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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04394741
Other study ID # DNStiffness
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date August 31, 2020

Study information

Verified date September 2020
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date August 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Intervention-Dry Needling
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 Needling
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.

Locations

Country Name City State
Spain Performance and Sport Rehabilitation Laboratory Toledo

Sponsors (1)

Lead Sponsor Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Ruiz-Sáez M, Fernández-de-las-Peñas C, Blanco CR, Martínez-Segura R, García-León 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Secondary 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. Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Secondary 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 Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Secondary 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) Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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