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临床试验/NCT06503549
NCT06503549已完成不适用

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

Acibadem University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Pressure Pain Threshold

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Pressure Pain Threshold

时间窗: 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).

Left/right discrimination (Lateralization)

时间窗: Baseline

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

Tactile Acuity (The two-point discrimination test)

时间窗: 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

Kinesthetic and Visual Imagery Questionnaire (KVIQ)

时间窗: 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.

Central Sensitization Scale

时间窗: 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.

次要结局

  • Fear avoidance belief questionnaire (FABQ)(Baseline)
  • The Numerical Rating Scale (NPRS-11)(Baseline)
  • Shoulder mobility on the Shoulder Range of Motion(Baseline)
  • The Shoulder Pain and Disability Index(Baseline)
  • Pain Catastrophizing Scale(Baseline)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuray Alaca

Prof Dr.

Acibadem University

研究点 (2)

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