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.: PACTR201711002675342 Date of Approval: 08/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of 8-weeks motor control exercises and graded activity on selected biopsychosocial variables and pattern of recovery among nonspecific chronic
Official scientific title Effect of 8-weeks motor control exercises and graded activity on selected biopsychosocial variables and pattern of recovery among nonspecific chronic low back pain patients; a mixed method study
Brief summary describing the background and objectives of the trial it has been projected that the greatest increase in LBP prevalence in the next few decades will be in the developing nations. While LBP prevalence among African's is rising and is of concern. It's management is costly corresponding or a large and increasing proportion of health care expenditures without evidence of corresponding improvements in outcomes. At present it has neither been very clear nor widely reported, whether a treatment more rooted in biopsychosocial approach encompassing combination of motor control Exercises and graded activity will offer a better approach to resolving the myriads of problems experienced by chronic low back pain patients. Therefore the present study is to compare the effect of 8-weeks motor control exercises and graded activity on selected biopsychosocial variables and pattern of recovery among patients with nonspecific cLBP attending three selected hospitals, Kano, Nigeria
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,nonspecific chronic low back pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 30/10/2017
Actual trial start date
Anticipated date of last follow up 30/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group motor control exercises twice weekly, 10 reps each lasting 10 seconds 8-weeks This will comprise of a warm-up period based on the McGill cat and camel exercises. the main exercise based on the protocol of Sokunbi et al. and the cool-down also based on McGill cat and camel exercises 25
Experimental Group combined graded activity and motor control exercises twice weekly 8-weeks this is the combinations of both the graded activity and motor city control exercises as described in respective protocol 25
Control Group minimal physiotherapy twice weekly 8-weeks minimal interventions of lumbar rotations, knee to chest and bridging exercises 25
Experimental Group graded activity twice weekly 8-weeks The goal is to use a cognitive behavioral therapy in the form of graded activity program to increase patients activity tolerance through individualized progressive sub maximal exercises in addition to ignoring illness behavior and reinforcing wellness behaviors towards LBP 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who scores medium to high risk level on the start back tool (SBST). Patients will be between 18-80 years old with mechanical nonspecific cLBP. Patients must have any of the following features which constitute the clinical prediction rules for Improvement with motor control exercises they are: positive prone spring test, FABQ,physical activity Scale greater than 9 points. Patients should be able to either read Hausa,English or both. Patients with LBP of specific origin Spine surgery Neuromusculoskeletal diseases that could affect exercise performance. Uncontrolled hypertension. Pregnancy. Recent lumbar cortisone Injection. Being under medications known to Impair physical efforts and limiting the capacity to undergo the evaluation and protocols of interventions used In this syudy. 18 Year(s) 80 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 12/09/2017 Health Research Ethics Committee of the Ministry of health
Ethics Committee Address
Street address City Postal code Country
2nd and 3rd floor, post office Road, P.M.B 3066, Kano Kano Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Baseline or pre-intervention assessment. Post-intervention assessment Follow-up at 2,6 and 12 months.
Primary Outcome functional disability Baseline or pre-intervention assessment. Post-intervention assessment. Follow-up assessment at 2,6 and 12 months
Secondary Outcome Quality of life Baseline or Post-intervention assessment. Post-intervention assessment. Follow-up assessment at 2,6 and 12 months.
Secondary Outcome fear of avoidance Baseline or pre-intervention assessment. Post-intervention assessment. Follow-up assessment at 2,6, 12 months.
Secondary Outcome patients global impression of change Baseline or pre-intervention assessment. Post-intervention assessment. Follow-up assessment at 6 and 12 more months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Specialist hospital Kano Kano Nigeria
Muhammad Abdullahi Wase Specialist hospital Kano Nigeria
Aminu Kano teaching hospital Zaria road Kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Aminu Kano teaching hospital Zaria road Kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Aminu Kano teaching hospital Zaria road Kano Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Bayero University Kano Kano Nigeria
University of Maiduguri Bama Road Maiduguri Nigeria
Murtala Muhammad specialist hospital Kano Nigeria
Muhammad Abdullahi Wase specialist hospital Kano Nigeria
Aminu Kano teaching hospital Zaria Road Kano Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Salamatu Umar Aliyu ptsalualiyu@yahoo.com +2348077073558 Bama road
City Postal code Country Position/Affiliation
Maiduguri Nigeria University of Maiduguri, Borno State
Role Name Email Phone Street address
Public Enquiries Salamatu Umar Aliyu ptsalualiyu@yahoo.com +2348077073558 Bama road
City Postal code Country Position/Affiliation
Maiduguri Nigeria University of Maiduguri, Borno State
Role Name Email Phone Street address
Scientific Enquiries Ganiyu Sokunbi ganiyusokunbi@gmail.com +234 813 846 8412 Zaria Road
City Postal code Country Position/Affiliation
Kano Nigeria Bayero University Kano
REPORTING
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