"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 82
- 主要终点
- Change in Shoulder Function
研究概览
简要总结
The purpose of this prospective, randomized, parallel-group, single-center, controlled non-inferiority clinical trial is to determine whether a telerehabilitation program is non-inferior to a conventional rehabilitation program in patients with subacromial pain. Subacromial pain is a prevalent musculoskeletal condition, and while therapeutic exercise is the cornerstone of conservative management, adherence to home programs is often low. Conversely, conventional in-person physical therapy presents logistical and economic barriers for patients. This study aims to evaluate if a well-designed telerehabilitation program, utilizing information and communication technologies for remote monitoring, can provide an effective, accessible, and non-inferior alternative to conventional care. The primary outcome measured will be the change in shoulder function utilizing the QuickDASH questionnaire at 12 weeks. Secondary outcomes will assess pain intensity (VAS), range of motion (ROM), treatment adherence, and long-term functional outcomes.
详细描述
Chronic subacromial pain represents a significant public health challenge and the most common musculoskeletal disorder after back and neck pain. Its etiology is multifactorial, causing substantial functional limitations, work disability, and a decrease in quality of life. The management of subacromial pain is primarily conducted through conservative interventions, with therapeutic exercise constituting the cornerstone of treatment to reduce joint pain, optimize shoulder function, and improve muscle strength.
Despite its efficacy, adherence to home exercise programs is often low due to a lack of supervision and motivation, which compromises long-term outcomes. While supervised, conventional in-person physical therapy improves adherence and functional outcomes, it presents significant logistical and economic barriers, such as travel costs, distance, and difficulty accommodating appointments within work schedules. This creates a gap in care, preventing many patients from receiving the necessary amount of therapy for optimal recovery.
Telerehabilitation, a remote healthcare delivery modality utilizing information and communication technologies, emerges as a promising solution to mitigate these barriers. Assisted digital therapy programs can be utilized to maximize treatment intensity, provide real-time biofeedback, and allow physical therapists to progressively adjust exercise complexity under remote guidance. This approach can potentially improve treatment adherence and reduce indirect costs for patients by eliminating travel needs and decreasing time off work.
Although current evidence provides compelling data regarding the efficacy of telerehabilitation, establishing its superiority over static home exercise programs, there is a lack of standardized protocols. Furthermore, a clear consensus has not been established regarding its non-inferiority to the conventional in-person model within a standard, non-pandemic clinical setting.
To address this gap, this study proposes a prospective, randomized, parallel-group, single-center, controlled non-inferiority clinical trial. The primary objective is to compare the change in shoulder function, as measured by the QuickDASH, at the end of a 12-week program between a telerehabilitation group and a conventional rehabilitation group. Secondary objectives include comparing changes in pain intensity (VAS) and range of motion (flexion, abduction, and external rotation), as well as evaluating treatment adherence, patient satisfaction, and long-term functional outcomes at 6 months. Answering this question will lay the groundwork for establishing a standardized, evidence-based telerehabilitation protocol as a highly accessible and sustainable care modality for patients with subacromial pain.
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)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 years or older.
- •Diagnosis of Subacromial Impingement Syndrome (SIS) based on clinical criteria (pain with overhead activities, painful arc, positive Neer, Hawkins, or Jobe test). Radiological confirmation (ultrasound and/or magnetic resonance imaging) is accepted.
- •Access to the internet and a device (smartphone, tablet, or computer) capable of running the telerehabilitation platform.
- •Willingness and ability to provide written informed consent.
排除标准
- •Shoulder pain caused by fractures, tumors, infections, or severe systemic pathologies.
- •Previous surgery on the affected shoulder within the last 3 months.
- •Prior joint injection (corticosteroid infiltration) in the affected shoulder within the last 3 months.
- •Subjects with partial or full-thickness rotator cuff tears.
- •Patients currently receiving concurrent physical therapy (PT) or any other external interventions for the shoulder condition.
- •Current participation in another rehabilitation or exercise program.
- •Pregnancy.
- •Cognitive impairment, communication barriers, or any condition that prevents the patient from following the remote instructions.
研究组 & 干预措施
Telerehabilitation
A 12- to 24-week digital intervention program including a structured exercise protocol, health education, and cognitive-behavioral therapy (CBT) delivered via the Moodle platform. Exercises focus on mobility, stretching, and gradual strengthening of the shoulder/scapular muscles, recommended 3-4 sessions per week (30 minutes daily).
干预措施: Digital Physical Therapy (Telerehabilitation) (Other)
Conventional Rehabilitation
High-dose, in-person physical therapy at the clinic. The program includes therapeutic exercises with graded exposure to movement, manual therapy, and verbal education. Recommended 2-3 in-person sessions per week (30 minutes per session), complemented by home exercises.
干预措施: Conventional Physical Therapy (Other)
结局指标
主要结局
Change in Shoulder Function
时间窗: Baseline, 12 and 24 weeks
Measured by the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). The QuickDASH is an 11-item self-report questionnaire that measures physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Scores range from 0 to 100, where 0 indicates no disability (best outcome) and 100 indicates the most severe disability (worst outcome).
次要结局
- Change in Pain Intensity(Baseline, 12 and 24 weeks)
- Change in Range of Motion (ROM)(Baseline, 12 and 24 weeks)
- Treatment Adherence(Baseline, 12 and 24 weeks)
- Patient Satisfaction(Baseline, 12 and 24 weeks)
- Long-Term Shoulder Function(24 weeks postintervention)
研究者
Roberto Carlos Pech Arguelles
principal investigator
Instituto Mexicano del Seguro Social
