Deep Neck Flexor Exercises Versus Myofascial Release of Suboccipital Muscles in Chronic Tension-type Headache
NCT ID: NCT05383365
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
44 participants
INTERVENTIONAL
2024-11-01
2026-12-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
No
Sponsors
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Iran University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Mobina Ahmadi, MSc student
Role: PRINCIPAL_INVESTIGATOR
MSc student
Mohammadreza Pourahmadi
Role: STUDY_DIRECTOR
Professor Assisstant
Central Contacts
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References
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Other Identifiers
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IR.IUMS.REC.1400.1239
Identifier Type: -
Identifier Source: org_study_id
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