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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06257992
Other study ID # RAT 2022-53
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date August 2024

Study information

Verified date February 2024
Source Universidad de Zaragoza
Contact Julian Müller-Thyssen Uriarte
Phone +34 0633673021
Email julianmuller.jmt@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical muscles's active trigger points in patients with chronic cervical pain.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date August 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Be older than 18 years old - Sign informed consent form prior to participating in this study - Have chronic cervical pain diagnosis of their primary care doctor. - Have one or more active myofascial trigger point in the cervical muscles according to the criteria established by Simons et al. Exclusion Criteria: - Major trauma on cervical spine stated from the medical history - Inflammatory, hormonal or neurological disorders - Have contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, wound in the puncture area, metal allergies, cancer or systemic diseases, or belonephobia) - Having received physiotherapy treatment for the condition in the past month

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dry Needling
3 treatments of dry needling to inactivate all active trigger points found in patient's cervical muscles.
Stretch
3 treatments of stretch applied to all cervical muscles that present active trigger points in patient's cervical muscles.

Locations

Country Name City State
Spain Centro Clínico de Fisioterapia OMT-E Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Ball AM, Finnegan M, Koppenhaver S, Freres W, Dommerholt J, Mayoral Del Moral O, Bron C, Moore R, Ball EE, Gaffney EE. The relative risk to the femoral nerve as a function of patient positioning: potential implications for trigger point dry needling of the iliacus muscle. J Man Manip Ther. 2019 Jul;27(3):162-171. doi: 10.1080/10669817.2019.1568699. Epub 2019 Feb 20. — View Citation

Cerezo-Tellez E, Torres-Lacomba M, Fuentes-Gallardo I, Perez-Munoz M, Mayoral-Del-Moral O, Lluch-Girbes E, Prieto-Valiente L, Falla D. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial. Pain. 2016 Sep;157(9):1905-1917. doi: 10.1097/j.pain.0000000000000591. — View Citation

Fernandez-de-las-Penas C, Alonso-Blanco C, Miangolarra JC. Myofascial trigger points in subjects presenting with mechanical neck pain: a blinded, controlled study. Man Ther. 2007 Feb;12(1):29-33. doi: 10.1016/j.math.2006.02.002. — View Citation

Navarro-Santana MJ, Sanchez-Infante J, Gomez-Chiguano GF, Cleland JA, Fernandez-de-Las-Penas C, Martin-Casas P, Plaza-Manzano G. Dry Needling Versus Trigger Point Injection for Neck Pain Symptoms Associated with Myofascial Trigger Points: A Systematic Review and Meta-Analysis. Pain Med. 2022 Mar 2;23(3):515-525. doi: 10.1093/pm/pnab188. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cervical Pain Intensity For the Assesment of cervical pain intensity the Numeric Pain Rating Scale (NPRS) was used. Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Primary Neck Disability Index For the assesment of perceived neck disability the neck disability index was used. Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Primary Pressure Pain Threshold For the assesment of pressure pain threshold of active trigger points a digital algometer was used Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Secondary Cervical range of movement For the assesment of cervical range of movement the universal goniometer was used Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Secondary Cervical muscles Electromyography For the assesment of cervical muscles electromyographic activity Trigno Avanti sensor was used. Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
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