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.: PACTR202110750995790 Date of Approval: 11/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of core stabilization exercise and Trunk balance exercise on pain-related disability in patients with non specific chronic low back pain
Official scientific title Effect of core stabilization exercise and Trunk balance exercise on pain-related disability in patients with non specific chronic low back pain
Brief summary describing the background and objectives of the trial ow back pain (LBP) has been the leading cause of disability worldwide (global burden of disease 2016) and the most common musculoskeletal problem affecting human population (Waddle and Burton, 2001; Tella et al., 2013) with a lifetime prevalence of 84% in industrialized countries (Balague et al, 2012). It is defined as pain and discomfort of varying duration, localized below the costal margin and above the inferior gluteal folds, with or without radiculopathy in the lower limbs (Van Tulder et al,2006). For many years, low back pain has beenthe leading cause of days lost from work and the indication for medical rehabilitation (Bernhard, 2017).Low back pain is such a frequent cause of disability in the community that it has become almost a disease itself (Bernhard, 2017). Increase in age is associated with an increase in musculoskeletal diseases such as arthritis, osteoporosis, spinal disc degeneration which sometimes present as LBP (Maher et al, 2016). It is generally assumed that LBP prevalence in Africa is comparatively lower than in developed countries. However, recent findings suggest that LBP prevalence among Africans is rising and is of concern (Edomwonyi and Ogbue,2017). The range of LBP point prevalence of 10%–59% in Africans and 12%–33% among Western societies(Edomwonyi and Ogbue, 2017) negates any assumptions that LBP prevalence is lower in developing world than developed societies. This supports the global burden of disease studies which predicts that the greatest increases in LBP prevalence will be in developing nations (WHO 2016). The economic, societal, and public health effects of LBP appear to be increasing. (WHO, 2016).Low back pain is a major cause of disability, expense from work-related conditions, and absence from work. This economic burden is of particular concern in poorer nations of Africa where the already limited and restricted health-care funds are directed toward epidemics and often misappropriated (Edomwonyi and Ogbue,2017).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/12/2020
Actual trial start date 22/02/2021
Anticipated date of last follow up 22/02/2021
Actual Last follow-up date 22/02/2021
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Core stabilization protocol Two times/week 8 weeks Core stabilization protocol Abdominal bracing Bracing with heel slides Bracing with leg lifts Bracing with bridging Bracing in standing Bracing with standing row Bracing with walking Quadruped arm lifts with bracing Quadruped leg lifts with bracing Quadruped alternate arm and legs lifts with bracing 15
Experimental Group Trunk Balance Protocol 2 times/week 8 weeks Kneeling on a pillow and arms abducted to 90°, rotate the trunk, head and upper limbs to 1 direction. Repeat 2 times per direction, maintaining each position for 30 seconds. 2. Kneeling on a pillow, move the upper limbs in flexion and extension, with a simultaneous movement of the head. The position is maintained for 3 minutes, performing 6 repetitions of upper limbs movement. The exercise is made more challenging by adding eye closure. 3. Supine with feet resting on the table, lifting the pelvis up, after reaching maximum hip extension, raise 1 lower limb from the table and extend the knee. This position is maintained twice for 30 seconds for each lower extremity. 4. From the quadruped position, extend opposite upper and lower limbs. The position is maintained for 1 minute for each combination of limbs. The exercise is made more challenging by first adding eye closure and then a pillow under the lower limb. 5. Sitting on the side of the table with unilateral support. This position is maintained for 1 minute each side. The exercise is made more challenging by adding eye closure, crossing the upper arms to the chest, closing the eyes, and putting a pillow under the lower limb. 6. Single-limb kneeling on the edge of the table with a pillow under the knee. The position is maintained for 30 seconds. Two repetitions for each limb. The exercise is made more challenging by first adding eye closure, then head extension, and finally arms across the chest. 15
Control Group Back care education 2 times / week 8 weeks Back care education Teach Lifting techniques Teach posture and ergonomics 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with recurrent history of non specific chronic low back pain. Patients with history of non-specific chronic low back with or without pain radiating to one or both lower limbs. Patients that score more than 5 on visual analogue scale.à Patients with previous spinal surgery. Patients with history of trauma to the back. Patient with specific low back pain e,g patients with referred LBP as a result of cancer, tuberculosis of the spine. Radiological disorders of spondylosis, spondylolisthesis and scoliosis. Rheumatic and inflammatory conditions. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 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 30/03/2021 Health research commitee
Ethics Committee Address
Street address City Postal code Country
University Of Lagos Nigeria PMB 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Weighing scale for body weight measurement . Stadiometer for measuring Height. Sphygomanometer and stethoscope for measuring Blood pressure. Baseline , 4th week and 8th week
Secondary Outcome Pain disability index for measuring disability, Hospital anxiety and depression scale for measuring anxiety and depression. Fear Avoidance belief questionnaire Baseline, 4th week , 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy Department Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State Nigeria Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self University of Lagos Nigeria Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ositelu Adurayemi Esther Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State. Sagamu Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ositelu Adurayemi lildurrzem@gmail.com +2347063653314 Olabisi Onabanjo University Teaching Hospital
City Postal code Country Position/Affiliation
Ogun State Nigeria Student
Role Name Email Phone Street address
Public Enquiries Fapojuwo Oluwaseun researchproject.drfapojuwo@gmail.com +2348060081382 College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Supervisor
Role Name Email Phone Street address
Scientific Enquiries Akodu Ashiyat akoduashiyat@gmail.com +2348034269053 College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos state Nigeria Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary of individual participant data will be made available data to be shared will include IPD that underlie the result that will be shared in this article. Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication Researchers with methodological proposal
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