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

NCT ID: NCT04454671

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-05
• Study Completion Date: 2024-05-31

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ultrasound-guided percutaneous neuromodulation

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

Group Type: EXPERIMENTAL

Ultrasound-guided percutaneous neuromodulation (NMPE)

Intervention Type: 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 needling

Dry needling technique applied by ultrasound-guided but without electrical stimulation of a peripheral nerve.

Group Type: PLACEBO_COMPARATOR

Ultrasound-guided dry needling

Intervention Type: OTHER

Dry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results.

Interventions

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

Intervention Type: OTHER

Ultrasound-guided dry needling

Dry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Daniel Pecos Martín

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomas Gallego-Izquierdo, PhD

Role: STUDY_CHAIR

Alcala University

Locations

Institut Physiotherapy AND pain

Alcalá de Henares, Madrid, Spain

Overall Study Officials

Alcalá de Henares, Madrid, Spain

Countries

Spain

Other Identifiers

CEIM/HU/2019/26)

Identifier Type: -

Identifier Source: org_study_id