| CTRI Number |
CTRI/2024/07/071032 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Posterior Chain Myofascial Releases Impact on Pain and Quality of Life in Sinus Headaches: A Pre-Post Study |
|
Scientific Title of Study
|
Impact of Posterior Chain Myofascial Release on Pain intensity, Pain threshold, Quality of life in Sinus Headaches: A Pre-Post Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nithisha G |
| Designation |
Postgraduate |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD NO 39,Room No 18, Nehru Nagar, Belagavi, Karnataka.
KAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD NO 39,Room No 18, Nehru Nagar, Belagavi, Karnataka.
Raichur
KARNATAKA
584128
India |
| Phone |
9113541186 |
| Fax |
|
| Email |
nithisharambabu1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Peeyoosha Gurudut |
| Designation |
Professor, head of department, Orthopedic physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advance physiotherapy, OPD NO.18, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi
Advance physiotherapy, OPD NO.18, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Peeyoosha Gurudut |
| Designation |
Professor, head of department, Orthopedic physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advance physiotherapy, OPD NO.18, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi
Advance physiotherapy, OPD NO.18, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education & Research
Nehru Nagar, Belagavi, Karnataka,India.590010 |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education Research |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD NO 39,Room No 18, Nehru Nagar, Belagavi, Karnataka. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Peeyoosha Gurudut |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre |
KAHER Institute of physiotherapy, Department of Orthopedic Physiotherapy, OPD NO 39, Room No 18, Nehru Nagar, Belgaum, Karnataka
Belgaum
KARNATAKA |
9844821355
peeyooshagurudut@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manual myofascial release |
Manual myofascial release treatment will be given in 3 sets of the release with a 60-second hold, on alternate days for two weeks. A total of 5 sessions will be conducted.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
All gender subjects diagnosed with sinus headaches according to ICHD-3 criteria, Within 20-55 years of age, Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of headache intensity using NPRS(Numerical pain rating scale) |
2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of pressure pain using Pressure algometer, assessment of the quality of life using Sino-Nasal Outcome Test (SNOT-22). |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2024 |
| Date of Study Completion (India) |
14/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/02/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |