Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202109867376877 Date of Approval: 23/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF SUBOCCIPITAL RELEASE VERSUS TRIGGER POINT RELEASE ON FORWARD HEAD SUBJECTS WITH TENSION HEADACHE.
Official scientific title EFFECT OF SUBOCCIPITAL RELEASE VERSUS TRIGGER POINT RELEASE ON FORWARD HEAD SUBJECTS WITH TENSION HEADACHE.
Brief summary describing the background and objectives of the trial this trail aims to compare the effectiveness of various soft tissue manipulative techniques in reducing suboccipital muscles stiffness in subjects presenting with forward head posture and tension type headache.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 30/09/2021
Actual trial start date
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group postural exercises Twice per day and 3 times per week. ONE month. Participants will be given a list and description (with illustrations) of an exercise program. The program consists of two strengthening exercises (deep cervical flexors and shoulder retractors) and two stretching exercises (cervical extensors and pectoral muscles). 20 Active-Treatment of Control Group
Experimental Group Suboccipital inhibition technique Participants will receive 2 sessions per week for four weeks duration to have a total number of 8 sessions. ONE month. The subject will be placed in a supine position, whereas the therapist will sit at his head with the elbows resting on the surface of the table. The therapist place both hands behind the head of the subject, with the palms facing upwards, the fingers flexed, and the finger pads positioned on the space between the occipital condyles and the spinal process of C2 to allow the occiput to rest in the palm of the hands. A force is applied with the finger pads over the atlas in the direction of the ceiling with slight traction in a cranial direction and maintained for 2 minutes until the therapist perceive relaxation of subject’s suboccipital muscle. After tissue relaxation is achieved, the pressure was smoothly released, leaving the subject’s head on the bed 20
Experimental Group Suboccipital trigger point progressive pressure release Participants will receive 2 sessions per week for four weeks duration to have a total number of 8 sessions. ONE month. the patient will be in supine position, ask him to raise his head as the therapist slide his hands underneath it, now have the patient lower his head into the therapist’s palms contacting the region just below the base of the skull or the occiput, gently turn his head to one side being careful not to cover his ears as the trigger points lie just below the occiput and about halfway between the mastoid process and the midline of the upper neck. Using the thumb gentle, gradual increasing pressure is applied to the trigger points a direction towards the patient’s nose. Once tissue resistance is felt, pressure is maintained, until resistance dissipate, and a slow release or a "melting away" sensation of the tissue is felt, further increase in pressure moving again inward toward the center is applied. Pressure application should be guided by the patient’s pain tolerance, where constant feedback is provided by the patient. It will be applied for at least 30 seconds and up to two minutes at a time and repeated three to four times. The patient should breathe deeply and slowly while we progressively increase the pressure 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Subjects of both genders ranging in age from 18-30 years old. 2) Subjects having craniovertebral angle < 52°. 3) Participant had to be suffering from tension-type headaches. The diagnostic criteria for tension-type headaches, according to the International Headache Society are: A) Headaches lasting anywhere from 30 minutes to 7 days B) At least two of the following characteristics: • A pressing or tightening (non pulsating) quality around the head - Mild to moderate intensity • Bilateral location • No aggravation from walking stairs or similar routine activities C) Absence of the following: • Nausea or vomiting • Phonophobia and photophobia; however, one may be present but not both. Subjects who have: 1) A history of cervical trauma or surgery. 2) Complaints of dizziness. 3) Complaints of radicular pain. 4) Pathology in the spine or the upper limbs. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 30 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/06/2020 faculty of physical therapy research ethical committee
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District. Giza Governorate 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome craniovertebral angle measurement pre-treatment and post-treatment
Primary Outcome tension type headache measurement pre-treatment and post-treatment
Secondary Outcome cervical range of motion pre-treatment and post-treatment
Secondary Outcome pain pressure threshold pre-treatment and post-treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Badr University in Cairo Badr city Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of physical therapy Cairo University El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District. Giza Governorate 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District Giza Governorate Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Neveen Abdellatif DR_NEVEEN_69@YAHOO.COM +201064615553 El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District, Giza Governorate
City Postal code Country Position/Affiliation
Giza Governorate Egypt Professor of Physical therapy Basic Science Department
Role Name Email Phone Street address
Public Enquiries Mahmoud Ibrahim mahmoud.el-sayed@buc.edu.eg +201001234806 82 Bashayer district, 6 october
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of Physical Therapy Basic Science Department
Role Name Email Phone Street address
Scientific Enquiries Amira Draz Amira.draz@pt.cu.edu.eg +201149411373 New Administrative Capital, Cairo, Egypt
City Postal code Country Position/Affiliation
cairo Egypt Professor of Physical Therapy basic science Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available (including data dictionaries). Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared. Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code will be available. Data will be available immediately following publication. To gain access, data requestors will need to sign a data access agreement. Informed Consent Form,Study Protocol Data will be available immediately following publication for 3 years. Researchers who provide a methodologically sound proposal will be able to access the data to achieve aims in the approved proposal. Proposals should be directed to shaza.samir@buc.edu.eg.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
shaza.samir@buc.edu.eg No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information