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.: PACTR202005559728039 Date of Approval: 28/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of mulligan concept SNAG on sagital cervical alignment of patients with chronic mechanical neck pain
Official scientific title Efficacy of mulligan concept SNAG on sagital cervical alignment of patients with chronic mechanical neck pain
Brief summary describing the background and objectives of the trial Chronic mechanical Neck pain (CMNP) is one of the most common musculoskeletal problems. CMNP caused by multifactorial in nature and can be by the stress over the musculoskeletal system due to postural disorders. The use of various methods of manual treatments such as exercise, mobilization, and manipulation is supported by recent reviews on conservative treatments for CMNP. An important component of a rehabilitation programme for patients with CMNP is Mulligan concept. Mulligan pioneered specific manual approach called mobilization with movement (MWM).The advance of this approach was aimed for application on the spinal joints. The most commonly used Mulligan technique is called “sustained natural apophyseal glides” or SNAGs, this technique has introduced in 1999 by Mulligan and is per- formed by applying an accessory glide along the axis of the facet joint of the affected level while the patient is doing an active movement from weight-bearing position.A according to our knowledge, there is no clinical trials investigated the efficacy of mulligan on different sagital cervical alignment, so this study will conducted to determine the effect of mulligan concept SNAG on different cervical angles on patient with chronic mechanical neck pain.
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 manual therapy treatment
Anticipated trial start date 01/06/2020
Actual trial start date 01/06/2020
Anticipated date of last follow up 01/08/2020
Actual Last follow-up date 01/08/2020
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants)
Recruitment status Completed
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mulligan concept treatment Treatment will be total of 12 sessions 3 session per weeks for one month. one month. The experimental group consisted of 20 participants who will receive the traditional program and Mulligan technique SNAG at C5, C6 and C7 for 10 repetition at each level. Angles were measured using radiographs: (a) Occipital to 2nd cervical (Oc-C2): Angle between McGregor line and the line tangential to the inferior aspect of the axis was defined as the Oc-C2 angle. (b) 1st and 2nd cervical (C1-C2): angle between inferior aspect of atlas and axis.(c) Sagittal alignment of 2nd to 7th cervical vertebrae (C2-C7): angle between the posterior aspect of vertebral bodies of C2 and C7 for both groups before first session and after 12 session (end of treatment).Treatment will be 12 sessions 3 session per weeks for one month. Pain intensity will measured by VAS and neck impairment will measure by NDI. Total duration of traditional session will be 30 min and traditional session plus mulligan will be 36 min (20 min hot packs, 10 min stretching exercise, 10 min strengthening exercise, 6 min mulligan SNAGs ) as I will perform stretching exercise after 10 min of applying hot packs. 20
Control Group traditional treatment Total of 12 sessions 3 session per week 12 month The control group consisted of 20 participants who will receive the traditional program of stretching, strengthening exercises and hot backs. The traditional program will consisted of manual passive stretching exercises for trapezius, sternocleidomastoid and levator scapulae muscles. These exercises will perform from sitting positions, respectively. Each stretching position will maintained for 30 seconds and was repeated 3 times per session. Isometric strengthening exercise will applied for the neck flexors, extensors, Sid bender and rotators for 3 sets each set of 10 repetitions. The hot packs will applied for 20 minutes. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with pain involving the posterior or posterolateral aspect of the neck for more than 3 months. A score of 20% (or at least 10 points) on the Neck Disability Index (NDI) (scored out of 50 points). An average cervical pain intensity of 5 or more on a visual analog scale (VAS) (scored out of 10).  Their age ranged from 18-25 years old.  Their BMI ranged from 21 to 25 kg/cm  History of cervical spine disc herniation.  History of cervical trauma.  Pregnant women.  Participants with congenital postural deformities.  Participants with definitive visual disorder.  Participants who received previous postural control training or any sort of physical exercise.  Participants with previous spinal surgery Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 25 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 01/03/2020 research ethical committee Faulty yof physical therapy CAIRO university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzaiat St.BenElsaryat EI Dokki-Giza Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Different cervical angles : x-rays Pre and post treatment
Secondary Outcome 2. Pain intensity assessment: The scale used was the VAS pre and post treatment
Secondary Outcome 3. Functional Disability Index: Functional disability of each patient was assessed by neck disability index pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Students in various fields by the Faculty of Physical Therapy at Cairo University 7 Ahmed Elzaiat St.BenElsaryat EI Dokki Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mariam Omran Grase 7 Ahmed ElZaiat St. Ben Elsaryat ElDokki Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mariam Omran Grase 7 Ahmed Elzaiat St.BenElsaryat EI Dokki Giza 12612 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Al Shaymaa Shaaban Abdelazeim 7 Ahmed El Zaiat St. BenElsaryat El Dokki Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mariam Omran Grase dr.mariamomran@yahoo.com 00201281940603 7 Ahmed Elzaiat St.BenElsaryat EI Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Mariam Omran Grase dr.mariamomran@yahoo.com 0020281940603 7 Ahmed Elzaiat St.BenElsaryat EI Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mariam Omran Grase dr.mariamomran@yahoo.com 00201281940603 7 Ahmed Elzaiat St.BenElsaryat EI Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt lacturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of the trial 1)cervical angles, 2)pain intensity, 3) function Study Protocol beginning 3 months and ending two year following article publication the criteria will be accessed by the publication of trials in international journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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