Back to resultsIntratissue Percutaneous Electrolysis vs Dry Needling in Myofascial Pain Syndrome of Shoulder Pain
Primary Purpose
Shoulder Pain, Myofascial Pain Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intratissue Percutaneous Electrolysis
Dry Needling
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Intratissue Percutaneous Electrolysis, Dry Needling, Myofascial trigger points, infraspinatus muscle, non-specific shoulder pain
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.
Sites / Locations
- University of SalamancaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group (Intratissue Percutaneous Electrolysis Group)
Active Control Group (Dry Needling Group)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in Pain intensity, before, during and after the intervention
Numerical pain rating scale (score 0-10 points)
Secondary Outcome Measures
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
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
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.
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)
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05593848
Brief Title
Intratissue Percutaneous Electrolysis vs Dry Needling in Myofascial Pain Syndrome of Shoulder Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Myofascial Pain Syndrome
Keywords
Intratissue Percutaneous Electrolysis, Dry Needling, Myofascial trigger points, infraspinatus muscle, non-specific shoulder pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group (Intratissue Percutaneous Electrolysis Group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Control Group (Dry Needling Group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intratissue Percutaneous Electrolysis
Intervention Description
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
Intervention Name(s)
Dry Needling
Intervention Description
Each subject will undergo 3 treatment sessions spaced one week apart. Ultrasound-guided dry needling in the myofascial trigger points of the infraspinatus muscle
Primary Outcome Measure Information:
Title
Changes in Pain intensity, before, during and after the intervention
Description
Numerical pain rating scale (score 0-10 points)
Time Frame
4 months (7 points)
Secondary Outcome Measure Information:
Title
Changes in Shoulder flexion range of motion, before, during and after the intervention
Description
The range of motion in flexion will be measured with an inclinometer to assess changes in the mobility to shoulder pain subjects
Time Frame
4 months (7 points)
Title
Changes in Shoulder external rotation range of motion, before, during and after the intervention
Description
The range of motion in external rotation will be measured with an inclinometer to assess changes in the mobility to shoulder pain subjects
Time Frame
4 months (7 points)
Title
Changes in Pressure pain threshold at proximal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention
Description
The pressure threshold will be recorded using a digital algometer.
Time Frame
4 months (7 points)
Title
Changes in Pressure pain threshold at distal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention
Description
The pressure threshold will be recorded using a digital algometer (Pain Test™ FPIX 10)
Time Frame
4 months (7 points)
Title
Changes in Strength in shoulder external rotation before, during and after the intervention
Description
The strength will be recorded with wireless MicroFET 2: Hand-held dynamometer for force assessment.
Time Frame
4 months (7 points)
Title
Changes in Hand grip strength, before, during and after the intervention
Description
The strength will be recorded with Jamar Plus: Digital dynamometer to assess grip strength.
Time Frame
4 months (7 points)
Title
Changes in Disability and functionality of the upper limb, before, during and after the intervention
Description
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.
Time Frame
4 months (7 points)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Méndez-Sánchez, PhD
Phone
+34 923294500
Ext
3201
Email
ro_mendez@usal.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Méndez-Sánchez
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Méndez-Sánchez, PhD
Phone
+34 923294400
Ext
3201
Email
ro_mendez@usal.es
12. IPD Sharing Statement
Learn more about this trial
Intratissue Percutaneous Electrolysis vs Dry Needling in Myofascial Pain Syndrome of Shoulder Pain
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