Shoulder Pain
Conditions
Keywords
shoulder pain, physiotherapy, hybrid rehabilitation, home exercise, real-world evidence, shoulder dysfunction, in-clinic rehabilitation, digital rehabilitation, WMSSR, time to clinical discharge
Brief summary
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.
Detailed description
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. (3) To describe longitudinal changes in maximum pain and the number of painful tests across assessment visits in both rehabilitation modalities. (4) To describe adherence to prescribed rehabilitation sessions in each rehabilitation modality.
Interventions
None listed
Sponsors
Universidad Pública de Navarra
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 71 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* Acute fractures or dislocations * Arthritis/osteoarthritis * Osteosarcoma or osteomyelitis * Recent shoulder surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed time to documented clinical discharge among completed rehabilitation episodes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total clinical deficit score from baseline to discharge | Baseline visit (V1) and documented clinical discharge, up to 200 days after baseline | The total clinical deficit score was calculated from the standardized 24-test shoulder assessment and ranged from 0 to 36 points, with higher scores indicating greater clinical impairment. Change was calculated as baseline score minus discharge score; therefore, positive values indicate a reduction in clinical deficit. The analysis included rehabilitation episodes with paired baseline and documented discharge assessments. |
| 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 | Pain during test performance was recorded using a 0-10 visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the greatest pain intensity. Maximum pain per visit was defined as the highest VAS value recorded across the test records completed at a given assessment visit. Values were summarized at baseline, across scheduled reassessments, and at documented clinical discharge. Lower values indicate less pain. |
| 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 | The number of painful tests per visit was defined as the count of test records with VAS \>0 within the standardized 24-test shoulder assessment. One episode-level count was calculated for each assessment visit. Values were summarized at baseline, across scheduled reassessments, and at documented clinical discharge. Lower counts indicate fewer painful responses during the assessment. |
| Constant-Murley score at clinical discharge | At documented clinical discharge, up to 200 days after baseline | The Constant-Murley score was recorded at documented clinical discharge as an additional measure of shoulder functional status. The score ranges from 0 to 100 points, with higher values indicating better shoulder function. It was measured at discharge only and was not included among the predefined clinical discharge criteria. |
| Adherence to prescribed rehabilitation sessions | Throughout the rehabilitation episode, from baseline until documented clinical discharge, up to 200 days | Episode-level rehabilitation adherence was calculated as the percentage of prescribed rehabilitation sessions completed during the rehabilitation episode: (number of completed prescribed sessions / total number of prescribed sessions) × 100. In the hybrid group, prescribed sessions included one supervised in-clinic session and two unsupervised home-based sessions per week. In the in-clinic group, prescribed sessions included three supervised in-clinic sessions per week. Higher percentages indicate greater adherence. |
Countries
Spain
Contacts
STUDY_DIRECTORJosé A Sanz, PHD
Universidad Pública de Navarra
STUDY_DIRECTORIgor Setuain, PHD
TDN Clinica
STUDY_DIRECTORIban Latasa, PHD
IED Electronics
Outcome results
None listed