An observational study in Rotator Cuff Syndrome, Rotator Cuff Tears and Rotator Cuff Tendinosis, sponsored by University of Thessaly. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by University of Thessaly · Observational
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
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.
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's planned enrollment of 100 is above the median of 67 across 52 observational studies indexed under Tendinopathy.
Browse Tendinopathy studies →University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Testing procedures that follow previously used protocols of the literature for all the Quantitative Sensory Testing, Dynamometry \& Goniometry
Also known as: Dynamometry, Goniometry
Numeric Pain Rating Scale (NPRS)
Obtain a measurement of pain Score: 0-10 Higher scores indicate more pain
Time frame: 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
Time frame: 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
Time frame: Once - Baseline
Central Sensitisation Inventory (CSI)
Identify participants suspicious of central sensitisation symptoms Score: 0-100 Score\>40 indicates central sensitisation
Time frame: Once - Baseline
Pain Drawings (PD)
Capture painful body locations for participants with the spectrum of pathologies
Time frame: Once - Baseline
Nociplastic Pain Flow Chart by IASP
Identification of Predominant Pain Mechanism, especially participants with possible nociplastic pain
Time frame: Once - Baseline
Quantitative Sensory Testing (QST)
Assessment of Pressure Pain Threshold, Conditioned Pain Modulation \& Temporal Summation
Time frame: Once - Baseline
Range of Motion (ROM)
Assess Range of motion of the movements of interest
Time frame: Once - Baseline
Dynamometry
Assess strength and explore pain provocation in participants
Time frame: Once - Baseline
Posterior Shoulder Endurance Test (PSET)
Assess the endurance of the Rotator Cuff myotendinous unit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Once - Baseline
Pittsburgh Sleep Quality Index (PSQI)
Assess sleep quality of participants Score: 0-21 Higher scores indicate worse sleep quality
Time frame: Once - Baseline
Modified Baecke Physical Activity Questionnaire (MBPAQ)
Evaluate Physical Activity levels of participants Score: low - moderate - high Higher scores indicate higher activity levels
Time frame: Once - Baseline
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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University of Thessaly