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

Comparative Study of the Effects of Intratissue Percutaneous Electrolysis vs. Dry Needling in the Treatment of Myofascial Pain Syndrome in Subjects With Non-specific Shoulder Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Pain; Myofascial Pain Syndrome
• Intervention / Treatment: Procedure: Intratissue Percutaneous Electrolysis; Procedure: Dry Needling

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Méndez-Sánchez, PhD; Phone Number: 3201 +34 923294500; Email: ro_mendez@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Recruiting
    • University of Salamanca
    • Contact: Roberto Méndez-Sánchez, PhD; Phone Number: 3201 +34 923294400; Email: ro_mendez@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group (Intratissue Percutaneous Electrolysis Group); The treatment to be performed in the Intratissue percutaneus electrolysis Group will consist of: Palpation and localization of the myofascial trigger points in the infraspinatus muscle of the affected shoulder.; 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).; Performance of an eccentric work protocol of the infraspinatus muscle to reduce post-puncture pain.	Procedure: 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
Active Comparator: Active Control Group (Dry Needling Group); The treatment to be performed in the Dry Needling Group will consist of: palpation and localization of myofascial trigger points in the infraspinatus muscle of the affected shoulder.; 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.; Performance of an eccentric work protocol of the infraspinatus muscle to reduce post-puncture pain.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain intensity, before, during and after the intervention	Numerical pain rating scale (score 0-10 points)	4 months (7 points)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Shoulder flexion range of motion, before, during and after the intervention	The range of motion in flexion will be measured with an inclinometer to assess changes in the mobility to shoulder pain subjects	4 months (7 points)
Changes in Shoulder external rotation range of motion, before, during and after the intervention	The range of motion in external rotation will be measured with an inclinometer to assess changes in the mobility to shoulder pain subjects	4 months (7 points)
Changes in Pressure pain threshold at proximal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention	The pressure threshold will be recorded using a digital algometer.	4 months (7 points)
Changes in Pressure pain threshold at distal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention	The pressure threshold will be recorded using a digital algometer (Pain Test™ FPIX 10)	4 months (7 points)
Changes in Strength in shoulder external rotation before, during and after the intervention	The strength will be recorded with wireless MicroFET 2: Hand-held dynamometer for force assessment.	4 months (7 points)
Changes in Hand grip strength, before, during and after the intervention	The strength will be recorded with Jamar Plus: Digital dynamometer to assess grip strength.	4 months (7 points)
Changes in Disability and functionality of the upper limb, before, during and after the intervention	To measure the upper limb disability and functionality we will use the Disabilities of the Arm, Shoulder and Hand (DASH), which is a validated questionnaire that measures the functionality and disability that shoulder pain generates in the subject.	4 months (7 points)

Collaborators and Investigators

• Sponsor: University of Salamanca
• Investigators: Principal Investigator: Roberto Méndez-Sánchez, University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Estimated): July 30, 2023
• Study Completion (Estimated): July 30, 2023

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Dry Needling; Myofascial trigger points; Intratissue Percutaneous Electrolysis; infraspinatus muscle; non-specific shoulder pain
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Arthralgia; Syndrome; Fibromyalgia; Shoulder Pain; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: 419-2019 USalamanca

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No