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.: PACTR202201602315491 Date of Approval: 14/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Suboccipital Release Versus Muscle Energy Technique in Patients With Mechanical Neck Pain and Forward Head Posture
Official scientific title Suboccipital Release Versus Muscle Energy Technique in Patients With Mechanical Neck Pain and Forward Head Posture
Brief summary describing the background and objectives of the trial BACKGROUND: Forward head posture (FHP) is one of the most common cervical abnormalities that predisposes individuals toward pathological conditions, such as headache, neck pain , temporomandibular disorders , vertebral bodies disorders , soft-tissue length and strength alteration , or even scapula and shoulder dyskinesis. Suboccipital muscles are the “proprioceptor monitors” that contribute significantly to regulation of head posture, and they have the most muscle spindles in the human body. In general, Suboccipital muscles control head rotation over the cervical area and Sternocleidomastoid assists with neck flexion .With FHP, suboccipital muscles are in a state of hypertonicity to maintain the level of the eye with horizon. Forward head posture has also been reported to be associated with trigger points in the suboccipital muscles (rectus capitis posterior minor and major and oblique capitis superior) .In which excessive anterior head positioning (forward-head posture) is often accompanied by a posteriorly-rotated occiputto accommodate the line of vision. This position activates and perpetuates TrPs in the suboccipital muscles and in other posterior cervical muscles . Researchers have found MET to be effective in producing a significant increase in overall regional cervical range of motion in the treatment group when compared with control Subjects. It was found also that suboccipital release was highly effective in reducing pain in patients with forward head posture PURPOSE: The purpose of this study is to: to examine and compare between the effect of suboccipital release technique and suboccipital muscle energy technique technique on patients with mechanical neck pain and FHP regarding changes in: 1.craniovertebral angle 2.Pain intensity. 3.Cervical range of motion (Flexion, Extension, Side bending, Rotation). 4.Neck disability.
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 21/12/2020
Actual trial start date 01/02/2021
Anticipated date of last follow up 01/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status 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
Parallel: different groups receive different interventions at same time during study 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
Experimental Group suboccipital release and conventional treatment 3 times per week 4 weeks suboccipital release kendel excercises hot packs 15
Experimental Group muscle energy technique and conventional therapy 3 times per week 4 weeks muscle energy technique to suboccipital muscles kendell exc hot packs 15
Control Group conventional treatment 3 times per week 4 weeks kendell excercises hot packs 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients were suffering from mechanical neck pain with Cranivertebral angle <53 • Both gender are included in this study . • Their age ranged from 20-40 years • All patients are completing Neck disability index(NDI) , their results ranged from 30-48%(moderate disability) All patients excluded from this study if they have the following : • History of Injury or trauma to cervical region. • Spinal Surgery. • Cervical canal stenosis • Radicular pain. • Malignancy. Adult: 19 Year-44 Year 20 Year(s) 40 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 05/12/2020 Research ethical committee of faculty of physical therapy cairo univercity
Ethics Committee Address
Street address City Postal code Country
dokki street Geiza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome craniovertebral angle via surgimap software ,Pain intensity via numerical pain rating scale,neck disability via neck disability index,cervical range of motion via inclinometer application 1 month
Secondary Outcome functional ability will be measured using neck disability index questionnaire in arabic form 1 month
Secondary Outcome pain intensity will be measured by using numerical pain rating scale 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of faculty of physical therapy cairo university dokki street giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mariam Mohamed Abdallah 5 b Hafez Ramadan Nasr city cairo 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mariam Mohamed dokki street Geiza 12511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Marwa shafeik dokki street Geiza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mariam Mohamed www.mariam.mohamed420@gmail.com 0020121337723 5B hafez ramadan nasr city
City Postal code Country Position/Affiliation
cairo 11865 Egypt Teaching Assistant at Basic science departement .faculty of physical therapy .cairo university
Role Name Email Phone Street address
Public Enquiries Marwa Shafeik Marwa_shafiek2000@yahoo.com 00201008342466 dokii
City Postal code Country Position/Affiliation
geiza 12511 Egypt Assistant professor at Basic science department at Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mariem Mohamed mariam.mohamed420@gmail.com 00201221337723 5B hafez ramdan nasr city
City Postal code Country Position/Affiliation
cairo 11865 Egypt teaching assistant at basic science departement faculty of physical therapy cairo univercity
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the individual participant data is provided in form of: craniovertebral angle,pain ,neck disability,cervical range of motion(flexion ,extension,sidebending and rotation) Study Protocol 1 year Criteria will be accessed by publication on international journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet 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