NCT06108180

Brief Summary

Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical, cranial, and facial musculature in patients with frequent and chronic tension-type headache.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 20, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

25 days

First QC Date

October 20, 2023

Last Update Submit

May 13, 2024

Conditions

Tension-Type HeadacheDry Needling

Outcome Measures

Primary Outcomes (1)

  • Active trigger points

    The investigators assess the sensitivity of trigger points using algometry to determine which points reproduce the participants tensional-type headache.

    1 month

Secondary Outcomes (1)

  • cervical ROM

    1 month

Study Arms (2)

Dry Needling group

EXPERIMENTAL
Other: Dry Needling

Control group

NO INTERVENTION

Interventions

Dry NeedlingOTHER

3 treatment to eliminate active trigger points that patients have

Dry Needling group

Eligibility Criteria

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

You may qualify if:

  • Patients with a diagnosis of tension headache according to IHS

You may not qualify if:

  • Documented major trauma through medical history in the cervical area and/or recent surgery.
  • Pregnancy.
  • Generalized pain.
  • Inflammatory, hormonal, or neurological disorders.
  • Tendon disorders in the upper extremities.
  • Severe psychiatric illnesses.
  • Inability to complete the form in Spanish.
  • Having a pacemaker (due to the use of equipment with magnetic sensors).
  • Specific contraindications to invasive or conservative physiotherapy (infection, fever, hypothyroidism, wounds in the puncture area, metal allergies, cancer, 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)

  • Ferrante T, Manzoni GC, Russo M, Camarda C, Taga A, Veronesi L, Pasquarella C, Sansebastiano G, Torelli P. Prevalence of tension-type headache in adult general population: the PACE study and review of the literature. Neurol Sci. 2013 May;34 Suppl 1:S137-8. doi: 10.1007/s10072-013-1370-4.

    PMID: 23695063BACKGROUND

  • Fernandez-de-Las-Penas C, Ge HY, Arendt-Nielsen L, Cuadrado ML, Pareja JA. The local and referred pain from myofascial trigger points in the temporalis muscle contributes to pain profile in chronic tension-type headache. Clin J Pain. 2007 Nov-Dec;23(9):786-92. doi: 10.1097/AJP.0b013e318153496a.

    PMID: 18075406BACKGROUND

  • 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

  • Stephens LR, Humphrey JD, Little PB, Barnum DA. Morphological, biochemical, antigenic, and cytochemical relationships among Haemophilus somnus, Haemophilus agni, Haemophilus haemoglobinophilus, Histophilus ovis, and Actinobacillus seminis. J Clin Microbiol. 1983 May;17(5):728-37. doi: 10.1128/jcm.17.5.728-737.1983.

    PMID: 6408118BACKGROUND

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

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

October 20, 2023

First Posted

October 30, 2023

Study Start

October 23, 2023

Primary Completion

November 17, 2023

Study Completion

December 5, 2023

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)