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Trigger Point Dry Needling for Chronic Tension-Type Headache

Primary Purpose

Tension-Type Headache, Trigger Points

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dry Needling
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache focused on measuring headache characteristics, health-related quality of life.

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dry Needling

Sham Dry Needling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

The headache frequency
On the diary, patients registered the frequency of headaches (days per week)
The headache duration
On the diary, patients registered the duration of each headache attack (hours per day).
The quality of life
The health related quality of life assessments of patients were performed using the Turkish version of Short Form-36. It includes eight multi-item scales containing between 2 and 10 items each, plus a single item to compare current health with a person's health 1 year ago (health transition). The scales cover the dimensions of physical functioning (PF), role physical (RP), bodily pain (P), general health (GH), vitality (V), social functioning (SF), role emotional (RE), and mental health (MH). All items pertaining to each scale (excluding health transition) are summed and transformed to form a scale from 0 to 100, where a higher score indicates a better state of health or well-being.

Full Information

First Posted
April 3, 2018
Last Updated
April 20, 2018
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT03500861
Brief Title
Trigger Point Dry Needling for Chronic Tension-Type Headache
Official Title
A Randomized Trial of Trigger Point Dry Needling Versus Sham Needling for Chronic Tension-Type Headache
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
According to the 2013 Global Burden of Disease study, recurrent tension-type headache is the second most common chronic disease worldwide, with an age-standardized prevalence of 21.75 % (1). Although high prevalence of chronic tension-type headache (CTTH) has been reported in all world regions, it is also the most neglected disorder and it leads to headaches that are difficult to treat (2). Myofascial pain can play an important etiologic role. It has been claimed that pain from pericranial head, neck and shoulder muscles is associated with the head and experienced as headache (5, 6). Within the cervical musculature, there are several head and neck muscles, eg. temporal, masseter, upper trapezius, sternocleidomastoid, temporalis, sub-occipital muscles, from which trigger points (TrPs) spread referred pain to the head (6). There are several pharmacological and non-pharmacological therapies for patients with CTTH. Physiotherapy is the most commonly used non-pharmacological treatment of CTTH. Although sports and orthopedic physiotherapists have used dry needling (DN) for a long time to address the pain and dysfunction associated with myofascial trigger points (11), there is insufficient evidence to strongly advocate for use of DN for treatment of CTTH (12). In this double-blind randomized trial, we aimed to explore the effectiveness of trigger point dry needling in patients with CTTH in reduction of headache frequency, intensity, duration, and improve health-related quality of life (HRQoL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache, Trigger Points
Keywords
headache characteristics, health-related quality of life.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Dry Needling
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry Needling
Other Intervention Name(s)
Sham Dry Needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
The headache intensity
Description
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)
Time Frame
Change from baseline headache intensity at the end of 2 weeks and at the end of the 1-month follow-up period.
Secondary Outcome Measure Information:
Title
The headache frequency
Description
On the diary, patients registered the frequency of headaches (days per week)
Time Frame
Change from baseline headache frequency at the end of 2 weeks and at the end of the 1-month follow-up period.
Title
The headache duration
Description
On the diary, patients registered the duration of each headache attack (hours per day).
Time Frame
Change from baseline headache duration at the end of 2 weeks and at the end of the 1-month follow-up period.
Title
The quality of life
Description
The health related quality of life assessments of patients were performed using the Turkish version of Short Form-36. It includes eight multi-item scales containing between 2 and 10 items each, plus a single item to compare current health with a person's health 1 year ago (health transition). The scales cover the dimensions of physical functioning (PF), role physical (RP), bodily pain (P), general health (GH), vitality (V), social functioning (SF), role emotional (RE), and mental health (MH). All items pertaining to each scale (excluding health transition) are summed and transformed to form a scale from 0 to 100, where a higher score indicates a better state of health or well-being.
Time Frame
Change from baseline assessment at the end of the 1-month follow-up period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine H. Tüzün, Prof.Dr.
Organizational Affiliation
Instructor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sıla Gildir, MsC.
Organizational Affiliation
Physical Therapist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Goncagül Eroğlu, PT.
Organizational Affiliation
Physical Therapist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Levent Eker, Assist.Prof.
Organizational Affiliation
Instructor
Official's Role
Principal Investigator
Facility Information:
Facility Name
1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation,
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30813155
Citation
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.
Results Reference
derived

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Trigger Point Dry Needling for Chronic Tension-Type Headache

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