Back to resultsStructural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial. (EPTE)
Primary Purpose
Supraspinatus Tendinitis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental Group
Conventional group
Sponsored by
About this trial
This is an interventional treatment trial for Supraspinatus Tendinitis focused on measuring tendinopathy, electrolysis, exercise, dry needling, physiotherapy
Eligibility Criteria
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.
Sites / Locations
- Manuel Rodríguez Huguet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Percutaneous Electrolysis and neuromodulation.
Conventional group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
Electromyographic activity
Electromyography (EMG) measures and records the electrical activity of a muscle.
Strength of The rotator cuff
The use of the hand dynamometer to measure the strength of shoulder movements
Questionnaire DASH.
Functionality in the arm.
Scale SPADI.
Functionality in the arm.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05627102
Brief Title
Structural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial.
Acronym
EPTE
Official Title
Structural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cadiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraspinatus Tendinitis
Keywords
tendinopathy, electrolysis, exercise, dry needling, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A specialist physician will be diagnosed the supraspinatus tendinopathy.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Electrolysis and neuromodulation.
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental Group
Intervention Description
Therapeutic Percutaneous Electrolysis an neuromodulation associated with eccentric exercises devices at home.
Intervention Type
Other
Intervention Name(s)
Conventional group
Intervention Description
Ultrasound pulsatil therapy (US), transcutaneous electric nerve stimulation (TENS) for 20 minutes and associated with eccentric exercises devices at home.
Primary Outcome Measure Information:
Title
The intensity of shoulder pain
Description
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
Secondary Outcome Measure Information:
Title
The intensity of shoulder pain
Description
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
Title
The intensity of shoulder pain
Description
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
Title
The intensity of shoulder pain
Description
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
Title
Electromyographic activity
Description
Electromyography (EMG) measures and records the electrical activity of a muscle.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
Strength of The rotator cuff
Description
The use of the hand dynamometer to measure the strength of shoulder movements
Time Frame
Baseline, four, twelve weeks and twenty four weeks .
Title
Questionnaire DASH.
Description
Functionality in the arm.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
Scale SPADI.
Description
Functionality in the arm.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
Assessment of structural changes in the tendon by ultrasound evaluation
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
manuel manuel, Physiotherapy
Organizational Affiliation
University of Cádiz
Official's Role
Study Director
Facility Information:
Facility Name
Manuel Rodríguez Huguet
City
Cadiz
State/Province
Cádiz
ZIP/Postal Code
11008
Country
Spain
12. IPD Sharing Statement
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Structural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial.
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