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临床试验/NCT07131839
NCT07131839已完成不适用

Effects of Central Sensitization Presence on the Results of Shoulder Adhesive Capsulitis Treatment With Physical Therapy Agents and Exercise

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

Patients with adhesive capulitis longlasting more than 3 months were participated in the study. they were divided into two groups whether they have central sensitizaiton or not. Conventional physical therapy responses were measured and compared between two groups.

详细描述

Adhesive capsulitis is a well known musculoskeletal syndrome that effects daily living activities and patiemts suffer from chronic shoulder pain. Central sensitization has been defined in patients with chronic pain due to amplified neuronal connections and signals in the central nervous system. Previously, it was shown that refractory long lasting musculoskeletal disorders may show challenging treatment process and decreased outcome due to central sensitization. However to the best of our knowledge there was not any study that evaluates the treatment response of presence of central sensitization in adhesive capsulitis patients. Total of 32 adhesive capsulitis patients were particapted in the study. Sixteen patients with adhesive capsulitis with (Group 1) and without central sensitization (Group 2) were received conventional physical therapy and exercise. Treatment response were evaluated with Visual Analog Scale (VAS), Shoulder pain and disability index (SPADI) Tampa Kinesiophobia Scale (TKS) and Pain Catastrophizing Scale (PCS). Additionally shoulder range of motion was measured at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2).

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with adhesive capsulitis between 18-80 years old 2) symptoms ongoing more than 3 months 3) willing to participated in the study

排除标准

  • patients with cervical radiculopathy 2) Patients with predisposing factors to adhesive capsulitis, such as diabetes mellitus, thyroid disease, coronary artery disease, lung pathologies or tuberculosis 3) any defined central sensitization syndrome such as fibromiyalgia before 4) presence of rheumatologic diseases 5) pregnancy 6) patients underwent bypass surgery or who have cardiac pacemaker 7) patients with septic arthritis or sepsis 8) malignancy 9) patients that underwent surgery through the shoulder region or had injection through the shoulder joint in the last 3 months.

结局指标

主要结局

Visual Analog Scale

时间窗: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

A 10 cm VAS, with known validity and reliability, was used as a self-reported measure for the severity of joint pain.

Shoulder Pain Disability Index (SPADI)

时间窗: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

This questionnaire was developed to assess shoulder joint pain and disability. The SPADI has two sections; first section contains 5 questions to evaluate pain, whereas second item contains 8 questions to evaluate disability. Scores vary 0-130 and higher scores indicates high disability rates and pain

Measurement of Shoulder range of motion

时间窗: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

The same physician performed the measurement for the joint ranges in each plane of the joint with a goniometer. The goniometer's pivot point was positioned on the lateral projection of the shoulder joint while subjects in supine position. The fixed arm aligned parallel to the axillary lateral midline , while the movable arm tracked the humerus' lateral midline movement towards the axilla. The joint was passively forced to the end of the direction of range and measured twice and the average was taken

次要结局

  • Tampa Kinesiophobia Scale (TKS)(at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2))
  • Pain Catastrophizing Scale (PCS)(at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2).)
  • Beck Depression Inventory (BDI)(at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hüma Bölük Şenlikci

Associate Prof

Ankara City Hospital Bilkent

研究点 (1)

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