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

May 13, 2024 updated by: Sofía Monti Ballano, Universidad de Zaragoza
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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Centro clínico de Fisioterapia OMT-E

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 month
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
Time Frame: 1 month
general cervical range of movement, upper and lower cervical
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Zaragoza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2023

Primary Completion (Actual)

November 17, 2023

Study Completion (Actual)

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)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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