Clinical trial NCT03500861: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Trigger Points
Keywords: headache characteristics, health-related quality of life.
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: The headache intensity
timeFrame: Change from baseline headache intensity at the end of 2 weeks and at the end of the 1-month follow-up period.
Secondary outcomes:
measure: The headache frequency
timeFrame: Change from baseline headache frequency at the end of 2 weeks and at the end of the 1-month follow-up period.
measure: The headache duration
timeFrame: Change from baseline headache duration at the end of 2 weeks and at the end of the 1-month follow-up period.
measure: The quality of life
timeFrame: Change from baseline assessment at the end of the 1-month follow-up period.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: 1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation,
Study officials:
affiliation: Instructor
name: Emine H. Tüzün, Prof.Dr.
role: STUDY_CHAIR
affiliation: Physical Therapist
name: Sıla Gildir, MsC.
role: PRINCIPAL_INVESTIGATOR
affiliation: Physical Therapist
name: Goncagül Eroğlu, PT.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instructor
name: Levent Eker, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.