Clinical trial NCT05383365: Deep Neck Flexor Exercises Versus Myofascial Release of Suboccipital Muscles in Chronic Tension-type Headache
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intensity of headache using by Numeric Pain Rating Scale(NPRS)
timeFrame: 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
measure: intensity of Forward Head Posture(FHP) using by Craniovertebral Angle(CVA)
timeFrame: 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:
measure: Duration of headache using by headache questionnaire and diary
timeFrame: 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
measure: Frequency of headache using by headache questionnaire and diary
timeFrame: 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
measure: Disability using by Henry Ford Hospital Headache Disability Inventory (HDI) questionnaire
timeFrame: Change in the disability after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
measure: Quality of life using by Headache Impact Test -6 (HIT-6) questionnaire
timeFrame: 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
measure: Pressure Pain Threshold(PPT) using by algometer
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: MSc student
name: Mobina Ahmadi, MSc student
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor Assisstant
name: Mohammadreza Pourahmadi
role: STUDY_DIRECTOR
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