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

Overview

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.

Interventions

• Other Instrument Assisted soft tissue mobilization
  The blade is a surgical instrument for soft tissue mobilization, made of 100% surgical stainless steel with 8 treatment planes and 2 treatment edges. It is used to locate muscle limitations and apply gentle strokes along the affected muscle, detecting changes in soft tissue consistency. The procedure is repeated three times a week for four weeks.
• Other Suboccipital release
  The patient will lie in a relaxed supine position, with a therapist sitting on a chair. The therapist will apply pressure to the C2 area, holding it until a melting sensation is felt. The intervention time is 4 minutes. The patient will close both eyes during the Suboccipital release procedure to prevent eye movements affecting muscle tone. Interventions will be three times a week for four weeks.
• Other conventional physical therapy program
  The patient is placed in a sitting position and a hot pack is applied to the back of the neck for 15 minutes. The therapist then performs active range of motion exercises for neck flexion, extension, rotation, and lateral flexion without resistance. They also perform stretching exercises for upper Trapezius muscle and suboccipital muscle. Strengthening exercises for neck muscles are performed through isometric exercises, such as side pending to right, side pending to left, extension, and flexion

Primary outcome measures

• assessment of pain intensity using numeric pain rating scale [Time frame: at baseline and after 4 weeks]

Secondary outcome measures (3)

• Assessment of pressure pain threshold using pressure algometer [Time frame: at baseline and after 4 weeks]
• Assessment of the impact of headache using the Headache Impact Test questionnaire [Time frame: at baseline and after 4 weeks]
• Assessment of Frequency of headache [Time frame: at baseline and after 4 weeks]

Eligibility criteria

Inclusion criteria

• Participants of both gender will be between the ages of 18 and 60.
• 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
• Patients have active trigger points in suboccipital muscle and upper trapezius muscle
• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• out-patient clinic, national institute of neuromotor system, Egypt — Cairo

Identifiers

NCT: NCT06703385 · Nada-005491

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗