Clinical Trials Logo
  1. Home
  2. Supraspinatus Tendinitis
  3. NCT05793918
  4. Details
NCT05793918 Clinical Trial

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

Supraspinatus Tendinitis Clinical Trial

Official title:
Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulation Therapy and Eccentric Exercise in Supraspinatus Tendinopathy: A Single-Blind Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05793918
Other study ID # Percutaneous Electrolysis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date September 15, 2023

Study information
Verified date August 2023
Source University of Cadiz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Therapeutic Percutaneous Electrolysis an neuromodulation
Therapeutic Percutaneous Electrolysis an neuromodulation associated with eccentric exercises devices at home.
• Conventional group
Ultrasound pulsatil therapy (US), transcutaneous electric nerve stimulation (TENS) for 20 minutes and associated with eccentric exercises devices at home.

Locations
Country Name City State
Spain Policlínica Santa María Cadiz Cádiz

Sponsors (1)
Lead Sponsor Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

References & Publications (15)

See more »

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary GROCS scale The multidimensional health related quality of life. Baseline, four, twelve weeks and twenty four weeks.
Secondary The jobe test Jobe's test assesses for possible supraspinatus weakness and/or impingement. Baseline, four, twelve weeks and twenty four weeks.
Secondary 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.
Secondary Hawkins-Kennedy test the Hawkins-Kennedy test is a test for impingement in the shoulder Baseline, four, twelve weeks and twenty four weeks.
See also
  Status Clinical Trial Phase
Completed NCT05627102 - Structural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial. N/A
Completed NCT03184181 - Application of Percutaneous Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise N/A
Withdrawn NCT05184985 - TrueRelief Efficacy for Supraspinatus Tendonitis N/A
Not yet recruiting NCT06386926 - Radial Shockwave Versus Ultrasound Phonophoresis N/A
Completed NCT05241977 - MINIMUM EFFECTIVE VOLUME OF BUPIVACAİNE FOR ANTERIOR SUPRASCAPULAR NERVE BLOCK
Not yet recruiting NCT05192746 - Radial Extracorporeal Shock Wave Therapy Versus High Power Pain Threshold Ultrasound Therapy in Supraspinatus Tendinitis N/A
Completed NCT04851951 - Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis
Completed NCT03744195 - Effect of Kinesotaping on Management of Supraspinatus Tendinitis N/A