Effectiveness of Diacutaneous Fibrolysis on Pain and Mobility in Patients Suffering From Painful Shoulder. A Randomized Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Active Flexion Movement After Intervention Minus Baseline
研究概览
简要总结
While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its effectiveness has not been tested in clinical trials. The investigators hypothesized that the use of DF in patients suffering from painful shoulder would increase the active mobility and reduce the pain during movement. To test the hypothesis a double blind (patient and investigator) randomized clinical trial was carried out in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session.
详细描述
Background and objectives:
Diacutaneous fibrolysis (DF) is a manual technique to treat the mechanical pain of the musculoskeletal system. While this technique has achieved promising results empirically, its effectiveness has not been tested in clinical trials. We aimed at evaluating the effectiveness of a single session of DF on pain and mobility in patients suffering from painful shoulder.
Subjects and methods:
This clinical trial took place in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session. The degree of active mobility (flexion, abduction, extension, external and internal rotation), the pain in the hand behind back position and the participant's perception of the technique in terms of comfort and results obtained were measured.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age
- •being referred for treatment of painful shoulder (except for adhesive capsulitis)
- •not having been previously treated with DF
排除标准
- •Damaged skin and/or cutaneous lesions in the shoulder area
- •History of shoulder surgery
- •Vascular abnormalities
- •Platelet antiaggregant therapy
- •Acute inflammatory condition of the shoulder (<1 week)
- •Patients with a pending litigation or court claim
结局指标
主要结局
Change in Active Flexion Movement After Intervention Minus Baseline
时间窗: Baseline and the same day (just after intervention)
A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Change in Active Abduction Movement After Intervention Minus Baseline
时间窗: Baseline and the same day (just after intervention)
A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination
Change in Active extensión Movement After Intervention Minus Baseline
时间窗: Baseline and the same day (just after intervention)
A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Change in Active External Rotation After Intervention Minus Baseline
时间窗: Baseline and the same day (just after intervention)
A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward)
Change in Active Internal Rotation After Intervention Minus Baseline
时间窗: Baseline and the same day (just after intervention)
Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility
次要结局
- Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline(Baseline and the same day (just after intervention))