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Trigger Point Dry Needling for Chronic Tension-Type Headache

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ClinicalTrials.gov Identifier: NCT03500861
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Emine Handan Tüzün, Eastern Mediterranean University

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.

Condition or disease Intervention/treatment Phase
Tension-Type Headache Trigger Points Other: Dry Needling Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Trigger Point Dry Needling Versus Sham Needling for Chronic Tension-Type Headache
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Dry Needling
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

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.

Other Name: Sham Dry Needling

Sham Comparator: Sham Dry Needling
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

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.

Other Name: Sham Dry Needling




Primary Outcome Measures :
  1. The headache intensity [ Time Frame: Change from baseline headache intensity at the end of 2 weeks and at the end of the 1-month follow-up period. ]
    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 :
  1. The headache frequency [ Time Frame: Change from baseline headache frequency at the end of 2 weeks and at the end of the 1-month follow-up period. ]
    On the diary, patients registered the frequency of headaches (days per week)

  2. The headache duration [ Time Frame: Change from baseline headache duration at the end of 2 weeks and at the end of the 1-month follow-up period. ]
    On the diary, patients registered the duration of each headache attack (hours per day).

  3. The quality of life [ Time Frame: Change from baseline assessment at the end of the 1-month follow-up period. ]
    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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500861


Locations
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Turkey
1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation,
Ankara, Turkey
Sponsors and Collaborators
Eastern Mediterranean University
Investigators
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Study Chair: Emine H. Tüzün, Prof.Dr. Instructor
Principal Investigator: Sıla Gildir, MsC. Physical Therapist
Principal Investigator: Goncagül Eroğlu, PT. Physical Therapist
Principal Investigator: Levent Eker, Assist.Prof. Instructor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emine Handan Tüzün, Prof. Dr., Eastern Mediterranean University
ClinicalTrials.gov Identifier: NCT03500861    
Other Study ID Numbers: ETK00-2017-0121
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emine Handan Tüzün, Eastern Mediterranean University:
headache characteristics, health-related quality of life.
Additional relevant MeSH terms:
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Tension-Type Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases