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临床试验/CTRI/2024/07/071032
CTRI/2024/07/071032已完成不适用

Impact of Posterior Chain Myofascial Release on Pain intensity, Pain threshold, Quality of life in Sinus Headaches: A Pre-Post Experimental Study

KLE Academy of Higher Education Research1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Assessment of headache intensity using NPRS(Numerical pain rating scale)

研究概览

简要总结

Sinus headache is a common facial pain issue, often misdiagnosed as migraines or sinusitis. It is an inflammatory process of the nasal mucosa and can be classified as acute (ARS) or chronic (CRS). The paranasal sinuses are made up of the ethmoid, maxillary, and sphenoid diverticula. Common symptoms include neck pain and facial heaviness, nasal congestion, pressure in the cheeks, and decreased sense of smell.

The International Classification of Headache Disorders (ICHD-3) diagnoses sinus headaches based on clinical, nasal endoscopic, and imaging evidence of acute rhinosinusitis. The majority of patients with sinus headaches actually have migraines. Other causes include cluster headaches, Sluder’s neuralgia, trigeminal neuralgia, myofascial trigger point pain, and contact point headaches.

Establishing whether neck pain is a localized cause related to cervical muscular dysfunction or if it is a component of the sinus headache symptom complex is crucial for diagnosis and therapy planning. Posterior Chain Myofascial Release (MFR) has been shown to have positive effects on mental health by reducing stress and anxiety levels.

This study aims to determine the effect of MFR in individuals with sinus headaches using the Numerical Pain Rating Scale, Pain threshold using a Pressure algometer, and Quality of life using the Sino-Nasal Outcome Test (SNOT-22). The hypothesis is either no change in the effect of MFR on pain intensity, pain threshold, or quality of life in sinus headaches.

This study focuses on sinus headaches in subjects aged 20-55 years. The study design is an experimental study with a sample size of 40.The study includes all gender subjects diagnosed with sinus headaches, those within 20-55 years of age, and those with primary headaches, autonomic system symptoms, or conditions that might contraindicate MFR technique in posterior chain regions.

The study uses a numerical pain rating scale (NPRS) and pressure algometer to assess pain intensity and quality of life. The NPRS is a self-reported or clinician-administered measurement scale with extreme anchors ranging from 0-10 to 100. The pressure algometer calculates the pressure pain threshold (PPT) throughout a 4-point range. The SNOT-22 is a valid and reliable tool with a reliability coefficient of 0.93.

Following up assessment, patients will be followed by telephone after completing all five treatment sessions within a month and reassessed based on the outcomes i.e. NPRS and SNOT-22.

Participant’s selection will be done as per the Inclusion and exclusion criteria. The purpose of the study will be explained to the participants. A written informed consent will be obtained from the participants. A brief demographic data will be obtained from the subjects prior to the assessment. Baseline assessment of the participants will be done before the intervention. Then the participants will be given Myofascial release. Post- intervention data will be collected and analyzed.

INTERVENTION

Manual method of Myofascial release will be done for thoraco- lumbar fascia, erecter spinae muscle, hamstring muscle, calf muscle, sub-occipital muscles, frontal sinus and maxillary sinus. Subjects will  receive three sets of the release with a 60-second hold, on alternate days for two weeks. A total sessions will be conducted. You will receive education on dietary guidelines, including recommended practices and what to avoid, and will be advised to use steam.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • All gender subjects diagnosed with sinus headaches according to ICHD-3 criteria, Within 20-55 years of age, Willing to participate in the study.

排除标准

  • Subjects with primary headaches , Presence of autonomic system symptoms like vertigo, dizziness and visual impairment, Any condition that might contraindicate MFR technique in posterior chain regions (Febrile states, Systemic or localized infections, Surgical incisions and open wounds, Healing fractures, Acute inflammation-Rheumatoid conditions, Cancer or tumors conditions, Aneurysm, Anti coagulant therapy, Osteoporosis or advanced degenerative changes, Hypersensitivity to skin, Advanced diabetes), Pregnancy.

结局指标

主要结局

Assessment of headache intensity using NPRS(Numerical pain rating scale)

时间窗: 2 Weeks

次要结局

  • Assessment of pressure pain using Pressure algometer, assessment of the quality of life using Sino-Nasal Outcome Test (SNOT-22).(2 weeks)

研究者

发起方
KLE Academy of Higher Education Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nithisha G

KAHER Institute of Physiotherapy

研究点 (1)

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