An interventional study of Suboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exercise and Deep Neck Flexor(DNF)exercise with sham Suboccipital Myofascial Release(MFR) in Chronic Tension-Type Headache, sponsored by Iran University of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Iran University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
Previous studies demonstrated that suboccipital active Trigger Points(TrPs) and forward head posture were associated with Chronic Tension-Type Headache(CTTH) and they can aggravate parameters of headache in these patients. The greater suboccipital muscle contraction, as would be exexpected in greater FHP, the more the nociceptive input into the trigeminal nucleus caudalis, and the lower the headache or pain threshold, consistent with increased central sensitization; Therefore it is important to evaluate the effectiveness of interventions on FHP and suboccipital active TrPs in patients with CTTH.
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 exercises with a pressure biofeedback unit as a top-down intervention.
Primary outcomes will be the intensity of headache and FHP. headache duration and frequency, disability, quality of life, and pain pressure threshold will be considered as secondary outcomes.
In this study, a double-dummy randomized clinical trial, 44 participants will be divided into two groups of DNF exercises with pressure biofeedback combined with sham MFR (first group) and sub-occipital MFR combined with sham DNF exercises(second group). The intervention will take place over a 4-week period, with three 1-hour sessions a week, totaling 12 treatment sessions. this study has a 6-week follow-up.
This study is a double-blind study in which the participants, the person evaluating the outcome, and the statistician of the data will be blinded to the allocation of patients to the two treatment groups.
143 studies on the registry are indexed under Tension-Type Headache; 42 are open to participants now.
This study's planned enrollment of 44 is below the median of 60 across 108 interventional studies indexed under Tension-Type Headache.
Browse Tension-Type Headache studies →Iran University of Medical Sciences is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
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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
Other: Suboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exercise
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.
Other: Deep Neck Flexor(DNF)exercise with sham Suboccipital Myofascial Release(MFR)
The 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.
The 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.
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.
Time frame: Change in the intensity of headache after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
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).
Time frame: Change in the intensity of Forward Head Posture after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
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.
Time frame: Change in the duration of headache after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
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.
Time frame: Change in the frequency of headache after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
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).
Time frame: Change in the disability after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
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.
Time frame: Change in the quality of life after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
Pressure Pain Threshold(PPT) using by algometer
An algometer (JTECH Medical, made in the USA) is used to assess the pain pressure threshold of suboccipital muscles. In this method, the participant is lying on a Manual Physical Therapy Table (MPT) with a cavity for placing the face lying down and an algometer with a 1 cm\^2 cross-sectional area vertically and at a speed of about 1 kg / cm\^2 at the bottom of the occiput bone and outside of the upper trapezius muscle are placed on both sides. Pressure is applied until the feeling of pressure turns into a feeling of pain and the participant is asked to announce the moment of onset of pain. The measurement is repeated 3 times with an interval of 30 seconds, then the average is calculated. It should be noted that this device has high reliability (ICC = 0.78 - 0.93)
Time frame: Change in the pain pressure threshold after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
No study locations are listed for this record.
Plan to share: Yes — The data sets of this study will be available on a reasonable request to the corresponding author
Supporting information: Study protocol
Time frame: starting 6 months after the publication
Access criteria: The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders and headaches. The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of tension-type headache. Applicants can contact Mobina Ahmadi by Email. Email Address:M.oahmadi@ymail.com Applicants should explain their project and how the data/documents of the study will be used in their project in detail. Then, the data/documents files will be sent by email to applicants on request. This process may take 10-12 working days.
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Iran University of Medical Sciences