Effectiveness of the Dry Needling Approach in Patients Wi... | NCT06108180

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

NCT06108180

Sponsor

Universidad de Zaragoza

Status

Completed

Last Update Posted

May 14, 2024Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Tension-Type Headache
Dry Needling

Interventions

Dry Needling

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2023Actual

Primary Completion Date

Nov 17, 2023Actual

Completion Date

Dec 5, 2023Actual

First Submitted Date

Oct 20, 2023

First Submission Date that Met QC Criteria

Oct 26, 2023

First Posted Date

Oct 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2024

Last Update Posted Date

May 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dry Needling group	Experimental		Other: Dry Needling
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dry Needling	Other	3 treatment to eliminate active trigger points that patients have	Dry Needling group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Clínico de Fisioterapia OMT-E		Zaragoza		50009	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23695063	Background	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.
18075406	Background

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities