Tension-Type HeadacheNCT04091100
Effects of Electroacupuncture and Myofascial Release on Headache
A study testing Electroacupuncture and Myofascial Release in people with Tension-Type Headache, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Tension-type headaches (TTH) last from thirty minutes to seven days, were ranked second among the primary types of headaches. The diagnosis of TTH is made according to the diagnostic criteria of the Second Beta version of the International Classification of Headache Disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Electroacupuncture and Myofascial Release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2019to 22 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indiviuals with cervical tension headache
- aged 18 years or older
- Accepting voluntary participation in the study
Who cannot join
- Epilepsy seizures,
- Heart disease
- Pacemaker,
- Patients with a history of stroke
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahçeşehir University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Istanbul, 34353
About this study
Official title: Effects of Electroacupuncture and Myofascial Release on Pain, Neck Functions and Depression Status in Patients With Tension-Type Headaches
Tension-type headaches (TTH) last from thirty minutes to seven days, were ranked second among the primary types of headaches. The diagnosis of TTH is made according to the diagnostic criteria of the Second Beta version of the International Classification of Headache Disorders. The causes of TTH include the activation of extremely tense peripheric afferent neurons through the head and neck muscles, muscle sensitivity and stress. Additionally, a limited range of motion (ROM) in the neck may also lead to TTH.
The treatment of TTH involve both pharmacological and non-pharmacological methods. It is known that the pharmacological treatment of TTH has a limited effect. However, previous studies have shown that physical therapy programs that include methods such as acupuncture, Transcutaneous Electrical Nerve Stimulation (TENS), exercise, biofeedback, manipulation, cryotherapy, massage, strengthening of the neck muscles, stretching exercises are effective in alleviating TTH.
Read more
It has been observed that the trigger points in muscles play a role in TTH. Trigger points are generally defined as hyper-irritable points inside taut bands. It has been demonstrated that myofascial release, which is applied to the trigger points and is effective in relaxation treatments through stimulation of the neuromuscular system, relieves headaches via muscle relaxation. Electroacupuncture is another method used in relieving myofascial pain origin that involves the application of acupuncture needles to particular points and delivery of an electrical current at a specific frequency. The stimulation of muscle and skin tissues in affected areas is carried out by means of needles and the electrical current relieves pain and muscle spasms. In a meta-analysis study, it was found that electroacupuncture had a higher pain-relieving effect. However, a review of related studies deemed them to be lacking because the assessments were too limited to make it possible to unequivocally state that electroacupuncture has a high level of therapeutic efficacy.
The studies performed, however, did not examine the efficacy of electroacupuncture and myofascial release on TTH. Given that situation, the purpose of our study is to investigate the effects of electroacupuncture and myofascial release applied to points of tension in the neck muscles and trigger points of people suffering from TTH in terms of the headache intensity and frequency, neck functions, sleep quality and depression status.
Read the detailed description
The 19 individuals who were referred to Bahçeşehir University's Department of Physiotherapy and Rehabilitation at the School of Health Sciences, with TTH, and who were 18 years of age and older, were recruited for the study. The individuals were randomly allocated into electroacupuncture and myofascial release groups with the Research Randomizer program.
Evaluation Methods A Visual Analogue Scale (VAS) to evaluate pain levels of the participants, CROM (Cervical Range of Motion) to evaluate neck ROM, Beck's Depression Inventory to evaluate depression status, Neck Pain Disability Scale to evaluate to evaluate the effect of their neck pain on the activities of the daily living Headache Diary to evaluate clinical features of the headache
- Conditions
- Tension-Type Headache
- Being tested
- Electroacupuncture, Myofascial Release
- Keywords
- Pain, Acupuncture, Tension-Type Headache, Myofascial Releasing, Depression
- Medical subject headings
- Tension-Type Headache, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
An electrical current of 2 mA and 60 Hz was administered using the Enraf Nonius Sonoplus 492 (OPTOMED) device for 20 minutes. All the treatments were performed for 2 sessions per week for 3 weeks. Both groups were given a home program involving neck stretching and posture exercises. The exercises were to be performed at least two times a day in two sets of fifteen repetitions.
Myofascial ReleaseProcedure or surgery
longitudinal stretching, friction massage and pinching technique, All the treatments were performed for 2 sessions per week for 3 weeks. Both groups were given a home program involving neck stretching and posture exercises. The exercises were to be performed at least two times a day in two sets of fifteen repetitions.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture | Active comparator | The individuals in the electroacupuncture group were administered the therapy by a certified acupuncturist. Two Shenlong acupuncture needles were inserted in each of the trapezius and levator scapulae muscles at intervals of 0-3 mm and clips were attached to their ends. Afterwards, an electrical current of 2 mA and 60 Hz was administered using the Enraf Nonius Sonoplus 492 (OPTOMED) device for 20 minutes. Receives: Procedure: Electroacupuncture |
| myofascial release | Active comparator | Firstly, longitudinal stretching was done with forearm to the muscles in the person's neck in order to relax. Afterwards, the researcher placed one hand under the person's head and placed their fingertips on the muscles under the occipital bone in the neck area. The researcher applied lateral flexion to the neck with one hand while placing the other hand on the trapezius and levator scapulae muscles and then stretched the muscles with friction massage. After this step, the participant's neck was guided back into a neutral position and the pinching technique was applied to the muscles. During the administration of therapies, the trigger points on muscles were identified and friction was applied to these sites until a loosening could be felt. The myofascial release sessions concluded with the administration of the friction massage technique once again to the muscles. Receives: Procedure: Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pain Intensity at Three Weeks
VAS, is used to evaluate the intensity of pain, using a scale comprised of a 100-mm-long horizontal line and ending with at both ends by descriptors of pain intensity beginning with "no pain" to "extreme pain. Patients are asked to indicate their levels of pain on this range by placing a dot on the line
Measured: 3 weeks
Change from Baseline Headache Intensity at Three Weeks
Headache diary (HD): Patients kept an HD for three weeks to record the clinical features of their headaches. In this diary, subjects documented the number of days per week that they experienced a headache, the duration of each headache (hour/day), and the headache intensity on a 5-point numerical pain rating scale (0: no pain, 5: maximum pain). For each subject, Headache index (HI) was calculated for the first and last ten days of the intervention period as following:
Headache index (HI) = mean headache intensity X mean number of days with headache X mean duration of headache
Measured: 3 weeks
Change from Baseline Range of Motion of the Neck at Three Weeks
The join ROM of the neck was measured via C-ROM goniometer which consists of two inclinometers for gravity on the sagittal and frontal planes, an inclinometer with magnetic needles that is inserted from above on the horizontal plane, a magnetic cervical collar, an arm with a ruler in cm units and a vertebral fixating arm with a balance system. This device has a plastic frame with a shape that is similar to a pair of glasses, as it rests on the nose and ears. During all measurements, the subjects were asked to sit on a chair with their arms held close to their bodies. Subjects were asked to look forward in a comfortable sitting position for the performance of the measurements. The initial position of each movement was set an angle of 0 degrees. The measurements were conducted while the subjects performed forward/backward bending, left/right side-bending and rotation movements on the left and right sides of the neck.
Measured: 3 weeks
Change from Baseline Depression Status at Three Weeks
The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory, which was developed to measure depression symptoms in adult individuals. The individuals assigned a score of 0 to 3 for the items of the 21-item scale, which measures characteristic attitudes and depression symptoms. The highest score that can be obtained on the scale is 63, while the threshold value is considered to be 17.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start5 Aug 2019
- Primary completion26 Sep 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Parallel groups
- Model description
- The individuals were randomly allocated into electroacupuncture and myofascial release groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Ataş Balcı, Bahçeşehir University
- Investigators
- Leyla ATAŞ BALCI, Principal investigator, Bahçeşehir University, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091100
- Sponsor's protocol ID
- LAB2
- Status last verified
- Feb 2021
- First submitted
- 12 Sep 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chowdhury D. Tension type headache. Ann Indian Acad Neurol. 2012 Aug;15(Suppl 1):S83-8. doi: 10.4103/0972-2327.100023.
PubMed 23024570Karadaş, Ö. (2013) Gerilim Tipi Baş Ağrısı: Kronik Tip Değerlendirmesi, J Clin Anal Med, 4 (6), 522-6
Madsen BK, Sogaard K, Andersen LL, Skotte J, Tornoe B, Jensen RH. Neck/shoulder function in tension-type headache patients and the effect of strength training. J Pain Res. 2018 Feb 23;11:445-454. doi: 10.2147/JPR.S146050. eCollection 2018.
PubMed 29503581Bendtsen L. Drug and Nondrug Treatment in Tension-type Headache. Ther Adv Neurol Disord. 2009 May;2(3):155-61. doi: 10.1177/1756285609102328.
PubMed 21179525Barbanti P, Egeo G, Aurilia C, Fofi L. Treatment of tension-type headache: from old myths to modern concepts. Neurol Sci. 2014 May;35 Suppl 1:17-21. doi: 10.1007/s10072-014-1735-3.
PubMed 24867829Georgoudis G, Felah B, Nikolaidis PT, Papandreou M, Mitsiokappa E, Mavrogenis AF, Rosemann T, Knechtle B. The effect of physiotherapy and acupuncture on psychocognitive, somatic, quality of life, and disability characteristics in TTH patients. J Pain Res. 2018 Oct 23;11:2527-2535. doi: 10.2147/JPR.S178110. eCollection 2018.
PubMed 30425565Alonso-Blanco C, de-la-Llave-Rincon AI, Fernandez-de-las-Penas C. Muscle trigger point therapy in tension-type headache. Expert Rev Neurother. 2012 Mar;12(3):315-22. doi: 10.1586/ern.11.138.
PubMed 22364330McKenney K, Elder AS, Elder C, Hutchins A. Myofascial release as a treatment for orthopaedic conditions: a systematic review. J Athl Train. 2013 Jul-Aug;48(4):522-7. doi: 10.4085/1062-6050-48.3.17. Epub 2013 Apr 3.
PubMed 23725488Ulett GA, Han S, Han JS. Electroacupuncture: mechanisms and clinical application. Biol Psychiatry. 1998 Jul 15;44(2):129-38. doi: 10.1016/s0006-3223(97)00394-6.
PubMed 9646895Wu, B., Zhan, G., Lin, Lian, Q. (2017), Electroacupuncture for treatment of cervicogenic headache: A meta-analysis. Transl Perioper & Pain Med, 2 (2).
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
PubMed 2197679Cheng LL, Ding MX, Xiong C, Zhou MY, Qiu ZY, Wang Q. Effects of electroacupuncture of different frequencies on the release profile of endogenous opioid peptides in the central nerve system of goats. Evid Based Complement Alternat Med. 2012;2012:476457. doi: 10.1155/2012/476457. Epub 2012 Oct 24.
PubMed 23133494Ajimsha MS. Effectiveness of direct vs indirect technique myofascial release in the management of tension-type headache. J Bodyw Mov Ther. 2011 Oct;15(4):431-5. doi: 10.1016/j.jbmt.2011.01.021. Epub 2011 Feb 11.
PubMed 21943616Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005 Aug 13;331(7513):376-82. doi: 10.1136/bmj.38512.405440.8F. Epub 2005 Jul 29.
PubMed 16055451Doraisamy, M. A., Kumar, C. P., & Gnanamuthu, C. (2010). Chronic tension type headache and the impact of myofascial trigger point release in the short term relief of headache. Global Journal of Health Science, 2(2), 238
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electroacupuncture and Myofascial Release on Pain, Neck Functions and Depression Status in Patients With Tension-Type Headaches
- ClinicalTrials.gov ID
- NCT04091100
- Acronym / sponsor ID
- LAB2
- Conditions
- Tension-Type Headache
- Keywords
- Pain, Acupuncture, Tension-Type Headache, Myofascial Releasing, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 16 Sep 2019 (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.
Tension-type headaches (TTH) last from thirty minutes to seven days, were ranked second among the primary types of headaches. The diagnosis of TTH is made according to the diagnostic criteria of the Second Beta version of the International Classification of Headache Disorders. The causes of TTH include the activation of extremely tense peripheric afferent neurons through the head and neck muscles, muscle sensitivity and stress. Additionally, a limited range of motion (ROM) in the neck may also lead to TTH.
The treatment of TTH involve both pharmacological and non-pharmacological methods. It is known that the pharmacological treatment of TTH has a limited effect. However, previous studies have shown that physical therapy programs that include methods such as acupuncture, Transcutaneous Electrical Nerve Stimulation (TENS), exercise, biofeedback, manipulation, cryotherapy, massage, strengthening of the neck muscles, stretching exercises are effective in alleviating TTH.
It has been observed that the trigger points in muscles play a role in TTH. Trigger points are generally defined as hyper-irritable points inside taut bands. It has been demonstrated that myofascial release, which is applied to the trigger points and is effective in relaxation treatments through stimulation of the neuromuscular system, relieves headaches via muscle relaxation. Electroacupuncture is another method used in relieving myofascial pain origin that involves the application of acupuncture needles to particular points and delivery of an electrical current at a specific frequency. The stimulation of muscle and skin tissues in affected areas is carried out by means of needles and the electrical current relieves pain and muscle spasms. In a meta-analysis study, it was found that electroacupuncture had a higher pain-relieving effect. However, a review of related studies deemed them to be lacking because the assessments were too limited to make it possible to unequivocally state that electroacupuncture has a high level of therapeutic efficacy.
The studies performed, however, did not examine the efficacy of electroacupuncture and myofascial release on TTH. Given that situation, the purpose of our study is to investigate the effects of electroacupuncture and myofascial release applied to points of tension in the neck muscles and trigger points of people suffering from TTH in terms of the headache intensity and frequency, neck functions, sleep quality and depression status.
Detailed description
The 19 individuals who were referred to Bahçeşehir University's Department of Physiotherapy and Rehabilitation at the School of Health Sciences, with TTH, and who were 18 years of age and older, were recruited for the study. The individuals were randomly allocated into electroacupuncture and myofascial release groups with the Research Randomizer program.
Evaluation Methods A Visual Analogue Scale (VAS) to evaluate pain levels of the participants, CROM (Cervical Range of Motion) to evaluate neck ROM, Beck's Depression Inventory to evaluate depression status, Neck Pain Disability Scale to evaluate to evaluate the effect of their neck pain on the activities of the daily living Headache Diary to evaluate clinical features of the headache
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The individuals were randomly allocated into electroacupuncture and myofascial release groups
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture | Active comparator | Procedure: ElectroacupunctureThe individuals in the electroacupuncture group were administered the therapy by a certified acupuncturist. Two Shenlong acupuncture needles were inserted in each of the trapezius and levator scapulae muscles at intervals of 0-3 mm and clips were attached to their ends. Afterwards, an electrical current of 2 mA and 60 Hz was administered using the Enraf Nonius Sonoplus 492 (OPTOMED) device for 20 minutes. |
| myofascial release | Active comparator | Procedure: Myofascial ReleaseFirstly, longitudinal stretching was done with forearm to the muscles in the person's neck in order to relax. Afterwards, the researcher placed one hand under the person's head and placed their fingertips on the muscles under the occipital bone in the neck area. The researcher applied lateral flexion to the neck with one hand while placing the other hand on the trapezius and levator scapulae muscles and then stretched the muscles with friction massage. After this step, the participant's neck was guided back into a neutral position and the pinching technique was applied to the muscles. During the administration of therapies, the trigger points on muscles were identified and friction was applied to these sites until a loosening could be felt. The myofascial release sessions concluded with the administration of the friction massage technique once again to the muscles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indiviuals with cervical tension headache
- aged 18 years or older
- Accepting voluntary participation in the study
Key exclusion criteria (4 listed)
- Epilepsy seizures,
- Heart disease
- Pacemaker,
- Patients with a history of stroke
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 |
|---|---|---|
| ElectroacupunctureAn electrical current of 2 mA and 60 Hz was administered using the Enraf Nonius Sonoplus 492 (OPTOMED) device for 20 minutes. All the treatments were performed for 2 sessions per week for 3 weeks. Both groups were given a home program involving neck stretching and posture exercises. The exercises were to be performed at least two times a day in two sets of fifteen repetitions. | Procedure or surgery | electroacupuncture |
| Myofascial Releaselongitudinal stretching, friction massage and pinching technique, All the treatments were performed for 2 sessions per week for 3 weeks. Both groups were given a home program involving neck stretching and posture exercises. The exercises were to be performed at least two times a day in two sets of fifteen repetitions. | Procedure or surgery | myofascial release |
Primary outcome
Change from Baseline Pain Intensity at Three Weeks
Time frame: 3 weeks
VAS, is used to evaluate the intensity of pain, using a scale comprised of a 100-mm-long horizontal line and ending with at both ends by descriptors of pain intensity beginning with "no pain" to "extreme pain. Patients are asked to indicate their levels of pain on this range by placing a dot on the line
Change from Baseline Headache Intensity at Three Weeks
Time frame: 3 weeks
Headache diary (HD): Patients kept an HD for three weeks to record the clinical features of their headaches. In this diary, subjects documented the number of days per week that they experienced a headache, the duration of each headache (hour/day), and the headache intensity on a 5-point numerical pain rating scale (0: no pain, 5: maximum pain). For each subject, Headache index (HI) was calculated for the first and last ten days of the intervention period as following: Headache index (HI) = mean headache intensity X mean number of days with headache X mean duration of headache
Change from Baseline Range of Motion of the Neck at Three Weeks
Time frame: 3 weeks
The join ROM of the neck was measured via C-ROM goniometer which consists of two inclinometers for gravity on the sagittal and frontal planes, an inclinometer with magnetic needles that is inserted from above on the horizontal plane, a magnetic cervical collar, an arm with a ruler in cm units and a vertebral fixating arm with a balance system. This device has a plastic frame with a shape that is similar to a pair of glasses, as it rests on the nose and ears. During all measurements, the subjects were asked to sit on a chair with their arms held close to their bodies. Subjects were asked to look forward in a comfortable sitting position for the performance of the measurements. The initial position of each movement was set an angle of 0 degrees. The measurements were conducted while the subjects performed forward/backward bending, left/right side-bending and rotation movements on the left and right sides of the neck.
Change from Baseline Depression Status at Three Weeks
Time frame: 3 weeks
The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory, which was developed to measure depression symptoms in adult individuals. The individuals assigned a score of 0 to 3 for the items of the 21-item scale, which measures characteristic attitudes and depression symptoms. The highest score that can be obtained on the scale is 63, while the threshold value is considered to be 17.
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 21 Feb 2021.
- Background: PubMed 23024570Chowdhury D. Tension type headache. Ann Indian Acad Neurol. 2012 Aug;15(Suppl 1):S83-8. doi: 10.4103/0972-2327.100023.
- BackgroundKaradaş, Ö. (2013) Gerilim Tipi Baş Ağrısı: Kronik Tip Değerlendirmesi, J Clin Anal Med, 4 (6), 522-6
- Background: PubMed 29503581Madsen BK, Sogaard K, Andersen LL, Skotte J, Tornoe B, Jensen RH. Neck/shoulder function in tension-type headache patients and the effect of strength training. J Pain Res. 2018 Feb 23;11:445-454. doi: 10.2147/JPR.S146050. eCollection 2018.
- Background: PubMed 21179525Bendtsen L. Drug and Nondrug Treatment in Tension-type Headache. Ther Adv Neurol Disord. 2009 May;2(3):155-61. doi: 10.1177/1756285609102328.
- Background: PubMed 24867829Barbanti P, Egeo G, Aurilia C, Fofi L. Treatment of tension-type headache: from old myths to modern concepts. Neurol Sci. 2014 May;35 Suppl 1:17-21. doi: 10.1007/s10072-014-1735-3.
- Background: PubMed 30425565Georgoudis G, Felah B, Nikolaidis PT, Papandreou M, Mitsiokappa E, Mavrogenis AF, Rosemann T, Knechtle B. The effect of physiotherapy and acupuncture on psychocognitive, somatic, quality of life, and disability characteristics in TTH patients. J Pain Res. 2018 Oct 23;11:2527-2535. doi: 10.2147/JPR.S178110. eCollection 2018.
- Background: PubMed 22364330Alonso-Blanco C, de-la-Llave-Rincon AI, Fernandez-de-las-Penas C. Muscle trigger point therapy in tension-type headache. Expert Rev Neurother. 2012 Mar;12(3):315-22. doi: 10.1586/ern.11.138.
- Background: PubMed 23725488McKenney K, Elder AS, Elder C, Hutchins A. Myofascial release as a treatment for orthopaedic conditions: a systematic review. J Athl Train. 2013 Jul-Aug;48(4):522-7. doi: 10.4085/1062-6050-48.3.17. Epub 2013 Apr 3.
- Background: PubMed 9646895Ulett GA, Han S, Han JS. Electroacupuncture: mechanisms and clinical application. Biol Psychiatry. 1998 Jul 15;44(2):129-38. doi: 10.1016/s0006-3223(97)00394-6.
- BackgroundWu, B., Zhan, G., Lin, Lian, Q. (2017), Electroacupuncture for treatment of cervicogenic headache: A meta-analysis. Transl Perioper & Pain Med, 2 (2).
- Background: PubMed 2197679Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
- Background: PubMed 23133494Cheng LL, Ding MX, Xiong C, Zhou MY, Qiu ZY, Wang Q. Effects of electroacupuncture of different frequencies on the release profile of endogenous opioid peptides in the central nerve system of goats. Evid Based Complement Alternat Med. 2012;2012:476457. doi: 10.1155/2012/476457. Epub 2012 Oct 24.
- 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.
Leyla ATAŞ BALCI principal investigator
Bahçeşehir University, Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Myofascial Release in people with Tension-Type Headache, run by Bahçeşehir 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 3 inclusion and 4 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 21 Feb 2021. 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. 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?
Change from Baseline Pain Intensity at Three Weeks (time frame: 3 weeks). The study lists 4 primary outcomes in all. 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 NCT04091100, which also lists 15 linked publications.
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 21 Feb 2021.