Shoulder PainNCT04454671
Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment
A study testing Ultrasound-guided percutaneous neuromodulation (NMPE) and Ultrasound-guided dry needling in people with Shoulder Pain, run by University of Alcala at 2 sites in Spain.
Trial summary
Background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12 months in half of patients. Ultrasound-guided Percutaneous Neuromodulation (US-guided PNM) is an intervention based in an electrical stimulation of a peripheral nerve through a needle located close to the target nerve by the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Ultrasound-guided percutaneous neuromodulation (NMPE) and Ultrasound-guided dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Sep 2020to 31 May 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic mechanical unilateral shoulder pain of non-specific origin of at least 3 months of evolution
- Weakness in the abduction force and / or external rotation of the shoulder.
Who cannot join
- Previous shoulder surgery.
- Previous history of shoulder dislocation
- Whiplash.
- Cervical radiculopathy.
- Total rupture of the rotator cuff.
- Adhesive capsulitis.
Show all 11Show fewer
- Fibromyalgia diagnosis.
- Diabetes.
- Needle phobia or some contraindication for dry needling (anticoagulants or psychiatric disorders).
- Bilateral shoulder pain.
- Pregnancy or having received a dry puncture in the shoulder region in the last 6 months
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Institut Physiotherapy AND pain
Alcalá de Henares, Madrid, 28805
Overall Study Officials
Alcalá de Henares, Madrid, 28807
About this study
Official title: Efficacy of Ultrasound-guided Percutaneous Neuromodulation Versus Ultrasound-guided Dry Needling of the Suprascapular Nerve in Shoulder Pain
Background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12 months in half of patients. Ultrasound-guided Percutaneous Neuromodulation (US-guided PNM) is an intervention based in an electrical stimulation of a peripheral nerve through a needle located close to the target nerve by the use of an ultrasound guidance.
Objectives: the primary aim is to determine changes in strength after US-guided PNM or Ultrasound-guided Dry Needling (US-guided DN) intervention in the Suprascapular Nerve (SN) as well as its effectiveness in changes of muscle function, pain and disability.
Methods: randomised clinical trial (ratio 1:1), single-blind (examiners), parallel, with assessment of third parties. 62 adult participants with unilateral mechanical chronic nonspecific shoulder pain with at least 3-month evolution and shoulder muscle weakness will randomised to one of two procedures: US-guided PNM or US-guided DN. It will be assessed muscle strength, muscle function, pain and disability before, just after, a week and a month after the intervention.
Read the detailed description
Shoulder pain is the third reason for medical consultation in the world. Many treatment techniques have been proposed. Neuromodulation techniques through the application of an analgesic electric current using a needle as an electrode, are increasingly used in the treatment of pain.
In this study, the investigators will compare whether the application of a neuromodulation technique is more effective than applying the dry needling technique in isolation.
- Conditions
- Shoulder Pain
- Being tested
- Ultrasound-guided percutaneous neuromodulation (NMPE), Ultrasound-guided dry needling
- Keywords
- Electric Stimulation Therapy, Dry Needling
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided percutaneous neuromodulation (NMPE)Other
It is a technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor site. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve
Ultrasound-guided dry needlingOther
Dry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound-guided percutaneous neuromodulation | Experimental | Technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor point. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve Receives: Other: Ultrasound-guided percutaneous neuromodulation (NMPE) |
| Ultrasound-guided dry needling | Placebo comparator | Dry needling technique applied by ultrasound-guided but without electrical stimulation of a peripheral nerve. Receives: Other: Ultrasound-guided dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Force
Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of external rotation and abduction of both shoulders.
Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in external rotation of the shoulder, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98). The minimum value is 0 and de Maximum values is 55
Measured: Change from Baseline force at 6 month
Secondary outcomes (3)
Shoulder Pain
Pain intensity will be measured using the Visual Analog Scale (VAS) for pain. The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
Measured: Change from Baseline pain at 6 month.
Disability
Disability will be measured by Shoulder Pain and Disability Index (SPADI).The Spanish version of SPADI has high test-retest reliability (ICC 0.89-0.93).The clinically important minimum difference varies between 8 and 13.2. The minimum value is 0 and de maximum value is 100
Measured: Change from Baseline disability at 6 month.
Muscle function
Muscle function will be measured by an ultrasound scanner (VINNO® E35; VINNO ULTRASOUND S.L.U. ©, Barcelona, Spain) with a linear transducer with a frequency range of 6-16MHz (X6-16L, 5cm footprint) will be used. The unit of measurement used will be millimeters. Muscle thickness at rest and contraction will be measured. On the other hand, the percentage of change in thickness will be measured using the equation (Shrinkage thickness - Rest thickness) * 100 / Rest thickness.
Measured: Change from Baseline muscle function at 6 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start5 Sep 2020
- Primary completion31 May 2024
- Study completion31 May 2024
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Tomas Gallego-Izquierdo, PhD, Study chair, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454671
- Sponsor's protocol ID
- CEIM/HU/2019/26)
- Status last verified
- May 2024
- First submitted
- 27 Jun 2020
- Last updated
- 3 Jun 2024
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-guided Percutaneous Neuromodulation Versus Ultrasound-guided Dry Needling of the Suprascapular Nerve in Shoulder Pain
- ClinicalTrials.gov ID
- NCT04454671
- Acronym / sponsor ID
- CEIM/HU/2019/26)
- Conditions
- Shoulder Pain
- Keywords
- Electric Stimulation Therapy, Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 1 Jul 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.
Background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12 months in half of patients. Ultrasound-guided Percutaneous Neuromodulation (US-guided PNM) is an intervention based in an electrical stimulation of a peripheral nerve through a needle located close to the target nerve by the use of an ultrasound guidance.
Objectives: the primary aim is to determine changes in strength after US-guided PNM or Ultrasound-guided Dry Needling (US-guided DN) intervention in the Suprascapular Nerve (SN) as well as its effectiveness in changes of muscle function, pain and disability.
Methods: randomised clinical trial (ratio 1:1), single-blind (examiners), parallel, with assessment of third parties. 62 adult participants with unilateral mechanical chronic nonspecific shoulder pain with at least 3-month evolution and shoulder muscle weakness will randomised to one of two procedures: US-guided PNM or US-guided DN. It will be assessed muscle strength, muscle function, pain and disability before, just after, a week and a month after the intervention.
Detailed description
Shoulder pain is the third reason for medical consultation in the world. Many treatment techniques have been proposed. Neuromodulation techniques through the application of an analgesic electric current using a needle as an electrode, are increasingly used in the treatment of pain.
In this study, the investigators will compare whether the application of a neuromodulation technique is more effective than applying the dry needling technique in isolation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound-guided percutaneous neuromodulation | Experimental | Other: Ultrasound-guided percutaneous neuromodulation (NMPE)Technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor point. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve |
| Ultrasound-guided dry needling | Placebo comparator | Other: Ultrasound-guided dry needlingDry needling technique applied by ultrasound-guided but without electrical stimulation of a peripheral nerve. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic mechanical unilateral shoulder pain of non-specific origin of at least 3 months of evolution
- Weakness in the abduction force and / or external rotation of the shoulder.
Key exclusion criteria (11 listed)
- Previous shoulder surgery.
- Previous history of shoulder dislocation
- Whiplash.
- Cervical radiculopathy.
- Total rupture of the rotator cuff.
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 |
|---|---|---|
| Ultrasound-guided percutaneous neuromodulation (NMPE)It is a technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor site. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve | Other | ultrasound-guided percutaneous neuromodulation |
| Ultrasound-guided dry needlingDry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results. | Other | Ultrasound-guided dry needling |
Primary outcome
Muscle Force
Time frame: Change from Baseline force at 6 month
Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of external rotation and abduction of both shoulders. Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in external rotation of the shoulder, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98). The minimum value is 0 and de Maximum values is 55
3 secondary outcomes
Shoulder Pain
Time frame: Change from Baseline pain at 6 month.
Disability
Time frame: Change from Baseline disability at 6 month.
Muscle function
Time frame: Change from Baseline muscle function at 6 month.
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 3 Jun 2024.
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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.
Tomas Gallego-Izquierdo, PhD study chair
Alcala University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided percutaneous neuromodulation (NMPE) and Ultrasound-guided dry needling in people with Shoulder Pain, run by University of Alcala at 2 sites 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 11 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 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Muscle Force (time frame: Change from Baseline force at 6 month). 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 3 Jun 2024.