- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03869710
Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain
Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain by Active and Latent Myofascial Trigger Points.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
L'Aquila
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Coppito, L'Aquila, Italy, 67100
- San Salvatore Academic Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
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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])
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3 months after treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pierfrancesco Fusco, MD, San Salvatore Academic Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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