Neck PainNCT03762252
Dry Needling of Scalene Muscle Trigger Points in Mechanical 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 preliminary evidence suggesting that referred pain from active trigger points can play a relevant role in individuals with mechanical neck pain. Some studies have investigated the effectiveness of dry needling over the upper trapezius muscle in this population. Read more about this study
- Who is it for?
- Ages 18 to 45 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
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2018to 1 Jul 2019
- 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 45 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 45 years of age
- fear to needles
- any respiratory disease, e.g., chronic brochitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dry Needling of Active Trigger Points in the Scalene Muscles on Individuals With Mechanical Neck Pain
There is preliminary evidence suggesting that referred pain from active trigger points can play a relevant role in individuals with mechanical neck pain. Some studies have investigated the effectiveness of dry needling over the upper trapezius muscle in this population. However, other muscles, such as the scalene muscles, can be also relevant for neck pain symptoms. No study has investigated the effects of the application of dry needling over active trigger points in the scalenes muscles in a sample of patients with mechanical neck pain.
- Conditions
- Neck Pain
- Being tested
- Dry needling, Manual Therapy
- 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
A solid filiform needle will be inserted over active trigger points in the scalene muscles for 30 seconds. The aim will be to elicit local twitch responses or the referred pain pattern of the scalene muscles.
Manual TherapyOther
The therapist will apply manual compression over active trigger points in the scalene muscles for 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Patients will receive dry needling over active trigger points in the scalene muscles Receives: Other: Dry needling |
| Manual Therapy | Active comparator | Patients will receive a manual compression for 30seconds over active trigger points in the scalene muscles Receives: Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Secondary outcomes (3)
Changes in oxigen saturation with a pulse oximeter before and after the intervention
Oxygen saturation will be monitored with a handheld pulse oximeter with Masimo SET® measure-through Motion and Low Perfusion™ pulse oximeter
Measured: Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Changes in inspiratory vital capacity with an incentive spirometer before and after the intervention
Changes in inspiratory vital capacity will be assessed with the incentive spirometer DHD Coach 2®
Measured: Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Changes in neck-related disability with the Neck Disability Index before and after the intervention
The Neck Disability Index (NDI, 0-50), a specific neck pain related disability questionaire, will be used for assessing neck pain related-disability
Measured: Baseline and 7 days (one week) and 30 days (one month) after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start5 Dec 2018
- Primary completion15 May 2019
- Study completion1 Jul 2019
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 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
- Investigators
- César Fernández-de-las-Peñas, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762252
- Sponsor's protocol ID
- URJC 2018-12-10
- Status last verified
- Jul 2019
- First submitted
- 30 Nov 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling of Active Trigger Points in the Scalene Muscles on Individuals With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT03762252
- Acronym / sponsor ID
- URJC 2018-12-10
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 3 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 preliminary evidence suggesting that referred pain from active trigger points can play a relevant role in individuals with mechanical neck pain. Some studies have investigated the effectiveness of dry needling over the upper trapezius muscle in this population. However, other muscles, such as the scalene muscles, can be also relevant for neck pain symptoms. No study has investigated the effects of the application of dry needling over active trigger points in the scalenes muscles in a sample of 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 scalene muscles |
| Manual Therapy | Active comparator | Other: Manual TherapyPatients will receive a manual compression for 30seconds over active trigger points in the scalene muscles |
Who may qualify
- Ages
- 18 to 45 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 (8 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 needlingA solid filiform needle will be inserted over active trigger points in the scalene muscles for 30 seconds. The aim will be to elicit local twitch responses or the referred pain pattern of the scalene muscles. | Other | Dry needling |
| Manual TherapyThe therapist will apply manual compression over active trigger points in the scalene muscles for 30 seconds | Other | Manual Therapy |
Primary outcome
Changes in neck pain intensity with a numerical pain rate scale before and after the intervention
Time frame: Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous neck pain intensity
3 secondary outcomes
Changes in oxigen saturation with a pulse oximeter before and after the intervention
Time frame: Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Changes in inspiratory vital capacity with an incentive spirometer before and after the intervention
Time frame: Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention
Changes in neck-related disability with the Neck Disability Index before and after the intervention
Time frame: Baseline and 7 days (one week) and 30 days (one month) after the intervention
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 9 Jul 2019.
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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.
César Fernández-de-las-Peñas principal investigator
Universidad Rey Juan Carlos
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 8 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 9 Jul 2019. 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 neck pain intensity with a numerical pain rate scale before and after the intervention (time frame: Baseline, one day (immediately post), 7 days (one week) and 30 days (one month) after the intervention). 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 9 Jul 2019.