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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05593848
• Other study ID #: 419-2019 USalamanca
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: May 2023
• Source: University of Salamanca
• Contact: Roberto Méndez-Sánchez, PhD
• Phone: +34 923294500
• Email: ro_mendez[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Shoulder Pain
• Somatoform Disorders
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	University of Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Pain intensity, before, during and after the intervention	Numerical pain rating scale (score 0-10 points)	4 months (7 points)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)