Clinical trial NCT06703385: Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache
Official title: Effect of Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suboccipital Release
Instrumental Assisted Soft Tissue Mobilization
Tension-Type Headache
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to explore the impact of suboccipital release versus instrument-assisted soft tissue mobilization on pain intensity, pressure pain threshold, headache impact test, and headache frequency in patients with tension headache. The research will also examine the effects of these methods on headache impact tests and frequency.

Detailed description: Headache prevalence ranges from 38.2 to 59.4%, with a lifetime prevalence of 26.1-45%. Tension Type Headache can be episodic or chronic, with 78% occurring less than 15 times/month and 6% occurring more than 15 times/month. Tension Type Headache has a greater socioeconomic burden, leading to lower productivity and workday loss. Tension Type Headache is linked to myofascial pain and trigger points, which can cause sensory changes and reduced pain threshold. Studies show that referred pain from myofascial trigger points reproduces headache in patients with , leading to increased symptom severity. Frequent Episodic tension type headache increases the risk of developing chronic tension type headache due to analgesic overuse. instrumental assisted soft tissue mobilization, a physical therapy technique, promotes fascia realignment and reduces strain on the clinician's hands.

Eligibility criteria: Inclusion Criteria:

1. Participants of both gender will be between the ages of 18 and 60.
2. Episodic tension type headache criteria, according to the International Headache Society's Headache Classification Committee., have at least two of the following characteristics.

   * Recurrent episodes of headache on less than 15 days per month for at least 3 months
   * Headache that last for from around 30 min till seven days.
   * At least 2 of the following features are found in a headache:
   * A location that is on two sides.
   * Tightening/pressing quality (non-pulsating).
   * Intensity is mild to moderate.
   * Both of the following: Not worsened by routine physical activity, there is no nausea or vomiting.
   * Only have one photophobia/ phonophobia
3. Patients have active trigger points in suboccipital muscle and upper trapezius muscle
4. The presence of myofascial trigger points was determined by therapist using the diagnostic criteria described by Simons .,(1999) ,The major criteria of active myofascial trigger points were: Regional neck pain, Pain or altered sensation in the expected distribution of referred pain from a myofascial trigger point, Taut band palpable in an accessible muscle.

Exclusion Criteria:

1. Patients who have had a history of cancer
2. Patients who have had cervical and cranial surgery
3. Patients with severe psychological disorders (major Depression)
4. Patients with uncontrolled hypertension
5. Dysfunctions in the tempo-mandibular joint
6. Headaches associated with high fever, stiff neck, or rash, problems of vision or profound dizziness
7. Female who are pregnant or lactating

Primary outcomes:
measure: assessment of pain intensity using numeric pain rating scale
timeFrame: at baseline and after 4 weeks
Secondary outcomes:
measure: Assessment of pressure pain threshold using pressure algometer
timeFrame: at baseline and after 4 weeks
measure: Assessment of the impact of headache using the Headache Impact Test questionnaire
timeFrame: at baseline and after 4 weeks
measure: Assessment of Frequency of headache
timeFrame: at baseline and after 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: out-patient clinic, national institute of neuromotor system, Egypt
Study officials:
References: