Effectiveness of the Dry Needling Approach in Patients With Tension-Type Headache

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.

Study Overview

• Status: Recruiting
• Conditions: Tension-Type Headache; Dry Needling
• Intervention / Treatment: Other: Dry Needling

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofía Monti; Phone Number: +34603489828; Email: smonti@unizar.es

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Recruiting
    • Centro Clínico de Fisioterapia OMT-E
    • Contact: Jesús Marcen; Phone Number: +34644161870; Email: info@centroclinicoomt.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with a diagnosis of tension headache according to IHS

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Dry Needling group	Other: Dry Needling; 3 treatment to eliminate active trigger points that patients have

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
cervical ROM	general cervical range of movement, upper and lower cervical	1 month

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Actual): November 17, 2023
• Study Completion (Estimated): December 5, 2023

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: RAT 2023-195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No