NCT04157426

Brief Summary

The objective will be to determine the effectiveness of ultrasound-guided percutaneous electrolysis versus ultrasound-guided dry needling in active myofascial trigger points of the levator scapulae muscle on pain intensity, disability and range of motion. A randomized clinical trial will be carried out. Fifty-four patients with at least one active myofascial trigger point in the levator scapulae muscle were recruited and divided into ultrasound-guided percutaneous electrolysis (n = 27) and ultrasound-guided dry needling (n=27). Pain intensity, disability and range of motion will measured before, immediately after and 1 week after intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 28, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

November 6, 2019

Last Update Submit

December 31, 2021

Conditions

Trigger Point Pain, MyofascialMyofascial Pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Neck pain intensity scores from 0 to 100 points measured by the visual analogue scale

    Change from baseline pain intensity immediately and at 1 week after intervention

Secondary Outcomes (2)

  • Disability

    Change from baseline pain intensity at 1 week after intervention

  • Range of motion

    Change from baseline pain intensity immediately and at 1 week after intervention

Study Arms (2)

Ultrasound-guided percutaneous electrolysis

EXPERIMENTAL
Other: Percutaneous electrolysis

ultrasound-guided dry needling

ACTIVE COMPARATOR
Other: Dry needling

Interventions

Percutaneous electrolysisOTHER

Ultrasound-guided percutaneous electrolysis in the active myofascial trigger point of the levator scapulae muscle

Ultrasound-guided percutaneous electrolysis
Dry needlingOTHER

Ultrasound-guided dry needling the active myofascial trigger point of the levator scapulae muscle

ultrasound-guided dry needling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neck pain
  • At least two active myofascial trigger point in the levator scapulae muscle

You may not qualify if:

  • Systemic diseases
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisiofuenla SLP

Fuenlabrada, Madrid, 28040, Spain

Location

Related Publications (1)

  • Benito-de-Pedro AI, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Rodriguez-Sanz D, Calvo-Lobo C, Benito-de-Pedro M. Efficacy of Deep Dry Needling versus Percutaneous Electrolysis in Ultrasound-Guided Treatment of Active Myofascial Trigger Points of the Levator Scapulae in Short-Term: A Randomized Controlled Trial. Life (Basel). 2023 Apr 3;13(4):939. doi: 10.3390/life13040939.

    PMID: 37109468DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

September 28, 2021

Primary Completion

December 31, 2021

Study Completion

January 1, 2022

Last Updated

January 14, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)