Trigger PointsNCT04394741
Effects of Dry Needling on Stiffness in Latent Trigger Points
A study testing Intervention-Dry Needling in people with Trigger Points, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether application of Dry Needling (DN) is effective for reduced on Stiffness in Latent trigger point (LTrP) of upper trapezius. The secondary purposes are to determine the correlation on two elastography for stiffness measure (Shear-wave elastography and Strain… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Points
- What is being tested?
- Intervention-Dry Needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 31 Aug 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 30 years
- The presence of LTrP in the middle third of the upper trapezius muscle on the dominant side
- Being able to provide written informed consent
- Being able to follow instructions and realize clinical tests
Who cannot join
- Any pharmacological therapeutic
- Any medical treatment or physical therapies at cervical region during the 6-month before this study - Any diagnosed health problem
- Any history of head and upper extremity surgery or trauma
- Any red flags to DN, (ie: metabolic diseases, pregnancy, kinesiophobia, Infection, cancer)
- Absence of recurrent history of neck pain
- No neck pain symptomatology the previous 6 months
- Cervical disk herniation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dry Needling on Stiffness in Latent Myofascial Trigger Points: a Randomized Controlled Trial
The purpose of this study is to determine whether application of Dry Needling (DN) is effective for reduced on Stiffness in Latent trigger point (LTrP) of upper trapezius. The secondary purposes are to determine the correlation on two elastography for stiffness measure (Shear-wave elastography and Strain elastography). Randomized controlled trial, in parallel with cross-control design. Two groups with LTrP in upper trapezius, and will be randomly selected to DN group or Sham-Dn group.
- Conditions
- Trigger Points
- Being tested
- Intervention-Dry Needling, Control-Dry Needling
- Keywords
- Pain, Latent trigger point, Stiffness, Dry Needling
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention-Dry NeedlingDevice
Deep Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle.
1 session in upper trapezius muscle moving the needle up and down ten times.
Control-Dry NeedlingDevice
Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
1 session in upper trapezius muscle moving the needle up and down ten times.
| Study group | Role | What they receive |
|---|---|---|
| Deep Dry Needling | Experimental | Intervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle Receives: Device: Intervention-Dry Needling |
| Sham Dry Needling | Sham comparator | Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle Receives: Device: Intervention-Dry Needling; Device: Control-Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Stiffness (Shear wave elastography and Strain Elastography)
Shear-wave Elastography (SWE) as assessed using an Logiq S8 US system (GE Healthcare).
The stiffness was determined with measuring velocity of shear waves in trapezius muscle on SWE exam.
Strain elastography (SEL) as assessed using an Logiq S8 US system (GE Healthcare).
The stiffness was determined by applying light repetitive compression with the hand-held transducer
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Secondary outcomes (3)
Change in Pain Pressure Threshold (PPT)
Pressure-Pain Threshold as assessed by an manual mechanical algometer. PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Thickness of muscle
The muscle was scanned in the longitudinal and axial planes, taking care to avoid anisotropy. B-Mode gray scale was employed to measure muscle thickness
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Post-needling soreness
The procedure performed was the subject had to characterize the level of pain using a visual analog scale (VAS), ranging from 0mm (no pain) to 10mm (worst imaginable pain)
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Jun 2020
- Primary completion31 Jul 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trigger PointsStudies 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
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Abián-Vicén, PhD, Study director, Castilla-La Mancha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394741
- Sponsor's protocol ID
- DNStiffness
- Status last verified
- Sep 2020
- First submitted
- 10 May 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruiz-Saez M, Fernandez-de-las-Penas C, Blanco CR, Martinez-Segura R, Garcia-Leon R. Changes in pressure pain sensitivity in latent myofascial trigger points in the upper trapezius muscle after a cervical spine manipulation in pain-free subjects. J Manipulative Physiol Ther. 2007 Oct;30(8):578-83. doi: 10.1016/j.jmpt.2007.07.014.
PubMed 17996549Grabowski PJ, Slane LC, Thelen DG, Obermire T, Lee KS. Evidence of Generalized Muscle Stiffness in the Presence of Latent Trigger Points Within Infraspinatus. Arch Phys Med Rehabil. 2018 Nov;99(11):2257-2262. doi: 10.1016/j.apmr.2018.03.024. Epub 2018 Apr 28.
PubMed 29709524Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.
PubMed 23684553Luan S, Zhu ZM, Ruan JL, Lin CN, Ke SJ, Xin WJ, Liu CC, Wu SL, Ma C. Randomized Trial on Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Dry Needling in Myofascial Trigger Points. Am J Phys Med Rehabil. 2019 Aug;98(8):677-684. doi: 10.1097/PHM.0000000000001173.
PubMed 31318748Sanchez-Infante J, Bravo-Sanchez A, Jimenez F, Abian-Vicen J. Effects of Dry Needling on Muscle Stiffness in Latent Myofascial Trigger Points: A Randomized Controlled Trial. J Pain. 2021 Jul;22(7):817-825. doi: 10.1016/j.jpain.2021.02.004. Epub 2021 Feb 23.
PubMed 33636373
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Stiffness in Latent Myofascial Trigger Points: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04394741
- Acronym / sponsor ID
- DNStiffness
- Conditions
- Trigger Points
- Keywords
- Pain, Latent trigger point, Stiffness, Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 19 May 2020 (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 purpose of this study is to determine whether application of Dry Needling (DN) is effective for reduced on Stiffness in Latent trigger point (LTrP) of upper trapezius. The secondary purposes are to determine the correlation on two elastography for stiffness measure (Shear-wave elastography and Strain elastography). Randomized controlled trial, in parallel with cross-control design. Two groups with LTrP in upper trapezius, and will be randomly selected to DN group or Sham-Dn group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Dry Needling | Experimental | Device: Intervention-Dry NeedlingIntervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle |
| Sham Dry Needling | Sham comparator | Device: Intervention-Dry Needling, Device: Control-Dry NeedlingControl-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 30 years
- The presence of LTrP in the middle third of the upper trapezius muscle on the dominant side
- Being able to provide written informed consent
- Being able to follow instructions and realize clinical tests
Key exclusion criteria (7 listed)
- Any pharmacological therapeutic
- Any medical treatment or physical therapies at cervical region during the 6-month before this study - Any diagnosed health problem
- Any history of head and upper extremity surgery or trauma
- Any red flags to DN, (ie: metabolic diseases, pregnancy, kinesiophobia, Infection, cancer)
- Absence of recurrent history of neck pain
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 |
|---|---|---|
| Intervention-Dry NeedlingDeep Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle. 1 session in upper trapezius muscle moving the needle up and down ten times. | Device | Deep Dry Needling, Sham Dry Needling |
| Control-Dry NeedlingSham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles 1 session in upper trapezius muscle moving the needle up and down ten times. | Device | Sham Dry Needling |
Primary outcome
Change on Stiffness (Shear wave elastography and Strain Elastography)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Shear-wave Elastography (SWE) as assessed using an Logiq S8 US system (GE Healthcare). The stiffness was determined with measuring velocity of shear waves in trapezius muscle on SWE exam. Strain elastography (SEL) as assessed using an Logiq S8 US system (GE Healthcare). The stiffness was determined by applying light repetitive compression with the hand-held transducer
3 secondary outcomes
Change in Pain Pressure Threshold (PPT)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Thickness of muscle
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Post-needling soreness
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours 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 5 Oct 2020.
- Background: PubMed 17996549Ruiz-Saez M, Fernandez-de-las-Penas C, Blanco CR, Martinez-Segura R, Garcia-Leon R. Changes in pressure pain sensitivity in latent myofascial trigger points in the upper trapezius muscle after a cervical spine manipulation in pain-free subjects. J Manipulative Physiol Ther. 2007 Oct;30(8):578-83. doi: 10.1016/j.jmpt.2007.07.014.
- Background: PubMed 29709524Grabowski PJ, Slane LC, Thelen DG, Obermire T, Lee KS. Evidence of Generalized Muscle Stiffness in the Presence of Latent Trigger Points Within Infraspinatus. Arch Phys Med Rehabil. 2018 Nov;99(11):2257-2262. doi: 10.1016/j.apmr.2018.03.024. Epub 2018 Apr 28.
- Background: PubMed 23684553Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.
- Background: PubMed 31318748Luan S, Zhu ZM, Ruan JL, Lin CN, Ke SJ, Xin WJ, Liu CC, Wu SL, Ma C. Randomized Trial on Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Dry Needling in Myofascial Trigger Points. Am J Phys Med Rehabil. 2019 Aug;98(8):677-684. doi: 10.1097/PHM.0000000000001173.
- Derived from this study: PubMed 33636373Sanchez-Infante J, Bravo-Sanchez A, Jimenez F, Abian-Vicen J. Effects of Dry Needling on Muscle Stiffness in Latent Myofascial Trigger Points: A Randomized Controlled Trial. J Pain. 2021 Jul;22(7):817-825. doi: 10.1016/j.jpain.2021.02.004. Epub 2021 Feb 23.
- 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.
Javier Abián-Vicén, PhD study director
Castilla-La Mancha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention-Dry Needling in people with Trigger Points, run by University of Castilla-La Mancha 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 4 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 5 Oct 2020. 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. Some participants in this study may receive a placebo. 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?
Change on Stiffness (Shear wave elastography and Strain Elastography) (time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours 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 NCT04394741, which also lists 5 linked publications.
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 5 Oct 2020.