Clinical trial NCT06503549: Tactile Acuity, Right-left Discrimination, and Motor Imagery in Chronic Rotator Cuff-related Shoulder Pain
Official title: Investigation of Tactile Acuity, Right-left Discrimination, and Motor Imagery in Chronic Rotator Cuff-related Shoulder Pain - A Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Rotator Cuff Syndrome
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 and 65 years old were eligible to participate if they had rotator cuff related shoulder pain

Brief summary: A common finding in various chronic musculoskeletal pain conditions is changes in the cortical sensorimotor region. Functional brain changes associated with chronic pain include changes in the working body schema and associated mechanisms. However, the number of studies on this subject is quite limited, especially in the shoulder joint. There is no study on rotator cuff-related shoulder pain. In the light of this information, the present study aims to compare tactile acuity, right-left reasoning ability and motor imagery ability in chronic rotator cuff-related shoulder pain with healthy controls. In addition, the relationship of these markers with pain level, pressure pain threshold, range of motion, functionality, pain-related fear and central synthesis level will be investigated as a secondary objective.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Participants were classified with chronic Chronic Rotator Cuff-related Shoulder Pain if duration was equal or greater than 6 months, as recommended by the International Association for the Study of Pain for research purposes
* Pain at rest maximum 2 out of 10 on verbal numerical rating scale
* Pain over the deltoid and/or upper arm region for more than 4 weeks, pain associated with arm movement, and familiar pain reproduced with loading or resisted testing during abduction or external rotation of the arm
* Patient had to test positive at least 3 out of 5 symptoms-provoking tests: pain during Neer test, Hawkins-Kennedy test, Jobe test, painful arc between 60° and 120°, pain or weakness during external rotation resistance test

Exclusion Criteria:

* Bilateral shoulder pain
* Corticosteroid injections less than 6 weeks prior to the enrolment
* Participants who were pregnant, Mini Mental State Examination score \>24
* Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests or drop arm test)
* Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation)
* Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
* Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints)
* Primary diagnosis of acromioclavicular pathology, shoulder instability
* Previous medical imaging confirming full-thickness rotator cuff tears or calcifications larger than 5mm
* Patients with competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy)
* History of cancer, neurologic, systemic, rheumatic or vascular disorder and use of psychiatric medication
* Participants performing overhead sport activities for more than 4hours/week

Primary outcomes:
measure: Tactile Acuity (The two-point discrimination test)
timeFrame: Baseline
measure: Left/right discrimination (Lateralization)
timeFrame: Baseline
measure: Kinesthetic and Visual Imagery Questionnaire (KVIQ)
timeFrame: Baseline
measure: Pressure Pain Threshold
timeFrame: Baseline
measure: Central Sensitization Scale
timeFrame: Baseline
Secondary outcomes:
measure: The Numerical Rating Scale (NPRS-11)
timeFrame: Baseline
measure: The Shoulder Pain and Disability Index
timeFrame: Baseline
measure: Shoulder mobility on the Shoulder Range of Motion
timeFrame: Baseline
measure: Pain Catastrophizing Scale
timeFrame: Baseline
measure: Fear avoidance belief questionnaire (FABQ)
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University
city: İzmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
References: