Myofascial Neck PainPhase 2NCT02230709
Immediate Effects of Dry Needling and Tens in Chronic Neck Pain
A Phase 2 study testing Dry Needling and "TENS" and "dry needling" in people with Myofascial Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The aim of this study is to determinate the effects of percutaneous electrical nerve stimulation in the short-term for pain in patients with myofascial chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 48 years
- Conditions the study is for
- Myofascial Neck Pain
- What is being tested?
- Dry Needling and "TENS" and "dry needling"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Nov 2012
- Phase
- Phase 2
- 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 48 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Neck pain for more than six months of evolution.
- Active Myofascial Trigger Point number 2 on Trapezius muscle.
- Score of more than 2 points in a Visual Analog Scale.
Who cannot join
- Neck pain specific.
- Radiculopathies.
- Whiplash.
- Dizziness and migraines
- Cervical surgical intervention
- Previous treatment of Dry Needling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMMEDIATE EFFECTS OF DRY NEEDLING VERSUS DRY NEEDLING AND TENS ON PAIN IN PATIENTS WITH CHRONIC MIOFASCIAL NECK PAIN
The aim of this study is to determinate the effects of percutaneous electrical nerve stimulation in the short-term for pain in patients with myofascial chronic neck pain.
- Conditions
- Myofascial Neck Pain
- Being tested
- Dry Needling, "TENS" and "dry needling"
- Keywords
- Neck pain, Myofascial pain syndrome, Soreness
- Medical subject headings
- Neck Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
Needling with acupuncture needle in a myofascial trigger point.
"TENS" and "dry needling"Other
Application of TENS current after dry needling technique
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Dry needling treatment on the trigger point number 2 of the trapezius muscle. Receives: Other: Dry Needling |
| "TENS" and "dry needling" | Active comparator | Application of TENS current after dry needling treatment. Receives: Other: "TENS" and "dry needling" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Pain
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Measured: 4 days
Post-needling pain
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Measured: 4 days
Secondary outcomes (2)
Pressure Pain threshold
Pressure needed to evoke pain recognized by patient. Measured using an algometer in Kg/cm2
Measured: 4 days
Range of Motion
The subjects sat in a chair and a CROM goniometer was placed over the head. They were asked to perform active neck movements to the fullest extent of their mobility. Each movement was recorded three times and the average value was calculated.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startNov 2012
- Primary completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230709
- Sponsor's protocol ID
- 50/2012
- Status last verified
- Sep 2016
- First submitted
- 28 Aug 2014
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMEDIATE EFFECTS OF DRY NEEDLING VERSUS DRY NEEDLING AND TENS ON PAIN IN PATIENTS WITH CHRONIC MIOFASCIAL NECK PAIN
- ClinicalTrials.gov ID
- NCT02230709
- Acronym / sponsor ID
- 50/2012
- Conditions
- Myofascial Neck Pain
- Keywords
- Neck pain, Myofascial pain syndrome, Soreness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2012 (actual)
- First posted
- 3 Sep 2014 (estimated)
- 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 aim of this study is to determinate the effects of percutaneous electrical nerve stimulation in the short-term for pain in patients with myofascial chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry NeedlingDry needling treatment on the trigger point number 2 of the trapezius muscle. |
| "TENS" and "dry needling" | Active comparator | Other: "TENS" and "dry needling"Application of TENS current after dry needling treatment. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Neck pain for more than six months of evolution.
- Active Myofascial Trigger Point number 2 on Trapezius muscle.
- Score of more than 2 points in a Visual Analog Scale.
Key exclusion criteria (6 listed)
- Neck pain specific.
- Radiculopathies.
- Whiplash.
- Dizziness and migraines
- Cervical surgical intervention
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 |
|---|---|---|
| Dry NeedlingNeedling with acupuncture needle in a myofascial trigger point. | Other | Dry needling |
| "TENS" and "dry needling"Application of TENS current after dry needling technique | Other | "TENS" and "dry needling" |
Primary outcome
Neck Pain
Time frame: 4 days
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Post-needling pain
Time frame: 4 days
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
2 secondary outcomes
Pressure Pain threshold
Time frame: 4 days
Range of Motion
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dry Needling and "TENS" and "dry needling" in people with Myofascial Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Sep 2016. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neck Pain (time frame: 4 days). The study lists 2 primary outcomes in all. 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 21 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.