Effect of the Application of Real Dry Needling and Placebo Dry Needling Applied With and Without Ultrasound Guidance on the Infraspinatus Muscle in Shoulder Pain and Functionality in Patients Diagnosed With Rotator Cuff Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Pain (VAS)
研究概览
简要总结
The infraspinatus muscle is one of the four muscles that form the rotator cuff. The dry needling technique involves inserting a sterile needle to stimulate a myofascial trigger point with the aim of reducing pain and increasing range of motion and quality of life. This technique can be performed using ultrasound guidance, which allows us to visualize the needle at all times, but it can also be done using anatomical landmarks. This study includes a self-directed exercise plan for rotator cuff tendinopathy. Variables such as strength, shoulder functionality level, grip strength, and active range of motion will be measured. As part of the intervention, two dry needling sessions will be performed, 14 days apart, along with two different exercise programs. Three measurements will be taken, and the intervention will last for 6 weeks. The sample will be divided into four equal groups: Group 1: ultrasound-guided real dry needling; Group 2: ultrasound-guided placebo dry needling; Group 3: non-ultrasound-guided real dry needling; and Group 4: non-ultrasound-guided placebo dry needling
详细描述
Pathologies affecting the rotator cuff are the most common among shoulder patho-logies. The infraspinatus muscle is one of the four muscles that make up the rotator cuff. Dry needling is a technique used to reduce pain and increase the range of motion. The ul-trasound-guided technique involves using an ultrasound device to visualize the needle and guide it to the target tissue. Physical exercise helps improve tendon recovery. Objective: To evaluate the effect of real dry needling and placebo dry needling, whether ultrasound-guided or not, on pain (VAS), shoulder functionality (SPADI questionnaire), grip strength (Jamar dynamometer), and ac-tive range of motion (electronic goniometer). A total of 76 subjects diagnosed by a physician with rotator cuff tendinopathy based on imaging, aged between 18 and 60 years, and meeting the inclusion and exclusion criteria, were divided into 4 groups: Group 1 (real ultrasound-guided dry needling on the infraspinatus muscle + exercise), Group 2 (placebo ultrasound-guided dry needling on the infraspinatus muscle + exercise), Group 3 (real non-ultrasound-guided dry needling on the infraspinatus muscle + exercise), and Group 4 (placebo non-ultrasound-guided dry needling on the infraspinatus muscle + exercise). The dry needling technique will be applied twice: at the beginning and at 14 days. The intervention duration is 6 weeks.
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
- Single (Participant)
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
- •Patients aged between 18 and 60 years. Patients diagnosed with rotator cuff tendinopathy by a physician. The physician must have determined this diagnosis based on an imaging test: ultrasound or MRI. Presence of a taut band in the infraspinatus muscle with active trigger points that reproduce the patient's symptoms upon pressure.
排除标准
- •High-level athletes, patients diagnosed with capsulitis, patients with a history of humeral or scapular fracture, patients with a complete or partial rotator cuff tear, patients diagnosed with cancer, and patients with any contraindications related to dry needling, patients who have previously undergone shoulder surgery, patients with a history of shoulder dislocation, patients diagnosed with fibromyalgia, patients taking medication for shoulder pain, and pregnant patients
研究组 & 干预措施
Real ultrasound-guided dry needling on the infraspinatus muscle + exercise
Patients who undergo ultrasound-guided real dry needling, using the ultrasound to visualize the needle, and who follow an exercise program.
干预措施: Dry needling with and without ultrasound guidance (Procedure)
Placebo ultrasound-guided dry needling on the infraspinatus muscle + exercise
Patients who will undergo ultrasound-guided placebo dry needling on the infraspinatus muscle and will follow an established exercise protocol.
干预措施: Dry needling with and without ultrasound guidance (Procedure)
Non-ultrasound-guided real dry needling on the infraspinatus muscle + exercise
Patients who will undergo non-ultrasound-guided dry needling on the infraspinatus muscle and will follow an established exercise protocol
干预措施: Dry needling with and without ultrasound guidance (Procedure)
Non-ultrasound-guided placebo dry needling on the infraspinatus muscle + exercise
Patients who will undergo non-ultrasound-guided placebo dry needling on the infraspinatus muscle and will follow an established exercise protocol
干预措施: Dry needling with and without ultrasound guidance (Procedure)
结局指标
主要结局
Pain (VAS)
时间窗: Before starting the treatment, at the end of the treatment, and six months after completing the treatment
To assess the pain variable, the Visual Analog Scale (VAS) will be used. This scale consists of a range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. The patient autonomously selects a number from this scale based on the level of pain they feel
次要结局
- Shoulder functionality(Before starting the treatment, at the end of the treatment, and six months after completing the treatment)
- Grip strength(Before starting the treatment, at the end of the treatment, and six months after completing the treatment)
- Active range of motion(Before starting the treatment, at the end of the treatment, and six months after completing the treatment)
研究者
Enrique Coca
Student
University of Alcala