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Trial record 2 of 17 for:    supraspinatus | Spain

Effectiveness of Therapeutic Percutaneous Electrolysis in Persons With the Treatment of Supraspinatus Tendinopathy (MRH-EPTE)

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ClinicalTrials.gov Identifier: NCT03184181
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
Jorge Manuel Góngora Rodriguez
Manuel Rodriguez Huguet
Pablo Rodriguez Huguet
Rocío Martín Valero
Information provided by (Responsible Party):
Manuel Rodriguez Huguet, 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.

Condition or disease Intervention/treatment Phase
Supraspinatus Tendinitis Other: EPTE® group Other: Dry needling group Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A specialist physician will be diagnosed the supraspinatus tendinopathy.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Results After Ultrasound-guided Therapeutic Percutaneous Electrolysis (EPTE®) and Eccentric Exercises in the Treatment of Supraspinatus Tendynopathy
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: EPTE® group
Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.
Other Name: EPTE + EXER

Active Comparator: 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.
Other: Dry needling group
The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.
Other Name: DN + EXER




Primary Outcome Measures :
  1. The intensity of shoulder pain [ Time Frame: 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 :
  1. The intensity of shoulder pain [ Time Frame: 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).

  2. The intensity of shoulder pain [ Time Frame: Eight 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).

  3. Active shoulder range of motion [ Time Frame: Baseline, four weeks and eight weeks ]
    Measured by a two branches goniometer

  4. Pressure pain thresholds in supraspinatus trigger points [ Time Frame: Baseline, four weeks and eight weeks ]
    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.



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184181


Locations
Spain
Policlínica Santa María
Cadiz, Cádiz, Spain, 1108
Sponsors and Collaborators
University of Cadiz
Jorge Manuel Góngora Rodriguez
Manuel Rodriguez Huguet
Pablo Rodriguez Huguet
Rocío Martín Valero
Investigators
Principal Investigator: Manuel Rodriguez Huguet, BSc University of Cadiz

Publications:
Responsible Party: Manuel Rodriguez Huguet, Degree Physiotherapy, University of Cadiz
ClinicalTrials.gov Identifier: NCT03184181     History of Changes
Other Study ID Numbers: 168/16
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manuel Rodriguez Huguet, University of Cadiz:
tendinopathy
electrolysis
exercise
dry needling

Additional relevant MeSH terms:
Tendinopathy
Rotator Cuff Injuries
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Rupture
Shoulder Injuries