Back to resultsAnalgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain
Primary Purpose
Neck Pain, Head Pain
Status
Suspended
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ultrasound-guided Dry-Needling Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Pain
Eligibility Criteria
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
Sites / Locations
- San Salvatore Academic Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dry-Needling
Arm Description
Ultrasound-Guided Dry-Needling Therapy focused on the active and latent myofascial trigger points.
Outcomes
Primary Outcome Measures
Trigger Point
The number of the elicited myofascial trigger points assessed during dry-needling treatment
Secondary Outcome Measures
Analgesic request
The analgesic request will be assessed in mg of equianalgesic morphine
Karnofsky Performance Status
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]).
Range Of Motion (ROM)
The alpha angle expressed in degrees and assessed during
Motion Related Pain
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
Perception
Pain assessed by Numeric Rating Scale (a 10-steps scale, from 0 [no pain] to 10 [worse pain])
Full Information
NCT ID
NCT03869710
First Posted
March 8, 2019
Last Updated
June 13, 2023
Sponsor
San Salvatore Hospital of L'Aquila
1. Study Identification
Unique Protocol Identification Number
NCT03869710
Brief Title
Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain
Official Title
Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain by Active and Latent Myofascial Trigger Points.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
Because of COVID pandemic
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Salvatore Hospital of L'Aquila
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The analgesic effects of ultrasound-guided dry-needling therapy will be evaluated in the management of head and neck pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Head Pain
Keywords
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dry-Needling
Arm Type
Experimental
Arm Description
Ultrasound-Guided Dry-Needling Therapy focused on the active and latent myofascial trigger points.
Intervention Type
Device
Intervention Name(s)
Ultrasound-guided Dry-Needling Therapy
Intervention Description
The needle will be insert under ultrasound guidance to elicit the myofascial response on the neck of the patients
Primary Outcome Measure Information:
Title
Trigger Point
Description
The number of the elicited myofascial trigger points assessed during dry-needling treatment
Time Frame
The first hour of the treatment
Secondary Outcome Measure Information:
Title
Analgesic request
Description
The analgesic request will be assessed in mg of equianalgesic morphine
Time Frame
3 months trom treatment
Title
Karnofsky Performance Status
Description
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]).
Time Frame
3 months from treatment
Title
Range Of Motion (ROM)
Description
The alpha angle expressed in degrees and assessed during
Time Frame
3 months after treatment
Title
Motion Related Pain
Description
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
Time Frame
3 months after treatment
Title
Perception
Description
Pain assessed by Numeric Rating Scale (a 10-steps scale, from 0 [no pain] to 10 [worse pain])
Time Frame
3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierfrancesco Fusco, MD
Organizational Affiliation
San Salvatore Academic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Salvatore Academic Hospital
City
Coppito
State/Province
L'Aquila
ZIP/Postal Code
67100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain
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