EPTE: Percutaneous Electrolysis, Ultrasound-Guided Percutaneous Neuromodulation Therapy and Eccentric Exercise in Supraspinatus Tendinopathy

Sponsor

University of Cadiz (Other)

Overall Status

Completed

CT.gov ID

NCT05627102

Collaborator

(none)

Enrollment

Location

Arms

11.5

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Supraspinatus Tendinitis	Other: Experimental Group Other: Conventional group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A specialist physician will be diagnosed the supraspinatus tendinopathy.A specialist physician will be diagnosed the supraspinatus tendinopathy.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2021

Actual Primary Completion Date :

Apr 15, 2022

Actual Study Completion Date :

Sep 30, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Percutaneous Electrolysis and neuromodulation.

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

Therapeutic Percutaneous Electrolysis an neuromodulation associated with eccentric exercises devices at home.

Active Comparator: 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.

Other: Conventional group

Ultrasound pulsatil therapy (US), transcutaneous electric nerve stimulation (TENS) for 20 minutes and associated with eccentric exercises devices at home.

Outcome Measures

Primary Outcome Measures

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

The intensity of shoulder pain [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).
The intensity of shoulder pain [Twelve 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).
The intensity of shoulder pain [Six months]
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).
Active shoulder range of motion [Baseline, four, twelve weeks and six months.]
Measured by a two branches goniometer
Pressure pain thresholds in supraspinatus trigger poin [Baseline, four, twelve weeks and six months.]
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. [Baseline, four, twelve weeks and six months.]
The multidimensional health related quality of life.
Questionnaire WOSI. [Baseline, four, twelve weeks and six months.]
Functionality in the arm.
Electromyographic activity [Baseline, four, twelve weeks and six months.]
Electromyography (EMG) measures and records the electrical activity of a muscle.
Strength of The rotator cuff [Baseline, four, twelve weeks and six months.]
The use of the hand dynamometer to measure the strength of shoulder movements
GROCS scale [Baseline, four, twelve weeks and six months.]
The multidimensional health related quality of life.
Questionnaire DASH. [Baseline, four, twelve weeks and six months.]
Functionality in the arm.
Scale SPADI. [Baseline, four, twelve weeks and six months.]
Functionality in the arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.