About this trial
According to the study of the burden of diseases in 2018, tension-type headache(TTH) is the most common type of primary headache and ranks third in terms of prevalence among 328 diseases and injuries in 195 countries from 1990 to 2016. Suffering from this disorder (especially chronic type) reduces the quality of life of patients.
The main objective of this study is to compare the effects of myofascial release of suboccipital muscles as a bottom-up intervention and Deep Neck Flexor(DNF) exercises with Pressure Biofeedback Unit(PBU) as a top-down intervention on headache parameters, the intensity of Forward Head Posture(FHP), disability, quality of life, and suboccipital Pressure Pain Threshold(PPT) in patients with chronic tension-type headache with forward head posture.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 55 years;
based on ICHD-3, Headache that occurs 15 days per month and lasts on average for >3 months (180 days per year), lasting hours to days, or unremitting, and has at least two of the following four characteristics recognized as CTTH: bilateral location, pressing or tightening (non-pulsating) quality, mild or moderate intensity, not aggravated by routine physical activity such as walking or climbing stairs and both of the following: no more than one of photophobia, phonophobia or mild nausea, neither moderate or severe nausea nor vomiting;
Dosage and type of prophylactic medication have not changed in the months before the beginning of the trial;
The participant does not intend to change the dosage and type of prophylactic medication during the study;
Disqualifiers
Participants with infrequent ETTH, or other primary or secondary types of headache;
Pain aggravated by movement of the head;
Severe pain or significant decrease in ROM of the cervical spine;
Previous trauma to the cervical spine;
Trial design
Parallel
Treatments tested in this trial
Suboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exercise
Other interventionThe treatment includes Suboccipital MFR in the supine position.The therapist places the supinated forearm on the bed and positions the tips of the middle three fingers inferior to the occiput bone and the head is supported by the thenar eminences.The therapist will develop a line of tension through the suboccipital tissues by supinating the forearms and pulling apart two hands from each other;Then, for the second level in the first position of hands,pressure is applied to the anterior and superior direction.The pressure is held and increased until the therapist feels the decrease of muscle tone.These techniques last 10 minutes. Another intervention in this group is the sham DNF exercise with a Pressure Biofeedback Unit(PBU).Considering that minimum detective change with PBU is 15 mmHg; After placing the airbag of PBU under the occiput bone in the supine position and inflating it to a base pressure of 11 mmHg,the participant will increase the pressure to 12 mmHg by nodding action.
Deep Neck Flexor(DNF)exercise with sham Suboccipital Myofascial Release(MFR)
Other interventionThe treatments include the DNF exercise with a PBU. The treatment is performed in the supine position and the airbag is placed under the occiput bone and is inflated to a base pressure of 20 mmHg. The participant will increase and hold the pressure to a special point by nodding action. The exercise is repeated for 3 sets, in each set 2 mm Hg is added to the pressure. The pressure will be increased from 22 to 32 mm Hg during 4-week of treatment, and each goal is held for 10 seconds and repeated 10 times. There will be 5 sec of rest between each repetition and 2 min of rest between each set. Another intervention in this group is sham MFR. The therapist's hands will be placed only inferior to the occipital bone and a superficial touch is applied without any upward or lateral pressure. sham treatment in this group, like the opposite group, lasts 10 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Intensity of headache using by Numeric Pain Rating Scale(NPRS)
In the initial evaluation of the participants, the pain intensity will be determined based on the NPRS on a scale of 0-100. For this purpose, the participant is asked to mark their average pain intensity in the last month on a 100 cm line without scaling from zero to 100. The number zero indicates the absence of pain and the number 100 indicates the most pain the person has experienced in their life. The marked point is then measured with a ruler. Participants are asked to record their average intensity of pain during the past month on the Headache Questionnaire. Evaluation of the headache intensity will be done after treatment and in a 6 weeks follow-up by the headache diary; For this purpose, during the four weeks of treatment and up to 6 weeks after the treatment, the participant is asked to record the amount of headache intensity on a daily basis in this diary.
intensity of Forward Head Posture(FHP) using by Craniovertebral Angle(CVA)
The amount of is measured using the photogrammetric method of body profile for measuring the FHP. This method has high reliability (ICC = 0.83). This angle will be assessed in sitting posture from profile view, in this picture the spinous process of the seventh cervical vertebra and tragus of the ear is marked with landmarks. Photography is done with a camera (smartphone iPhone 13 pro, Apple Inc) with a magnification of 1 and is placed at a certain distance from the person on a fixed base. Finally, the images are transferred to a computer and the angle between the line connecting the ear tragus to the spinous process of the seventh cervical vertebra and the horizon line is measured using Kinovea software (ICC=.99).
Secondary outcomes
Duration of headache using by headache questionnaire and diary
The duration of pain will be determined based on the average number of hours a person experiences a headache in a month. Participants are asked to record their average duration of pain during the past month on the Headache Questionnaire. Evaluation of the headache duration will be done after treatment and in a 6-week follow-up by the headache diary; For this purpose, during the four weeks of treatment and up to 6 weeks after the treatment, the participant is asked to record the amount of headache duration on a daily basis in this diary.
Frequency of headache using by headache questionnaire and diary
The frequency of headaches is based on the number of days in the month that the person experiences the headache. Participants are asked to record their average frequency of pain during the past month on the Headache Questionnaire. Evaluation of the headache frequency will be done after treatment and in a 6 week follow-up by the headache diary; For this purpose, during the four weeks of the treatment and up to 6 weeks after treatment, the participant is asked to record the amount of headache frequency on a daily basis in this diary.
Disability using by Henry Ford Hospital Headache Disability Inventory (HDI) questionnaire
The Persian version of the Henry Ford Hospital Headache Disability Inventory (HDI) questionnaire will be used to assess the amount of disability. The questionnaire has 25 questions that include functional and emotional subsets, and each "yes" answer is a 4-point answer, each "sometimes" answer is a 2-point answer, and each "no" answer is a zero-point answer. This questionnaire consists of 12 questions in the functional field with a maximum score of 48 and 13 questions in the emotional field with a maximum score of 52, which adds up to 100 points. The higher the score, the greater the disability due to the headache. If, as a result of the therapeutic approach, a score equal to or greater than 29 points is seen in this questionnaire, it indicates significant changes. The internal consistency of the Persian version of this questionnaire with Cronbach's alpha is 0.91 for the whole questionnaire, 0.82 for the functional area and 0.86 for the emotional area (ICC = 0.97).
Quality of life using by Headache Impact Test -6 (HIT-6) questionnaire
The Persian version of the Headache Impact Test -6 (HIT-6) questionnaire will be used. This short questionnaire includes 6 questions that are a reminder of the last 4 weeks. Scores are between 36 and 78, and higher scores indicate a higher intensity of headache and a greater impact of headache on a person's quality of life. This questionnaire is used to measure the effect of headache and its treatment on a person's functional status and quality of life, and its psychological characteristics have been extensively studied. The questions in this questionnaire cover problems including pain, ability to perform daily life activities, social functioning, energy/fatigue, cognitive function, and psychological problems. The reliability coefficient of this questionnaire in different researches through retesting, peer forms, and internal stability are 0.8, 0.9, and 0.89, respectively.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: