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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201512001268270 Date of Registration: 15/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF MOTOR CONTROL EXERCISE IN THE MANAGEMENT OF LUMBOSACRAL RADICULOPATHY
Official scientific title EFFECT OF MOTOR CONTROL EXERCISE IN THE MANAGEMENT OF LUMBOSACRAL RADICULOPATHY : A SINGLE BLINDED RANDOMIZED CONTROL PILOT TRIAL
Brief summary describing the background and objectives of the trial Radiculopathy is not a specific condition, but rather a description of a problem in which one or more spinal nerves are affected. The nerve or nerves may be inflamed, had lack of blood flow, or may be affected by a disease in part or totally. Lumbosacral radiculopathy (LSR) is a common clinical problem that involves L5and S1 nerve roots. It may affect anyone at any time in their lives, regardless of their sex, age and profession. LSR comprises 62% to 90% of all radiculopathies. . Generally, LSR occurs as a result of disc herniation or acute injury in younger population and as a result of foraminal narrowing from osteophyte formation in older population. It may also result from spinal cord injuries, spinal stenosis, spinal diseases and other conditions. LSR often results in persistent disability, extensive medical evaluation and aggressive treatment. Low back pain is a major health and socioeconomic problem and is associated with high costs in care, work absenteeism, and disability worldwide. A recent inception cohort study demonstrated that 43% of patients with acute low back pain seen in primary care settings developed chronic low back pain and that nearly a third of them did not recover within1 year . In the field of physiotherapy there is a growing interest toward developing an evidence based practice of common procedures used in the physiotherapy treatment programs. Low back pain and LSR constitute a major part of daily load for physiotherapists worldwide, and have been managed with various methods. One of these methods is rehabilitation of control of movement and muscle activity of musculoskeletal system. This is based on the premise that pain and movement are intimately linked . The purpose of the study to investigate the effect of addition of motor control exercise in the management of lumbo-sacral radiculopathy using H-reflex
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,radiculopathy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/10/2015
Actual trial start date
Anticipated date of last follow up 01/10/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status 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 Simple randomisation Simple randomisation using by using procedures : coin-tossing Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation Simple randomisation using by using procedures : coin-tossing Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Motor control exercises in addition to traditional physiotherapy 2 sessions per week and 2 days home program 6 weeks Motor control exercises in addition to ultrasonic therapy infra-red stretching and mobilizations 35
Control Group traditional physiotherapy 2 sessions per week 6 weeks therapeutic ultra sonic infra-red ,stretching & mobiliztions 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Unilateral discogenic lumbosacral radiculopathy. - Side to side H- reflex latency difference more than 1 msec . - Prolonged H-reflex latency more than 30 msec . - Symptoms lasting longer than 3 months to avoid inflammatory condition . - Patient score at least 5 out of 24 on Roland and Morris disability questionnaire - Systematic disease. - Lumbar canal stenosis - Pervious surgeries - Scoliosis - Kyphosis - Spinal fracture - Bilateral symptoms - Steroid injection 25 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 04/10/2015 Ethics Committee of the Faculty of Physical Therapy, Cairo University
Ethics Committee Address
Street address City Postal code Country
ahmed el zayat street . doqqi giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Roland and Morris disability questionnaire - after 6 weeks post intervention -after 6 months following intervention
Primary Outcome Visual analouge scale - after 6 weeks post intervention - after 6 months following intervention
Secondary Outcome H- reflex latency - 6 weeks post intervention - 6 months following intervention
Secondary Outcome Side to side H-reflex latency difference - after 6 weeks post intervention - after 6 months following intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university ahmed el zayat street ,el doqqi giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No funding sources
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy ,cairo university University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Badr Mohamed el haram st giza Egypt
Abdallah Mohamed faisal giza Egypt
Alaa Magdi madinat nasr cairo Egypt
Wael shendy madinat nasr cairo Egypt
Fatma el zahraa 6 october giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Badr mohamed_19913@hotmail.com +2011142253884
City Postal code Country Position/Affiliation
giza Egypt
Role Name Email Phone Street address
Public Enquiries abdallah mohamed mohamed.pt2011@gmail.com 00201144881439 6 october
City Postal code Country Position/Affiliation
cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries alaa magdi lola_so7ba@yahoo.com 00201120090963 madint nasr
City Postal code Country Position/Affiliation
cairo Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information