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

August 6, 2024 updated by: Nuray Alaca, Acibadem University

Investigation of Tactile Acuity, Right-left Discrimination, and Motor Imagery in Chronic Rotator Cuff-related Shoulder Pain - A Case Control Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, +90
        • Acıbadem University
      • İzmir, Turkey
        • Dokuz Eylul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy control
Only the current assessments will be made
Patient with rotator cuff-related shoulder pain
Only the current assessments will be made

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold
Time Frame: Baseline
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
Tactile Acuity (The two-point discrimination test)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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
Central Sensitization Scale
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Numerical Rating Scale (NPRS-11)
Time Frame: Baseline
the Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain).0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Baseline
The Shoulder Pain and Disability Index
Time Frame: Baseline
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
Baseline
Pain Catastrophizing Scale
Time Frame: Baseline
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.The person may score a total of 52 (Pain Catastrophizing Scale). A high score indicates a high level of catastrophic.
Baseline
Fear avoidance belief questionnaire (FABQ)
Time Frame: Baseline
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Baseline
Shoulder mobility on the Shoulder Range of Motion
Time Frame: Baseline
Shoulder ROM was measured in six directions (Flexion, Extension, Abduction, Adduction, Right rotation, Left rotation, degree) with goniometer.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

August 6, 2024

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023/32-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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