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.: PACTR201910691645076 Date of Registration: 22/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTS OF TREADMILL WALKING CONCURRENTLY WITH CORE MUSCLE ACTIVATION ON ADULTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN BASED ON CLINICAL PREDICTION RULES
Official scientific title EFFECTS OF TREADMILL WALKING CONCURRENTLY WITH CORE MUSCLE ACTIVATION ON ADULTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN BASED ON CLINICAL PREDICTION RULES
Brief summary describing the background and objectives of the trial Low back pain (LBP) has been found out to be an enormous problem that continues to pose a major health challenge associated with functional disability, while its global burden for individuals and society comes at a great cost (Ehrlich, 2003; Hoy et al., 2015). Africa has been the major hit of this musculoskeletal burden as reported by an author with a submission that adult population of patients with low back pain is common in developed countries affecting approximately 70% of this population at some stage during their life. ( Deyo & Williums 1996). Functional instability of the lumbar spine has been proposed as an identifiable distinct subset of patients with NSLBP (Demoulin et al., 2007). It is a type of instability that refers to a lack of neuromuscular control of the joint during activities and loss of segmental stiffness and one of mid-range spinal segmental control during motion (aberrant motion), and its better addressed by physical therapy (Beazell et al., 2010). Recently, CPRs have been shown to be useful in classifying patients with LBP who are likely to benefit from a particular treatment approach, such as spine manipulation, pilates - based exercise, mechanical traction, and lumbar stabilization ((J. Childs et al., 2004; Gregory E. Hicks et al., 2005; Stolze et al 2012), but effects of combined exercise has not been investigated on an identifiable sub-type of lumbar l instability. This study, therefore, aims to determine if lumbar stabilization exercise (LSE) combined with Treadmill walking (TW) and standard physiotherapy care (SPC) will be more effective than either LSE, TW or SPC alone to reduce pain intensity, functional limitation, enhance the quality of life , also useful to delineate NSLBP patients who will show improvement based on the minimum clinically important difference (MCID) in ODQ and predict treatment success.
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 01/11/2019
Actual trial start date 01/11/2019
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 31/08/2023
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 87
Recruitment status Completed
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 randomization using a randomization 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 combined exercise twice per week for consecutive six weeks six weeks Participants in this group will undergo both lumbar stabilization exercises and treadmill walking as prescribed by McGill (2003) the treadmill protocol according to Bruce as described above with standard physiotherapy care. The order of treatment will be randomly determined by asking the participants to pick from an opaque paper envelope which contains a strip of papers on which the order of treatment to be carried out will be indicated. 35
Control Group standard physiotherapy care twice per week for six weeks six weeks Participants assigned to the standard physiotherapy care treatment group were assigned to perform minimal or conventional physiotherapy intervention, including lumbar rotation, knee-to-chest exercises, bridging exercises, and alternate straight leg raises twice a week for six weeks. These exercises are considered the minimum standard for treating low back pain. 35 Active-Treatment of Control Group
Experimental Group treadmill walking and standard physiotherapy care twice per week six weeks Participants in this group will undergo treadmill exercises using the Bruce protocol in addition to standard physiotherapy care. Participants in the Treadmill Walk Group (TWSTG) will undertake 30 minutes walking exercise on the treadmill targeting performance at 65 to 80% of the maximum heart rate (HRmax). 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The main inclusion criteria will be patients with NSLBP of mechanical origin with no radicular symptoms. patients must be between 18 to 65 years old. The patients will be eligible irrespective of their educational status, in as much as they could read in either Hausa or English languages and consent to participating in the study. The patients must have the presence of 3 or more positive LFI provocation tests based on Hick’s Clinical prediction rules. Patients with other painful conditions and systemic disorders will be triaged to screen for both yellow and red flags that constitute contraindications for participation in both exercise program and will be excluded from this study. Such yellow or red flags could include participants with a history of medical or surgical conditions which might hinder exercise performance. Recent fracture of the spine (over the past 12 months), History of operative intervention for the lower back problems. Pregnant women. Participants with metastatic disease and evidence of serious spinal pathology. History of neurosis, depressive symptomatology and any other specific pathology. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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
Yes 31/01/2020 national orthopaedic hospital reserch ethics committe
Ethics Committee Address
Street address City Postal code Country
dala-kano kano 700252 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
Yes 06/06/2023 Health reasearch committes
Ethics Committee Address
Street address City Postal code Country
DALA KANO 700252 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Modified Oswestry disability index (ODI), This will be the primary outcome for this study. The modified Oswestry Disability Index which is also known as the Oswestry Low Back Pain Disability Questionnaire is an important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. though several tools have been studied for measuring lumbar- related function in patients with low back pathology (Longo, Loppini, Denaro, & Maffulli, 2010 ; Chapman et al. 2011). ODI is the most commonly used and cited tool for this purpose, followed by the Roland Morris disability questionnaire (RMDQ) (Chapman et al., 2011) This test is considered the ‘gold standard’ of low back functional outcome tools. This will be used to assess the level of disability among the participants. It has an internal consistency of 0.75 and test-retest reliability of 0.91 as reported by (Clement et al., 2015; P. Kent, Marks, Pearson, & Keating, 2005). At baseline and six weeks and three months follow-up post intervention
Secondary Outcome The box Numerical Pain Rating Scale (BNPRS), numerical scales with 11 or 21 response alternatives which have been proposed as good candidates for pain assessment in most clinical and research situations by some authors (Brunelli et al., 2010). A scale with 21 levels has been shown to provide a sufficient level of discrimination for chronic pain patients to describe their pain (Jensen et al 1994) based on both psychometric properties and preference, it was thus proposed by (Peters, Patijn, and Lamé,( 2007) that the Box-21 is the instrument of the first choice in a mixed or heterogeneous population of patients such as low back pain. The numerical Box-21 scale was also said to be an excellent choice for pain intensity assessment in heterogeneous patient groups. Reliability has been demonstrated even in some other musculoskeletal condition (r = 0.96 and 0.95, respectively) respectively with the validity of (r= 0.86 to 0.95.) when compared to VAS (Hjermstad et al., 2011). At baseline ,six weeks and three months follow -up post intervention
Secondary Outcome Fear-avoidance belief questionnaire (FABQ); FABQ will serve as a secondary outcome measure. The Fear-Avoidance Beliefs Questionnaire (FABQ) will be used to quantify the patient’s fear of pain and beliefs about avoiding activity as earlier described by Wadell et al (1993). Previous studies have found a high level of test-retest reliability for both domains of the FABQ. This is a questionnaire based on the theories for fear avoidance behaviour. It has an internal consistency of 0.88 and test-retest reliability of 0.74 (Wadell et al, 1993). The FABQ consists of 2 subscales, which are reflected in the division of the outcome form into 2 separate sections. The first subscale (items 1-5) is the Physical Activity subscale (FABQPA), and the second subscale (items 6-16) is the Work subscale (FABQW). Interestingly, not all items contribute to the score for each subscale; however, the patient should still complete all items as these items were included when the reliability and validity of the scale was initially established. Each subscale is graded separately by summing the responses of respective scale items (0 – 6 for each item); for scoring purposes, only 4 of the physical activity scale items were scored (24 possible points) and only 7 of the work items (42 possible points).It is extremely important to ensure all items are completed, as there is no procedure to adjust for incomplete items. The FABQ has been demonstrated to be valid and reliable in a chronic LBP population (Waddell et al 1993) and appears to be a useful screening tool for identifying acute LBP patients who will not return to work by 4wks (Fritz et al, 2001). at baseline, six weeks and three months follow- up
Secondary Outcome SF-12 QoL Baseline, six weeks and three months follow up post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
anational orthopaedic hospital dalakano dala-kano Kano 700252 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
olowe olajide olubanji physiotherapy department national orthopaedic hospital dal-kano Kano 700252 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor olowe olajide olubanji physiotherapy department national orthopaedic hospital dala-kano Kano 700252 Nigeria self
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator olajide olowe olajidebanji@yahoo.com 2348078278988 national orthopaedic hospital Dala Kano, Physiotherapy department.
City Postal code Country Position/Affiliation
Kano 700213 Nigeria assistant director of physiotherapy
Role Name Email Phone Street address
Scientific Enquiries Ganiyu Sokunbi ganiyusokunbi@gmail.com 2348138468412 Bayero university
City Postal code Country Position/Affiliation
Kano 700231 Nigeria professor of physiotherapy
Role Name Email Phone Street address
Public Enquiries Bashir Kaka kakabashir2000@yahoo.co.uk 2347036954258 Bayero University Kano
City Postal code Country Position/Affiliation
Kano 700231 Nigeria Head of Department physiotherapy Bayero university Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I intend to share the participant data set that underlines a requirement for publication Informed Consent Form,Statistical Analysis Plan,Study Protocol one month before the completion of clinical trial title, abstract, keywords methods statistical methods participants, test results, estimates Discussion, protocol and funding
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