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NCT Number: NCT05793918

Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulation Therapy and Eccentric Exercise in Supraspinatus Tendinopathy.

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlínica Santa María

Cadiz, Cádiz, 11007, 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

Therapeutic Percutaneous Electrolysis an neuromodulation

Other

Therapeutic Percutaneous Electrolysis an neuromodulation associated with eccentric exercises devices at home.

Conventional Group

Other

Ultrasound pulsatil therapy (US), transcutaneous electric nerve stimulation (TENS) for 20 minutes and associated with eccentric exercises devices at home.

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: Twelve 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. Questionnaire DASH.

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

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-re, four, twelve weeks and twenty four weeks.

  4. Scale SPADI.

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

    The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Both dimensions account for 50% of the overall score, and scores from 0 to 100.

  5. Active shoulder range of motion

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

    The range of motion will be evaluated in flexion, extension, internal rotation, external rotation and abduction with a goniometric

  6. Pressure pain thresholds in supraspinatus trigger points

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

  7. Questionnaire SF 12

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

    SF-12 questionnaire is a reliable measure of perceived health that describes the degree of general physical health status and mental health distress. It consists of 12 items, derived from the physical and mental domains. In our study SF-12 was considered altered if the score was <40, either from the physical or mental functioning point of view, because means of 50 and standard deviations of 10 are usually achieved in the general population.

  8. GROCS scale

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

    The multidimensional health related quality of life.

  9. The jobe test

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

    Jobe's test assesses for possible supraspinatus weakness and/or impingement.

  10. The Neer test

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

    The Neer test is performed to check for compression of the rotator cuff tendons at the coracoacromial arch.

  11. Hawkins-Kennedy test

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

    the Hawkins-Kennedy test is a test for impingement in the shoulder

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Registry information

Official study title

Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulation Therapy and Eccentric Exercise in Supraspinatus Tendinopathy: A Single-Blind Randomized Controlled Trial.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2023
Registry last updated
Jan 23, 2024

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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