Rotator Cuff SyndromeNCT05817578
Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
An observational study of Rotator Cuff Syndrome and Rotator Cuff Tears, run by University of Thessaly.
Trial summary
The aim of this study is to collect a sum of different characteristics that have been mentioned previously in people presenting with RCRSP and by clustering them to create a phenotype system which may assist the individualisation of their management Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Syndrome, Rotator Cuff Tears, Rotator Cuff Tendinosis
- What is being tested?
- Quantitative Sensory Testing / Dynamometry / Goniometry
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2023to 30 Sep 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People in the 18-65 spectrum that have a gradual onset of shoulder pain without being able to recall any injuries to the area and pain to be present for at least three months
Who may be able to join
- Age: 18-65
- Pain: >3 months, non-traumatic, unilateral or bilateral of anterolateral location
- ROM: >50% all planes, AROM painful in forward flexion and/or abduction
- Provocation testing: Hawkins-Kennedy, Neer, Painful Arc, Resisted ER, Empty Can (3 or more out of the 5 +ve)
Who cannot join
- Pain < 3months
- History of neck or shoulder trauma
- Radicular signs, shoulder pain reproduced with neck movements
- GH OA
- Frozen Shoulder
- Tears >C3 according to Snyder Classification
Show all 10Show fewer
- Fibromyalgia
- Neurological, systemic local or autoimmune inflammatory conditions
- Clinical depression
- No injected corticosteroids or physiotherapy the last 3/12
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Profiling the Rotator Cuff - Related Shoulder Pain (RCRSP) Patient: a Pain Phenotype Classification Algorithm
The aim of this study is to collect a sum of different characteristics that have been mentioned previously in people presenting with RCRSP and by clustering them to create a phenotype system which may assist the individualisation of their management
Read the detailed description
This study will be conducted at a hospital environment by recruiting people that will seek help for their shoulder pain by a specialist upper- limb Orthopaedic Surgeon at the Department of Hand \& Upper Limb Microsurgery of the 'KAT General Hospital' in Athens, Greece. Participants that will be diagnosed with RCRSP by the orthopaedic surgeon and fulfil the eligibility criteria will undergo a series of one-off measurements. Written consent will have to be obtained before a sum of self-reported outcome measures and objective testing will take place. The main categories for which outcome measures will be used are: pain, function, psychosocial and lifestyle factors.
- Conditions
- Rotator Cuff Syndrome, Rotator Cuff Tears, Rotator Cuff Tendinosis, Rotator Cuff Impingement, Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- Being tested
- Quantitative Sensory Testing / Dynamometry / Goniometry
- Keywords
- Rotator Cuff Related Shoulder Pain, Chronic Pain
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Impingement Syndrome, Rupture, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory Testing / Dynamometry / GoniometryDevice
Also called Dynamometry, Goniometry
Testing procedures that follow previously used protocols of the literature for all the Quantitative Sensory Testing, Dynamometry \& Goniometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Obtain a measurement of pain
Score: 0-10
Higher scores indicate more pain
Measured: Once - Baseline
Western Ontario Rotator Cuff Index (WORC)
Assess the self-reported functional ability of participants
Score: 0-100 %
Higher scores indicate higher functional status
Measured: Once - Baseline
The Self-Report Leeds Assessment of Neuropathic Symptoms & Signs (SLANSS)
Identify possible participants with neuropathic type of pain
Score: 0-24
Score >12 indicates neuropathic pain
Measured: Once - Baseline
Central Sensitisation Inventory (CSI)
Identify participants suspicious of central sensitisation symptoms
Score: 0-100
Score>40 indicates central sensitisation
Measured: Once - Baseline
Pain Drawings (PD)
Capture painful body locations for participants with the spectrum of pathologies
Measured: Once - Baseline
Nociplastic Pain Flow Chart by IASP
Identification of Predominant Pain Mechanism, especially participants with possible nociplastic pain
Measured: Once - Baseline
Quantitative Sensory Testing (QST)
Assessment of Pressure Pain Threshold, Conditioned Pain Modulation \& Temporal Summation
Measured: Once - Baseline
Range of Motion (ROM)
Assess Range of motion of the movements of interest
Measured: Once - Baseline
Dynamometry
Assess strength and explore pain provocation in participants
Measured: Once - Baseline
Posterior Shoulder Endurance Test (PSET)
Assess the endurance of the Rotator Cuff myotendinous unit
Measured: Once - Baseline
Hospital Anxiety & Depression Scale (HADS)
Obtain a score of Anxiety \& Depression among participants
Score: 0-42 (Two scales between 0 \& 21 each - one for anxiety and 1 for depression)
Higher Scores indicate higher anxiety \& depression
Measured: Once - Baseline
Pain Catastrophising Scale (PCS)
Explore how the pain experience is perceived by the individual
Scale: 0-52
Higher scores indicate higher levels of catastrophising
Measured: Once - Baseline
Tampa Scale of Kinesiophobia (TSK)
Explore fear of movement and avoidance of participants
Score: 17-68
Higher scores indicate higher levels of Kinesiophobia, cut-off point: scores >37 are indicative of kinesiophobia
Measured: Once - Baseline
Pain Self-Efficacy Questionnaire (PSEQ)
Assess the ability of the participant to cope with a spectrum of activities
Score: 0-60
Lower scores indicate less self-efficacy
Measured: Once - Baseline
Allostatic Index-5 (ALI-5)
Investigate psychosocial stressors reflective of chronc adaptive states for 'wear \& tear' of the human body
Score: 0-5
Higher score indicating higher allostatic load
Measured: Once - Baseline
EuroQol-5Dimension (EQ-5D)
Investigate quality of life levels of participants
Score: 5-likert with no problem, slight, moderate, severe and extreme in each of the dimensions plus the 0-100 VAS as a global rating of self-perceived health with higher scores indcating better health
Measured: Once - Baseline
Pittsburgh Sleep Quality Index (PSQI)
Assess sleep quality of participants
Score: 0-21
Higher scores indicate worse sleep quality
Measured: Once - Baseline
Modified Baecke Physical Activity Questionnaire (MBPAQ)
Evaluate Physical Activity levels of participants
Score: low - moderate - high
Higher scores indicate higher activity levels
Measured: Once - Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start2 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff SyndromeStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achilleas Paliouras, University of Thessaly
- Investigators
- ELENI KAPRELI, PT, PROF, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817578
- Sponsor's protocol ID
- 9
- Status last verified
- Jun 2023
- First submitted
- 5 Apr 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling the Rotator Cuff - Related Shoulder Pain (RCRSP) Patient: a Pain Phenotype Classification Algorithm
- ClinicalTrials.gov ID
- NCT05817578
- Acronym / sponsor ID
- 9
- Conditions
- Rotator Cuff Syndrome, Rotator Cuff Tears, Rotator Cuff Tendinosis, Rotator Cuff Impingement, Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- Keywords
- Rotator Cuff Related Shoulder Pain, Chronic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 2 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Apr 2023 (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.
The aim of this study is to collect a sum of different characteristics that have been mentioned previously in people presenting with RCRSP and by clustering them to create a phenotype system which may assist the individualisation of their management
Detailed description
This study will be conducted at a hospital environment by recruiting people that will seek help for their shoulder pain by a specialist upper- limb Orthopaedic Surgeon at the Department of Hand \& Upper Limb Microsurgery of the 'KAT General Hospital' in Athens, Greece. Participants that will be diagnosed with RCRSP by the orthopaedic surgeon and fulfil the eligibility criteria will undergo a series of one-off measurements. Written consent will have to be obtained before a sum of self-reported outcome measures and objective testing will take place. The main categories for which outcome measures will be used are: pain, function, psychosocial and lifestyle factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People in the 18-65 spectrum that have a gradual onset of shoulder pain without being able to recall any injuries to the area and pain to be present for at least three months
Key inclusion criteria (4 listed)
- Age: 18-65
- Pain: >3 months, non-traumatic, unilateral or bilateral of anterolateral location
- ROM: >50% all planes, AROM painful in forward flexion and/or abduction
- Provocation testing: Hawkins-Kennedy, Neer, Painful Arc, Resisted ER, Empty Can (3 or more out of the 5 +ve)
Key exclusion criteria (10 listed)
- Pain < 3months
- History of neck or shoulder trauma
- Radicular signs, shoulder pain reproduced with neck movements
- GH OA
- Frozen Shoulder
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 |
|---|---|---|
| Quantitative Sensory Testing / Dynamometry / GoniometryAlso: Dynamometry, GoniometryTesting procedures that follow previously used protocols of the literature for all the Quantitative Sensory Testing, Dynamometry \& Goniometry | Device | – |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Once - Baseline
Obtain a measurement of pain Score: 0-10 Higher scores indicate more pain
Western Ontario Rotator Cuff Index (WORC)
Time frame: Once - Baseline
Assess the self-reported functional ability of participants Score: 0-100 % Higher scores indicate higher functional status
The Self-Report Leeds Assessment of Neuropathic Symptoms & Signs (SLANSS)
Time frame: Once - Baseline
Identify possible participants with neuropathic type of pain Score: 0-24 Score >12 indicates neuropathic pain
Central Sensitisation Inventory (CSI)
Time frame: Once - Baseline
Identify participants suspicious of central sensitisation symptoms Score: 0-100 Score>40 indicates central sensitisation
Pain Drawings (PD)
Time frame: Once - Baseline
Capture painful body locations for participants with the spectrum of pathologies
Nociplastic Pain Flow Chart by IASP
Time frame: Once - Baseline
Identification of Predominant Pain Mechanism, especially participants with possible nociplastic pain
Quantitative Sensory Testing (QST)
Time frame: Once - Baseline
Assessment of Pressure Pain Threshold, Conditioned Pain Modulation \& Temporal Summation
Range of Motion (ROM)
Time frame: Once - Baseline
Assess Range of motion of the movements of interest
Dynamometry
Time frame: Once - Baseline
Assess strength and explore pain provocation in participants
Posterior Shoulder Endurance Test (PSET)
Time frame: Once - Baseline
Assess the endurance of the Rotator Cuff myotendinous unit
Hospital Anxiety & Depression Scale (HADS)
Time frame: Once - Baseline
Obtain a score of Anxiety \& Depression among participants Score: 0-42 (Two scales between 0 \& 21 each - one for anxiety and 1 for depression) Higher Scores indicate higher anxiety \& depression
Pain Catastrophising Scale (PCS)
Time frame: Once - Baseline
Explore how the pain experience is perceived by the individual Scale: 0-52 Higher scores indicate higher levels of catastrophising
Tampa Scale of Kinesiophobia (TSK)
Time frame: Once - Baseline
Explore fear of movement and avoidance of participants Score: 17-68 Higher scores indicate higher levels of Kinesiophobia, cut-off point: scores >37 are indicative of kinesiophobia
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Once - Baseline
Assess the ability of the participant to cope with a spectrum of activities Score: 0-60 Lower scores indicate less self-efficacy
Allostatic Index-5 (ALI-5)
Time frame: Once - Baseline
Investigate psychosocial stressors reflective of chronc adaptive states for 'wear \& tear' of the human body Score: 0-5 Higher score indicating higher allostatic load
EuroQol-5Dimension (EQ-5D)
Time frame: Once - Baseline
Investigate quality of life levels of participants Score: 5-likert with no problem, slight, moderate, severe and extreme in each of the dimensions plus the 0-100 VAS as a global rating of self-perceived health with higher scores indcating better health
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Once - Baseline
Assess sleep quality of participants Score: 0-21 Higher scores indicate worse sleep quality
Modified Baecke Physical Activity Questionnaire (MBPAQ)
Time frame: Once - Baseline
Evaluate Physical Activity levels of participants Score: low - moderate - high Higher scores indicate higher activity levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- 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.
ELENI KAPRELI, PT, PROF study director
University of Thessaly
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Syndrome and Rotator Cuff Tears, run by University of Thessaly.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ACHILLEAS PALIOURAS, PT, MSc (6975768673 ext. +30, apaliouras@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Once - Baseline). The study lists 18 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 22 Jun 2023.