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

March 4, 2024 updated by: Iran University of Medical Sciences

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 and 55 years;
  2. 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;
  3. Dosage and type of prophylactic medication have not changed in the months before the beginning of the trial;
  4. The participant does not intend to change the dosage and type of prophylactic medication during the study;
  5. CVA less than 49 degrees,
  6. Participants have the ability to understand and read Persian to complete the questionnaire.

Exclusion Criteria:

  1. Participants with infrequent ETTH, or other primary or secondary types of headache;
  2. Pain aggravated by movement of the head;
  3. Severe pain or significant decrease in ROM of the cervical spine;
  4. Previous trauma to the cervical spine;
  5. History of injection, surgery, severe disc protrusion, or neck or shoulder fracture that affects treatment;
  6. Metabolic or Neurological disorders such as Bow hunter's syndrome or epilepsy;
  7. Taking more than 200 pieces of morphine or other strong analgesics per month;
  8. Physiotherapy treatment for headache within 6 months before starting treatment;
  9. Joint stiffness, atherosclerosis, or advanced osteoarthritis;
  10. 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);
  11. Pregnancy;
  12. Spielberger State-Trait Anxiety Inventory (STAI) scores more than 85;
  13. Absence of two consecutive sessions and more than treatment sessions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suboccipital Myofascial Release
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

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.
Experimental: Deep Neck Flexor 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
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)
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
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of headache using by headache questionnaire and 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

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.
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
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

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.
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
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
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).
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
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
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.
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
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
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iran University of Medical Sciences

Investigators

  • Principal Investigator: Mobina Ahmadi, MSc student, MSc student
  • Study Director: Mohammadreza Pourahmadi, Professor Assisstant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.IUMS.REC.1400.1239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets of this study will be available on a reasonable request to the corresponding author

IPD Sharing Time Frame

starting 6 months after the publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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