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Chronic Tension-Type HeadacheNCT05383365

Deep Neck Flexor Exercises Versus Myofascial Release of Suboccipital Muscles in Chronic Tension-type Headache

A study of Chronic Tension-Type Headache, run by Iran University of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Chronic Tension-Type Headache
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
No sites listed yet
Study dates
1 Nov 2024to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
  • CVA less than 49 degrees,
  • Participants have the ability to understand and read Persian to complete the questionnaire.

Who cannot join

  • 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;
  • History of injection, surgery, severe disc protrusion, or neck or shoulder fracture that affects treatment;
  • Metabolic or Neurological disorders such as Bow hunter's syndrome or epilepsy;
Show all 13Show fewer
  • Taking more than 200 pieces of morphine or other strong analgesics per month;
  • Physiotherapy treatment for headache within 6 months before starting treatment;
  • Joint stiffness, atherosclerosis, or advanced osteoarthritis;
  • Manual contraindication includes: (a)The participant has substance or alcohol abuse; (b)For whatever reason, the participant does not want to be touched by the therapist; (c)Symptoms are severe and irritating; (d)Underlying diseases (such as rheumatoid arthritis) or metabolic disorders (such as osteoporosis or soft tissue laxity of the treatment area);
  • Pregnancy;
  • Spielberger State-Trait Anxiety Inventory (STAI) scores more than 85;
  • Absence of two consecutive sessions and more than treatment sessions.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mobina Ahmadi, MSc student contact

00989039182326

m.oahmadi@ymail.com

Mohammadreza Pourahmadi, PhD contact

00989122245593

Pourahmadi.m@iums.ac.ir

About this study

Official title: The Effectiveness of Deep Neck Flexor Exercises in Comparison With Myofascial Release of Suboccipital Muscle on Pain and Forward Head Posture in People With Chronic Tension-type Headache and Forward Head Posture

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.

Read the detailed description

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.

Being tested
Suboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exercise, Deep Neck Flexor(DNF)exercise with sham Suboccipital Myofascial Release(MFR)
Keywords
Chronic tension-type headache, Chronic primary headache, Forward head posture, Deep neck flexor exercise, Pressure biofeedback, Myofascial release, Pressure pain threshold, Quality of life, Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exerciseOther

    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.

  • Deep Neck Flexor(DNF)exercise with sham Suboccipital Myofascial Release(MFR)Other

    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.

Study groups in NCT05383365
Study groupRoleWhat they receive
Suboccipital Myofascial ReleaseExperimentalThe 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
Receives: Other: Suboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exercise
Deep Neck Flexor ExerciseExperimentalAfter 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.
Receives: Other: Deep Neck Flexor(DNF)exercise with sham Suboccipital Myofascial Release(MFR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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).

    Measured: 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

Secondary outcomes (5)

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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).

    Measured: Change in the disability after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up

  4. 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.

    Measured: 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

  5. 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)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start1 Nov 2024 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05383365
Sponsor's protocol ID
IR.IUMS.REC.1400.1239
Status last verified
Feb 2024
First submitted
21 Apr 2022
Last updated
1 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sets of this study will be available on a reasonable request to the corresponding author

Publications

  • Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137. doi: 10.1186/s10194-020-01208-0. No abstract available.

    PubMed 33267788

  • Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.

    PubMed 23771276

  • Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.

    PubMed 17381554

  • GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.

    PubMed 28919117

  • Ashina S, Buse DC, Bjorner JB, Bendtsen L, Lyngberg AC, Jensen RH, Lipton RB. Health-related quality of life in tension-type headache: a population-based study. Scand J Pain. 2021 Jan 25;21(4):778-787. doi: 10.1515/sjpain-2020-0166. Print 2021 Oct 26.

    PubMed 33544560

  • GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3.

    PubMed 30353868

  • Fumal A, Schoenen J. Tension-type headache: current research and clinical management. Lancet Neurol. 2008 Jan;7(1):70-83. doi: 10.1016/S1474-4422(07)70325-3.

    PubMed 18093564

  • Bendtsen L. Central sensitization in tension-type headache--possible pathophysiological mechanisms. Cephalalgia. 2000 Jun;20(5):486-508. doi: 10.1046/j.1468-2982.2000.00070.x.

    PubMed 11037746

  • Fernandez-de-las-Penas C, Cuadrado ML, Arendt-Nielsen L, Simons DG, Pareja JA. Myofascial trigger points and sensitization: an updated pain model for tension-type headache. Cephalalgia. 2007 May;27(5):383-93. doi: 10.1111/j.1468-2982.2007.01295.x. Epub 2007 Mar 14.

    PubMed 17359516

  • Rasmussen BK. Migraine and tension-type headache in a general population: precipitating factors, female hormones, sleep pattern and relation to lifestyle. Pain. 1993 Apr;53(1):65-72. doi: 10.1016/0304-3959(93)90057-V.

    PubMed 8316392

  • Wober C, Holzhammer J, Zeitlhofer J, Wessely P, Wober-Bingol C. Trigger factors of migraine and tension-type headache: experience and knowledge of the patients. J Headache Pain. 2006 Sep;7(4):188-95. doi: 10.1007/s10194-006-0305-3. Epub 2006 Aug 11.

    PubMed 16897622

  • Marcus DA, Scharff L, Mercer S, Turk DC. Musculoskeletal abnormalities in chronic headache: a controlled comparison of headache diagnostic groups. Headache. 1999 Jan;39(1):21-7. doi: 10.1046/j.1526-4610.1999.3901021.x.

    PubMed 15613190

  • Griegel-Morris P, Larson K, Mueller-Klaus K, Oatis CA. Incidence of common postural abnormalities in the cervical, shoulder, and thoracic regions and their association with pain in two age groups of healthy subjects. Phys Ther. 1992 Jun;72(6):425-31. doi: 10.1093/ptj/72.6.425.

    PubMed 1589462

  • Chu ECP, Lo FS, Bhaumik A. Plausible impact of forward head posture on upper cervical spine stability. J Family Med Prim Care. 2020 May 31;9(5):2517-2520. doi: 10.4103/jfmpc.jfmpc_95_20. eCollection 2020 May.

    PubMed 32754534

  • Fernandez-de-las-Penas C, Alonso-Blanco C, Cuadrado ML, Pareja JA. Forward head posture and neck mobility in chronic tension-type headache: a blinded, controlled study. Cephalalgia. 2006 Mar;26(3):314-9. doi: 10.1111/j.1468-2982.2005.01042.x.

    PubMed 16472338

Questions about this trial

What is this clinical trial studying?

A study of Chronic Tension-Type Headache, run by Iran University of Medical Sciences.

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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mobina Ahmadi, MSc student (00989039182326, m.oahmadi@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensity of headache using by Numeric Pain Rating Scale(NPRS) (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). The study lists 2 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 NCT05383365, which also lists 66 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 1 Oct 2024.

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