Trigger Point Dry Needling for Chronic Tension-Type Headache

NCT03500861 | Completed

• 1 other identifier: ETK00-2017-0121
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

In this double-blind randomized trial, we aimed to explore the effectiveness of trigger point dry needling in patients with chronic tension type headache (CTTH) in reduction of headache frequency, intensity, duration, and improvement of health-related quality of life (HRQoL).A total of 160 CTTH patients participated in this double-blind, sham-controlled randomized trial. The patients received dry needling using sterile stainless-steel acupuncture needles of 0.25x40 mm and 0.25x 25 mm dimensions three times a week for 2 weeks. The primary outcome measurement which was the headache intensity and, the secondary outcome measurements which were the headache frequency and duration were collected using a headache diary before and after treatment. Another secondary outcome measurement which was the health related quality of life was measured before treatment and at the end of the 1-month follow-up period. HRQoL assessments of patients were performed using Short Form-36 (SF-36). In the dry needling (DN) group, both the primary outcome measurements and the scores of SF-36 subscales were significantly improved after treatment. In the DN group, all effect sizes for headache variables were large. The results of this clinical trial suggest that trigger point dry needling in patients with CTTH is effective and safe in reduction of headache frequency, intensity, duration, and increasing health-related quality of life.

Conditions

Tension-Type Headache; Trigger Points

Keywords

headache characteristics, health-related quality of life.

Outcome Measures

Primary Outcomes (1)

• The headache intensity

  On the diary, patients registered the headache intensity, Headache intensity was evaluated using a 10-cm horizontal Visual Analog Scale (cm), (VAS; range: 0 = no pain and 10 = maximum pain)

  Change from baseline headache intensity at the end of 2 weeks and at the end of the 1-month follow-up period.

Secondary Outcomes (3)

• The headache frequency

  Change from baseline headache frequency at the end of 2 weeks and at the end of the 1-month follow-up period.

• The headache duration

  Change from baseline headache duration at the end of 2 weeks and at the end of the 1-month follow-up period.

• The quality of life

  Change from baseline assessment at the end of the 1-month follow-up period.

Study Arms (2)

Dry Needling

EXPERIMENTAL

While the patient was sitting, the therapist firstly cleaned the area with alcohol. Then, DN was applied into the active TrPs on the basis of the technique described by Hong (19). The needle remained in the trigger points for 20 minutes. Upon removal of the needle, the area was compressed firmly with a cotton swab for 60 secs. The DN procedure used sterile stainless-steel acupuncture needles of 0.25x40 mm and 0.25x 25 mm dimensions (Hua Long ®). DN was applied three times a week for 2 weeks, in previously diagnosed active trigger points located in the musculature of the head and the neck.

Other: Dry Needling

Sham Dry Needling

SHAM COMPARATOR

In the Sham Dry Needling (SDN) group, three times a week for 2 weeks, the SDN procedure was applied into the adipose tissue located at any area where an active TrPs was absent.

Other: Dry Needling

Interventions

Dry Needling OTHER

The trigger point DN procedure was performed by a certified physiotherapist. While the patient was sitting, the therapist firstly cleaned the area with alcohol. Then, DN was applied into the active TrPs on the basis of the technique described by Hong (19). The needle remained in the trigger points for 20 minutes. Upon removal of the needle, the area was compressed firmly with a cotton swab for 60 secs. The DN procedure used sterile stainless-steel acupuncture needles of 0.25x40 mm and 0.25x 25 mm dimensions (Hua Long ®). DN was applied three times a week for 2 weeks, in previously diagnosed active trigger points located in the musculature of the head and the neck. the Sham Dry Needling procedure was applied into the adipose tissue located at any area where an active TrPs was absent.

Also known as: Sham Dry Needling

Dry Needling; Sham Dry Needling

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• being between 20 and 50 years of age,
• diagnosed with CTTH according to the International Classification of Headache Disorders-3 (ICHD-3) beta criteria,
• having at least one active TrP, and
• having pain intensity greater than 2 cm on the Visual Analog Scale (VAS).

You may not qualify if:

• subjects who have migraine, cluster headache, episodic tension-type headache, secondary headaches and facial pain,
• subjects who used any medication, except simple analgesics, during treatment.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation,

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Gildir S, Tuzun EH, Eroglu G, Eker L. A randomized trial of trigger point dry needling versus sham needling for chronic tension-type headache. Medicine (Baltimore). 2019 Feb;98(8):e14520. doi: 10.1097/MD.0000000000014520.

  PMID: 30813155 DERIVED

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Emine H. Tüzün, Prof.Dr.

  Instructor

  STUDY CHAIR

• Sıla Gildir, MsC.

  Physical Therapist

  PRINCIPAL INVESTIGATOR

• Goncagül Eroğlu, PT.

  Physical Therapist

  PRINCIPAL INVESTIGATOR

• Levent Eker, Assist.Prof.

  Instructor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 18, 2018
• Study Start: April 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: August 30, 2017
• Last Updated: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)