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.: PACTR202010685660957 Date of Approval: 19/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title KINETIC CONTROL VERSUS MULLIGAN’S MOBILISATION ON FUNCTIONAL OUTCOMES IN PATIENTS WITH LUMBER RADICULOPATHY
Official scientific title KINETIC CONTROL VERSUS MULLIGAN’S MOBILISATION ON FUNCTIONAL OUTCOMES, RANGE OF MOTION, AND PAIN IN PATIENTS WITH LUMBER RADICULOPATHY
Brief summary describing the background and objectives of the trial Low back pain (LBP) is one of the most common causes of disability among the general population. Approximately 50%–80% of adults are affected at some time during their lives. It is a leading cause of disability and work loss (Park et al., 2014). Low back pain is arguably the most prevalent musculoskeletal condition found among both developed and developing nations (Manchikanti, 2000; Hoy et al., 2010; Hoy et al., 2012 and Froud et al., 2014). It is defined as pain and discomfort of varying duration. It is localized below the costal margin and above the inferior gluteal folds, with or without irradiation in the lower limb (Van Tulder et al., 2006).There is evidence that persisting LBP influences lumbar motor control (Luomajoki et al., 2008), decreases spinal mobility (Hodges et al., 2009) and compromises postural control (Mok et al., 2010). The kinetic control is the movement performed with optimum interaction between neuromuscular control (sensory feedback, central nervous system processing and motor coordination) and physiological stresses (Comerford and Mottram 2012). Brian Mulligan introduced techniques known as: spinal mobilization with limb movements (SMWLMs) . Here, a sustained transverse glide is applied to the spinous process of a vertebra while the restricted peripheral upper or lower limb movement is performed, actively or passively.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LBP
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 24/09/2020
Actual trial start date 24/09/2020
Anticipated date of last follow up 24/11/2020
Actual Last follow-up date 24/11/2020
Anticipated target sample size (number of participants) 30
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 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 kinetic control three times per week two months 1-Retraining the coordination of movement: Flexion control retraining From standing position, the researcher will ask the patient to flex the trunk on hip without flexing the lumbar spine. The patient should self-monitor the lumbopelvic alignment and control with a variety of feedback options such as self-palpation, visual observation (e.g. observation in a mirror) or adhesive tape to the skin across the uncontrolled segments. Patient maintains 10 sec. for 10 17 repetions till benchmark (50º of forward trunk leaning)+ 2-Muscle synergy retraining: for Superficial lumbar multifidus-Iliacus Retraining: 3-Extensibility: for hamstrings-for anterior abdominals (Rectus abdominis) 4-Home program 15
Control Group Mulligan Three times per week Two Months It will receive Mulligans spinal mobilization with limb movement (SMWLM) in addition to the selected physical therapy program. 1. Patients will be asked lie on their unaffected side and move their affected leg to the limit of pain-free range of SLR. At the same time, the examiner will apply firm transverse pressure to the superior vertebrae at the affected spinal level (L4 or L5) away from the painful side. Participants will then be instructed to stop the leg movement at the point leg pain is provoked, easing back, and then maintain the position for three seconds before returning to the starting position. The technique will be progressed from a single set of three repetitions on the first occasion to 2-3 sets of 6-8 repetitions with a rest interval of 30 seconds between sets on subsequent applications. Progression will also be achieved by applying pain-free overpressure to the range of SLR. 2. A neural slider mobilization will be applied with the subject in side lying, a rhythmical movement of hip and knee flexion followed by hip and knee extension will be carried out for 30 seconds and repeated 5 times . 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Thirty patients from both sexes(25:44) will participate in the study. 2-All the patients suffering from chronic low back pain with radiculopathy & flexion uncontrolled movement due to lumbar disc prolapse (posterolateral or lateral disc prolapse at the levels of L4-L5/ L5-S1). 3- The radiculopathy signs will be identified by the presence of LBP with numbness radiating below the knee. 4- The duration of illness will be from 3-6 months. 5- The uncontrolled movement will be towards flexion. 6- Body mass index will be 25 - 30 kg/m2. 7-Patients will have unilateral radiculopathy. 1-Previous spinal surgery 2-other causes of the radiculopathy (e.g. piriformis syndrome, diabetic neuropathy) 3-spinal tumor, lumbar instability, pregnancy, will be excluded from the study. Adult: 19 Year-44 Year 25 Year(s) 44 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 ethical committee
Ethics Committee Address
Street address City Postal code Country
7th elzayat street giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Functional disability by Oswastrey Disability Index Before and after completion of study
Secondary Outcome Lumbar range of motion by inclinometer Before and after completion of study
Secondary Outcome pain by VAS Before and after completion of study
Secondary Outcome Neuropathic component by Pain DETECT(PD-Q): Before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy 7th Elzayat st Giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahmoud Abo Alfa 7thelzayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairouniversity el qasr el einiy street giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud abo alfa mahmoud.aboalfa@pt.cu.edu.eg 01276264443 7th elzayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt demonstrator at faculty of physicaltherapy
Role Name Email Phone Street address
Scientific Enquiries enas el sayed dr.inaselsayed@yahoo.com 01125525463 7th elayat street
City Postal code Country Position/Affiliation
giza Egypt 12511
Role Name Email Phone Street address
Public Enquiries nora abdelhamed noura_124@yahoo.com 01066366879 7th elayatstreet
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer at physiclterapy cairounuversity
Role Name Email Phone Street address
Public Enquiries mohammed el sayed mohamedelawady1967@gmail.com 01223713914 7th elzayat street
City Postal code Country Position/Affiliation
gia 12511 Egypt professor ofphysical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of the trial 1-function 2-pain 3-range of motion Study Protocol six months the criteria will be accessed by the publication of trial in an 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