An interventional study of Experimental Group and Conventional group in Supraspinatus Tendinitis, sponsored by University of Cadiz. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by University of Cadiz · Not applicable, Interventional, and Treatment
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.
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.
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 339 interventional studies indexed under Tendinopathy.
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Exclusion Criteria:
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: Experimental 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.
Other: Conventional group
Therapeutic Percutaneous Electrolysis an neuromodulation associated with eccentric exercises devices at home.
Ultrasound pulsatil therapy (US), transcutaneous electric nerve stimulation (TENS) for 20 minutes and associated with eccentric exercises devices at home.
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).
Time frame: Baseline
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).
Time frame: 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).
Time frame: Twelve 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).
Time frame: twenty four weeks
Electromyographic activity
Electromyography (EMG) measures and records the electrical activity of a muscle.
Time frame: Baseline, four, twelve weeks and twenty four weeks.
Strength of The rotator cuff
The use of the hand dynamometer to measure the strength of shoulder movements
Time frame: Baseline, four, twelve weeks and twenty four weeks .
Questionnaire DASH.
Functionality in the arm.
Time frame: Baseline, four, twelve weeks and twenty four weeks.
Scale SPADI.
Functionality in the arm.
Time frame: Baseline, four, twelve weeks and twenty four weeks.
Assessment of structural changes in the tendon by ultrasound evaluation
Assessment of possible structural changes in the tendon by ultrasound evaluation of thickening, hypoechogenicity, and hypervascularity.
Time frame: Baseline, four, twelve weeks and twenty four weeks.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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University of Cadiz