Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Ultrasound-guided Percutaneous Neuromodulation Versus Ultrasound-guided Dry Needling of the Suprascapular Nerve in Shoulder Pain

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: Ultrasound-guided percutaneous neuromodulation (NMPE)
* Other: Ultrasound-guided dry needling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Previous shoulder surgery. Previous history of shoulder dislocation Whiplash. Cervical radiculopathy. Total rupture of the rotator cuff. Adhesive capsulitis. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasound-guided percutaneous neuromodulation<br>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 | Other: Ultrasound-guided percutaneous neuromodulation (NMPE)<br>* 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<br>|
| Placebo Comparator: Ultrasound-guided dry needling<br>Dry needling technique applied by ultrasound-guided but without electrical stimulation of a peripheral nerve. | Other: Ultrasound-guided dry needling<br>* Dry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from Baseline force at 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | Change from Baseline muscle function at 6 month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electric Stimulation Therapy, Dry Needling