MRH-EPTE: Application of Percutaneous Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise.

Sponsor
University of Cadiz (Other)
Overall Status
Completed
CT.gov ID
NCT03184181
Collaborator
Jorge Manuel Góngora Rodriguez (Other), Manuel Rodriguez Huguet (Other), Pablo Rodriguez Huguet (Other), Rocío Martín Valero (Other)
32
1
2
3
10.6

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 (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
  • Other: EPTE® group
  • Other: Dry needling 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 :
32 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:
Application of Ultrasound-guided Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise in Supraspinatus Tendinopathy
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Feb 1, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • DN + EXER
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. The intensity of shoulder pain [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. 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).

    4. Active shoulder range of motion [Baseline, four weeks and one year.]

      Measured by a two branches goniometer

    5. 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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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 Manuel, BSc, University of Cadiz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Manuel Rodriguez Huguet, Degree Physiotherapy, University of Cadiz
    ClinicalTrials.gov Identifier:
    NCT03184181
    Other Study ID Numbers:
    • 168/16
    First Posted:
    Jun 12, 2017
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Degree Physiotherapy, University of Cadiz
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2022