Clinical Trials Directory

Trials / Completed

CompletedNCT03500861

Trigger Point Dry Needling for Chronic Tension-Type Headache

A Randomized Trial of Trigger Point Dry Needling Versus Sham Needling for Chronic Tension-Type Headache

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
160 (actual)
Sponsor
Eastern Mediterranean University · Academic / Other
Sex
All
Age
20 Years – 50 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
OTHERDry NeedlingThe 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.

Timeline

Start date
2017-04-01
Primary completion
2017-08-01
Completion
2017-08-30
First posted
2018-04-18
Last updated
2018-04-24

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03500861. Inclusion in this directory is not an endorsement.