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临床试验/NCT04440046
NCT04440046已完成不适用

Real Versus Sham Manual Therapy in Addition to Therapeutic Exercise in the Treatment of Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial

University of Alcala1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Shoulder Pain and Disability Index (SPADI)

研究概览

简要总结

A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks.

The hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with RCRSP.

详细描述

The objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain.

For this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied.

The investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •unilateral shoulder pain of non-traumatic origing lasting more than three months.
  • •Pain evoked with active shoulder movements.
  • •Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation.
  • •Minimal or no rest pain (less than 3 points in a numeric pain rating scale).

排除标准

  • •Other shoulder pathologies than RCRSP.
  • •Systemic diseases.
  • •Neural symptoms.
  • •Neck pain.
  • •Radiculopathy.
  • •To have been treated for shoulder pain in the last three months.

研究组 & 干预措施

Real manual therapy

Experimental

Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program

干预措施: Manual therapy thoracic spine (Other)

Real manual therapy

Experimental

Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program

干预措施: Manual therapy glenohumeral joint (Other)

Real manual therapy

Experimental

Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program

干预措施: Therapeutic exercise (Other)

Sham thoracic manual therapy

Sham Comparator

Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

干预措施: Manual therapy glenohumeral joint (Other)

Sham thoracic manual therapy

Sham Comparator

Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

干预措施: Sham thoracic manual therapy (Other)

Sham thoracic manual therapy

Sham Comparator

Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

干预措施: Therapeutic exercise (Other)

Sham manual therapy

Sham Comparator

Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

干预措施: Sham thoracic manual therapy (Other)

Sham manual therapy

Sham Comparator

Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

干预措施: Sham glenohumeral manual therapy (Other)

Sham manual therapy

Sham Comparator

Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

干预措施: Therapeutic exercise (Other)

结局指标

主要结局

Shoulder Pain and Disability Index (SPADI)

时间窗: Change from Baseline at 17- week

The SPADI points from 0 (no disability) to 130 (maximum degree of disability)

次要结局

  • Pain intensity measured with a visual analogue scale(Change from Baseline at 17-week)
  • Pain-free range of movement of the shoulder(Change from Baseline at 17-week)

研究者

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

Prof. Dr. Daniel Pecos Martín

Principal Investigator

University of Alcala

研究点 (1)

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