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Completed

NCT Number: NCT07635550

Assessment of 3D Angular Arm Velocity During Elevation in People With Subacromial Pain Syndrome Pre-post Rehabilitation: a Pilot Study

Clinicians need accurate, simple and interpretable indicators to evaluate shoulder 3 performance, including movement speed. The primary objective was to assess the changes in mean 4 angular velocity norm and velocity variation measured by an innovative score, after rehabilitation. The 5 secondary objective was to assess the relationship between changes in both velocity variables and in 6 shoulder pain and activity limitation.

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Key information

Conditions

Subacromial Pain Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin

Paris, IDF, 75014, France

About this study

Current clinical assessment of shoulder pain focus on range of motion (RoM), clinical tests and disability, but lack information on shoulder performance. Shoulder performance is an imprecise multidimensional concept including RoM, accuracy, smoothness, and velocity. Clinicians need simple and accurate methods to measure shoulder performance.

Rotator cuff lesions are the most common shoulder pathologies. These pathologies include a wide range of soft-tissue conditions surrounding the humeral head that are grouped under the term subacromial pain syndrome (SPS). SPS is associated with pain, decreased active shoulder elevation, activity limitation and decreased quality of life. Physiotherapy is the first-line treatment for chronic SPS for pain and function.

Inertial measurement units (IMUs) have been used to assess velocity variables in people with SPS. The intra- and inter-observer reliability of kinematic temporal variables measured using IMUs is excellent in people with shoulder disorders. Most studies assessed functional arm activities rather than analytic arm elevation movements that are typically evaluated in clinical practice. Furthermore, they used rather complex kinematic temporal parameters (cumulative velocity distribution, power, moment or asymmetry scores) that can lack interpretability for clinicians. We wanted to employ accurate and clinically meaningful velocity variables used to assess arm movements during standard clinical shoulder examinations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years,
  • unilateral SPS diagnosed by a physician using clinical tests and imaging,
  • enrolled in a usual care 4-session rehabilitation program in the PMR outpatient department.

Exclusion criteria

  • shoulder fracture or dislocation or shoulder surgery (with implant) <1 year previously,
  • SLAP lesion,
  • neurological pathology,
  • cervico-brachial neuralgia.

Treatment and study plan

Assessment of 3D angular arm velocity during elevation

Other

Assessment of 3D angular arm velocity during elevation

Primary outcomes

  1. Mean angular velocity norm in degrees per second

    Time frame: Day 0

    The angular velocity norm provides a measure of velocity during arm elevation, taking into account the 3 movement axes and not only the main movement axis.

  2. Mean angular velocity norm in degrees per second

    Time frame: Day 21

    The angular velocity norm provides a measure of velocity during arm elevation, taking into account the 3 movement axes and not only the main movement axis.

  3. Velocity variation during movement time

    Time frame: Day 0

    By normalizing the cumulative velocity change by the highest frame-to-frame variation, this metric captures the overall irregularity of motion.

  4. Velocity variation during movement time

    Time frame: Day 21

    By normalizing the cumulative velocity change by the highest frame-to-frame variation, this metric captures the overall irregularity of motion.

Secondary outcomes

  1. Numeric Rating Scale

    Time frame: Day 0

    Pain intensity assessed on a Numeric Rating Scale (NRS, 0-100, 0: no pain, 100: maximum pain imaginable)

  2. Numeric Rating Scale

    Time frame: Day 21

    Pain intensity assessed on a Numeric Rating Scale (NRS, 0-100, 0: no pain, 100: maximum pain imaginable)

  3. Quick DASH Questionnaire

    Time frame: Day 0

    Measurement of disability and symptoms of musculoskeletal disorders related to upper limb impairment (DASH self-report questionnaire; 30 = no functional impairment to 150 = maximum impairment)

  4. Quick DASH Questionnaire

    Time frame: Day 21

    Measurement of disability and symptoms of musculoskeletal disorders related to upper limb impairment (DASH self-report questionnaire; 30 = no functional impairment to 150 = maximum impairment)

  5. SPADI self-administered questionnaire

    Time frame: Day 0

    Pain and disability (SPADI self-administered questionnaire), pain subscore (0: no pain, 50: maximum imaginable pain) and disability subscore (0: no disability, 80: maximum signs of disability).

  6. SPADI self-administered questionnaire

    Time frame: Day 21

    Pain and disability (SPADI self-administered questionnaire), pain subscore (0: no pain, 50: maximum imaginable pain) and disability subscore (0: no disability, 80: maximum signs of disability).

  7. FABQ self-administered questionnaire on shoulder pain

    Time frame: Day 0

    Misconceptions and apprehension regarding physical activities and work (FABQ-Shoulder self-report questionnaire), physical activities subscore (questions 2, 3, 4, 5: 0 = no apprehension/misconceptions, 24 = maximum signs of apprehension/misconceptions) and work subscore (questions 6, 7, 9, 10, 11, 12, 15: 0 = no apprehension/misconceptions, 42 = maximum signs of apprehension/misconceptions)

  8. FABQ self-administered questionnaire on shoulder pain

    Time frame: Day 21

    Misconceptions and apprehension regarding physical activities and work (FABQ-Shoulder self-report questionnaire), physical activities subscore (questions 2, 3, 4, 5: 0 = no apprehension/misconceptions, 24 = maximum signs of apprehension/misconceptions) and work subscore (questions 6, 7, 9, 10, 11, 12, 15: 0 = no apprehension/misconceptions, 42 = maximum signs of apprehension/misconceptions)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CoiFFaX

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2026
Registry last updated
Jun 9, 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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