Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202001587283053 Date of Approval: 14/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mulligan versus thoracic manipulation on mechanical neck pain
Official scientific title Mulligan sustained natural apophyseal glides versus thoracic manipulation on mechanical neck pain: A randomized controlled study
Brief summary describing the background and objectives of the trial Recently, evidence has begun to emerge for the use of manual procedures directed at the thoracic spine for patients with mechanical neck pain (Cleland et al., 2005, 2007a, b & Ferna´ndez-de-lasPen˜as et al., 2004, 2007a). It was found that thoracic thrust manipulation results in immediate improvements in neck pain at rest as measured by the visual analogue scale, compared to patients receiving a placebo manipulation (Cleland et al., 2005). Further, it has also been found that at short-term follow-up patients receiving thoracic manipulation exhibit superior outcomes to patients receiving non-thrust techniques (Cleland et al., 2007a). Recent studies have shown that performing thoracic spine manipulations (multiple levels) on mechanical neck pain patients can result in immediate improvements in symptoms and neck function (Cleland et al., 2007b & Cleland et al., 2005). It has been found that thoracic spine manipulation can activate descending inhibitory mechanisms resulting in hypoalgesia in distant areas, and may restore normal biomechanics of the thoracic region, potentially lowering mechanical stress and increasing the distribution of joint forces in the cervical spine (Gonzalez-Iglesias et al., 2008).
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 Rehabilitation
Anticipated trial start date 02/06/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 17/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC/012/002344
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional physical therapy program 3 sessions per week 4 weeks The cervical spine is the top portion of the spine in the back of the neck. Muscles of the neck, including the suboccipital, longus capitis, colli, multifidi, semispinalis cervicis and longissimus cervicis, stabilize the neck. The upper back and shoulder muscles, including the lower trapezius and the serratus anterior, are also important for spinal stabilization. Simple exercises increase the strength in these muscles for improved stabilization. (Murphy, 1999). Cervical stabilization training is a method of exercise that, like its counterpart in the lumbar spine, is designed to improve the inborn mechanisms by which the cervical spine maintains a stable, injury-free state. This is accomplished through a series of exercises that are relatively simple from the standpoint of time and equipment, but are physiologically complex. (Solomonow et al., 1998). Proper stability mechanisms of the cervical spine are dependant on a normally functioning lumbar spine and pelvic stability system and vice versa, but there are unique characteristics of the cervical spine that require us to make modifications in our approach to training for stability in this area. (Murphy, 1999). Unlike the lumbar spine, the cervical spine is a structure that has the burden of carrying the head around. It must maintain not only intersegmental stability but also stability of the head. The purpose of head stability is both to prevent the head from flopping around during body movements and to maintain the sense organs in a stable position for optimum function. (Panjabi, 1992). To accomplish this, there must be a stable relationship between the neck and thoracic spine and between the neck and the head. The most important muscles responsible for maintaining these relationships are the posterior intersegmental muscles, (multifidi and suboccipitals); the deep cervical flexors, (longus capitis and colli); and the lower cervical/upper thoracic extensors (semispinalis cervicis and longissimus cervicis). The stability of the cervical spine is also greatly dependant on the stability of the scapula and upper extremities. The most important muscles in scapular stability are the middle and lower trapezius and the serratus anterior. Therefore, in stabilization training, these are the muscles that must receive the greatest focus. (Janda, 1994). There is another aspect of cervical stability that differentiates it from that of the lumbar spine: the importance of eye-head-neck coordination. This coordination is primarily brought about by reflexes, specifically the cervico-ocular reflex, vestibulo-ocular reflex, cervicocollic reflex, vestibulocollic reflex, optokinetic reflex, smooth pursuit and saccades. In addition, as was stated earlier, good lumbar stability is essential for good cervical stability, as are proper stability mechanisms of the foot. (Langley, 1997). 20 Active-Treatment of Control Group
Experimental Group Mulligan SNAG 3 sessions per week 4 weeks Sustained natural apophyseal glides (SNAGs) is a spinal mobilization technique which combines elements of active physiological movement with an accessory glide directed along the facet joint plane that facilitates pain-free movement throughout osteokinematic range of motion (Mulligan, 1993). They must never cause pain, however they might cause discomfort to some extent. These oscillatory mobilizations are utilized to increase spinal movement and reduce pain (Mulligan, 2004). Mobilizations repeated for less than 6 times with 2 hertz (Hussain et al., 2016). 20
Experimental Group Thoracic manipulation 3 sessions per week 4 weeks Spinal manipulation is utilized by physical therapists, chiropractors and other healthcare practitioners to treat a multitude of musculoskeletal disorders, most commonly mechanical back and neck pain, headaches and spinal stiffness. (Kuczynski et al., 2012). Thrust joint manipulation (TJM) to the spine differs significantly from non-thrust joint mobilization in that the rate of vertebral joint motion (the speed of the technique) does not allow the patient to prevent its occurrence. Thrust joint manipulation techniques involve the application of high-velocity low-amplitude forces directed to spinal joints with the intent of achieving joint cavitation or an audible pop. Non-thrust spinal mobilization techniques involve cyclic low-velocity forces through varying amplitudes of motion with no intent to achieve joint cavitation. The safety of TJM to the spine has been an issue of significant debate over the past decade, with much of the focus being on AEs associated with its application to the cervical spine, and to a lesser extent the lumbar spine. (Goertz et al., 2012) Thrust joint manipulation to the thoracic spine has been recommended in the management of patients with mechanical neck pain provide short-term success in some individuals with shoulder pain and also reported to be beneficial in the management of temporomandibular disorders when combined with mobilizations with movement and dry needling. (Rodine and Vernon , 2012 & Michaleff et al., 2012). 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients aged from 18-45 years old. 2- Patients who were diagnosed with primary complaint of neck pain as referred by physician. 3- Consent to participate in the study and follow the treatment schedule. 1. Any known case of cervical spine canal stenosis. 2. Previous history of malignancy. 3. History of whiplash injury, within 6 weeks of examination. 4. Any past history of cervico-thoracic surgery. 5. Patients with history of fractures of cervical and thoracic spine. 6. Patients diagnosed with, cervicogenic headache and vertigo. 7. Exposure to acute trauma. 8. Having history of inflammatory joint, muscle disease or infection. 9. Having an evidence of neurological deficit. 10. Exhibiting inadequate cooperation. 11. Having a diagnosis of cervical radiculopathy or myelopathy. Adult: 19 Year-44 Year 18 Year(s) 45 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 05/05/2019 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat St. BienElsarayat, Dokky, Giza Giza 12618 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cervical range of motion by CROM Immediate before starting treatment, Immediate after finishing treatment and one month later
Secondary Outcome Pain By pressure algometer, visual analogue scale and neck disability index Immediate before starting treatment, Immediate after finishing treatment and one month later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Cairo university 7 Ahmed Elzayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Heba Allah Samy Said Ahmed 27 Ibn Fadlan St. Nasr City Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo university 7 Ahmed Elzayat St. BienElsarayat, Dokky, Giza Giza 12618 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Maher Ahmed Elkeblawy 7 Ahmed Elzayat St. BienElsarayat, Dokky, Giza Giza 12618 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maher Elkeblawy maher_ma2014@yahoo.com 01001419544 7 Ahmed Elzayat St. BienElsarayat, Dokky
City Postal code Country Position/Affiliation
Giza Egypt Professor of physical therapy
Role Name Email Phone Street address
Principal Investigator Nabil AbdelAal nabil.mahmoud@cu.edu.eg 01200133613 7 Ahmed Elzayat St. BienElsarayat, Dokki
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
Role Name Email Phone Street address
Public Enquiries Nabil AbdelAal nabil.mahmoud@cu.edu.eg 01200133613 7 Ahmed Elzayat St. BienElsarayat, Dokki
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Nabil AbdlAal nabil.mahmoud@cu.edu.eg 01200133613 7 Ahmed Elzayat St. BienElsarayat, Dokki
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underline the results reported in this article, after identification (Text, tables, figures and appendices) Statistical Analysis Plan,Study Protocol 6 months follow publication Any one who wishes to access the data
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