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

Iran University of Medical Sciences

Status: Not yet enrolling

Conditions: Chronic Tension-Type Headache

Treatments: Other: Deep Neck Flexor(DNF)exercise with sham Suboccipital Myofascial Release(MFR); Other: Suboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05383365

IR.IUMS.REC.1400.1239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Suboccipital Myofascial Release

Experimental group

Description:

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

Treatment:

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

Deep Neck Flexor Exercise

Experimental group

Description:

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.

Treatment:

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