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Effects of Electroacupuncture and Myofascial Release on Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091100
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Leyla Ataş Balcı, Bahçeşehir University

Tracking Information
First Submitted Date  ICMJE September 12, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE August 5, 2019
Actual Primary Completion Date September 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Electroacupuncture and Myofascial Release on Headache
Official Title  ICMJE Effects of Electroacupuncture and Myofascial Release on Pain, Neck Functions and Depression Status in Patients With Tension-Type Headaches
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Tension-Type Headache
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Electroacupuncture
  • 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.
    Intervention: Procedure: Myofascial Release
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 13, 2019)
19
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 22, 2019
Actual Primary Completion Date September 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04091100
Other Study ID Numbers  ICMJE LAB2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leyla Ataş Balcı, Bahçeşehir University
Study Sponsor  ICMJE Bahçeşehir University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leyla ATAŞ BALCI Bahçeşehir University, Department of Physiotherapy and Rehabilitation
PRS Account Bahçeşehir University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP