Trigger Point Pain, MyofascialNCT04157426
Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae
A study testing Percutaneous electrolysis and Dry needling in people with Trigger Point Pain, Myofascial and Myofascial Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The objective will be to determine the effectiveness of ultrasound-guided percutaneous electrolysis versus ultrasound-guided dry needling in active myofascial trigger points of the levator scapulae muscle on pain intensity, disability and range of motion. A randomized clinical trial will be carried out. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Trigger Point Pain, Myofascial, Myofascial Pain
- What is being tested?
- Percutaneous electrolysis and Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 28 Sep 2021to 1 Jan 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck pain
- At least two active myofascial trigger point in the levator scapulae muscle
Who cannot join
- Systemic diseases
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ultrasound-guided Interventions of Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae Active Myofascial Trigger Points
The objective will be to determine the effectiveness of ultrasound-guided percutaneous electrolysis versus ultrasound-guided dry needling in active myofascial trigger points of the levator scapulae muscle on pain intensity, disability and range of motion. A randomized clinical trial will be carried out. Fifty-four patients with at least one active myofascial trigger point in the levator scapulae muscle were recruited and divided into ultrasound-guided percutaneous electrolysis (n = 27) and ultrasound-guided dry needling (n=27). Pain intensity, disability and range of motion will measured before, immediately after and 1 week after intervention.
- Conditions
- Trigger Point Pain, Myofascial, Myofascial Pain
- Being tested
- Percutaneous electrolysis, Dry needling
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous electrolysisOther
Ultrasound-guided percutaneous electrolysis in the active myofascial trigger point of the levator scapulae muscle
Dry needlingOther
Ultrasound-guided dry needling the active myofascial trigger point of the levator scapulae muscle
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided percutaneous electrolysis | Experimental | Not described Receives: Other: Percutaneous electrolysis |
| ultrasound-guided dry needling | Active comparator | Not described Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Neck pain intensity scores from 0 to 100 points measured by the visual analogue scale
Measured: Change from baseline pain intensity immediately and at 1 week after intervention
Secondary outcomes (2)
Disability
Neck disability scores measured from 0 to 50 points measured by the Neck Disability Index
Measured: Change from baseline pain intensity at 1 week after intervention
Range of motion
Neck rotation range of motion measured with an universal goniometer
Measured: Change from baseline pain intensity immediately and at 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start28 Sep 2021
- Primary completion31 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigger Point Pain, MyofascialStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157426
- Sponsor's protocol ID
- PE_vs_DN
- Status last verified
- Dec 2021
- First submitted
- 6 Nov 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benito-de-Pedro AI, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Rodriguez-Sanz D, Calvo-Lobo C, Benito-de-Pedro M. Efficacy of Deep Dry Needling versus Percutaneous Electrolysis in Ultrasound-Guided Treatment of Active Myofascial Trigger Points of the Levator Scapulae in Short-Term: A Randomized Controlled Trial. Life (Basel). 2023 Apr 3;13(4):939. doi: 10.3390/life13040939.
PubMed 37109468
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound-guided Interventions of Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae Active Myofascial Trigger Points
- ClinicalTrials.gov ID
- NCT04157426
- Acronym / sponsor ID
- PE_vs_DN
- Conditions
- Trigger Point Pain, Myofascial, Myofascial Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 8 Nov 2019 (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.
The objective will be to determine the effectiveness of ultrasound-guided percutaneous electrolysis versus ultrasound-guided dry needling in active myofascial trigger points of the levator scapulae muscle on pain intensity, disability and range of motion. A randomized clinical trial will be carried out. Fifty-four patients with at least one active myofascial trigger point in the levator scapulae muscle were recruited and divided into ultrasound-guided percutaneous electrolysis (n = 27) and ultrasound-guided dry needling (n=27). Pain intensity, disability and range of motion will measured before, immediately after and 1 week after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided percutaneous electrolysis | Experimental | Other: Percutaneous electrolysis |
| ultrasound-guided dry needling | Active comparator | Other: Dry needling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Neck pain
- At least two active myofascial trigger point in the levator scapulae muscle
Key exclusion criteria (2 listed)
- Systemic diseases
- Cognitive impairment
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 |
|---|---|---|
| Percutaneous electrolysisUltrasound-guided percutaneous electrolysis in the active myofascial trigger point of the levator scapulae muscle | Other | Ultrasound-guided percutaneous electrolysis |
| Dry needlingUltrasound-guided dry needling the active myofascial trigger point of the levator scapulae muscle | Other | ultrasound-guided dry needling |
Primary outcome
Pain intensity
Time frame: Change from baseline pain intensity immediately and at 1 week after intervention
Neck pain intensity scores from 0 to 100 points measured by the visual analogue scale
2 secondary outcomes
Disability
Time frame: Change from baseline pain intensity at 1 week after intervention
Range of motion
Time frame: Change from baseline pain intensity immediately and at 1 week after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 37109468Benito-de-Pedro AI, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Rodriguez-Sanz D, Calvo-Lobo C, Benito-de-Pedro M. Efficacy of Deep Dry Needling versus Percutaneous Electrolysis in Ultrasound-Guided Treatment of Active Myofascial Trigger Points of the Levator Scapulae in Short-Term: A Randomized Controlled Trial. Life (Basel). 2023 Apr 3;13(4):939. doi: 10.3390/life13040939.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous electrolysis and Dry needling in people with Trigger Point Pain, Myofascial and Myofascial Pain, run by Universidad Complutense de Madrid 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Change from baseline pain intensity immediately and at 1 week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04157426, which also lists 1 linked publication.
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 14 Jan 2022.