Tension-Type HeadacheNCT03500861
Trigger Point Dry Needling for Chronic Tension-Type Headache
A study testing Dry Needling in people with Tension-Type Headache and Trigger Points, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Tension-Type Headache, Trigger Points
- What is being tested?
- Dry Needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation,
Ankara
About this study
Official title: A Randomized Trial of Trigger Point Dry Needling Versus Sham Needling for Chronic Tension-Type Headache
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.
Read the 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
- Tension-Type Headache, Trigger Points
- Being tested
- Dry Needling
- Keywords
- headache characteristics, health-related quality of life.
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
Also called Sham 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.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | 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. Receives: Other: Dry Needling |
| Sham Dry Needling | Sham comparator | 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. Receives: Other: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline headache intensity at the end of 2 weeks and at the end of the 1-month follow-up period.
Secondary outcomes (3)
The headache frequency
On the diary, patients registered the frequency of headaches (days per week)
Measured: Change from baseline headache frequency at the end of 2 weeks and at the end of the 1-month follow-up period.
The headache duration
On the diary, patients registered the duration of each headache attack (hours per day).
Measured: Change from baseline headache duration at the end of 2 weeks and at the end of the 1-month follow-up period.
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.
Measured: Change from baseline assessment at the end of the 1-month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Apr 2017
- Primary completion1 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Handan Tüzün, Eastern Mediterranean University
- Investigators
- Emine H. Tüzün, Prof.Dr., Study chair, InstructorSıla Gildir, MsC., Principal investigator, Physical TherapistGoncagül Eroğlu, PT., Principal investigator, Physical TherapistLevent Eker, Assist.Prof., Principal investigator, Instructor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500861
- Sponsor's protocol ID
- ETK00-2017-0121
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30813155
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Trigger Point Dry Needling Versus Sham Needling for Chronic Tension-Type Headache
- ClinicalTrials.gov ID
- NCT03500861
- Acronym / sponsor ID
- ETK00-2017-0121
- Conditions
- Tension-Type Headache, Trigger Points
- Keywords
- headache characteristics, health-related quality of life.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Other: Dry NeedlingWhile 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. |
| Sham Dry Needling | Sham comparator | Other: Dry NeedlingIn 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingAlso: Sham Dry 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. | Other | Dry Needling, Sham Dry Needling |
Primary outcome
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)
3 secondary outcomes
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.
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.
The quality of life
Time frame: Change from baseline assessment at the end of the 1-month follow-up period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Derived from this study: PubMed 30813155Gildir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine H. Tüzün, Prof.Dr. study chair
Instructor
Sıla Gildir, MsC. principal investigator
Physical Therapist
Goncagül Eroğlu, PT. principal investigator
Physical Therapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Tension-Type Headache and Trigger Points, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03500861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.