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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03869710
Other study ID # 0209913/17
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date March 8, 2019
Est. completion date December 25, 2023

Study information

Verified date June 2023
Source San Salvatore Hospital of L'Aquila
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Suspended
Enrollment 43
Est. completion date December 25, 2023
Est. primary completion date December 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasound-guided Dry-Needling Therapy
The needle will be insert under ultrasound guidance to elicit the myofascial response on the neck of the patients

Locations

Country Name City State
Italy San Salvatore Academic Hospital Coppito L'Aquila

Sponsors (1)

Lead Sponsor Collaborator
San Salvatore Hospital of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trigger Point The number of the elicited myofascial trigger points assessed during dry-needling treatment The first hour of the treatment
Secondary Analgesic request The analgesic request will be assessed in mg of equianalgesic morphine 3 months trom treatment
Secondary 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]). 3 months from treatment
Secondary Range Of Motion (ROM) The alpha angle expressed in degrees and assessed during 3 months after treatment
Secondary 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 3 months after treatment
Secondary Perception Pain assessed by Numeric Rating Scale (a 10-steps scale, from 0 [no pain] to 10 [worse pain]) 3 months after treatment
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