A Randomized Trial of Trigger Point Dry Needling Versus Sham Needling for Chronic Tension-Type Headache
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tension-Type Headache
- Sponsor
- Eastern Mediterranean University
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- The headache intensity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
Emine Handan Tüzün
Prof. Dr.
Eastern Mediterranean University
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.
Outcomes
Primary Outcomes
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 Outcomes
- 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 quality of life(Change from baseline assessment 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.)