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Effects of Electroacupuncture and Myofascial Release on Headache

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ClinicalTrials.gov Identifier: NCT04091100
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Leyla Ataş Balcı, Bahçeşehir University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Tension-Type Headache Procedure: Electroacupuncture Procedure: Myofascial Release Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The individuals were randomly allocated into electroacupuncture and myofascial release groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Electroacupuncture and Myofascial Release on Pain, Neck Functions and Depression Status in Patients With Tension-Type Headaches
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : September 26, 2019
Estimated Study Completion Date : October 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: electroacupuncture
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.
Procedure: Electroacupuncture
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.

Active Comparator: myofascial release
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.
Procedure: Myofascial Release
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.




Primary Outcome Measures :
  1. 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

  2. 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


  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indiviuals with cervical tension headache
  • aged 18 years or older
  • Accepting voluntary participation in the study

Exclusion Criteria:

  • Epilepsy seizures,
  • Heart disease
  • Pacemaker,
  • Patients with a history of stroke

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091100


Locations
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Turkey
Bahçeşehir University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Istanbul, Turkey, 34353
Sponsors and Collaborators
Bahçeşehir University
Investigators
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Principal Investigator: Leyla ATAŞ BALCI Bahçeşehir University, Department of Physiotherapy and Rehabilitation

Publications:
Karadaş, Ö. (2013) Gerilim Tipi Baş Ağrısı: Kronik Tip Değerlendirmesi, J Clin Anal Med, 4 (6), 522-6
Wu, B., Zhan, G., Lin, Lian, Q. (2017), Electroacupuncture for treatment of cervicogenic headache: A meta-analysis. Transl Perioper & Pain Med, 2 (2).
Doraisamy, 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

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Responsible Party: Leyla Ataş Balcı, Assist. Prof, Bahçeşehir University
ClinicalTrials.gov Identifier: NCT04091100     History of Changes
Other Study ID Numbers: LAB2
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leyla Ataş Balcı, Bahçeşehir University:
Pain
Acupuncture
Tension-Type Headache
Myofascial Releasing
Depression
Additional relevant MeSH terms:
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Tension-Type Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases