- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04394741
Effects of Dry Needling on Stiffness in Latent Trigger Points
Effects of Dry Needling on Stiffness in Latent Myofascial Trigger Points: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Toledo, Spain, 45071
- Performance and Sport Rehabilitation Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deep Dry Needling
Intervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle
|
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. |
Sham Comparator: Sham Dry Needling
Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle
|
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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Pressure Threshold (PPT)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
|
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.
|
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
|
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
|
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
|
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)
|
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Javier Abián-Vicén, PhD, Castilla-La Mancha University
Publications and helpful links
General Publications
- Maher 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.
- 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.
- Grabowski 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.
- Luan 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.
- Sanchez-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DNStiffness
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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