Shoulder PainNCT05593848
Intratissue Percutaneous Electrolysis vs Dry Needling in Myofascial Pain Syndrome of Shoulder Pain
A study testing Intratissue Percutaneous Electrolysis and Dry Needling in people with Shoulder Pain and Myofascial Pain Syndrome, run by University of Salamanca at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Shoulder Pain, Myofascial Pain Syndrome
- What is being tested?
- Intratissue Percutaneous Electrolysis and Dry Needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2022to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Salamanca
Salamanca, 37007
Roberto Méndez-Sánchez, PhD, +34 923294400 ext. 3201, ro_mendez@usal.es
About this study
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
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.
Read more
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
- Being tested
- Intratissue Percutaneous Electrolysis, Dry Needling
- Keywords
- Intratissue Percutaneous Electrolysis, Dry Needling, Myofascial trigger points, infraspinatus muscle, non-specific shoulder pain
- Medical subject headings
- Shoulder Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intratissue Percutaneous ElectrolysisProcedure or surgery
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 NeedlingProcedure or surgery
Each subject will undergo 3 treatment sessions spaced one week apart. Ultrasound-guided dry needling in the myofascial trigger points of the infraspinatus muscle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain intensity, before, during and after the intervention
Numerical pain rating scale (score 0-10 points)
Measured: 4 months (7 points)
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months (7 points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start8 Feb 2022
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Méndez Sánchez, University of Salamanca
- Investigators
- Roberto Méndez-Sánchez, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593848
- Sponsor's protocol ID
- 419-2019 USalamanca
- Status last verified
- May 2023
- First submitted
- 19 Oct 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05593848
- Acronym / sponsor ID
- 419-2019 USalamanca
- Conditions
- Shoulder Pain, Myofascial Pain Syndrome
- Keywords
- Intratissue Percutaneous Electrolysis, Dry Needling, Myofascial trigger points, infraspinatus muscle, non-specific shoulder pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Intratissue Percutaneous Electrolysis Group) | Experimental | Procedure: Intratissue Percutaneous ElectrolysisThe 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. |
| Active Control Group (Dry Needling Group) | Active comparator | Procedure: Dry NeedlingThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intratissue Percutaneous ElectrolysisEach subject will undergo 3 treatment sessions spaced one week apart. Ultrasound-guided Intratissue Percutaneous Electrolysis in the myofascial trigger points of the infraspinatus muscle | Procedure or surgery | Experimental Group (Intratissue Percutaneous Electrolysis Group) |
| Dry NeedlingEach subject will undergo 3 treatment sessions spaced one week apart. Ultrasound-guided dry needling in the myofascial trigger points of the infraspinatus muscle | Procedure or surgery | Active Control Group (Dry Needling Group) |
Primary outcome
Changes in Pain intensity, before, during and after the intervention
Time frame: 4 months (7 points)
Numerical pain rating scale (score 0-10 points)
7 secondary outcomes
Changes in Shoulder flexion range of motion, before, during and after the intervention
Time frame: 4 months (7 points)
Changes in Shoulder external rotation range of motion, before, during and after the intervention
Time frame: 4 months (7 points)
Changes in Pressure pain threshold at proximal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention
Time frame: 4 months (7 points)
Changes in Pressure pain threshold at distal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention
Time frame: 4 months (7 points)
Changes in Strength in shoulder external rotation before, during and after the intervention
Time frame: 4 months (7 points)
Changes in Hand grip strength, before, during and after the intervention
Time frame: 4 months (7 points)
Changes in Disability and functionality of the upper limb, before, during and after the intervention
Time frame: 4 months (7 points)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Méndez-Sánchez principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intratissue Percutaneous Electrolysis and Dry Needling in people with Shoulder Pain and Myofascial Pain Syndrome, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Méndez-Sánchez, PhD (+34 923294500 ext. 3201, ro_mendez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain intensity, before, during and after the intervention (time frame: 4 months (7 points)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.