Neck PainNCT03869710
Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain
A study testing Ultrasound-guided Dry-Needling Therapy in people with Neck Pain and Head Pain, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
Trial summary
The analgesic effects of ultrasound-guided dry-needling therapy will be evaluated in the management of head and neck pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Ultrasound-guided Dry-Needling Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2019to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic neck pain
- Chronic head pain
Who cannot join
- previous surgery of neck and head
- Body Mass Index > 39,99
- politrauma patients
- pregnancy
- neck and head infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Ultrasound-guided Dry-Needling Therapy
- Keywords
- Pain
- Medical subject headings
- Neck Pain, Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Dry-Needling TherapyDevice
The needle will be insert under ultrasound guidance to elicit the myofascial response on the neck of the patients
| Study group | Role | What they receive |
|---|---|---|
| Dry-Needling | Experimental | Ultrasound-Guided Dry-Needling Therapy focused on the active and latent myofascial trigger points. Receives: Device: Ultrasound-guided Dry-Needling Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trigger Point
The number of the elicited myofascial trigger points assessed during dry-needling treatment
Measured: The first hour of the treatment
Secondary outcomes (5)
Analgesic request
The analgesic request will be assessed in mg of equianalgesic morphine
Measured: 3 months trom treatment
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]).
Measured: 3 months from treatment
Range Of Motion (ROM)
The alpha angle expressed in degrees and assessed during
Measured: 3 months after treatment
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
Measured: 3 months after treatment
Perception
Pain assessed by Numeric Rating Scale (a 10-steps scale, from 0 [no pain] to 10 [worse pain])
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start8 Mar 2019
- Primary completion25 Dec 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Why it stopped: Because of COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Salvatore Hospital of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
- Investigators
- Pierfrancesco Fusco, MD, Principal investigator, San Salvatore Academic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869710
- Sponsor's protocol ID
- 0209913/17
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2019
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain by Active and Latent Myofascial Trigger Points.
- ClinicalTrials.gov ID
- NCT03869710
- Acronym / sponsor ID
- 0209913/17
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of COVID pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry-Needling | Experimental | Device: Ultrasound-guided Dry-Needling TherapyUltrasound-Guided Dry-Needling Therapy focused on the active and latent myofascial trigger points. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic neck pain
- Chronic head pain
Key exclusion criteria (5 listed)
- previous surgery of neck and head
- Body Mass Index > 39,99
- politrauma patients
- pregnancy
- neck and head infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided Dry-Needling TherapyThe needle will be insert under ultrasound guidance to elicit the myofascial response on the neck of the patients | Device | Dry-Needling |
Primary outcome
Trigger Point
Time frame: The first hour of the treatment
The number of the elicited myofascial trigger points assessed during dry-needling treatment
5 secondary outcomes
Analgesic request
Time frame: 3 months trom treatment
Karnofsky Performance Status
Time frame: 3 months from treatment
Range Of Motion (ROM)
Time frame: 3 months after treatment
Motion Related Pain
Time frame: 3 months after treatment
Perception
Time frame: 3 months after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierfrancesco Fusco, MD principal investigator
San Salvatore Academic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Dry-Needling Therapy in people with Neck Pain and Head Pain, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trigger Point (time frame: The first hour of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.