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

NCT05383365 | Not Yet Recruiting

• 1 other identifier: IR.IUMS.REC.1400.1239
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Tension-Type Headache

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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)

• Duration of headache using by headache questionnaire and 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

  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

  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

  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

  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

Study Arms (2)

Suboccipital Myofascial Release

EXPERIMENTAL

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

Deep Neck Flexor Exercise

EXPERIMENTAL

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)

Interventions

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

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.

Suboccipital Myofascial Release

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.

Deep Neck Flexor Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

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Study Officials

• Mobina Ahmadi, MSc student

  MSc student

  PRINCIPAL INVESTIGATOR

• Mohammadreza Pourahmadi

  Professor Assisstant

  STUDY DIRECTOR

Central Study Contacts

Mobina Ahmadi, MSc student

CONTACT

00989039182326; m.oahmadi@ymail.com

Mohammadreza Pourahmadi, PhD

CONTACT

00989122245593; Pourahmadi.m@iums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 20, 2022
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.