Structural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial.

University of Cadiz50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Baseline

Secondary Outcomes

The intensity of shoulder pain

Time frame: Four weeks

The intensity of shoulder pain

Time frame: Twelve weeks

The intensity of shoulder pain

Time frame: twenty four weeks

Electromyographic activity

Electromyography (EMG) measures and records the electrical activity of a muscle.

Time frame: Baseline, four, twelve weeks and twenty four weeks.

Strength of The rotator cuff

The use of the hand dynamometer to measure the strength of shoulder movements

Time frame: Baseline, four, twelve weeks and twenty four weeks .

Questionnaire DASH.

Functionality in the arm.

Time frame: Baseline, four, twelve weeks and twenty four weeks.

Scale SPADI.

Functionality in the arm.

Time frame: Baseline, four, twelve weeks and twenty four weeks.

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.

Time frame: Baseline, four, twelve weeks and twenty four weeks.

Structural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes