Clinical trial NCT05627102: Structural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial.
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
Overall status: COMPLETED
Phase: NA
Conditions: Supraspinatus Tendinitis
Keywords: tendinopathy
electrolysis
exercise
dry needling
physiotherapy
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A specialist physician will be diagnosed the supraspinatus tendinopathy.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The intensity of shoulder pain
timeFrame: Baseline
Secondary outcomes:
measure: The intensity of shoulder pain
timeFrame: Four weeks
measure: The intensity of shoulder pain
timeFrame: Twelve weeks
measure: The intensity of shoulder pain
timeFrame: twenty four weeks
measure: Electromyographic activity
timeFrame: Baseline, four, twelve weeks and twenty four weeks.
measure: Strength of The rotator cuff
timeFrame: Baseline, four, twelve weeks and twenty four weeks .
measure: Questionnaire DASH.
timeFrame: Baseline, four, twelve weeks and twenty four weeks.
measure: Scale SPADI.
timeFrame: Baseline, four, twelve weeks and twenty four weeks.
measure: Assessment of structural changes in the tendon by ultrasound evaluation
timeFrame: Baseline, four, twelve weeks and twenty four weeks.
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Manuel Rodríguez Huguet
state: Cádiz
Study officials:
affiliation: University of Cádiz
name: manuel manuel, Physiotherapy
role: STUDY_DIRECTOR
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