Neck PainNCT03787706
Dry Needling and Electromyographic Changes in Neck Pain
A study testing Dry Needling and Manual Therapy in people with Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
There is evidence suggesting that patients with mechanical neck pain exhibit higher activity of the superficial neck flexor muscles during the execution of the cranio-cervical flexion test. In addition, some studies have reported the presence of active trigger points in the neck flexor and extensor muscles. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry Needling and Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2019to 1 Sep 2021
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.
Who cannot join
- whiplash injury;
- previous cervical or thoracic surgery;
- cervical radiculopathy or myelopathy;
- diagnosis of fibromyalgia syndrome;
- having undergone physical therapy in the previous 6 months;
- less than 18 or greater than 55 years of age
- fear to needles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromyographic Changes in the Cranio-Cervical Flexion Test After Dry Needling of the Upper Trapezius Muscle in Patients With Mechanical Neck Pain
There is evidence suggesting that patients with mechanical neck pain exhibit higher activity of the superficial neck flexor muscles during the execution of the cranio-cervical flexion test. In addition, some studies have reported the presence of active trigger points in the neck flexor and extensor muscles. Since preliminary evidence suggests that trigger points can affect motor control behaviour, it is possible that management of these trigger points with dry needling could be effective for improving muscle activity during low-load activities, such as the cranio-cervical flexion test. Therefore, the aim of this study will be to investigate the effects on electromyographical activity, pressure pain thresholds and cervical range of motion after the application of dry needling over active TrPs in the upper trapezius muscle in patients with mechanical neck pain.
- Conditions
- Neck Pain
- Being tested
- Dry Needling, Manual Therapy
- Keywords
- Neck Pain, Trigger points, Dry needling, Cranio-cervical flexion test
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
Patients will receive dry needling over active trigger points in the upper trapezius muscle
Manual TherapyOther
Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Patients will receive dry needling over active trigger points in the upper trapezius muscle Receives: Other: Dry Needling |
| Manual Therapy | Active comparator | Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle Receives: Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in electromyographic activity of the neck superficial flexor muscles before and after the intervention
Bipolar surface EMG will be recorded with pairs of electrodes positioned 20mm apart and fixed firmly with an adhesive tape bilaterally over the sternocleidomastoid, the anterior scalene, the upper trapezius and the splenius capitis muscles.
Measured: Baseline and 5 minutes after treatment
Secondary outcomes (3)
Changes in neck pain intensity with a numerical pain rate scale before and after the intervention
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous neck pain intensity
Measured: Baseline and 5 minutes after treatment
Changes in widespread pressure pain sensitivity before and after the intervention
Pressure pain thresholds will be assessed over C5/C6 zygapophyseal joints, second metacarpal, and tibialis anterior muscle
Measured: Baseline and 5 minutes after treatment
Changes in cervical range of motion before and after the intervention
Active cervical range of motion will be assessed with a Cervical Range of Motion (CROM) device in all cervical motions
Measured: Baseline and 5 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start15 Jan 2019
- Primary completion15 Jun 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787706
- Sponsor's protocol ID
- URJC3010201812618
- Status last verified
- Sep 2021
- First submitted
- 22 Dec 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodriguez-Jimenez J, Ortega-Santiago R, Bonilla-Barba L, Falla D, Fernandez-de-Las-Penas C, Florencio LL. Immediate Effects of Dry Needing or Manual Pressure Release of Upper Trapezius Trigger Points on Muscle Activity During the Craniocervical Flexion Test in People with Chronic Neck Pain: A Randomized Clinical Trial. Pain Med. 2022 Sep 30;23(10):1717-1725. doi: 10.1093/pm/pnac034.
PubMed 35179608
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Changes in the Cranio-Cervical Flexion Test After Dry Needling of the Upper Trapezius Muscle in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT03787706
- Acronym / sponsor ID
- URJC3010201812618
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Trigger points, Dry needling, Cranio-cervical flexion test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 26 Dec 2018 (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.
There is evidence suggesting that patients with mechanical neck pain exhibit higher activity of the superficial neck flexor muscles during the execution of the cranio-cervical flexion test. In addition, some studies have reported the presence of active trigger points in the neck flexor and extensor muscles. Since preliminary evidence suggests that trigger points can affect motor control behaviour, it is possible that management of these trigger points with dry needling could be effective for improving muscle activity during low-load activities, such as the cranio-cervical flexion test. Therefore, the aim of this study will be to investigate the effects on electromyographical activity, pressure pain thresholds and cervical range of motion after the application of dry needling over active TrPs in the upper trapezius muscle in patients with mechanical neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry NeedlingPatients will receive dry needling over active trigger points in the upper trapezius muscle |
| Manual Therapy | Active comparator | Other: Manual TherapyPatients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.
Key exclusion criteria (7 listed)
- whiplash injury;
- previous cervical or thoracic surgery;
- cervical radiculopathy or myelopathy;
- diagnosis of fibromyalgia syndrome;
- having undergone physical therapy in the previous 6 months;
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 NeedlingPatients will receive dry needling over active trigger points in the upper trapezius muscle | Other | Dry needling |
| Manual TherapyPatients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle | Other | Manual Therapy |
Primary outcome
Changes in electromyographic activity of the neck superficial flexor muscles before and after the intervention
Time frame: Baseline and 5 minutes after treatment
Bipolar surface EMG will be recorded with pairs of electrodes positioned 20mm apart and fixed firmly with an adhesive tape bilaterally over the sternocleidomastoid, the anterior scalene, the upper trapezius and the splenius capitis muscles.
3 secondary outcomes
Changes in neck pain intensity with a numerical pain rate scale before and after the intervention
Time frame: Baseline and 5 minutes after treatment
Changes in widespread pressure pain sensitivity before and after the intervention
Time frame: Baseline and 5 minutes after treatment
Changes in cervical range of motion before and after the intervention
Time frame: Baseline and 5 minutes after treatment
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 29 Sep 2021.
- Derived from this study: PubMed 35179608Rodriguez-Jimenez J, Ortega-Santiago R, Bonilla-Barba L, Falla D, Fernandez-de-Las-Penas C, Florencio LL. Immediate Effects of Dry Needing or Manual Pressure Release of Upper Trapezius Trigger Points on Muscle Activity During the Craniocervical Flexion Test in People with Chronic Neck Pain: A Randomized Clinical Trial. Pain Med. 2022 Sep 30;23(10):1717-1725. doi: 10.1093/pm/pnac034.
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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 study testing Dry Needling and Manual Therapy in people with 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 1 inclusion and 7 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 29 Sep 2021. 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.
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?
Changes in electromyographic activity of the neck superficial flexor muscles before and after the intervention (time frame: Baseline and 5 minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03787706, which also lists 1 linked publication.
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 29 Sep 2021.