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.: PACTR201710002646362 Date of Approval: 26/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Core Stability and Treadmill Walk Exercises on the Functional Status of Post Lumbar -Surgical Patients With Low Back Pain: A Randomised Cont
Official scientific title Effect of Core Stability and Treadmill Walk Exercises on the Functional Status of Post Lumbar -Surgical Patients With Low Back Pain: A Randomised Control Trial
Brief summary describing the background and objectives of the trial Low back pain (LBP) is one of the most common musculoskeletal disorders for which patients consult medical care. It is also the most important cause of disability and work absenteeism with increasing prevalence leading to a major socioeconomic impact on society. These facts highlight the importance of finding effective and validated treatments for this disabling condition.Physiotherapy management of chronic low back pain has been recently focused on identifying specific muscles that are able to stabilize the back and enhancing the activity of those muscles whose primary function is considered to be dynamic stability and segmental control of the spine. Stabilization Exercises and Treadmill Walk Exercise are widely reported to be effective in the management of LBP. However, their effects on Post -Surgical LBP have not been widely reported. It is therefore, not clear whether Core Stability Exercise and Treadmill Walk Exercise will provide greater benefits in terms of pain reduction, improvement of functions and higher quality of life among LBP lumbar spinal post-surgical patients. The study therefore, is aimed at determining the effects of Core-stability exercises and Treadmill walking exercises in the treatment of Low Back Pain in Lumbar spinal post-surgical patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,POST-SURGICAL LOW BACK PAIN,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2018
Actual trial start date
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group GROUP A Twice a week 8 weeks Core stability exercises 20
Experimental Group GROUP B Twice a week 8 weeks Treadmill Exercises 20
Experimental Group GROUP C Twice a week 8 weeks Core stability exercises and Treadmill walk exercises 20
Control Group GROUP D Twice a week 8-weeks lumbar rotation, bridging and knee to chestExercises 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants for this study will be at least 18 years old, had undergone spinal surgery and a history of chronic and/or recurrent LBP (repeated episodes of pain in past year collectively lasting for more than 3 months), with or without leg pain, and is presenting with recurrent LBP. They should be able to read/understand English and/or Hausa languages. Participants should be at Phase IV which is the Recovery phase (20 weeks to 1 year post-surgery) according to the Recommendations for the rehabilitation of post-surgical spinal patients by Maxey and Magnusson (2001). Participants with low back pain caused by red flag factors (such as cancer, tuberculosis, tumour and other serious spinal pathological conditions as outlined in the Clinical Standards Advisory Group (CSAG) report for back pain (CSAG 1994) and also those patients with any organic pathology like spinal cord injury, systemic inflammatory diseases, disc prolapse, radiculopathy, inflammatory arthritis, pregnancy related, fractures, infections osteoporosis, spondylolisthesis, spinal stenosis and morbid obesity, uncontrolled diabetes and uncontrolled hypertension or heart problems will be excluded from the study. Participants will also be excluded from the study if they have one or more of the following criteria: pregnancy; significant physical or mental deficiencies preventing a clear understanding of the clinical trial procedure. 18 Year(s) 65 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 09/10/2017 Research and Ethics Comittee, Aminu Kano Teaching Hospital, Kano
Ethics Committee Address
Street address City Postal code Country
No 2 New court Road, AKTH Kano Kano, Nigeria +234 Nigeria
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 09/10/2017 Research and Ethics Comittee, National Orthopaedic Hospital Dala, Kano
Ethics Committee Address
Street address City Postal code Country
No 3 Gwammaja Street, NOHD, Kano. Kano, Nigeria +234 Nigeria
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 Health Research and Ethics Comittee, Ministry of Health, Kano State
Ethics Committee Address
Street address City Postal code Country
No. 4 Post Office Road, Kano. Kano, Nigeria +234 Nigeria
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 09/10/2017 Health Research and Ethics Comittee, Ministry of Health, Kano State
Ethics Committee Address
Street address City Postal code Country
No. 4 Post Office Road, Kano. Kano, Nigeria +234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain 2-weeks 4-weeks 6-weeks 8-weeks
Primary Outcome Functional Disability 2-weeks 4-weeks 6-weeks 8-weeks
Primary Outcome Quality of Life 2 WEEKS,4 WEEKS, 6 WEEKS, 8 WEEKS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Orthopaedic Hospital Dala, Kano No 3 Gwammaja Street,Kano Kano, Nigeria +234 Nigeria
Murtala Muhammad Specialist Hospital Kano No 1 Murtala Muhammad Street, Kano Kano, Nigeria +234 Nigeria
Sir Sunusi General Hospital, Kano No. 6 Yankaba Street, Kano Kano, Nigeria +234 Nigeria
Aminu Kano Teaching Hospital, Kano No 2 New court Road, Kano Kano, Nigeria +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
BAYERO UNIVERSITY KANO No 1 Gwarzo Road, KANO Kano, Nigeria +234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FARIDA GARBA SUMAILA Physiotherapy Department, BUK Kano, Nigeria +234 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
PROF. GANIYU O. SOKUNBI Physiotherapy Department, BUK Kano, Nigeria +234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator FARIDA GARBA SUMAILA fareedat2006@gmail.com +234 80 3616 4228 Physiotherapy Department, BUK,Kano.
City Postal code Country Position/Affiliation
Kano, Nigeria +234 Nigeria LECTURER I
Role Name Email Phone Street address
Public Enquiries FARIDA GARBA SUMAILA fareedat2006@gmail.com +234 80 3616 4228 Physiotherapy Department, BUK,Kano.
City Postal code Country Position/Affiliation
Kano, Nigeria +234 Nigeria LECTURER I
Role Name Email Phone Street address
Scientific Enquiries GANIYU OLUWALEKE SOKUNBI ganiyusokunbi@gmail.com +234 81 3846 8412 Physiotherapy Department, BUK,Kano.
City Postal code Country Position/Affiliation
Kano, Nigeria +234 Nigeria PROFESSOR
REPORTING
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Changes to trial information