count Icon 13
  • 10.1136/bmjopen-2016-011618
Barriers and enablers in primary care clinicians' management of osteoarthritis: protocol for a systematic review and qualitative evidence synthesis
  • May 1, 2016
  • BMJ Open
  • T Egerton + 4 more

  • Open Access Icon
  • Cite Count Icon 1138
  • 10.1056/nejmra1510059
Pragmatic Trials
  • Aug 4, 2016
  • New England Journal of Medicine
  • Ian Ford + 1 more

  • Open Access Icon
  • Cite Count Icon 649
  • 10.1136/bjsports-2016-096651
Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement
  • Nov 15, 2016
  • British Journal of Sports Medicine
  • Susan C Slade + 3 more

  • Open Access Icon
  • Cite Count Icon 270
  • 10.1016/j.jpain.2010.06.005
The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis.
  • Jul 22, 2010
  • The journal of pain
  • Debora Duarte Macea + 3 more

CitationsShowing 10 of 45 papers
  • Open Access Icon
  • Research Article
  • 10.1016/j.msksp.2023.102874
Physiotherapist-led exercise versus usual care (waiting-list) control for patients awaiting rotator cuff repair surgery: A pilot randomised controlled trial (POWER)
  • Oct 30, 2023
  • Musculoskeletal Science and Practice
  • Chris Littlewood + 14 more

Once a decision to undergo rotator cuff repair surgery is made, patients are placed on the waiting list. It can take weeks or months to receive surgery. There has been a call to move from waiting lists to 'preparation' lists to better prepare patients for surgery and to ensure it remains an appropriate treatment option for them. To evaluate the feasibility, as measured by recruitment rates, treatment fidelity and follow-up rates, of a future multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of undertaking a physiotherapist-led exercise programme while waiting for surgery versus usual care (waiting-list control). Two-arm, multi-centre pilot randomised controlled trial with feasibility objectives in six NHS hospitals in England. Adults (n=76) awaiting rotator cuff repair surgery were recruited and randomly allocated to a programme of physiotherapist-led exercise (n=38) or usual care control (n=38). Of 302 eligible patients, 76 (25%) were randomised. Of 38 participants randomised to physiotherapist-led exercise, 28 (74%) received the exercise programme as intended. 51/76 (67%) Shoulder Pain and Disability Index questionnaires were returned at 6-months. Of 76 participants, 32 had not received surgery after 6-months (42%). Of those 32, 20 were allocated to physiotherapist-led exercise; 12 to usual care control. A future multi-centre randomised controlled trial is feasible but would require planning for variable recruitment rates between sites, measures to improve treatment fidelity and opportunity for surgical exit, and optimisation of follow-up. A fully powered, randomised controlled trial is now needed to robustly inform clinical decision-making.

  • Research Article
  • Cite Count Icon 4
  • 10.1080/07317115.2023.2277333
Online Chair Yoga and Digital Learning for Rural Underserved Older Adults at Risk for Alzheimer’s Disease and Related Dementias
  • Nov 10, 2023
  • Clinical Gerontologist
  • Juyoung Park + 2 more

ABSTRACT Objectives We evaluated the feasibility and preliminary efficacy of a home-based online chair yoga (OCY) program for racially and ethnically diverse rural community-dwelling older adults. Methods We randomly assigned participants to OCY or a computer brain game (CBG). After a computer literacy training led by high school students, participants engaged in remotely supervised OCY or CBG in twice-weekly 45-minute sessions for 12 weeks. Outcome data (pain interference, cognitive function, mobility, computer skills) were collected at baseline, post-intervention, and 3-month follow-up. Results A total of 32 eligible residents with mean age of 71 years participated in this intervention study. The interventions were feasible (100% recruitment rate, 96.8% retention rate, 100% safety rate). There were significant improvements in pain interference, cognitive function, mobility, and computer skills from baseline to follow-up among participants in both OCY and CBG but no significant differences in outcomes between groups. Conclusions Preliminary results indicated that the CBG was as effective as online OCY in clinical outcomes in these participants. However, this should be confirmed in future studies. Clinical Implications This telehealth-based intervention is feasible for older adults in rural and digitally underserved communities and could provide a strategy for delivering health-promoting interventions for home-bound older adults at risk for Alzheimer’s disease and related dementias (ADRD) and connect caregivers to online resources.

  • Open Access Icon
  • Research Article
  • Cite Count Icon 23
  • 10.1093/ptj/pzae045
Telerehabilitation in Physical Therapist Practice: A Clinical Practice Guideline From the American Physical Therapy Association
  • Mar 21, 2024
  • Physical Therapy
  • Alan C Lee + 12 more

A clinical practice guideline on telerehabilitation was developed by an American Physical Therapy Association volunteer guideline development group consisting of international physical therapists and physiotherapists, a physician, and a consumer. The guideline was based on systematic reviews of current scientific literature, clinical information, and accepted approaches to telerehabilitation in physical therapist practice. Seven recommendations address the impact of, preparation for, and implementation of telerehabilitation in physical therapist practice. Research recommendations identify current gaps in knowledge. Overall, with shared decision-making between clinicians and patients to inform patients of service delivery options, direct and indirect costs, barriers, and facilitators of telerehabilitation, the evidence supports the use of telerehabilitation by physical therapists for both examination and intervention. The Spanish and Chinese versions of this clinical practice guideline, as well as the French version of the recommendations, are available as supplementary material (Suppl. Materials).

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  • Cite Count Icon 12
  • 10.1186/s12891-023-06194-3
Telemedicine in orthopaedics and trauma surgery during the first year of COVID pandemic: a systematic review
  • Feb 7, 2023
  • BMC Musculoskeletal Disorders
  • Ulf Krister Hofmann + 3 more

PurposePrior to the COVID-19 pandemic, telemedicine in orthopaedics and trauma surgery had mostly developed for joint arthroplasty, fracture management, and general pre- and postoperative care including teleradiology. With the corona-outbreak, telemedicine was applied on a broad scale to prevent assemblage and to guarantee access to medical care protecting critical areas. The purpose of the present study was to give an overview of the spectrum of clinical applications and the efficacy of telemedicine in orthopaedic and trauma surgery as published in times of the COVID-19 pandemic.MethodsAll published studies investigating the application of telemedicine related to orthopaedics and trauma during the COVID-19 pandemic were accessed and screened for suitability. The primary outcome of interest was the efficacy of telemedicine in various clinical applications. The secondary outcome of interest was the spectrum of different applications in which telemedicine applications were investigated.ResultsThe literature search resulted in 1047 articles. After the removal of duplicates, 894 articles were screened of which 31 finally met the inclusion criteria. Dimensions that were described by studies in the literature to have positive effects were preoperative patient optimisation, the usefulness of telemedicine to correctly diagnose a condition, conservative treatment, willingness to and feasibility for telemedicine in patients and doctors, and postoperative/post-trauma care improvement. The efficacy of telemedicine applications or interventions thereby strongly varied and seemed to depend on the exact study design and the research question addressed.ConclusionVarious successful applications of telemedicine have already been reported in orthopaedics and trauma surgery, with a strong increase in scientific output during the COVID-19 years 2020–2021. Whether the advantages of such an approach will lead to a relevant implementation of telemedicine in everyday clinical practice should be monitored after the COVID-19 pandemic.

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  • Research Article
  • Cite Count Icon 3
  • 10.3390/healthcare12121234
Which Multimodal Physiotherapy Treatment Is the Most Effective in People with Shoulder Pain? A Systematic Review and Meta-Analyses.
  • Jun 20, 2024
  • Healthcare (Basel, Switzerland)
  • Maria Aguilar García + 6 more

The study aimed to determine if combined physiotherapy treatments offer additional benefits over exercise-only programs for shoulder pain and to identify the most effective combined treatment. A systematic review, registered in PROSPERO (CRD42023417709), and meta-analyses were conducted. Quality analysis was performed using the PEDro scale on randomized clinical trials published from 2018 to 2023. Twenty articles met the inclusion criteria. The most commonly used combination was exercise plus manual therapy, without being statistically superior to exercise alone. The meta-analysis indicated that combining exercise with low-level laser therapy (mean difference of -1.06, 95% CI: -1.51 to -0.60) and high-intensity laser therapy (mean difference of -0.53, 95% CI: -1.12 to 0.06) resulted in the greatest reduction in SPADI scores. Adding manual therapy provided limited additional benefit (mean difference of -0.24, 95% CI: -0.74 to 0.27). Progressive exercise with advice or telerehabilitation yielded modest improvements. The multimodal meta-analysis for DASH scores showed significant improvement (mean difference of -1.06, 95% CI: -1.51 to -0.60). In conclusion, therapeutic exercise is the cornerstone of shoulder pain treatment, with the addition of laser therapy showing substantial benefits. Manual therapy and educational interventions offer some benefits but are not consistently superior. More rigorous studies are needed.

  • Research Article
  • Cite Count Icon 1
  • 10.1016/j.pec.2024.108453
Patient education for the management of subacromial pain syndrome: A scoping review
  • Sep 25, 2024
  • Patient Education and Counseling
  • Katherine Montpetit-Tourangeau + 3 more

Patient education for the management of subacromial pain syndrome: A scoping review

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  • Cite Count Icon 10
  • 10.3390/cancers15143700
Telemedicine in Care of Sarcoma Patients beyond the COVID-19 Pandemic: Challenges and Opportunities.
  • Jul 21, 2023
  • Cancers
  • Christos Tsagkaris + 3 more

The COVID-19 pandemic has created a challenging environment for sarcoma patients. Most oncology societies published guidelines or recommendations prioritizing sarcoma patients and established telehealth as an efficient method of approaching them. The aim of this review is the assessment of current evidence regarding the utilization of telemedicine in diagnosis, treatment modalities, telerehabilitation and satisfaction among sarcoma patients and healthcare providers (HP). This systematic review was carried out using the databases PubMed and Ovid MEDLINE according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The application of telemedicine to the management of sarcoma has yielded improved clinical and psychological outcomes. Specifically, significant progress has been demonstrated in the areas of tele-oncology and telerehabilitation during the last decade, and the COVID-19 outbreak has accelerated this transition toward them. Telehealth has been proven efficient in a wide spectrum of applications from consultations on physical therapy and psychological support to virtual care symptom management. Both HP and patients reported satisfaction with telehealth services at levels comparable to in-person visits. Telehealth has already unveiled many opportunities in tailoring individualized care, and its role in the management of sarcoma patients has been established in the post-COVID-19 era, as well.

  • Open Access Icon
  • Research Article
  • Cite Count Icon 29
  • 10.2147/jpr.s343308
Asynchronous and Tailored Digital Rehabilitation of Chronic Shoulder Pain: A Prospective Longitudinal Cohort Study
  • Jan 8, 2022
  • Journal of Pain Research
  • Dora Janela + 8 more

BackgroundChronic shoulder pain (SP) is responsible for significant morbidity, decreased quality of life and impaired work ability, resulting in high socioeconomic burden. Successful SP management is dependent on adherence and compliance with effective evidence-based interventions. Digital solutions may improve accessibility to such treatments, increasing convenience, while reducing healthcare-related costs.PurposePresent the results of a fully remote digital care program (DCP) for chronic SP.Patients and MethodsInterventional, single-arm, cohort study of individuals with chronic SP applying for a digital care program. Primary outcome was the mean change between baseline and 12 weeks on the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Secondary outcomes were change in pain (NPRS), analgesic consumption, intention to undergo surgery, anxiety (GAD-7), depression (PHQ-9), fear-avoidance beliefs (FABQ-PA), work productivity (WPAI) and engagement.ResultsFrom 296 patients at program start, 234 (79.1%) completed the intervention. Changes in QuickDASH between baseline and end-of-program were both statistically (p < 0.001) and clinically significant, with a mean reduction of 51.6% (mean −13.45 points, 95% CI: 11.99; 14.92). Marked reductions were also observed in all secondary outcomes: 54.8% in NPRS, 44.1% ceased analgesics consumption, 55.5% in surgery intent, 37.7% in FABQ-PA, 50.3% in anxiety, 63.6% in depression and 66.5% in WPAI overall. Higher engagement was associated with higher improvements in disability. Mean patient satisfaction score was 8.7/10.0 (SD 1.6).ConclusionThis is the first real-world cohort study reporting the results of a multimodal remote digital approach for chronic SP rehabilitation. High completion and engagement rates were observed, which were associated with clinically significant improvement in all health-related outcomes, as well as marked productivity recovery. These promising results support the potential of digital modalities to address the global burden of chronic musculoskeletal pain.

  • Open Access Icon
  • Research Article
  • Cite Count Icon 2
  • 10.46413/boneyusbad.1077637
Farklı Fizyoterapi ve Rehabilitasyon Alanlarında Telerehabilitasyon
  • Aug 28, 2022
  • Bandırma Onyedi Eylül Üniversitesi Sağlık Bilimleri ve Araştırmaları Dergisi
  • Rabia Kum + 1 more

Telesağlığın bir alt bileşeni olan telerehabilitasyon, rehabilitasyon hizmetlerinin hasta ile sağlık hizmeti sağlayıcısı arasında iletişim ve bilgi teknolojisi yoluyla sunulması olarak tanımlanmaktadır. Fizyoterapi ve rehabilitasyon alanında telerehabilitasyon; pulmoner, kardiyak, ortopedik, nörolojik, onkolojik hastalıkların rehabilitasyonu gibi çok çeşitli alanlarda uygulanabilmektedir. Sosyal izolasyon süreçleri, transfer problemleri, klinikte karşılanamayan iş yükleri gibi nedenlerle alternatif rehabilitasyon yöntemlerinden biri olan telerehabilitasyonun kullanımı hızla yaygınlaşmıştır. Bu derlemenin amacı rehabilitasyon alanlarına göre sıklıkla çalışılan patolojilerde yapılan telerehabilitasyon çalışmalarını incelemektir.

  • Research Article
  • Cite Count Icon 2
  • 10.1002/msc.1912
Effectiveness of telerehabilitation on pain and function in musculoskeletal disorders: A systematic review of randomized controlled trials
  • Jun 1, 2024
  • Musculoskeletal Care
  • Fayez Alahmri + 2 more

Abstract IntroductionMusculoskeletal disorders are common, causing high hospital and healthcare utilisation. Telerehabilitation (TR) is a new strategy to deliver treatment remotely to patients in their own homes, with lower costs and easier accessibility. This study investigated the effectiveness of TR on pain and function in musculoskeletal disorders.MethodsA literature search of randomised controlled trials (RCTs) in the Medline/PubMed, Cochrane Library, and PEDro databases was conducted by two reviewers on 10 Jan 2023. We included studies that investigated pain and function with TR compared with a control group in any musculoskeletal disorders. The data synthesis included the TR platforms and measured outcomes. Effectiveness was measured based on the pain and function results. The study methodological quality was assessed by the PEDro scale for RCTs.ResultsAfter removing duplicated and irrelevant studies, 200 were initially identified. This review includes seven RCTs of a total of 183 participants with musculoskeletal conditions such as low back pain, fibromyalgia, total knee arthroplasty, shoulder subacromial decompression, knee osteoarthritis, and rotator cuff syndrome. The TR platforms used were smartphone and web apps, video, phone calls, and teleconference sessions. The findings showed no significant differences between the TR and control groups in pain and function. TR showed better improvement with a significant short‐term difference in some variables, but this was not sustained in the long term.ConclusionTR was comparably effective to clinic‐based rehabilitation for treating musculoskeletal disorders. However, it was not superior to conventional rehabilitation. TR showed lower costs and a high level of adherence. We recommend implementing new TR tools to remotely treat patients.Systematic Review RegistrationPROSPERO Registration Number CRD42022375048.

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Pilot trials inform the design and conduct of larger scale trials. Using the Consolidated Standards of Reporting Trials (CONSORT) pilot extension guidelines, we assessed reporting quality in five high-impact anesthesia journals and explored factors associated with reporting quality. The five highest-impact anesthesia journals were screened for randomized-controlled trials published as pilot or feasibility trials between 2006 and 2016. A pair of reviewers independently screened citations, extracted data, and assessed reporting quality using the CONSORT pilot trial extension checklists for abstracts and full texts. We reported the percentage adherence for each item, along with the median [interquartile range (IQR)] or mean (standard deviation [SD]) for all items. The factors considered to influence reporting were: 1) trial registration, 2) industry funding, 3) trial identification as a pilot or feasibility in the title or abstract, 4) primary objective as "feasibility", and 5) the specific journal. The association was estimated using generalized estimating equations and reported as incidence rate ratios with 99% confidence intervals. Of 364 citations, 58 articles were eligible. The median [IQR] number of CONSORT abstract items reported was 5 [4-7], and the mean (SD) number of full text items reported was 13 (5). Significantly poor reporting was associated with "not registering the trial" (both abstracts and full texts), "trial not identified as a pilot" (abstracts), and "using clinical hypothesis as the primary objective" (full texts). The reporting quality of pilot trials published in leading anesthesia journals is poor. Journal editorial boards can encourage improved reporting by supporting adherence to the CONSORT extension for pilot trials.

  • Research Article
  • Cite Count Icon 34
  • 10.1097/ajp.0b013e3181b2c985
Adverse Event Reporting in Acupuncture Clinical Trials Focusing on Pain
  • Jan 1, 2010
  • The Clinical Journal of Pain
  • Bernadette Capili + 2 more

To review the quality of adverse event reporting for published randomized controlled trials (RCTs) focusing on acupuncture for pain reduction. With the release of the Consolidated Standards of Reporting Trials (CONSORT) in 2001, the quality of published RCTs has improved. To improve reporting on adverse events, CONSORT expanded the section on harms (adverse events) in 2004. This paper evaluates whether the updated harms guidelines have been implemented in RCTs evaluating acupuncture for pain relief. Systematic searches were conducted using the following databases: MEDLINE, Allied & Complementary Medicine, Cumulative Index to Nursing & Allied Health Literature, and All EBM Reviews. Each database was searched from 2005 through 2008, corresponding to the availability of the updated harms guideline. Ten studies met the inclusion criteria of this review. Six of the 10 studies mentioned or discussed adverse events. Four of the 6 studies did not detail how adverse events were collected. Only 2 studies discussed how adverse events were assessed. On the basis of our findings, acupuncture clinical trials for pain reduction have yet to comprehensively meet CONSORT's guidelines for adverse event reporting. Acupuncture is commonly used by patients experiencing pain and although typically viewed as a benign and minimally invasive therapy, serious adverse events have been reported in the literature. To effectively and comprehensively document and understand these events, routine reporting according to CONSORT's harms guidelines should become the norm. Both science and patients are served by accurately evaluating the safety of acupuncture for patient populations experiencing pain.

  • Research Article
  • Cite Count Icon 22
  • 10.1016/j.fertnstert.2011.02.040
Incomplete and inconsistent reporting of maternal and fetal outcomes in infertility treatment trials
  • Mar 24, 2011
  • Fertility and Sterility
  • Lisa Dapuzzo + 5 more

Incomplete and inconsistent reporting of maternal and fetal outcomes in infertility treatment trials

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