Cervical PainNCT03331653
Effectiveness of Dry Needling and Ischemic Compression in Sternocleidomastoid, on Cervical Motor Control in Patients With Cervical Pain.
A study testing Dry Needling and Ischemic Compression at the Trigger Point and Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point in people with Cervical Pain, run by University of Alcala at 1 site in Spain.
Trial summary
This study will compare the effect of dry needling on the active trigger point on sternocleidomastoid versus the effect of dry needling at 1.5 centimeters of active trigger point on sternocleidomastoid, both combined with ischemic compression, on cervical pain and cervical motor control short and medium term. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Dry Needling and Ischemic Compression at the Trigger Point and Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 10 Nov 2017to 10 Jun 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between 18 and 65 years old
- Have pain in the cervical region, which extends from the occipital to the 7th cervical vertebra.
- Have an active trigger point on the sternocleidomastoid.
Who cannot join
- Present history of trauma in the neck.
- Present cervical radiculopathy
- Present a vestibular pathology
- Previous surgery on the neck or shoulder area
- Having a primary headache diagnosis
- Have received dry needling in the neck in the previous 6 months
Show all 10Show fewer
- Present cognitive deficit.
- Be pregnant
- Taking anticoagulants.
- Have phobia to the needles (belonephobia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dry Needling and Ischemic Compression in the Sternocleidomastoid, on Cervical Motor Control in Patients With Cervical Pain, Versus Placebo Technique and Ischemic Compression, Randomized Trial.
This study will compare the effect of dry needling on the active trigger point on sternocleidomastoid versus the effect of dry needling at 1.5 centimeters of active trigger point on sternocleidomastoid, both combined with ischemic compression, on cervical pain and cervical motor control short and medium term.
- Conditions
- Cervical Pain
- Being tested
- Dry Needling and Ischemic Compression at the Trigger Point, Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point
- Keywords
- Cervical Pain, Motor Control, Sternocleidomastoid, Dry Needling
- 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 Needling and Ischemic Compression at the Trigger PointOther
The intervention consist on dry needling in the active trigger point, and next, do ischemic compression in the same point.
Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger PointOther
The intervention consist on dry needling at 1.5 centimeters from the active trigger point, and next, do ischemic compression in the same point.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling and Ischemic Compression at the Trigger Point | Experimental | Dry Needling and Ischemic Compression at the Trigger Point Receives: Other: Dry Needling and Ischemic Compression at the Trigger Point |
| Intervention at 1.5 cm from the Trigger Point | Active comparator | Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point Receives: Other: Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Pain
Changes in the level of Cervical Pain.
Measured: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Cervical Motor Control
Change in the Cervical Motor Control
Measured: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Secondary outcomes (3)
Cervical Range of Movement
Changes in grades of cervical movement
Measured: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Coordination of superficial and deep cervical flexor muscles
Changes in the coordination of cervical flexor muscles
Measured: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Cervical Disability
Changes in perceived cervical disability
Measured: Pre-intervention,1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start10 Nov 2017
- Primary completion15 May 2018
- Study completion10 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Model description
- Randomized Clinical Trial (RCT) with two groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Martín Rodríguez, University of Alcala
- Investigators
- Aida M. Rodríguez, Physiotherapy, Principal investigator, InvestigatorEsther S. Olmo, Physiotherapy, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331653
- Sponsor's protocol ID
- CEIM/HU/2017/15
- Status last verified
- Jun 2018
- First submitted
- 1 Nov 2017
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling and Ischemic Compression in the Sternocleidomastoid, on Cervical Motor Control in Patients With Cervical Pain, Versus Placebo Technique and Ischemic Compression, Randomized Trial.
- ClinicalTrials.gov ID
- NCT03331653
- Acronym / sponsor ID
- CEIM/HU/2017/15
- Conditions
- Cervical Pain
- Keywords
- Cervical Pain, Motor Control, Sternocleidomastoid, Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 10 Jun 2018 (actual)
- First posted
- 6 Nov 2017 (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.
This study will compare the effect of dry needling on the active trigger point on sternocleidomastoid versus the effect of dry needling at 1.5 centimeters of active trigger point on sternocleidomastoid, both combined with ischemic compression, on cervical pain and cervical motor control short and medium term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial (RCT) with two groups.
| Arm | Type | Receives |
|---|---|---|
| Dry Needling and Ischemic Compression at the Trigger Point | Experimental | Other: Dry Needling and Ischemic Compression at the Trigger PointDry Needling and Ischemic Compression at the Trigger Point |
| Intervention at 1.5 cm from the Trigger Point | Active comparator | Other: Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger PointDry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be between 18 and 65 years old
- Have pain in the cervical region, which extends from the occipital to the 7th cervical vertebra.
- Have an active trigger point on the sternocleidomastoid.
Key exclusion criteria (10 listed)
- Present history of trauma in the neck.
- Present cervical radiculopathy
- Present a vestibular pathology
- Previous surgery on the neck or shoulder area
- Having a primary headache diagnosis
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 Needling and Ischemic Compression at the Trigger PointThe intervention consist on dry needling in the active trigger point, and next, do ischemic compression in the same point. | Other | Dry Needling and Ischemic Compression at the Trigger Point |
| Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger PointThe intervention consist on dry needling at 1.5 centimeters from the active trigger point, and next, do ischemic compression in the same point. | Other | Intervention at 1.5 cm from the Trigger Point |
Primary outcome
Cervical Pain
Time frame: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Changes in the level of Cervical Pain.
Cervical Motor Control
Time frame: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Change in the Cervical Motor Control
3 secondary outcomes
Cervical Range of Movement
Time frame: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Coordination of superficial and deep cervical flexor muscles
Time frame: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month
Cervical Disability
Time frame: Pre-intervention,1 month
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 13 Jun 2018.
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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.
Aida M. Rodríguez, Physiotherapy principal investigator
Investigator
Esther S. Olmo, Physiotherapy principal investigator
Investigator
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 Ischemic Compression at the Trigger Point and Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point in people with Cervical Pain, run by University of Alcala 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 10 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 13 Jun 2018. 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?
Cervical Pain (time frame: Pre-intervention, immediately post-intervention, 1 day, 1 week, 1 month). 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 13 Jun 2018.