Effects of Percutaneous Electrical Stimulation Combined With a Therapeutic Exercise Program in Patients With Chronic Supraspinatus Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
The aim of this clinical trial is to evaluate the effects of two percutaneous stimulation techniques-Percutaneous Electrical Stimulation (PENS) and Percutaneous Electrolysis (PE)-combined with a therapeutic exercise (TE) program for the shoulder joint complex, on pain and function in individuals with chronic supraspinatus tendinopathy.
The main question this study seeks to answer is: Would incorporating percutaneous electrical stimulation (PENS) of the axillary and suprascapular nerves and galvanic percutaneous stimulation (PE) of the supraspinatus tendon into a therapeutic exercise (TE) program for the shoulder joint complex improve therapeutic outcomes in terms of pain, function, and upper limb disability? Based on an exercise program in all groups, researchers will compare the efficacy of active PENS and PE, as well as placebo, in all their combinations.
Participants will undergo a 12-week exercise program, during which they will receive four sessions (one session per week) of active percutaneous electrical stimulation or a placebo during the first month.
Participants will:
- Visit the center on four separate occasions for results measurement.
- Keep a session log to verify adherence to the exercise program.
详细描述
Four study groups will be established, constituting the arms of the clinical trial.
Intervention Group 1 (EP + PENS + TE)
This group will consist of individuals with chronic supraspinatus tendinopathy who will receive a treatment consisting of four sessions of percutaneous electrical stimulation (one session per week) using a dual approach: applied to the supraspinatus tendon (using the electrical EP modality-percutaneous electrolysis) and to the axillary and suprascapular nerves (using the electrical PENS modality), together with a therapeutic exercise (TE) program aimed at strengthening the shoulder joint complex.
For the localization of the target structures in the affected shoulder-the supraspinatus tendon and the axillary and suprascapular nerves-a Logiq E R8 ultrasound device (General Electric®) with an L4-12T-RS transducer will be used.
The electrical stimulation program (EP and PENS) will be applied once per week for four weeks. The exercise program will be carried out for 12 weeks at home, with a supervised process of instruction and guidance regarding both the exercises and the prescribed dosage. To ensure treatment safety, particularly in the case of percutaneous electrical stimulation, a protocol for reporting and monitoring adverse effects will be implemented and maintained until 30 days after the last intervention.
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, Outcomes Assessor)
盲法说明
Researcher 1 - blinded to the treatment. Responsible for receiving the patient and verifying that they meet the inclusion criteria in order to offer them participation in the study.
Researcher 2 - blinded to the treatment. Responsible for conducting the assessments.
Researchers 3, 4, and 5 - Perform the interventions.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects attending the shoulder unit of the traumatology and orthopedic surgery service at Clínica HLA Vistahermosa (TraumaVist) who are clinically diagnosed with supraspinatus tendinopathy (M75.1 Rotator cuff tendinopathy - ICD-10), according to the following criteria (Desmeules et al., 2025).
- •Participants of both sexes, aged between 18 and 65 years, diagnosed with chronic supraspinatus tendinopathy, or any of the related terms, provided they also meet the conditions detailed below.
- •Painful symptoms associated with the insertion area of the supraspinatus tendon, present for at least 3 months, of non-traumatic origin, which increase with palpation (score equal to or greater than 3/10 on a numerical pain scale) and with resisted movements, and not associated with signs of nerve root irritation.
- •Structural changes in the supraspinatus tendon (tendinosis), observed via ultrasound or MRI, and confirmed by a specialist physician.
- •Positive results in at least 2 of the 5 assessment tests: Hawkins-Kennedy, Neer, Jobe, painful arc of motion, and resisted external rotation.
- •Attend the center, referred by a specialist in traumatology and orthopedics, with a prescription for physiotherapy treatment.
排除标准
- •Individuals with any of the following circumstances will be excluded:
- •Intratendinous calcification in the supraspinatus muscle.
- •Partial or complete tear of any rotator cuff structure.
- •Serious illnesses, diabetes, or systemic inflammatory disease.
- •Pregnant women (at any stage of pregnancy).
- •Presence of concomitant pathology in the affected shoulder joint complex at the time of recruitment (previous trauma, capsulitis, fracture and dislocation, history of surgery, entrapment neuropathies, among others).
- •Regular analgesic or anti-inflammatory pharmacological treatment, including corticosteroid injections in the area, within the 6 months prior to recruitment.
- •Difficulty understanding and following the intervention program, in any of its modalities (percutaneous electrical stimulation and exercises). • Individuals with belonephobia (fear of needles), or a contraindication for the application of either percutaneous electrical stimulation technique (EP or PENS).
- •High scores on the Tampa - TSK-11 kinesiophobia scale (≥36 points).
结局指标
主要结局
Pain Intensity
时间窗: - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)
The Numerical Pain Rating Scale (NPRS) will be used to estimate pain intensity. This scale assigns a number between 0 (no pain) and 10 (worst possible pain) (Farrar et al., 2001). Using this instrument, the patient will rate the intensity of the pain they feel at the worst time of day and the average level of pain experienced over the past week. This easy-to-complete, quick, and simple scale has shown a Minimal Detectable Change (MDC) of 1.3 to 2.8 points in patients with musculoskeletal problems and 1.7 points in subacromial pain syndrome.
Pressure Pain Threshold (PPT)
时间窗: - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)
The test will be performed using a mechanical pressure algometer at specific study points to determine the amount of pressure applied at which the sensation of pressure changes to pain. The patient will be seated in a comfortable and relaxed position. The procedure consists of applying the tip of the algometer perpendicular to the skin and maintaining a pressure that will be progressively increased until the pain threshold is reached. Subjects will be instructed to signal when this pressure pain threshold (PPT) is exceeded. The physiotherapist will take three measurements, with a 30-second rest period between each measurement, calculating the average value in kg.. Measurements will be taken on the affected side, in the subacromial space region (treatment area), in the upper trapezius muscle (midpoint between the neck and shoulder muscle fibers), in the ventral part of the middle head of the deltoid muscle (segmental area), and in the tibialis anterior muscle,
Function
时间窗: - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)
The Constat-Murley (CM) questionnaire is a commonly used, specific instrument for assessing overall shoulder joint function (Roy et al., 2010). The maximum score is 100 points, with 90 to 100 considered excellent, 80 to 89 good, 70 to 79 fair, and below 70 poor, although scores may vary with age. This tool includes a subjective assessment of the patient's pain and ability to perform daily activities (35 points), and an objective assessment of mobility and strength through physical examination (65 points). Its use has been specifically validated in shoulder arthroplasty, rotator cuff repair, adhesive capsulitis, and proximal humerus fractures. This tool has shown a Minimal Detectable Change (MDC) of 11.6 points in patients with subacromial impingement.
Disability
时间窗: - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)
The Shoulder Pain and Disability Index (SPADI) focuses on the degree of pain or disability caused by shoulder problems during the past week. It is a self-administered questionnaire consisting of two dimensions: one for pain and one for functional activities. The pain dimension comprises five questions about the severity of pain. Functional activities are assessed with eight questions, designed to measure the degree of difficulty a person has performing various activities of daily living that require the use of the upper extremities. The patient answers the questions using a visual analog scale (from 0 to 10), both in the pain dimension (0 equals no pain and 10 equals the worst pain imaginable) and in the disability dimension (0 equals no difficulty and 10 equals so difficult that help was required). In patients with subacromial pain syndrome, this questionnaire has shown a Minimal Detectable Change (MDC) of 20.5 points.
次要结局
- Overall Perception of Clinical Change(- Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3))
- Kinesiophobia(- Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3))
- Perceived self-efficacy with pain(- Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3))
- Adherence to the exercise program(- Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3))
研究者
JOSE VICENTE TOLEDO MARHUENDA
Principal Investigator
Universidad Miguel Hernandez de Elche