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Not Yet RecruitingNCT05383365

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
44 (estimated)
Sponsor
Iran University of Medical Sciences · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSuboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exerciseThe 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.
OTHERDeep 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.

Timeline

Start date
2024-11-01
Primary completion
2025-12-01
Completion
2026-12-01
First posted
2022-05-20
Last updated
2024-10-01

Source: ClinicalTrials.gov record NCT05383365. Inclusion in this directory is not an endorsement.