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NCT Number: NCT03184181

Application of Percutaneous Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise

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.

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Key information

Conditions

Supraspinatus Tendinitis Behavior Motor Activity Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlínica Santa María

Cadiz, Cádiz, 1108, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EPTE® group

Other

Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.

Other names: EPTE + EXER

Dry needling group

Other

The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.

Other names: DN + EXER

Primary outcomes

  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 outcomes

  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. The intensity of shoulder pain

    Time frame: 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

    Time frame: Baseline, four weeks and one year.

    Measured by a two branches goniometer

  5. Pressure pain thresholds in supraspinatus trigger points

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Collaborators

  • Jorge Manuel Góngora Rodriguez
  • Manuel Rodriguez Huguet
  • Pablo Rodriguez Huguet
  • Rocío Martín Valero

Registry information

Official study title

Application of Ultrasound-guided Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise in Supraspinatus Tendinopathy

Acronym: MRH-EPTE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2017
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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