search
Back to results

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

Primary Purpose

Shoulder Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound-guided percutaneous neuromodulation (NMPE)
Ultrasound-guided dry needling
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Electric Stimulation Therapy, Dry Needling

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Physiotherapy AND painRecruiting
  • Overall Study Officials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ultrasound-guided percutaneous neuromodulation

Ultrasound-guided dry needling

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
June 27, 2020
Last Updated
August 2, 2023
Sponsor
University of Alcala
search

1. Study Identification

Unique Protocol Identification Number
NCT04454671
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2020 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Electric Stimulation Therapy, Dry Needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasound-guided percutaneous neuromodulation
Arm Type
Experimental
Arm Description
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
Arm Title
Ultrasound-guided dry needling
Arm Type
Placebo Comparator
Arm Description
Dry needling technique applied by ultrasound-guided but without electrical stimulation of a peripheral nerve.
Intervention Type
Other
Intervention Name(s)
Ultrasound-guided percutaneous neuromodulation (NMPE)
Intervention Description
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
Intervention Name(s)
Ultrasound-guided dry needling
Intervention Description
Dry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results.
Primary Outcome Measure Information:
Title
Muscle Force
Description
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
Time Frame
Change from Baseline force at 1 month
Secondary Outcome Measure Information:
Title
Shoulder Pain
Description
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.
Time Frame
Change from Baseline pain at 1 month.
Title
Disability
Description
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
Time Frame
Change from Baseline disability at 1 month.
Title
Muscle function
Description
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.
Time Frame
Change from Baseline muscle function at 1 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Pecos-Martín, PhD
Phone
+34 918855142
Email
gifyd@uah.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Gallego-Izquierdo, PhD
Organizational Affiliation
Alcala University
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Physiotherapy AND pain
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Martinez-Merinero, Phd
Phone
683378391
Email
info@institutofisioterapiaydolor.es
Facility Name
Overall Study Officials
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28807
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura López-García
Phone
+34 918855142
Email
gifyd@uah.es

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs