Structural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial.
- Conditions
- Supraspinatus Tendinitis
- Interventions
- Other: Experimental GroupOther: Conventional group
- Registration Number
- NCT05627102
- Lead Sponsor
- University of Cadiz
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Percutaneous Electrolysis and neuromodulation. Experimental Group 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. Conventional group Conventional group 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.
- Primary Outcome Measures
Name Time Method The intensity of shoulder pain Baseline 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).
- Secondary Outcome Measures
Name Time Method The intensity of shoulder pain twenty four weeks 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).
Strength of The rotator cuff Baseline, four, twelve weeks and twenty four weeks . The use of the hand dynamometer to measure the strength of shoulder movements
Questionnaire DASH. Baseline, four, twelve weeks and twenty four weeks. Functionality in the arm.
Electromyographic activity Baseline, four, twelve weeks and twenty four weeks. Electromyography (EMG) measures and records the electrical activity of a muscle.
Scale SPADI. Baseline, four, twelve weeks and twenty four weeks. Functionality in the arm.
Assessment of structural changes in the tendon by ultrasound evaluation Baseline, four, twelve weeks and twenty four weeks. Assessment of possible structural changes in the tendon by ultrasound evaluation of thickening, hypoechogenicity, and hypervascularity.
Trial Locations
- Locations (1)
Manuel Rodríguez Huguet
🇪🇸Cadiz, Cádiz, Spain