NCT03869710

Brief Summary

The analgesic effects of ultrasound-guided dry-needling therapy will be evaluated in the management of head and neck pain.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 8, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

4.8 years

First QC Date

March 8, 2019

Last Update Submit

November 29, 2024

Conditions

Neck PainHead Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • Trigger Point

    The number of the elicited myofascial trigger points assessed during dry-needling treatment

    The first hour of the treatment

Secondary Outcomes (5)

  • Analgesic request

    3 months trom treatment

  • Karnofsky Performance Status

    3 months from treatment

  • Range Of Motion (ROM)

    3 months after treatment

  • Motion Related Pain

    3 months after treatment

  • Perception

    3 months after treatment

Study Arms (1)

Dry-Needling

EXPERIMENTAL

Ultrasound-Guided Dry-Needling Therapy focused on the active and latent myofascial trigger points.

Device: Ultrasound-guided Dry-Needling Therapy

Interventions

Ultrasound-guided Dry-Needling TherapyDEVICE

The needle will be insert under ultrasound guidance to elicit the myofascial response on the neck of the patients

Dry-Needling

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic neck pain
  • Chronic head pain

You may not qualify if:

  • previous surgery of neck and head
  • Body Mass Index \> 39,99
  • politrauma patients
  • pregnancy
  • neck and head infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Salvatore Academic Hospital

Coppito, L'Aquila, 67100, Italy

Location

MeSH Terms

Conditions

Neck PainHeadachePain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pierfrancesco Fusco, MD

    San Salvatore Academic Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 11, 2019

Study Start

March 8, 2019

Primary Completion

December 25, 2023

Study Completion

December 25, 2023

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)