Knee Pain ChronicNCT04390438
Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome
A study testing Percutaneous Electrolysis and Dry needling in people with Knee Pain Chronic and Muscle Pain, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial summary
Muscle pain is frequently attributed to myofascial pain syndrome (MPS) in which myofascial trigger points (MTrP) are a characteristic feature. Dry needling is a frequent clinical practice to manage MPS but few evidence is published about percutaneous electrolysis effects for the treatment of MPS. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Knee Pain Chronic, Muscle Pain
- What is being tested?
- Percutaneous Electrolysis and Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2020to 27 Apr 2020
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Athletes with knee pain
- Presence of at least one active Trigger point
Who cannot join
- Farmacologic treatment
- Surgery or traumas
- Skin alterations or infections
- Prior 6 weeks DN nor PT treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome: A Pilot Study
Muscle pain is frequently attributed to myofascial pain syndrome (MPS) in which myofascial trigger points (MTrP) are a characteristic feature. Dry needling is a frequent clinical practice to manage MPS but few evidence is published about percutaneous electrolysis effects for the treatment of MPS.
This is a randomized clinical trial with 3 parallel groups: 1) High intensity-short time percutaneous electrolysis; 2) Low intensity-long time percutaneous electrolysis; 3) dry needling control group.
Read the detailed description
The current study aimed to evaluate changes in rectus femurs active trigger points and patellar tendon pain pressure thresholds and subjective anterior knee pain perception after application of two percutaneous electrolysis methods using a same charge (high intensity and low intensity) compared to a dry needling group in patients with patellofemoral pain syndrome (PFPS)
Fifteen patients diagnosed with unilateral PFPS were divided in two experimental groups (high intensity percutaneous electrolysis and low intensity percutaneous electrolysis) and one active control group (dry needling. The duration of the study was 7 days with only one intervention. Pain pressure thresholds were assessed using an algometer before the intervention, immediately after the intervention and after 7 days and a Visual Analogue Scale was used before the treatment and after 7 days to rate the subjective anterior knee pain perception. Also a VAS was used to rate the pain perception during the intervention
- Conditions
- Knee Pain Chronic, Muscle Pain
- Being tested
- Percutaneous Electrolysis, Dry needling
- Keywords
- Patellofemoral pain syndrome, Electrolysis, Myofascial Pain Syndromes, Acupuncture
- Medical subject headings
- Myalgia, Patellofemoral Pain Syndrome, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous ElectrolysisProcedure or surgery
Needle emplacement with a galvanic electrical current
Dry needlingProcedure or surgery
Needle emplacement without electrical current nor substance
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity short time percutaneous electrolysis | Experimental | Application of a 0,66uA galvanic current in the active TrP through a needle during 10 seconds. During the 20 seconds left necessary to blind the patient and the examiner, the needle was inside but with no electrical current Receives: Procedure: Percutaneous Electrolysis |
| Low-Intensity long time percutaneous electrolysis | Experimental | Application of a 0,22uA galvanic current in the active TrP through a needle during 30 seconds Receives: Procedure: Percutaneous Electrolysis |
| Dry needling | Active comparator | One acupuncture needle was placed in the active TrP to produce a local twitch response during 30 seconds Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold (Trigger Point)
Algometry (Wagner analogical algometer)
Measured: 7 days
Pressure Pain Threshold (Patellar Tendon)
Algometry (Wagner analogical algometer)
Measured: 7 days
Secondary outcomes (1)
Subjective pain perception
Visual Analogue Scale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start17 Feb 2020
- Primary completion30 Mar 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies 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
- Model description
- Randomized Clinical trial with 3 parallel groups; 2 experimental groups and 1 control group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Antonio Valera-Calero, PT, Msc, Principal investigator, Camilo Jose Cela UniversityAlberto Sanchez-Mayoral-Martín, PT, Study director, Free professional practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390438
- Sponsor's protocol ID
- 50997093
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT04390438
- Acronym / sponsor ID
- 50997093
- Conditions
- Knee Pain Chronic, Muscle Pain
- Keywords
- Patellofemoral pain syndrome, Electrolysis, Myofascial Pain Syndromes, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 15 May 2020 (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.
Muscle pain is frequently attributed to myofascial pain syndrome (MPS) in which myofascial trigger points (MTrP) are a characteristic feature. Dry needling is a frequent clinical practice to manage MPS but few evidence is published about percutaneous electrolysis effects for the treatment of MPS.
This is a randomized clinical trial with 3 parallel groups: 1) High intensity-short time percutaneous electrolysis; 2) Low intensity-long time percutaneous electrolysis; 3) dry needling control group.
Detailed description
The current study aimed to evaluate changes in rectus femurs active trigger points and patellar tendon pain pressure thresholds and subjective anterior knee pain perception after application of two percutaneous electrolysis methods using a same charge (high intensity and low intensity) compared to a dry needling group in patients with patellofemoral pain syndrome (PFPS)
Fifteen patients diagnosed with unilateral PFPS were divided in two experimental groups (high intensity percutaneous electrolysis and low intensity percutaneous electrolysis) and one active control group (dry needling. The duration of the study was 7 days with only one intervention. Pain pressure thresholds were assessed using an algometer before the intervention, immediately after the intervention and after 7 days and a Visual Analogue Scale was used before the treatment and after 7 days to rate the subjective anterior knee pain perception. Also a VAS was used to rate the pain perception during the intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Clinical trial with 3 parallel groups; 2 experimental groups and 1 control group
| Arm | Type | Receives |
|---|---|---|
| High-Intensity short time percutaneous electrolysis | Experimental | Procedure: Percutaneous ElectrolysisApplication of a 0,66uA galvanic current in the active TrP through a needle during 10 seconds. During the 20 seconds left necessary to blind the patient and the examiner, the needle was inside but with no electrical current |
| Low-Intensity long time percutaneous electrolysis | Experimental | Procedure: Percutaneous ElectrolysisApplication of a 0,22uA galvanic current in the active TrP through a needle during 30 seconds |
| Dry needling | Active comparator | Procedure: Dry needlingOne acupuncture needle was placed in the active TrP to produce a local twitch response during 30 seconds |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Athletes with knee pain
- Presence of at least one active Trigger point
Key exclusion criteria (4 listed)
- Farmacologic treatment
- Surgery or traumas
- Skin alterations or infections
- Prior 6 weeks DN nor PT treatment
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 ElectrolysisNeedle emplacement with a galvanic electrical current | Procedure or surgery | High-Intensity short time percutaneous electrolysis, Low-Intensity long time percutaneous electrolysis |
| Dry needlingNeedle emplacement without electrical current nor substance | Procedure or surgery | Dry needling |
Primary outcome
Pressure Pain Threshold (Trigger Point)
Time frame: 7 days
Algometry (Wagner analogical algometer)
Pressure Pain Threshold (Patellar Tendon)
Time frame: 7 days
Algometry (Wagner analogical algometer)
1 secondary outcome
Subjective pain perception
Time frame: 7 days
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 15 May 2020.
- 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.
Juan Antonio Valera-Calero, PT, Msc principal investigator
Camilo Jose Cela University
Alberto Sanchez-Mayoral-Martín, PT study director
Free professional practice
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 Knee Pain Chronic and Muscle Pain, run by Universidad Francisco de Vitoria 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 4 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 15 May 2020. 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?
Pressure Pain Threshold (Trigger Point) (time frame: 7 days). The study lists 2 primary outcomes in all. 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 15 May 2020.