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.: PACTR201810615549031 Date of Approval: 19/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between mulligan-mobilization with movement and spinal manipulation for the management of low back dysfunction: a randomized controlled trial
Official scientific title Comparison between mulligan-mobilization with movement and spinal manipulation for the management of low back dysfunction: a randomized controlled trial
Brief summary describing the background and objectives of the trial Aim of this study is to compare the effects of spinal manipulation (SM) and Mulligan-mobilization with movement (MWM) in low back dysfunction patients, through assessment of active lumbar flexion range of motion (ROM) using an inclinometer, Oswestry disability index, as well as pain using visual analogue scale (VAS)
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 01/11/2018
Actual trial start date 01/11/2018
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date 31/01/2019
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Spinal manipulation with spinal stabilzation exercises Once per session, where patient will receive 3 sessions per week for 4 consecutive weeks 3 sessions per week for 4 consecutive weeks Patient will be positioned side lying on non-affected side facing the therapist with the bottom leg in approximately 30 degrees of hip and knee flexion. The therapist stands in front of the patient and presses the front of the hip into the patient’s knee to support the top leg. The single leg forward bending technique is used to forward bend the lumbar spine up to the segment to be manipulated and then the hip and spine are slightly extended to maintain the spinal segment inferior to the targeted segment in a forward bent position. Once this point is reached, the top leg is “hooked” onto the bottom leg.The position of the hands is now switched so that the pad of the third digit of the caudal hand now palpates the inter-spinous space of the targeted segment and the second digit palpates one segment above. The spine is rotated to include the segment superior to the segment to be manipulated, but the segment to be manipulated is maintained in neutral. This is accomplished by pulling the patient’s bottom arm (from proximal to the elbow) in a forward and upward rotary motion with the cranial hand. Next, fold the patient’s arms loosely across the patient’s chest.The cranial hand slides underneath the patient’s top arm, and the pad of the long finger contacts the top right lateral side of the spinous process of segment. The cranial leg leaves the ground and the knee on the patient’s upper leg slides down the thigh of the therapist’s caudal leg. Equal and opposite forces through the forearms (with contact with the patient’s right anterior shoulder and chest and the right posterior hip and pelvis) are used to take up the slack and induce right rotation of the specified segment. The manipulation is coordinated with the patient’s breathing, with progressive oscillation into more rotation each time. 15
Experimental Group Mobilization with movement with spinal stabilzation exercises This technique will be repeated ten times/session 3 sessions per week for 4 consecutive weeks The patient sits on a plinth with his legs over the side. The therapist stands behind him and place a belt around his lower abdomen keeping it below the anterior superior iliac spine for comfort. The belt should be below therapist hip joints. The ulner border of therapist's right hand is placed under the spinous process of the vertebra above at the suspected spinal segment. Therapist's other hand should be placed on the bed to the left of the patient. The therapist will apply a gliding force with his right hand up along the treatment plane as the patient flexes forward. The therapist maintains the facet glide until the patient is erect again. 15
Control Group Spinal stabilzation exercises Each exercise was done ten times at each session with hold for six seconds at the end of the range, (Jari et al., 2004). three sessions/week for 4 consecutive weeks Strengthening exercises for back muscles by active back extension and bridging (Jari et al., 2004) and strengthening exercises for abdominal muscles by sit up exercise, and posterior pelvic tilt (El Naggar et al., 1991). 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age between 25 to 40 years old (Campbell and Muncer, 2005). 2 -Suffering from chronic LBD based on referral from orthopedic surgeon who is responsible for the diagnosis of cases based on clinical and radiographic examinations. 3- Duration of illness more than three months (Campbell and Muncer, 2005). 4- Patients with moderate disability and care (20-40%) determined through Oswestery Low Back Pain Disability Questionnaire (Fairbank and Pynsent, 2000). Arabic version of Oswestery Low Back Pain Disability Questionnaire which is valid and reliable (Thuraia Athwair and Safa Koushadam, 2015) was used. 5- Patients BMI ranged from18.5 to 30. 1- Patients with any previous back surgery. 2- Neurologic deficit. 3- Patients with spondylolisthesis, hip arthrosis. 4- Symptoms of vertigo or dizziness. 5- Patients with congenital musculoskeletal deformity. 6- Cardiopulmonary disease with decreased activity tolerance. Adult: 19 Year-44 Year 25 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 15/08/2017 The Board Council of Higher Education of the School of Physical Therapy
Ethics Committee Address
Street address City Postal code Country
El-Tahrir street - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432 Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analogue scale (VAS) for measurement of pain intensity level Data will be collected prior to the first treatment and at the end of the 4-week trial.
Secondary Outcome Oswestry disability index to measure low back function Data will be collected prior to the first treatment and at the end of the 4-week trial.
Secondary Outcome lumbar flexion range of motion (ROM) using an inclinometer Data will be collected prior to the first treatment and at the end of the 4-week trial.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Cairo University El-Tahrir street, in front of Ben El- Sarayat Traffic - Dokki - Giza. 11432 Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self 7nabil el wakad Cairo 11341 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo university El-Tahrir street - in front of Ben El- Sarayat Traffic - Dokki - Giza Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed Nabil Ibrahim Fiaad El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza Giza 11432 Egypt
Wadida Hussen El Sayed El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza Giza 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mary Takla marynassif@pt.cu.edu.eg 00201222817512 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assis Prof
Role Name Email Phone Street address
Public Enquiries Mary Takla marynassif@pt.cu.edu.eg 00201222817512 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assis Prof
Role Name Email Phone Street address
Scientific Enquiries Mary Takla marynassif@pt.cu.edu.eg 00201222817512 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assis Prof
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes publication in a journal Clinical Study Report 1year open
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