Psychomotor Therapy as Complimentary Treatment to Patients With Shoulder Pain - a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Patient reported function and pain on the "Disability in the Arm, Shoulder and Hand (DASH) questionnaire"
研究概览
简要总结
Some patients with shoulder pain have decreased body awareness (BA). To some degree, pain among these patients can be increased due to their lack in BA. Psychomotor therapy is thought to improve BA and thereby increase the effect of traditional therapy, such as physiotherapy and exercises.
The aim of this study is therefore to investigate if psychomotor therapy, as a complimenting treatment to physiotherapy, decreases shoulder patients' function deficits and pain reported on PRO's, compared to physiotherapy alone.
详细描述
Study design:
This trial, is a randomised, controlled, observer-blinded superiority trial, with a two-group parallel design, to be conducted in Denmark. The primary endpoint will be 12 weeks after baseline. Patients will be randomised to either "Intervention+Usual Care" or "Usual Care" (block randomization with a 1:1 allocation).
Settings and locations:
Patients will be recruited from the shoulder unit at the outpatient clinic, orthopaedic department at Hospital Lillebaelt - Vejle Hospital.
Randomisation and allocation concealment:
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>three months of should pain
- •Disturbed sleep due to shoulder pain
- •VAS resting pain above 2 OR VAS activity pain above 5
- •MAIA score <= 3
- •Read and understand Danish.
排除标准
- •Frozen shoulder
- •Glenohumeral (GH) arthritis
- •Rotator Cuff (RC) rupture
- •GH instability
- •Acromioclavicular joint arthritis
- •Operation in the shoulder joint within the last six months
- •Cervical problems
- •Psychiatric diagnosis
- •Alcohol or drug abuse
研究组 & 干预措施
Physiotherapy + Corticosteroid injection + Psychomotor therapy
Usual care + intervention
干预措施: Psychomotor therapy (Other)
Physiotherapy + Corticosteroid injection + Psychomotor therapy
Usual care + intervention
干预措施: Physiotherapy (Other)
Physiotherapy + Corticosteroid injection + Psychomotor therapy
Usual care + intervention
干预措施: corticosteroid injection (Drug)
Physiotherapy + Corticosteroid injection
Usual care
干预措施: Physiotherapy (Other)
Physiotherapy + Corticosteroid injection
Usual care
干预措施: corticosteroid injection (Drug)
结局指标
主要结局
Patient reported function and pain on the "Disability in the Arm, Shoulder and Hand (DASH) questionnaire"
时间窗: Change from baseline DASH at 12 weeks
Patient reported generic shoulder outcome questionnaire (questions upon function and pain related limitations).
次要结局
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(Change from baseline MAIA at 24 weeks)
- Hospital Anxiety and Depression score (HAD)(Change from baseline HAD at 24 weeks)
- Pain on the NRS Scale(Change from baseline NRS at weeks 1-24)