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

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • IDF
      • Paris, IDF, France, 75014
        • Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Unilateral subacromial pain syndrome diagnosed by a physician using clinical tests and imaging, enrolled in a usual care 4-session rehabilitation program in the PMR outpatient department.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subacromial pain syndrome
1
Assessment of 3D angular arm velocity during elevation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0
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.
Day 21
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.
Day 0
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.
Day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 0
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)
Day 21
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)
Day 0
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)
Day 21
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).
Day 0
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).
Day 21
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)
Day 0
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)
Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Subacromial Pain Syndrome

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