Clinical trial NCT04454671: Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment
Official title: Efficacy of Ultrasound-guided Percutaneous Neuromodulation Versus Ultrasound-guided Dry Needling of the Suprascapular Nerve in Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: Electric Stimulation Therapy
Dry Needling
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle Force
timeFrame: Change from Baseline force at 6 month
Secondary outcomes:
measure: Shoulder Pain
timeFrame: Change from Baseline pain at 6 month.
measure: Disability
timeFrame: Change from Baseline disability at 6 month.
measure: Muscle function
timeFrame: Change from Baseline muscle function at 6 month.
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Institut Physiotherapy AND pain
state: Madrid
city: Alcalá de Henares
country: Spain
facility: Overall Study Officials
state: Madrid
Study officials:
affiliation: Alcala University
name: Tomas Gallego-Izquierdo, PhD
role: STUDY_CHAIR
References: