Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain

June 13, 2023 updated by: Emiliano Petrucci, San Salvatore Hospital of L'Aquila

Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain by Active and Latent Myofascial Trigger Points.

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

Study Overview

Status

Suspended

Conditions

Detailed Description

The analgesic effects of ultrasound-guided dry-needling therapy will be evaluated in the management of head and neck pain by myofascial active and latent trigger point.

The myofascial pain control will be assessed for the superficial and deep posterolateral muscle complex of neck. The analgesic request, Range Of Motion (ROM), Motion Related Pain (MRP) and the quality of life, will be also assessed.

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • L'Aquila
      • Coppito, L'Aquila, Italy, 67100
        • San Salvatore Academic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic neck pain
  • Chronic head pain

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry-Needling
Ultrasound-Guided Dry-Needling Therapy focused on the active and latent myofascial trigger points.
The needle will be insert under ultrasound guidance to elicit the myofascial response on the neck of the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trigger Point
Time Frame: The first hour of the treatment
The number of the elicited myofascial trigger points assessed during dry-needling treatment
The first hour of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic request
Time Frame: 3 months trom treatment
The analgesic request will be assessed in mg of equianalgesic morphine
3 months trom treatment
Karnofsky Performance Status
Time Frame: 3 months from treatment
The quality of life assessed by Karnofsky Performance Status (a 0-100 steps scale, from 0 [Dead] to 100 [Normal no complaints; no evidence of disease]).
3 months from treatment
Range Of Motion (ROM)
Time Frame: 3 months after treatment
The alpha angle expressed in degrees and assessed during
3 months after treatment
Motion Related Pain
Time Frame: 3 months after treatment
Pain assessed by Numeric Rating Scale (a 10-steps scale, from 0 [no pain] to 10 [worse pain]), during flexion, extension and rotation of neck and head
3 months after treatment
Perception
Time Frame: 3 months after treatment
Pain assessed by Numeric Rating Scale (a 10-steps scale, from 0 [no pain] to 10 [worse pain])
3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pierfrancesco Fusco, MD, San Salvatore Academic Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2019

Primary Completion (Estimated)

December 25, 2023

Study Completion (Estimated)

December 25, 2023

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0209913/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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