Back to resultsPercutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulationtherapy and Eccentric Exercise in Supraspinatus Tendinopathy.
Primary Purpose
Supraspinatus Tendinitis
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic Percutaneous Electrolysis an neuromodulation
Conventional group
Sponsored by
About this trial
This is an interventional treatment trial for Supraspinatus Tendinitis focused on measuring tendinopathy, electrolysis, exercise, dry needling
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
- Policlínica Santa María
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Percutaneous Electrolysis and neuromodulation.
Control 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).
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.
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.
Active shoulder range of motion
The range of motion will be evaluated in flexion, extension, internal rotation, external rotation and abduction with a goniometric
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.
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.
GROCS scale
The multidimensional health related quality of life.
The jobe test
Jobe's test assesses for possible supraspinatus weakness and/or impingement.
The Neer test
The Neer test is performed to check for compression of the rotator cuff tendons at the coracoacromial arch.
Hawkins-Kennedy test
the Hawkins-Kennedy test is a test for impingement in the shoulder
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05793918
Brief Title
Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulationtherapy and Eccentric Exercise in Supraspinatus Tendinopathy.
Official Title
Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulationtherapy and Eccentric Exercise in Supraspinatus Tendinopathy.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
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
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
None (Open Label)
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
46 (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
Control 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)
Therapeutic Percutaneous Electrolysis an neuromodulation
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
Questionnaire DASH.
Description
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.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
Scale SPADI.
Description
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.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
Active shoulder range of motion
Description
The range of motion will be evaluated in flexion, extension, internal rotation, external rotation and abduction with a goniometric
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
Pressure pain thresholds in supraspinatus trigger points
Description
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.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
Questionnaire SF 12
Description
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.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
GROCS scale
Description
The multidimensional health related quality of life.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
The jobe test
Description
Jobe's test assesses for possible supraspinatus weakness and/or impingement.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
The Neer test
Description
The Neer test is performed to check for compression of the rotator cuff tendons at the coracoacromial arch.
Time Frame
Baseline, four, twelve weeks and twenty four weeks.
Title
Hawkins-Kennedy test
Description
the Hawkins-Kennedy test is a test for impingement in the shoulder
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 rodriguez huguet, Physiotherapy
Organizational Affiliation
University of Cádiz
Official's Role
Study Director
Facility Information:
Facility Name
Policlínica Santa María
City
Cadiz
State/Province
Cádiz
ZIP/Postal Code
11007
Country
Spain
12. IPD Sharing Statement
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18812414
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Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulationtherapy and Eccentric Exercise in Supraspinatus Tendinopathy.
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