Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache

Not Applicable

Not yet recruiting

• Conditions: Suboccipital Release; Instrumental Assisted Soft Tissue Mobilization; Tension-Type Headache

• Registration Number: NCT06703385
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Study Start: 2024-12-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
assessment of pain intensity using numeric pain rating scale	at baseline and after 4 weeks	Assessment of pain intensity using Numerical pain Rating Scale An 1l-point numeric scale with 0 representing one pain extreme(e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Assessment of pressure pain threshold using pressure algometer	at baseline and after 4 weeks	The Pain Pressure Threshold is measured using a pressure algometer on trapezius and suboccipital trigger points. The patient's maximum pain tolerance is recorded, and the procedure is repeated three times to calculate the average.
Assessment of the impact of headache using the Headache Impact Test questionnaire	at baseline and after 4 weeks	The Headache Impact Test (HIT-6) is a questionnaire measuring the impact of headaches on daily activities. It consists of six questions, each scoring 6-13, with a final score ranging from 36 to 78. A higher score indicates more headache-related disability. The test categorizes headache impact severity into four categories: little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).
Assessment of Frequency of headache	at baseline and after 4 weeks	The number of headache days per week will be used to identify it. The participant keep count of how many days they have a headache in the week previous treatment and after four weeks of treatment

Trial Locations

Locations (1)

out-patient clinic, national institute of neuromotor system, Egypt; 🇪🇬 Cairo, Egypt