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.: PACTR201904487417085 Date of Approval: 09/04/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Lumbar Stabilization and Graded Activity Exercises on Selected Biochemical Mediators and Clinical Outcomes in Patients with Non-Specific Chronic Low Back Pain
Official scientific title Effects of Lumbar Stabilization and Graded Activity Exercises on Selected Biochemical Mediators and Clinical Outcomes in Patients with Non-Specific Chronic Low Back Pain
Brief summary describing the background and objectives of the trial The pathogenesis of pain response is reported to be biochemically associated with the presence of mixture of biochemical mediators (bradykinin, serotonin, histamine, prostaglandins and nitric oxide, cytokines and leukotrienes) (Omoigui, 2007; Gawda et al, 2017). Also, biochemical mediators have been implicated in lumbar disc degeneration and lumbar radicular pain in chronic low back pain (Diatchenko et al, 2013; Omair et al, 2013; Martirosyan et al, 2016). Given the limited evidence in support of exercise therapies for Non-Specific Chronic Low Back Pain (NSCLBP) and the paucity of studies on effects of therapeutic exercise on immune response, it is imperative that the effects of commonly used therapeutic exercises for NSCLBP be evaluated on biochemical mediators interleukin 1A (IL1A), interleukin 18 receptor 1 (IL18R1), interleukin 6 (IL-6), interleukin 18 receptor accessory protein (IL18RAP), cyclooxygenase 2 (COX2), catechol-O-methyltransferase (COMT) encoding for pain in NSCLBP. Lumbar Stabilization Exercise (LSE) and Graded Activity Exercise (GAE) are the most popular and promising forms of exercise therapy for NSCLBP but little or no data exist about their effects on biochemical mediators of pain. Hence, this study is designed to evaluate the comparative efficacy of Lumbar Stabilization Exercise (LSE) and Graded Activity Exercise (GAE) on biochemical mediators of pain in patients with Non-Specific Chronic Low Back Pain (NSCLBP). The specific objectives include: To evaluate the effects of LSE on concentrations of IL1A, IL18R1, IL6, IL18RAP, and COX2 in patients with NSCLBP; To evaluate the effects of GAE on concentrations of L1A, IL18R1, IL6, IL18RAP, and COX2 in patients with NSCLBP; To evaluate the relationship between clinical outcomes (pain intensity, disability, catastrophizing, diverting-attention, cognitive-coping and reinterpretation, with concentrations of IL1A, IL18R1, IL6, IL18RAP, and COX2 after administering LSE and GAE.
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 Treatment: Drugs
Anticipated trial start date 21/01/2019
Actual trial start date 21/01/2019
Anticipated date of last follow up 21/08/2020
Actual Last follow-up date 23/12/2020
Anticipated target sample size (number of participants) 81
Actual target sample size (number of participants) 81
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lumbar Stabilization Exercise A minimum of 45 minutes session of therapy two times a week 10 weeks The Lumbar Stabilization Exercise will involve retraining programme designed to improve activity of muscles assessed to have poor control (commonly, but not limited to, the deeper muscles such as transverses abdominis, multifidus, pelvic floor, and diaphragm) and reducing activity of any muscle identified to be overactive majorly the superficial trunk muscles such as the obliquus externus abdominis and erector spinalis. Participants will be taught how to contract trunk muscles (multifidus and transverses abdominis) in a specific manner and progress until they were able to maintain isolated contractions of the target muscles for 10 repetitions of 10 seconds each while maintaining normal respiration. 27
Experimental Group Graded Activity Exercise A minimum of 45 minutes session of therapy twice a week 10 weeks The Graded Activity Exercise will involve individualized and submaximal exercises such as back school education, strength training of the lower limbs and erector spinalis, endurance training of the back and abdominal muscles, and 20 15 minutes of bicycle ergometry. 27
Control Group Nil 1 day None 27 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Aged 18 years but not more than 60 years 2. Pain duration of at least three months for patient participants 3. Non-Specific Chronic low back pain with or without radiating symptoms 4. No red flags indicating any serious pathology or peripheral neuropathy 5. History of no LBP for the apparently healthy participants within the last 6 months Participants having: 1. A diagnosis of spinal inflammatory disease like Ankylosing Spondylolistis 2. Spinal fracture or dislocation; 3. Motor or sensory deficit; 4. Spinal surgery; 5. Pregnancy; 6. Any cardiopulmonary diseases or systemic disease like diabetes; 7. Use of pain medications (Non-steroidal anti-inflammatories drugs, steroids and analgesics) whether orally or topical application within the last two days before presentation 8. Psychotropic medications like benzodiazepine. 9. Medical conditions such as haematological disorder, acute or chronic liver diseases, autoimmune disease. 10. History of smoking and drinking alcohol within the last 6 months Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 21/01/2019 LAGOS UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Room 107, 1st floor, LUTH Administrative Block Lagos 112102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum levels of interleukin 1A (IL1A), interleukin 18 receptor 1 (IL18R1), interleukin 6 (IL-6), interleukin 18 receptor accessory protein (IL18RAP), cyclooxygenase 2 (COX2), catechol-O-methyltransferase (COMT) will be determined before and after intervention. Interleukin-I is reported to cause intervertebral disc degeneration by regulating the destruction of disc matrix and by activating degradative enzymes and inhibiting the re-synthesis of proteoglycans (Le Maitre et al, 2005; Omair et al, 2013). It also modulates pain by inducing prostaglandin E2 (PGE2) synthesis which in turn enhances the activity of phospholipase A2 and COX2 (Le Maitre et al, 2005; Omair et al, 2013). Interleukin-I and IL6 both secreted by the intervertebral disc help sensitize the nociceptors that innervate the disc (Omair et al, 2013). Interleukin-18 is responsible for the production of IL-β, chemokines, nitric oxide and prostaglandins (Omair et al, 2013). The function of up regulation of PGE2 in disc degeneration and peripheral modulation of pain is said to be sub-served by COX2 genes (Miyamoto et al, 2002; Omair et al, 2013). Catechol O-methyltransferase have been associated with numerous endo-phenotypes believed to underlie chronic pain disorders, including autonomic dysregulation, alterations in pain processing and modulation, sleep dysfunction, and anxiety (Tegeder and Lotsch, 2009; Omair et al, 2013). first, fifth and tenth weeks of intervention
Secondary Outcome Visual Analogue Scale. To assess participants pain intensity before and after intervention. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end (Gould et al, 2001). The patient marks on the line the point that they feel represents their perception of their current state of pain (Gould et al, 2001). The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (Gould et al, 2001). first, fifth and tenth weeks of intervention
Secondary Outcome The Roland-Morris Disability Questionnaire 24 (RMDQ24): To assess participants disability before and after intervention. The Roland-Morris Disability Questionnaire 24 (RMDQ24) is designed to be completed by patients in order to assess their physical disability due to low back pain (Roland and Fairbank, 2000). The RMDQ is short, simple to complete, and readily understood by patients. It has twenty-four items related specifically to physical functions that were likely to be affected by low back pain (Roland and Fairbank, 2000) (Appendix B). The RMDQ score was calculated by adding up the number of items checked. Items are not weighted (Roland and Fairbank, 2000). The scores therefore range from 0 (no disability) to 24 (maximum disability). first, fifth and tenth weeks of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orthopaedic Outpatient Physiotherapy Department of Lagos University Teaching Hospital Idi-Araba Lagos 112102 Nigeria
Orthopaedic Outpatient Physiotherapy Department of National Orthopaedic Hospital Igbobi Igbobi Lagos 100252 Nigeria
Orthopaedic Outpatient Physiotherapy Department of General Hospital Gbagada Gbagada Lagos 100234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Oghumu Saturday Nicholas Idi-araba Lagos 112102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oghumu Saturday Nicholas Idi-araba Lagos 112102 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Mrs B.A. Tella Idi-araba Lagos 112102 Nigeria
Dr U.A.C. Okafor Idi-araba Lagos 112102 Nigeria
Dr O.B. Salu Idi-araba Lagos 112102 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saturday Oghumu nickyyivieosa@gmail.com +2348034215928 Idi-araba
City Postal code Country Position/Affiliation
Lagos 112102 Nigeria PhD Candidate at the School of Postgraduate Studies Department of Physiotherapy University of Lagos
Role Name Email Phone Street address
Public Enquiries Saturday Oghumu nickyyivieosa@gmail.com +2348034215928 Idi-araba
City Postal code Country Position/Affiliation
Lagos 112102 Nigeria PhD Candidate at the School of Postgraduate Studies Department of Physiotherapy University of Lagos
Role Name Email Phone Street address
Scientific Enquiries Saturday Oghumu nickyyivieosa@gmail.com +2348034215928 Idi-araba
City Postal code Country Position/Affiliation
Lagos 112102 Nigeria PhD Candidate at the School of Postgraduate Studies Department of Physiotherapy University of Lagos
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD of one participant pictures from each experiment group will be used for illustrations in the methodology of the dissertation at the completion of the study. Also, IPD of analytic codes will be used for statistical analysis. IPD will also be used in the course of making clinical reports of the study Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2019-2020 Statistical analysis, Examination panel of the school of postgraduate studies university of Lagos
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Nil for now 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