跳至主要内容
临床试验/NCT04636528
NCT04636528已完成不适用

Digital Care Program for Chronic Shoulder Tendinopathy Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study

Sword Health, SA1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年8月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)

研究概览

简要总结

This is a single-center, prospective, randomised, controlled study, with two parallel groups, designed to assess the clinical impact of a digital exercise program against conventional rehabilitation for shoulder tendonitis. The hypothesis is that all the clinical outcomes measured will significantly improve after the program, and patients using this novel system will attain at least the same outcomes than the ones attained by the conventional PT group.

详细描述

Shoulder pain is highly prevalent, being the third main complaint in primary care settings.There is a wide range of reported incidence and prevalence rates, with a median of 24.8% of adults reporting shoulder pain every month. In developed countries, 1% of adults annually consult a primary care provider due to shoulder pain.

Around 65 to 70% of shoulder pain complaints involve problems in the rotator cuff (RTC) tendons, with incidence rising higher after the 4th decade of life.Abundant data from across the world is available on the prevalence of RTC pathologies.

RTC dysfunction represent a huge burden for healthcare systems, insurance companies and employers alike. Shoulder problems account for 2.4% of all general practitioner consultations in the UK, and 4.5 million visits to physicians annually in the USA. One study in the UK20 estimated that nearly £310 million is spent on medical appointments in the first 6 months of shoulder pain onset, and additional costs of surgical procedures are estimated at approximately £30 million/year, with up to 50% of these costs related to sick leave from paid employment. More than 300,000 surgical repairs for RTC pathologies are performed annually in the USA, and the annual financial burden of RTC management was also estimated at $3 billion.

A myriad of international clinical practice guidelines have been put forth over the years, outlining the management of pain-causing shoulder disorders. Most causes of mild-to-moderate and gradual onset shoulder pain are treated initially with conservative care. Indeed, many recent studies and systematic reviews, as well as the American Academy of Orthopaedic Surgeons guidelines, support that firstly the patient should be directed to a physical therapy (PT) program and not surgery. For some specific conditions (e.g., symptomatic small to medium full-thickness RTC tears), strong evidence further supports that both PT and operative treatment attain significant improvements in patient-reported outcomes. Of note, another systematic review on treatment options for shoulder pain suggests that passive modalities, such as manual therapy, electrotherapy and taping should be avoided as mono-therapy but that they could, in specific cases, provide additional benefit when utilized in conjunction with therapeutic exercise programs. This suggests that the exercise component of PT is fundamental in the treatment of painful shoulder disorders.

Regarding rehabilitation setting, some studies show that home-based therapy, based on exercise, could be as effective as conventional PT interventions. This is in line with the recent trends in healthcare delivery, moving away from inpatient care and towards home-based care with the intent of improving cost-effectiveness. Furthermore, the need for home-based digital solutions is now felt more acutely than ever, in the face of the current pandemic. In this context, solutions enabling home-based rehabilitation without requiring real-time human supervision can be key to improving effectiveness and lowering costs, while keeping all stakeholders safe. Indeed, there are studies demonstrating the potential and cost-effectiveness of shoulder postoperative care and rehabilitation through telehealth solutions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Blinding of investigators and patients regarding allocation arm will not be possible, given the nature of the intervention. Analysis of study results will be performed by an independent statistician at UCSF.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subjects aged between 18 and 80 years of age at enrolment
  • •Reporting intermittent or persistent shoulder pain for at least 12 weeks, and/or present at least 50% of the time in the past 6 months
  • •Lack of visual/audio or cognitive impairment interfering with the ability to understand or comply with the program

排除标准

  • •Non-English speaking
  • •Residing outside greater SF area
  • •Known pregnancy
  • •Submitted to spinal surgery less than 3 months ago
  • •Symptoms and/or signs indicative of possible infectious disorder
  • •Referred pain from spine and/or thoracic outlet syndrome
  • •Active cancer diagnosis or undergoing treatment for cancer
  • •Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of light to moderate physical activity
  • •Concomitant neurological disorder (e.g. stroke, multiple sclerosis, Parkinson's disease)
  • •Dementia or psychiatric disorders precluding patient from complying with a home-based exercise program
  • •Illiteracy and/or serious visual or auditory impairment interfering with communication or compliance

研究组 & 干预措施

Digital Rehabilitation

Experimental

Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist

干预措施: Digital rehabilitation (Device)

Conventional Rehabilitation

Active Comparator

Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions

干预措施: Conventional rehabilitation (Device)

结局指标

主要结局

Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)

时间窗: 8 weeks after initiation of rehabilitation program

Shoulder physical function and symptoms will be measured using the shortened Disabilities of the Arm, Shoulder and Hand questionnaire QuickDASH, ranging from 0 (zero;non-disability) to 100 (maximum disability)

次要结局

  • Change in Shoulder Pain - Worst Pain Level(8 weeks after initiation of rehabilitation program)
  • Surgery Intent(8 weeks after initiation of rehabilitation program)
  • Anxiety(8 weeks after initiation of rehabilitation program)
  • Patient Satisfaction With Intervention(8 weeks after initiation of rehabilitation program)
  • Change in Shoulder Pain - Least Pain Level(8 weeks after initiation of rehabilitation program)
  • Change in Shoulder Pain - Average Pain Level(8 weeks after initiation of rehabilitation program)
  • Depression(8 weeks after initiation of rehabilitation program)
  • Dropout Rate(Program-end)
  • Total Sessions(8 weeks)
  • Treatment Intensity(Between baseline and 8 weeks.)
  • Frequency of Sessions Per Week(8 weeks)
  • Retention Rate(Between baseline and 8 weeks.)

研究者

发起方
Sword Health, SA
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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