Tactile Acuity, Right-left Discrimination, and Motor Imagery in Chronic Rotator Cuff-related Shoulder Pain

NCT06503549 | Completed

• 1 other identifier: 2023/32-18
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Shoulder Pain; Rotator Cuff Syndrome

Outcome Measures

Primary Outcomes (5)

• Tactile Acuity (The two-point discrimination test)

  The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception

  Baseline

• Left/right discrimination (Lateralization)

  Right-Left Discrimination will be evaluated with Recognise™ applications (Shoulder and Hand) developed by the "Neuro Orthopedic Institute".

  Baseline

• Kinesthetic and Visual Imagery Questionnaire (KVIQ)

  Motor imagery ability will be assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). The participant gives a score between 1 and 5 for the image he/she imagines: "1 point: no image, 5 points: as clear as the original." This process is repeated for each task and at the end of the survey, kinesthetic imagery score, visual imagery score and total score are calculated.

  Baseline

• Pressure Pain Threshold

  A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).

  Baseline

• Central Sensitization Scale

  Central Sensitization Scale, which can be applied in the presence of chronic pain, is used in central sensitization syndromes. It consists of two parts. Part A of the scale includes a Likert scale (0-4 points) that questions health-related symptoms. This section is scored from 0 to 100, with higher numbers being associated with a higher degree of central sensitization. Scores of 40 and above indicate the presence of central sensitization. In section B, it questions whether any of the central sensitization syndromes have been diagnosed before.

  Baseline

Secondary Outcomes (5)

• The Numerical Rating Scale (NPRS-11)

  Baseline

• The Shoulder Pain and Disability Index

  Baseline

• Shoulder mobility on the Shoulder Range of Motion

  Baseline

• Pain Catastrophizing Scale

  Baseline

• Fear avoidance belief questionnaire (FABQ)

  Baseline

Study Arms (2)

Healthy control

Other: Assessments

Patient with rotator cuff-related shoulder pain

Other: Assessments

Interventions

Assessments OTHER

Only the current assessments will be made

Healthy control; Patient with rotator cuff-related shoulder pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

18 and 65 years old were eligible to participate if they had rotator cuff related shoulder pain

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (2)

Acıbadem University

Istanbul, +90, Turkey (Türkiye)

Location

Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: May 1, 2024
• Primary Completion: July 15, 2024
• Study Completion: August 6, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

TU (2)