Intratissue Percutaneous Electrolysis vs Dry Needling in Myofascial Pain Syndrome of Shoulder Pain

NCT ID: NCT05593848

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2023-07-30

Brief Summary

This is a parallel-group randomised clinical trial:

Primary purpose: To analyse the clinical changes produced by two different physiotherapy treatments (Intratissue Percutaneous Electrolysis and Dry Needling) for myofascial trigger points in the infraspinatus muscle in subjects with non-specific shoulder pain.

Hypothesis: A physiotherapy treatment including Intratissue Percutaneous Electrolysis therapy present greater benefits in terms of pain reduction and increased mobility and functionality rather than Dry Needling treatment in subjects with non-specific shoulder pain.

The intervention consisted of 3 treatment sessions, different according to the group, once a week. Seven evaluation points were performed, two pre-intervention evaluations one week apart and after the second one the first treatment session was performed. The third and fourth assessments were prior to the second and third treatment sessions, one week apart. The fifth, sixth and seventh assessments were conducted one week, one month and two months after the last treatment session in each group.

Conditions

Shoulder Pain; Myofascial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group (Intratissue Percutaneous Electrolysis Group)

The treatment to be performed in the Intratissue percutaneus electrolysis Group will consist of:

1. Palpation and localization of the myofascial trigger points in the infraspinatus muscle of the affected shoulder.

2. Application of the ultrasound-guided intratissue percutaneus electroysis technique (1 or 2 approaches) on the myofascial trigger points with the greatest clinical manifestations for the subject. The needle will remain at intramuscular level without movement and a galvanic current discharge will be applied in the area, through the needle, whose intensity will oscillate between 0.5 and 3 milliAmperes (mA).

3. Performance of an eccentric work protocol of the infraspinatus muscle to reduce post-puncture pain.

Group Type: EXPERIMENTAL

Intratissue Percutaneous Electrolysis

Intervention Type: PROCEDURE

Each subject will undergo 3 treatment sessions spaced one week apart. Ultrasound-guided Intratissue Percutaneous Electrolysis in the myofascial trigger points of the infraspinatus muscle

Active Control Group (Dry Needling Group)

The treatment to be performed in the Dry Needling Group will consist of:

1. palpation and localization of myofascial trigger points in the infraspinatus muscle of the affected shoulder.

2. Application of the ultrasound-guided dry needling technique (1 or 2 approaches) on the myofascial trigger points with major clinical manifestations for the subject. The physiotherapist will move the needle into the muscle using Hong's rapid entry and exit technique.

3. Performance of an eccentric work protocol of the infraspinatus muscle to reduce post-puncture pain.

Group Type: ACTIVE_COMPARATOR

Dry Needling

Intervention Type: PROCEDURE

Each subject will undergo 3 treatment sessions spaced one week apart. Ultrasound-guided dry needling in the myofascial trigger points of the infraspinatus muscle

Interventions

Intratissue Percutaneous Electrolysis

Each subject will undergo 3 treatment sessions spaced one week apart. Ultrasound-guided Intratissue Percutaneous Electrolysis in the myofascial trigger points of the infraspinatus muscle

Intervention Type: PROCEDURE

Dry Needling

Each subject will undergo 3 treatment sessions spaced one week apart. Ultrasound-guided dry needling in the myofascial trigger points of the infraspinatus muscle

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Both male and female patients suffering from shoulder pain during at least three months before intervention protocol starts.
• Patients with free passive range of movement and at least 15 degrees active external rotation in the affected shoulder.
• Patients willing to participate in the study and return for all scheduled follow-up visits.
• Patient is capable of giving, and has given, written informed consent.

Exclusion Criteria

• Patients with a previous medical diagnosis (tendon rupture, bursitis, etc.) or a traumatic history that justifies shoulder pain.
• Patients with unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias.
• Patients allergic to metal or those who have needle phobia.
• Patient that has participated in any other shoulder pain treatment research study within 30 days prior.
• Patients that had prior shoulder surgery.
• Patients that are currently being treated with a narcotic or NSAIDs and/or has used analgesics or NSAIDs within the 72 hours prior.
• Patients that has a known bleeding disorder or that are currently being treated with anticoagulant therapy.
• Pregnant women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Roberto Méndez Sánchez

Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Méndez-Sánchez

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Locations

University of Salamanca

Salamanca, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Roberto Méndez-Sánchez, PhD

Role: CONTACT

ro_mendez@usal.es

+34 923294500 ext. 3201

Facility Contacts

Roberto Méndez-Sánchez, PhD

Role: primary

ro_mendez@usal.es

+34 923294400 ext. 3201

Other Identifiers

419-2019 USalamanca

Identifier Type: -

Identifier Source: org_study_id