Application of Percutaneous Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise

NCT03184181 | Completed DMC

• 1 other identifier: 168/16
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraspinatus Tendinitis

Keywords

tendinopathy; electrolysis; exercise; dry needling

Outcome Measures

Primary Outcomes (1)

• The intensity of shoulder pain

  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).

  Baseline

Secondary Outcomes (5)

• The intensity of shoulder pain

  Four weeks

• The intensity of shoulder pain

  Eight weeks

• The intensity of shoulder pain

  One year

• Active shoulder range of motion

  Baseline, four weeks and one year.

• Pressure pain thresholds in supraspinatus trigger points

  Baseline, four weeks and one year.

Study Arms (2)

EPTE® group

EXPERIMENTAL

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

Dry needling group

ACTIVE COMPARATOR

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

Interventions

EPTE® group OTHER

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

Also known as: EPTE + EXER

EPTE® group

Dry needling group OTHER

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

Also known as: DN + EXER

Dry needling group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead
• Jorge Manuel Góngora Rodriguez: collaborator
• Manuel Rodriguez Huguet: collaborator
• Pablo Rodriguez Huguet: collaborator
• Rocío Martín Valero: collaborator

Study Sites (1)

Policlínica Santa María

Cadiz, Cádiz, 1108, Spain

Location

Related Publications (2)

• Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.

  PMID: 26649058 BACKGROUND

• Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.

  PMID: 19297202 BACKGROUND

MeSH Terms

Conditions

Tendinopathy; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Behavior

Study Officials

• Manuel Manuel, BSc

  University of Cadiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Degree Physiotherapy

Model Details: A specialist physician will be diagnosed the supraspinatus tendinopathy.

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 12, 2017
• Study Start: November 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)