Clinical trial NCT05883813: Immediate Effects of Suboccipital Muscle Release Combined With Sustained Natural Apophyseal Glides in Patients With Chronic Tension Type Headache
Official title: Immediate Effects of Suboccipital Muscle Release Combined With Sustained Natural Apophyseal Glides in Patients With Chronic Tension Type Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tension-Type Headache
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is randomized controlled trial which consist of 2 groups. One group will be given suboccipital muscle release. Second group will be given SNAGS along with sub-occipital muscle release. All the groups were recruited concurrently.
Primary purpose: TREATMENT

Brief summary: Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished. It is managed both pharmacology and non-pharmacology which includes dry needling, acupuncture, manual techniques and massage. Several studies conducted which showed that both the soft tissue muscle inhibition and joint mobilization techniques are effective in decreasing pain. But there is lack of evidence which shows combined effects of soft tissue muscle inhibition and sustained natural apophyseal glides(SNAGS) in chronic tension type headache. so this study will compare the effects of soft tissue muscle release and SNAGS on pain intensity and cervical range of motion.

Detailed description: Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is one of the widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished.Chronic tension type headache causes tightness in the suboccipital muscle which may result in decrese in range of motion in cervical region. It is managed both pharmacology and non-pharmacology which includes dry needling, acupuncture, manual techniques and massage. Several studies conducted which showed that both the soft tissue muscle inhibition and joint mobilization techniques are effective in decreasing pain. But there is lack of evidence which shows combined effects of soft tissue muscle inhibition and sustained natural apophyseal glides(SNAGS) in chronic tension type headache. so this study will compare the effects of soft tissue muscle release and SNAGS on pain intensity and cervical range of motion.

This study will be conducted in fauji foundation hospital using non-probability purposive sampling technique. Sample size calaculated from open epi tool is 48, with 24 patients in each group. Patients are selected on the basis of inclusion criteria. Patients will be guided about the benefits and risks of the study, right to withdraw from the study at any point and confidentiality of the data. After diagnosis by the physician according to the ICHD-3 criteria, written consent will be taken from each participant. Then they randomly assigned into 2 groups via lottery method. Cervical range of motion, blood pressure and pain intensity will be measured before and after the treatment. Suboccipital muscle release and SNAGS will be given to experimental group and suboccipital muscle release only to the control group.

Group 1(Control group): suboccipital muscle release for 10 mins + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 3 sec hold and 5 reps.

Group 2(Experimental group): suboccipital muscle release for 10 mins + SNAGS: 3 glides with 10 sec hold of each glide + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 10 sec hold and 5 reps.

Sub-occipital muscle release: This technique will be performed in the supine position with the patient's eyes closed and the physiotherapist's hands placed under the patient's head, in contact with the sub-occipital muscles. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment.

SNAGS: This technique will be performed with patient in sitting position and the therapist may be standing behind the patient. The therapist would place the thumb on the spinous process of the vertebra. Move spinous process upward towards the eyeball direction \& maintain the glide and ask the patient to turn (rotation) his head slowly in painful direction, sustain the mobilization until head turn to the midline. Three repetitions of each glide were given and maintain for 10 seconds at end range.

Pain intensity, cervical range of motion and blood pressure will be measured immediately after the treatment.

Eligibility criteria: Inclusion Criteria:

* 18-64 years old
* Male and Female
* International classification of headache disorders-3 diagnosis:
* Headache occurring on 15 days/month on average for \>3 months (180 days/year),
* Lasting hours to days, or unremitting -At least two of the following four characteristics:-
* Bilateral location
* Pressing or tightening (non-pulsating) quality
* Mild or moderate intensity
* Not aggravated by routine physical activity such as walking or climbing stairs
* Both of the following:
* No more than one of photophobia, phonophobia or mild nausea
* Neither moderate or severe nausea nor vomiting
* Not better accounted for by another ICHD-3 diagnosis.

Exclusion Criteria:

* Patients with other types of primary or secondary headache e.g cervicogenic headache
* History of trauma to the cervical spine
* Vertigo, dizziness, uncompensated neck tension
* Spurling test positive
* Flexion compression test positive
* Extension compression test positive
* Cervical flexion rotation test positive
* Pregnancy

Primary outcomes:
measure: cervical range of motion
timeFrame: Immediate after treatment
Secondary outcomes:
measure: Pain intensity
timeFrame: Immediate after treatment
measure: Blood pressure
timeFrame: Immediate after treatment
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital
state: Punjab
Study officials:
References: