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

NCT04454671 | Completed

• 1 other identifier: CEIM/HU/2019/26)
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Shoulder Pain

Keywords

Electric Stimulation Therapy; Dry Needling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Shoulder Pain

  Change from Baseline pain at 6 month.

• Disability

  Change from Baseline disability at 6 month.

• Muscle function

  Change from Baseline muscle function at 6 month.

Study Arms (2)

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

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.

Other: Ultrasound-guided dry needling

Interventions

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 percutaneous neuromodulation

Ultrasound-guided dry needling OTHER

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

Ultrasound-guided dry needling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (2)

Institut Physiotherapy AND pain

Alcalá de Henares, Madrid, 28805, Spain

Location

Overall Study Officials

Alcalá de Henares, Madrid, 28807, Spain

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomas Gallego-Izquierdo, PhD

  Alcala University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 1, 2020
• Study Start: September 5, 2020
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

ES (2)