Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulationtherapy and Eccentric Exercise in Supraspinatus Tendinopathy.

Study Overview
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Brief Summary
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The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of awareness about the options of the physiotherapist treatment. It is necessary to do studies about effectiveness of therapeutic percutaneous electrolysis and neuromodulation. This technique enables treatment of the tendinopathies. To analyze the effectiveness of therapeutic percutaneou electrolysis and neuromodulation in the treatment of supraspinatus muscle tendinopathy. Single center randomized controlled trial, parallel treatment design. A specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants will be randomly assigned to receive treatmen for 4 weeks: percutaneou electrolysis and neuromodulation associated with eccentric exercises or conventional treatment of Physiotherapy with the same eccentric exercises. Both interventions were performed under ultrasound guidance with a portable ultrasound (General Electric LogicE). Data will be collected by a blinded evaluator.

Detailed Description
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Eccentric exercises of the supraspinatus muscle were performed in 3 sets of 10 repetitions. Participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the supraspinatus, infraspinatus, and scapular muscles. Participants were asked to do a normal abduction (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. The exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.

Official Title
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Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulationtherapy and Eccentric Exercise in Supraspinatus Tendinopathy.

Conditions
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Supraspinatus Tendinitis

Intervention / Treatment
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* Other: Therapeutic Percutaneous Electrolysis an neuromodulation
* Other: Conventional group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with supraspinatus tendinopathies that do not improve with conventional physiotherapy or pharmacological therapy protocols. Subjects who are in an active state of pain, who present painful symptoms in a sensitive and painful area of the tendon of insertion of the supraspinatus muscle in the humerus. Exclusion Criteria: Individuals who have received surgery intervention in the same shoulder, or have suffered fractures or dislocations in the same shoulder. Individuals have received the proposed treatment in one month´s period previously. Individuals who suffering from cervical radiculopathies, fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema. Pregnant women can not receive this treatment intervention.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A specialist physician will be diagnosed the supraspinatus tendinopathy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Electrolysis and neuromodulation.<br>The intervention for this group consisted of Therapeutic Percutaneous Electrolysis and neuromodulation. Patient received once week for four weeks associated with eccentric exercises device at home. | Other: Therapeutic Percutaneous Electrolysis an neuromodulation<br>* Therapeutic Percutaneous Electrolysis an neuromodulation associated with eccentric exercises devices at home.<br>|
| Active Comparator: Control group<br>The multimodal physical therapy program includes 10 sessions of: Ultrasound pulsatil therapy (US) for 10 minutes , transcutaneous electric nerve stimulation (TENS) for 20 minutes ans associated with eccentric exercises device at home. | Other: Conventional group<br>* Ultrasound pulsatil therapy (US), transcutaneous electric nerve stimulation (TENS) for 20 minutes and associated with eccentric exercises devices at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intensity of shoulder pain | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. The minimal clinically important difference (MCID) for the NPRS in patients with shoulder pain was 1.1 points (Mintken, Glynn, and Cleland 2009). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intensity of shoulder pain. | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. The minimal clinically important difference (MCID) for the NPRS in patients with shoulder pain was 1.1 points (Mintken, Glynn, and Cleland 2009). | Four weeks | 
| The intensity of shoulder pain | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. The minimal clinically important difference (MCID) for the NPRS in patients with shoulder pain was 1.1 points (Mintken, Glynn, and Cleland 2009). | Twelve weeks | 
| Questionnaire DASH. | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-re, four, twelve weeks and twenty four weeks. | Baseline, four, twelve weeks and twenty four weeks. | 
| Scale SPADI. | The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Both dimensions account for 50% of the overall score, and scores from 0 to 100. | Baseline, four, twelve weeks and twenty four weeks. | 
| Active shoulder range of motion | The range of motion will be evaluated in flexion, extension, internal rotation, external rotation and abduction with a goniometric | Baseline, four, twelve weeks and twenty four weeks. | 
| Pressure pain thresholds in supraspinatus trigger points | Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline, Pain TestTM, Wagner Instruments). The clinimetric properties of this instrument have been evaluated previously. The PPT will the point at which pressure elicited pain and will presented as kilograms per square centimeter. All measurements will be conducted by the same well-trained physician. | Baseline, four, twelve weeks and twenty four weeks. | 
| Questionnaire SF 12 | SF-12 questionnaire is a reliable measure of perceived health that describes the degree of general physical health status and mental health distress. It consists of 12 items, derived from the physical and mental domains. In our study SF-12 was considered altered if the score was <40, either from the physical or mental functioning point of view, because means of 50 and standard deviations of 10 are usually achieved in the general population. | Baseline, four, twelve weeks and twenty four weeks. | 
| GROCS scale | The multidimensional health related quality of life. | Baseline, four, twelve weeks and twenty four weeks. | 
| The jobe test | Jobe's test assesses for possible supraspinatus weakness and/or impingement. | Baseline, four, twelve weeks and twenty four weeks. | 
| The Neer test | The Neer test is performed to check for compression of the rotator cuff tendons at the coracoacromial arch. | Baseline, four, twelve weeks and twenty four weeks. | 
| Hawkins-Kennedy test | the Hawkins-Kennedy test is a test for impingement in the shoulder | Baseline, four, twelve weeks and twenty four weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tendinopathy, electrolysis, exercise, dry needling