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

NCT05593848 | Unknown

• 1 other identifier: 419-2019 USalamanca
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Intratissue Percutaneous Electrolysis; Dry Needling; Myofascial trigger points; infraspinatus muscle; non-specific shoulder pain

Outcome Measures

Primary Outcomes (1)

• Changes in Pain intensity, before, during and after the intervention

  Numerical pain rating scale (score 0-10 points)

  4 months (7 points)

Secondary Outcomes (7)

• Changes in Shoulder flexion range of motion, before, during and after the intervention

  4 months (7 points)

• Changes in Shoulder external rotation range of motion, before, during and after the intervention

  4 months (7 points)

• Changes in Pressure pain threshold at proximal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention

  4 months (7 points)

• Changes in Pressure pain threshold at distal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention

  4 months (7 points)

• Changes in Strength in shoulder external rotation before, during and after the intervention

  4 months (7 points)

Study Arms (2)

Experimental Group (Intratissue Percutaneous Electrolysis Group)

EXPERIMENTAL

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.

Procedure: Intratissue Percutaneous Electrolysis

Active Control Group (Dry Needling Group)

ACTIVE COMPARATOR

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.

Procedure: Dry Needling

Interventions

Intratissue Percutaneous Electrolysis 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

Experimental Group (Intratissue Percutaneous Electrolysis Group)

Dry Needling 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

Active Control Group (Dry Needling Group)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Roberto Méndez-Sánchez

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Méndez-Sánchez, PhD

CONTACT

+34 923294500; ro_mendez@usal.es

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: Professor, PhD

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 25, 2022
• Study Start: February 8, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

ES (1)