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.: PACTR202005715810295 Date of Approval: 07/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of mulligan SNAGs on cervical muscle activity in patients with chronic mechanical neck pain (randomized clinical trial)
Official scientific title Efficacy of mulligan SNAGs on cervical muscle activity, pain and function in patients with chronic mechanical neck pain (randomized clinical trial)
Brief summary describing the background and objectives of the trial Neck pain is a frequent complaint, more so in women than in men (Fejer et al., 2006). The lifetime preva- lence of neck pain varies between 43% and 66.7% (Bovim et al., 1994; Côté et al., 1998, 2004; Guez et al., 2002; Chiu and Leung, 2006), and with a point prevalence of ~20% (Côté et al., 1998), it is one of the most frequent musculoskeletal complaints (Picavet and Schouten, 2003). Effective treatment of neck pain is essential; however, in most cases, the structural source of pain cannot be identified. Consequently, a reasonable pharmacological or surgical treatment can rarely be offered (Bogduk and McGuirk, 2006). Many patients seek ongoing conservative management from a variety of health care practitioners (Freburger et al., 2005). 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(Konstantinou et al., 2007).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SNAGs
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 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) 40
Actual target sample size (number of participants) 40
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sustained natural apophyseal glides 3 times/week 4 weeks During application, the patient will be seated in a supportive low back chair, and with the therapist’s position behind the patient. The current range of cervical spine was checked for range such as increasing pain during range, pain at end of the available range, or painless stiffness at the end of a reduced range of motion (comparable sign). The therapist used the medial border of one thumb’s distal phalanx reinforced by the pad of the other thumb to apply an antero-superior accessory glide through the superior spinous process or articular pillar of the involved motion segment (i.e. the vertebra above the suspected site of the problem). The thumb nail would slope at approximately 45 degrees. Then the therapist moved the spinous process up in the direction that must follow the apophyseal joints plane under treatment, that is, toward the eyeball. While sustaining this pain-free accessory glide,the patient was instructed to actively perform the comparable sign + hot back+ stretch and strength of cervical muscle 20
Control Group traditional treatment 3 times /week 4 weeks hot back for 15 minutes, stretch for cervical muscle+isometric strength for cervical muscles 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) 40 patients with CMNP from both sexes. 2) The age of patients will range from 18-22 years old. 3) pain involving the posterior or posterolateral aspect of the neck for more than 3 months 4) score of 20% (or at least 10 points) on the Neck Disability Index (NDI) (scored out of 50 points 5) the average cervical pain intensity of 5 or more on a visual analog scale (VAS) (scored out of 10 1) had undergone postural control training 2) physical therapy during the preceding 12 months 3) spinal surgery 4) complained of any neurological signs 5) had any history of cervical spine disc herniation or cervical trauma 6) pregnant 7) had congenital postural deformities Adult: 19 Year-44 Year 18 Year(s) 22 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
No 04/05/2020 faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
7th el zayat street giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome muscle activity will be assessed by A two-channel digital electromyogram device (Neuro-EMG-Micro, Neurosoft, Ivanovo, Russia) to detect myoelectric signals bilaterally from the upper trapezius, cervical erector spinae (CE), SCM (at the sternal head) and anterior scalene muscles. before and after completion of study
Secondary Outcome the pain will be assessed by visual analogue scale before and after completion of study
Secondary Outcome neck function will be assessed by Arabic neck disability index before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7th el zayat street giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
al shaymaa shaaban 7 th el zayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university cairo university street giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
al shaymaa shaaban 7th el zayat street giza 12511 Egypt
Mariam Omran Grase 7th el zayat street giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator al shaymaa shaaban alshaymaa.shaaban@pt.cu.edu.eg 01033771553 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer at basic science department at faculty of physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries Mariam omran Dr.mariamomran@yahoo.com 01281940603 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer at Basic science department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries mariam omran Dr.mariamomran@yahoo.com 01281940603 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer at basic science department at cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 40 patients have chronic mechanical neck pain from both sexes.this patient will be assessed by vas, neck disability and emg for muscle activity Study Protocol this study will be started in June and ended at august and will be published at the beginning of 2021 after finishing the application, the results will be available and open, the data will be quantitative data at VAF, function and EMG
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