跳至主要内容
临床试验/NCT03815669
NCT03815669终止不适用

Improving Quality of Treatment for Shoulder Patients

University of Aarhus1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
58
试验地点
1
主要终点
Treatment effect

研究概览

简要总结

Introduction:

Previous studies indicate that patient characteristics and clinical and psychological factors are related to the effect of surgical treatment but more knowledge about predictors is important in the selection of patients for arthroscopic subacromial decompression.

Objective:

To identify patient characteristics and clinical and psychological factors for pre-operatively predicting the effect of arthroscopic subacromial decompression.

Method:

Patients meting the inclusion criteria will consecutively be enrolled in the study when referred to arthroscopic subacromial decompression. Prior to surgery, patient characteristics and clinical data will be collected. At six and twelve month postoperatively, the effect of the surgical treatment will be assessed. The relationship between effect of surgery and patient characteristics and clinical factors collected at baseline will be examined.

详细描述

Introduction: Shoulder disorders are the third most common musculoskeletal reason for seeking medical care and accounts for approximately 1% of all visits to the general practitioner and for up to 10% of all referrals to physiotherapists. The prevalence of shoulder disorders has been reported to range from 7% to 26% with some indication that the prevalence increases with age. Subacromial impingement syndrome (SIS) is usually described as a symptomatic irritation of the rotator cuff and the subacromial bursa, and it is considered as one of the most common shoulder disorders. Patients with SIS may present symptoms such as pain during activity, pain at night, loss of muscle strength, and stiffness. Because the shoulder stabilizes the upper limb in its activities, these symptoms affect the performance of tasks essential to daily living. Shoulder disorders produce significant impairments in function and health related quality of life (HR-QoL), and results in substantial health care utilization. SIS frequently affects the working population and is an important cause of sick leave.

Treatment of SIS consists of either conservative- or surgical treatment. Conservative treatments include rest, physiotherapy, non-steroid anti inflammatory drugs (NSAID) and glucocorticoid injections, while surgical treatment consists of arthroscopic or open subacromial decompression, bursectomy and rotator cuff repair. Physiotherapy interventions are recommended as first choice of treatment, while surgical treatment can be considered for those who fail to respond to conservative treatment after 3-6 months. Several studies comparing the effect of arthroscopic subacromial decompression (ASAD) and supervised physiotherapy exercises, have found no significant differences in outcomes between the two treatment strategies.

In Denmark, the number of patients with SIS has increased by 36% from 2006 to 2010. The number of patients treated surgically has increased by 60% to approximately 6500 a year in the same period. Similar increases are reported in other countries.

The literature indicates that some patients do not benefit from ASAD, and success rates between 65-80% have been reported. In Denmark, 10% of employed patients retire prematurely within two years after surgery. Results of studies investigating if ASAD is more effective in selected subgroups of patients showed that clinical and radiological factors and patient characteristics such as sociodemographic, duration of symptoms and duration of sick leave, were associated with the effect of treatment. In addition, psychological factors are reported to impact outcome in both shoulder patients, and other orthopaedic patients. A preoperative scoring system to select patients for ASAD has been developed. However, this focuses on clinical and radiographic factors, and does not consider patient characteristics and psychological factors. Knowledge about predictors for the effect of ASAD in a broader perspective will be of great importance, from both a patient- and an economic perspective.

Aim: The overall aim of the study is to identify patient characteristic and clinical and psychological factors that preoperatively can predict which patients will achieve effect of ASAD. Furthermore, to investigate the quality of objective methods to assess shoulder function, and the association between patient reported outcome measures (PROMs) and objective outcome measures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • treated with arthroscopic subacromial decompression

排除标准

  • Frozen shoulder, full-thickness tear, osteoarthritis, trauma, cancer or neurologic disorders
  • Previous surgical treatment in the affected shoulder

结局指标

主要结局

Treatment effect

时间窗: 12 month postoperatively

Patient evaluated success of treatment, 5 point Likert scale, Posible answers: much improved, moderate improved, unchanged, moderate worse, much worse

Comorbidity

时间窗: Baseline

Charlson comorbidity index

Function

时间窗: 12 month postoperatively

Questionnaire, Oxford Shoulder Score (OSS) 12 questions, each rated on a 5 point Likert scale from 1 to 5, total sum score reported, minimum score 12, maximun score 60, higher scores represent worst outcome

Pain self-efficacy

时间窗: 12 month postoperatively

Questionnaire, Pain Self-Efficacy Questionnaire 10 questions, each question rated on a 7-point numeric rating scale from 0 to 6, total sum score reported, minimum score 0, maximun score 60, higher scores indicate greater self-efficacy

Anxiety and depression

时间窗: 12 month postoperatively

Questionnaire, Hospital Anxiety and Depression Scale (HADS) 14 questions, 7 questions related to the subscale Anxiety, 7 questiion related to the subscale Depression, each question rated on a 4-point Likert scale from 0 to 3, total sum score for each subscale reported, higher scores indicate worse outcome

Range of motion (ROM)

时间窗: 6 month postoperatively

Internal and external rotation, abduction and flexion

Health related quality of life

时间窗: 12 month postoperatively

Questionnaire, EQ-5D-5L 5 questions representing 5 dimentions, each question rated on a 5-point Likert scale from 1 to 5, higher scores indicate worse outcome, EQ VAS scale representing overall Health status, rated from 0 to 100, higher score indicate better outcome

Pain, VAS

时间窗: 6 month postoperatively

Pain at rest, activity and at night, Visual Analogue Scale (VAS) Scale rating form 0 to 10, higher score indicate worse outcome

Muscle strength

时间窗: 6 month postoperatively

Internal and external rotation, abduction

Motor and process skills

时间窗: 6 month postoperatively

The Assessment of Motor and Process Skills (AMPS)

Return to work

时间窗: Baseline

Duration of sick leave

Fear-Avoidance beliefs

时间窗: 12 month postoperatively

Questionnaire, Fear-Avoidance Beliefs Questionnaire (FABQ) 16 items, 4 items related to the physical activity subscale, 7 items related to the Work subscale, 5 items not used in the scoring, each item rated on a 7-point Likert scale from 0 to 6, total sumscore for each subscale reported, minimum scores 0, maximum scores for the physical activity subscale 24, maximal score for the Work subscale 42, higher scores indicate worse outcome

次要结局

  • Pain self-efficacy(6 month postoperatively)
  • Health related quality of life(6 month postoperatively)
  • Function(6 month postoperatively)
  • Anxiety and depression(6 month postoperatively)
  • Treatment effect(6 month postoperatively)
  • Fear-Avoidance beliefs(6 month postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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