Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Visual analgesic pain scale (VAS)
研究概览
简要总结
The objective of this systematic alternating prospective experimental longitudinal analytical clinical trial is to compare the mean differences in Visual analgesic scale (VAS) at 1 month, 3 months and 6 months depending on the treatment received, ultrasound-guided barbotage (US-PICT) or shock waves (ESWT), in patients with calcifying tendinopathies according to the lesion based on the Bianchi Martinolli classification, as well as to know if there are variations in functionality with the Latinen test, joint balance, patient global improvement impression scale (PGI-I), global improvement impression scale (CGI - GI).
For this purpose, patients between 30 and 60 years old, with chronic shoulder pain for more than 3 months due only to calcifying tendinopathies who have not received these previous treatments will be selected.
The main question to be answered is:
Do patients with calcifying tendinopathies of the shoulder, in its different degrees, who have received as treatment barbottage, obtain the same VAS differences at 1 month, 3 month and 6 month as patients who received as treatment shock waves in the population?
Patients will be sorted into two arms according to the Bianchi Martinoli classification (I or II/ III) and subsequently included in groups according to the treatment received. The decision to treat with one or the other therapy will be made randomly 1:1, depending on the treatment assigned to the previous patient. An initial consultation and 3 revisions (1 month, 3 months and 6 months) will be performed after the end of therapy.
The following variables will be collected VAS, Lattinen test, joint balances (ROM) (flexion, abduction and external and internal rotation), PGI-I, CGI - GI.
详细描述
Shoulder pain is a very common health issue among adults, being 8% due to calcifying tendinopathies of the shoulder (CT). The evolutionary process of this lesion can be classified according to Bianchi Martinoli as I: hard, II: semi-soft and III: soft due to their ultrasound appearance.
In 50% of cases, with first-line treatments such as kinesitherapy and taking anti-inflammatories, they resolve spontaneously. However, in the remaining 50% they become chronic, requiring other lines of treatment such as shock waves (ESWT) or ultrasound-guided barbotage (US-PICT).
Starting hypothesis:
Patients with CT, in its different degrees, who have received barbottage as treatment, obtain the same VAS differences at 1 month, 3 months and 6 months as patients who received ESWT as treatment in the population.
Main objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Although neither patients nor treating physicians could be blinded due to the evident technical differences between the two procedures, the statistical analysis was performed under blinded conditions. Once the follow-up period was completed, the data were transferred to a database from which all personal identifiers and any information regarding treatment allocation were removed. The two treatment groups were masked using neutral, non-identifying labels, so that the analyst had no knowledge of which intervention corresponded to each group. The analyst, who had no prior contact with the patients and was not involved in the recruitment, treatment, or follow-up phases, therefore conducted all analyses blinded to group allocation. This procedure was implemented to minimize interpretation bias and to strengthen the internal validity of the results.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 30 - 60 years.
- •Omoalgia lasting more than 3 months.
- •Radiographic and ultrasound visualization in both planes of calcification.
- •Sizes > 5 millimeters (mm).
排除标准
- •Patients who do not meet inclusion criteria.
- •Presence of another obvious cause of pain (joint degeneration, capsulitis, rotator cuff tendon tears...)
- •Previously received barbotage or shock waves.
- •Contraindication of therapies: infection, allergies to medications, cancer...
研究组 & 干预措施
Type II/III calcifications
Type II/III calcifications according to the Bianchi Martinoli classification
干预措施: Barbotage (Procedure)
Type I calcifications
Type I calcifications according to the Bianchi Martinoli classification
干预措施: Barbotage (Procedure)
Type I calcifications
Type I calcifications according to the Bianchi Martinoli classification
干预措施: shockwave therapy (Procedure)
Type II/III calcifications
Type II/III calcifications according to the Bianchi Martinoli classification
干预措施: shockwave therapy (Procedure)
结局指标
主要结局
Visual analgesic pain scale (VAS)
时间窗: 6 months
The VAS will be measured in the initial consultation and at 1, 3 and 6 months after the intervention and a new variable "VAS Difference" (DifVAS) will be created for each corresponding VAS level in the review consultations.
次要结局
- Latineen test(6 months)
- Patient Global Patient Improvement Impression Scale (PGI-I)(6 months)
- Global CGI - GI Impression of Global Improvement Scale (CGI - GI)(6 months)
- Shoulder joint balances (ROM)(6 months)
- Latineen test(6 months)
- Patient Global Patient Improvement Impression Scale (PGI-I)(6 months)
- Global CGI - GI Impression of Global Improvement Scale (CGI - GI)(6 months)
- Shoulder joint balances (ROM)(6 months)
研究者
Javier Muñoz Paz
Medicine ( Principal Investigator)
Maimónides Biomedical Research Institute of Córdoba