Subacromial Pain SyndromeCoiFFaXNCT07635550
Assessment of 3D Angular Arm Velocity During Elevation in People With Subacromial Pain Syndrome Pre-post Rehabilitation: a Pilot Study
An observational study of Subacromial Pain Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Pain Syndrome
- What is being tested?
- Assessment of 3D angular arm velocity during elevation
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- shoulder fracture or dislocation or shoulder surgery (with implant) <1 year previously,
- SLAP lesion,
- neurological pathology,
- cervico-brachial neuralgia.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
Paris, IDF, 75014
About this 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.
Read the 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.
- Conditions
- Subacromial Pain Syndrome
- Being tested
- Assessment of 3D angular arm velocity during elevation
- Keywords
- shoulder, subacromial pain syndrome, inertial measurement unit, velocity, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of 3D angular arm velocity during elevationOther
Assessment of 3D angular arm velocity during elevation
| Study group | Role | What they receive |
|---|---|---|
| Subacromial pain syndrome | 1 Receives: Other: Assessment of 3D angular arm velocity during elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean angular velocity norm in degrees per second
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.
Measured: Day 0
Mean angular velocity norm in degrees per second
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.
Measured: Day 21
Velocity variation during movement time
By normalizing the cumulative velocity change by the highest frame-to-frame variation, this metric captures the overall irregularity of motion.
Measured: Day 0
Velocity variation during movement time
By normalizing the cumulative velocity change by the highest frame-to-frame variation, this metric captures the overall irregularity of motion.
Measured: Day 21
Secondary outcomes (8)
Numeric Rating Scale
Pain intensity assessed on a Numeric Rating Scale (NRS, 0-100, 0: no pain, 100: maximum pain imaginable)
Measured: Day 0
Numeric Rating Scale
Pain intensity assessed on a Numeric Rating Scale (NRS, 0-100, 0: no pain, 100: maximum pain imaginable)
Measured: Day 21
Quick DASH Questionnaire
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)
Measured: Day 0
Quick DASH Questionnaire
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)
Measured: Day 21
SPADI self-administered questionnaire
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).
Measured: Day 0
SPADI self-administered questionnaire
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).
Measured: Day 21
FABQ self-administered questionnaire on shoulder pain
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)
Measured: Day 0
FABQ self-administered questionnaire on shoulder pain
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)
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Mar 2025
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635550
- Sponsor's protocol ID
- APHP260761
- Acronym
- CoiFFaX
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of 3D Angular Arm Velocity During Elevation in People With Subacromial Pain Syndrome Pre-post Rehabilitation: a Pilot Study
- ClinicalTrials.gov ID
- NCT07635550
- Acronym / sponsor ID
- CoiFFaX / APHP260761
- Conditions
- Subacromial Pain Syndrome
- Keywords
- shoulder, subacromial pain syndrome, inertial measurement unit, velocity, rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subacromial pain syndrome | – | Other: Assessment of 3D angular arm velocity during elevation1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- shoulder fracture or dislocation or shoulder surgery (with implant) <1 year previously,
- SLAP lesion,
- neurological pathology,
- cervico-brachial neuralgia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of 3D angular arm velocity during elevationAssessment of 3D angular arm velocity during elevation | Other | Subacromial pain syndrome |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Numeric Rating Scale
Time frame: Day 0
Numeric Rating Scale
Time frame: Day 21
Quick DASH Questionnaire
Time frame: Day 0
Quick DASH Questionnaire
Time frame: Day 21
SPADI self-administered questionnaire
Time frame: Day 0
SPADI self-administered questionnaire
Time frame: Day 21
FABQ self-administered questionnaire on shoulder pain
Time frame: Day 0
FABQ self-administered questionnaire on shoulder pain
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subacromial Pain Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean angular velocity norm in degrees per second (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.