Application of Percutaneous Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise

Not Applicable

Completed

• Conditions: Supraspinatus Tendinitis
• Interventions: Other: EPTE® group; Other: Dry needling group

• Registration Number: NCT03184181
• Lead Sponsor: University of Cadiz

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 (EPTE®). This technique enables treatment of the tendinopathies and the broken muscle fibrilare. It is base on the application of galvanic current through a acupuncture needle. To analyze the effectiveness of therapeutic percutaneous electrolysis (EPTE®) 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: EPTE® associated with eccentric exercises or dry needling 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.

Study Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-12
• Study Start: 2017-11-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-02-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPTE® group	EPTE® group	The intervention for this group consisted of Therapeutic Percutaneous Electrolysis (EPTE®). Patient received EPTE® once week for four weeks associated with eccentric exercises device at home.
Dry needling group	Dry needling group	The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises device at home. Patient received 3 sessions of dry needling a week for four weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The intensity of shoulder pain	One year	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 weeks and one year.	Measured by a two branches goniometer
Pressure pain thresholds in supraspinatus trigger points	Baseline, four weeks and one year.	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.

Trial Locations

Locations (1)

Policlínica Santa María; 🇪🇸 Cadiz, Cádiz, Spain