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临床试验/NCT04242381
NCT04242381已完成不适用

Short Term Effect Of Kinesiotaping on Pain, Functionality, and Ultrasound Parameters In Patients With Shoulder Impingement Syndrome: A Randomized Sham-Controlled Study

Kars State Hospital2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2016年1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
75
试验地点
2
主要终点
Pain Level

研究概览

简要总结

We aimed to investigate the effect of kinesiotaping on pain, functionality and ultrasound parameters in patients with shoulder impingement syndrome (SIS).

详细描述

A total of 75 patients with SIS were randomly classified into the following three groups: kinesiotaping (KT), exercise (EX) and sham-kinesiotaping (sham-KT). Each group was underwent two weeks treatment program. The patients were then evaluated in terms of pain analyzed using the visual analog scale (VAS), joint range of motion, Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire before and after treatment. In addition, supraspinatus tendon (SsT) thickness and acromiohumeral distance (AHD) parameters were measured using ultrasonography (US). All parameters were measured before and after treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

All participants were assessed by the same clinician (F.B) at the baseline and at the two week after completing the interventions by visual analog scale (VAS), range of motion (ROM) and Disabilities of the Arm, Shoulder and Hand Questionnaire (Q-DASH). KT and sham-KT applications were made by same clinician (N.M). For ultrasnogohraphic (US) measurements, the participants were sent to a clinician (D.G.K) who was blinded to the group allocation.

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least three positive results in the Hawkins-Kennedy, Neer, empty can, drop-arm, and lift-off tests
  • magnetic resonance imaging findings
  • age between 45 and 70 years

排除标准

  • Patients who received physical therapy for the shoulder region within the past three months or those with a history of injections to the shoulder joint,
  • cervical pathologies,
  • clinical conditions accompanied by neuromotor or sensory dysfunction,
  • history of malignancy,
  • pregnancies,
  • partial or total rupture in the supraspinatus tendon,
  • adhesive capsulitis,
  • diabetes or chronic liver, or kidney failure

结局指标

主要结局

Pain Level

时间窗: 4 weeks

The severity of shoulder pain (resting, activity, and night pain) in the patients was evaluated through the VAS score. A VAS score of 0 represented no pain, whereas a score of 10 represented the most severe pain; the patients were asked to mark the average severity of the pain they felt during the past week and the marked point was measured using a centimeter ruler and recorded.

Functional Status

时间窗: 4 weeks

Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire: This questionnaire comprises three sections. The first section comprises 30 items: 21 items assess the patient's difficulties in performing daily activities, 5 assess symptoms (pain, activity-related pain, tingling, stiffness, and weakness), and each of the remaining 4 items assesses social function, work, sleep, and self-confidence. All items are rated on a 5-point Likert-type scale (1, no difficulty; 2, mild difficulty; 3, moderate difficulty; 4, extreme difficulty; 5, cannot perform at all). The total score possible through this questionnaire ranges from 0 to 100 (0, no disability; 100, maximum disability). Furthermore, Turkish reliability and validity have been performed for this questionnaire.

Ultrasonography

时间窗: 4 weeks

US was performed using a 7.5-mHz linear probe in the B mode (Mindray-China). Supraspinatus tendon (SsT) thickness was measured at three different points (10, 15, and 20 mm) lateral to the tendon after identifying the biceps tendon in the transverse section and the average of measurements was recorded. Acromiohumeral distance (AHD) was assessed by linearly measuring the distance between the inferior of the acromion from the anterior of the shoulder and the superior of the humeral head

Joint range of motion measurements

时间窗: 4 weeks

Flexion (FLX), abduction (ABD), internal rotation (IR) and external rotation (ER) were measured using a goniometer (saehan gonıometer - plastıc).

次要结局

未报告次要终点

研究者

发起方
Kars State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatih Bagcier

Principal Investigator

Kars State Hospital

研究点 (2)

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