NCT06257992

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 5, 2024

Last Update Submit

February 5, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Cervical range of movement

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months

  • Cervical muscles Electromyography

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months

Study Arms (2)

Dry Needling Group

EXPERIMENTAL
Other: Dry Needling

Stretch Group

ACTIVE COMPARATOR
Other: Stretch

Interventions

3 treatments of dry needling to inactivate all active trigger points found in patient's cervical muscles.

Dry Needling Group
StretchOTHER

3 treatments of stretch applied to all cervical muscles that present active trigger points in patient's cervical muscles.

Stretch Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Clínico de Fisioterapia OMT-E

Zaragoza, 50009, Spain

Location

Related Publications (4)

  • 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.

    PMID: 27537209BACKGROUND
  • 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.

    PMID: 21882489BACKGROUND
  • 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.

    PMID: 34114639BACKGROUND
  • 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.

    PMID: 30935326BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Julian Müller-Thyssen Uriarte

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 14, 2024

Study Start

February 1, 2024

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations