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Completed

NCT Number: NCT07374900

Hybrid Versus In-clinic Rehabilitation for Non-traumatic Shoulder Pain in Routine Care.

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.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Observational

Primary location

TDN Clínica Traumatología y Rehabilitación SLP

Noaín, Navarre, 31110, Spain

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Observed time to documented clinical discharge among completed rehabilitation episodes

    Time frame: 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 outcomes

  1. Change in total clinical deficit score from baseline to discharge

    Time frame: 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.

  2. Maximum pain per visit during rehabilitation

    Time frame: 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.

  3. Number of painful tests per visit during rehabilitation

    Time frame: 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.

  4. Constant-Murley score at clinical discharge

    Time frame: 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.

  5. Adherence to prescribed rehabilitation sessions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Pública de Navarra

Other

Registry information

Official study title

Hybrid Versus In-clinic Rehabilitation for Non-traumatic Shoulder Pain Within a Standardized Digital Care Pathway: a Prospective Longitudinal Observational Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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