Hybrid Versus In-clinic Rehabilitation for Non-traumatic Shoulder Pain Within a Standardized Digital Care Pathway: a Prospective Longitudinal Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Observed time to documented clinical discharge among completed rehabilitation episodes
研究概览
简要总结
This prospective longitudinal observational cohort study compared feasibility-allocated hybrid and in-clinic rehabilitation for adults with non-traumatic shoulder pain or dysfunction managed within the same standardized web- and mobile-supported semi-automated shoulder rehabilitation system (WMSSR). The primary outcome was observed time from baseline to documented clinical discharge among completed rehabilitation episodes. Secondary outcomes included total clinical deficit score, maximum pain per visit, number of painful tests per visit, Constant-Murley score at discharge, and adherence to prescribed rehabilitation sessions.
详细描述
This prospective consecutive observational study was conducted in routine outpatient care at TDN Clínica (Navarra, Spain) to assess whether outcomes differ between two physiotherapy delivery formats for adults with non-traumatic shoulder pain/dysfunction managed within the same standardized web- and mobile-supported semi-automated shoulder rehabilitation system (WMSSR) between March and September 2025 and followed within the study until 11 November 2025. Allocation to format was feasibility-based (non-random) according to routine-care constraints (e.g., work schedule, transport, distance). Both formats were delivered at a nominal frequency of three sessions/week: hybrid (1 supervised in-person session plus 2 unsupervised home sessions supported by smartphone access to prescribed exercises) and in-clinic rehabilitation (3 supervised in-clinic sessions/week).
WMSSR integrates a structured assessment-prescription-reassessment process. Patients completed a standardized 24-test functional battery at baseline (visit 1) and at follow-up evaluations scheduled every 3-5 weeks until clinical discharge. The battery includes measures of strength (digital dynamometry), range of motion (manual goniometry), flexibility, and clinical tests. Pain intensity during test performance was recorded using a 0-10 visual analogue scale (VAS). Pain-related variables included maximum pain per visit, the number of test records with VAS >0 within the 24-test assessment, and a composite VAS used to summarize episode-level pain burden and support discharge assessment. Test scoring yields a total clinical deficit score. Clinical discharge was defined within the workflow using explicit criteria (deficit score threshold, symmetric strength, functional ROM, and low pain during tests).
Study objectives:
1) To describe and compare observed time from baseline to documented clinical discharge among completed rehabilitation episodes managed with hybrid versus in-clinic rehabilitation.
(2) To describe and compare discharge total clinical deficit score and Constant-Murley score between rehabilitation modalities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-71 years
- •Non-traumatic shoulder pain or dysfunction persisting for more than 3 months before study entry
- •Access to a smartphone to view the prescribed exercise instructions
排除标准
- •Acute fractures or dislocations
- •Arthritis/osteoarthritis
- •Osteosarcoma or osteomyelitis
- •Recent shoulder surgery
研究组 & 干预措施
Group 2: In-clinic rehabilitation
Description: Three supervised in-clinic sessions per week. Clinical reassessments were performed face to face every 3-5 weeks, and the exercise prescription was updated according to the participant's clinical evolution.
Group 1: Hybrid rehabilitation
One supervised in-clinic session plus two unsupervised home-based sessions per week. Clinical reassessments were performed face to face every 3-5 weeks, and the exercise prescription was updated according to the participant's clinical evolution.
结局指标
主要结局
Observed time to documented clinical discharge among completed rehabilitation episodes
时间窗: From baseline visit (V1) to documented clinical discharge, up to 200 days
Number of days from the baseline visit (V1) to documented clinical discharge. This outcome was analyzed among rehabilitation episodes with a documented discharge event within the predefined study window. Episodes that discontinued treatment or remained under active follow-up at database closure did not have an observed discharge outcome and were summarized separately.
Time to clinical discharge
时间窗: From baseline (V1) until discharge (end of rehabilitation episode, approximately 1 to 6 months after baseline, depending on clinical evolution)
Days from first visit (baseline, V1) to clinical discharge.
次要结局
- Change in total clinical deficit score from baseline to discharge(Baseline visit (V1) and documented clinical discharge, up to 200 days after baseline)
- Maximum pain per visit during rehabilitation(At baseline, at face-to-face reassessments scheduled every 3-5 weeks, and at documented clinical discharge, up to 200 days after baseline)
- Number of painful tests per visit during rehabilitation(At baseline, at face-to-face reassessments scheduled every 3-5 weeks, and at documented clinical discharge, up to 200 days after baseline)
- Constant-Murley score at clinical discharge(At documented clinical discharge, up to 200 days after baseline)
- Adherence to prescribed rehabilitation sessions(Throughout the rehabilitation episode, from baseline until documented clinical discharge, up to 200 days)
- Change in total clinical deficit score(baseline and discharge (approximately 1 to 6 months after baseline, depending on clinical evolution))
- Change in pain (VAS / composite VAS)(baseline and discharge (approximately 1 to 6 months after baseline, depending on clinical evolution))