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.: PACTR201910488116888 Date of Approval: 30/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of core stabilization and Mckenzie back extension exercises on pain, disability, sleep disturbance in patients with non-specific chronic low back pain.
Official scientific title Effects of core stabilization and Mckenzie back extension exercises on pain, disability, sleep disturbance in patients with non-specific chronic low back pain.
Brief summary describing the background and objectives of the trial Low back pain (LBP) is a serious health problem and has attracted a significant amount of research (Akinbo et al, 2012). It is a significant public health problem in all industrial nations with considerable disability, health problems and social cost (Cesar et al, 2008). It is estimated that over 70% of adult would have at least one episode of low back pain during their life time (Lawrence et al, 2006). Low back pain (LBP) is often an indication of pathological condition of the vertebral discs, vertebral bodies or supporting soft tissues including traumatic causes (sprains or strains), resulting in weakness of low back muscles, tendons and ligaments. AIM OF THE STUDY The aim of this study is to determine the effects of core stabilization and Mckenzie back extension exercises on pain severity, functional disability, sleep disturbance and quality of life in patients with non-specific chronic low back pain (NSCLBP). The specific objectives for this study are: 1. To determine the effects of core stabilization exercise on pain severity, functional disability, sleep disturbance and quality of life in patients with non-specific chronic low back pain. 2. To determine the effects of Mckenzie back extension exercises on pain severity, functional disability, sleep disturbance and quality of life in patients with non-specific chronic low back pain. 3. To compare the effects of core stabilization and Mckenzie back extension exercises on pain severity, functional disability, sleep disturbance and quality of life in patients with non-specific chronic low back pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) none
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 08/07/2019
Actual trial start date 08/07/2019
Anticipated date of last follow up 12/07/2019
Actual Last follow-up date 19/09/2019
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 41
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 Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group core stabilization exercise and Mckenzie back extension exercise group Participants in group A will be scheduled to attend supervised intervention protocol twice weekly for 4 consecutive weeks Group A: Core stabilization group 4 weeks core stabilization exercise 1. Abdominal bracing: Participants will be instructed in supine lying position to perform drawing-in manoeuvre of the abdomen, holding it for 8 seconds, doing 30 repetitions for 4 seconds. 2. Bracing with heel slides: Participants will be instructed in supine lying to perform drawing-in manoeuvre of the abdomen, holding it for 4 seconds, doing 20 repetitions with sliding of each heel. 3. Bracing with bridging: Participants will be instructed in supine lying to perform drawing-in manoeuvre of the abdomen, gently raising the buttocks from the supporting surface and holding it for 8 seconds, doing 30 repetitions. 4. Bracing with leg lift: Participants will be instructed in supine lying position to perform drawing - in manoeuvre of the abdomen, holding it while raising each leg for 4 seconds, doing 20 repetitions. 5. Bracing with bridging and leg lift: Participants will be instructed in supine lying to perform drawing-in manoeuvre of the abdomen while gently raising the buttocks from the supporting surface, holding this position while raising each leg for 8 seconds, doing 30 repetitions. 6. Bracing with standing: Participants will be instructed while standing to perform drawing-in manoeuvre of the abdomen for 8 seconds, doing 30 repetitions. 7. Quadruped arm lift with bracing (one upper limb flexed): Participants will be instructed, while in prone kneeling position to perform drawing-in manoeuvre of the abdomen for 8 seconds, with one upper limb flexed, doing 30 repetitions. 8. Quadruped leg lift with bracing (one lower limb is extended and lifted off the supporting surface): Participants will be instructed, while in prone kneeling position, to perform the drawing- in manoeuvre of the abdomen with one lower limb flexed for 8 seconds, doing 30 repetitions. 9. Quadruped alternate arm and leg lift with bracing (contralateral upper and lower limbs are extended alternately): Participants will be instructed, while in prone kneeling position 15
Experimental Group Mckenzie back extension group twice in a week, for 4 consecutive weeks 4 weeks Back extension exercise (Figure 4) will be performed using the Mckenzie Back extension exercise protocol: 1. Prone lying: Patient is in a prone position with arms along their sides and head turned to one side. This position is maintained for 5 minutes. 2. Prone lying on elbows: Patient is in a prone position with weight on their elbows and forearms and their hips contacting the floor or the mat. The back is relaxed to allow contact with the floor or the mat. This position is maintained for 5 minutes. If there is too much pain, then this position is stopped and the patient returns to exercise number one. 3. Prone press ups: Patient is in a prone position with weight on their palms which are close to the shoulders. The patient slowly pushes the shoulders up, keeping the hips on the surface and the back and abdomen relaxed. The maximal height is maintained for 5 seconds and repeated up to 10 times per day. 4. Progressive extension with pillows: The patient is prone and a pillow is placed under the chest for about 3 minutes. A second pillow is placed after 3 minutes. If there is no significant pain, then a third pillow is added after 3 minutes, and this position is held for another 3 minutes. 5. Standing extension: With the patient standing with their hands on the lordosis of the back, the patient leans backward and holds this position for 20 seconds. This is repeated up to 10 times per day. 15
Control Group Transcutaneous electrical nerve stimulation and Back care education group twice a week for 4 consecutive weeks 4 weeks TENS APPLICATION Participants will be asked to lie prone on a plinth with the head supported with a pillow. Four (4) rubber electrodes (4cm by 4cm) from a dual channel TENS unit will be used. The participant’s skin will be cleaned with methylated spirit to prepare the low back for stimulation; the skin will be moistened with a damp cloth prior to application of electrodes in order to remove the electrode adhesion. The participants will be educated about the procedures for the first treatment session. The TENS device will be set-up and the self-adhesive electrodes plugged to the terminals of the TENS device and will be attached to the patients low back in coplanar. The parameters will be set at a frequency of 100Hz, a pulse width of 150µs, continuous mode, and time duration of 15minutes. The intensity will be adjusted to the level which was bearable for the patients (participants reported a mild to moderate feeling of sensation, but not unbearable during the course of the procedure). BACK CARE EDUCATION PROTOCOL 1. Anatomy of the back and biomechanical principle guiding the functions of the human spine. Injurious postures and activities that may hurt the back and how to avoid them. 2. Proper and safe lifting techniques for carrying loads. 3. Good postures that enhance the health of the back in different farming activities and other activities of daily living such as bathing, sitting, getting to and out of bed. 4. The following specific prophylactic instructions will be taught and given to the participants orally and in writing: -Avoid prolonged sitting, bending, stooping and squatting. -Interrupt static posture every thirty minutes before developing any discomfort during work in the farm. -Maintain lumbar lordosis (hollow in the low back) in sitting and other postures. -Use supportive roll/cushion placed in the hollow of the back in sitting position at home. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following participant will be included into this study: 1. If they are diagnosed of non-specific chronic low back pain with and without pain radiating to one or both lower limbs. 2. If pain severity is greater than or equal to five (5) on the numerical pain rating scale. The participants will be excluded from the study if they have: 1. History of recent trauma to the back, pelvis, hip and knee. 2. They are pregnant. 3. History of cognitive impairment. 4. Spinal infections (epidural abscess, discitis neuralgia). 5. Inflammatory conditions (Rheumatoid arthritis, ankylosing spondylitis). 6. Neurological disorders. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 78 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 02/07/2019 college of medicine of the university of lagos health research ethics committee
Ethics Committee Address
Street address City Postal code Country
college of medicine, idi-araba lagos. lagos 100213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Numerical pain rating scale The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which the participant will select a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Numerical Pain Rating Scale is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. “no pain”) to '10' representing the other pain extreme (e.g. “pain as bad as you can imagine” or “worst pain imaginable”). pre-intervention, baseline 2 weeks, and baseline 4 weeks.
Secondary Outcome INSOMNIA SEVERITY INDEX (ISI) This questionnaire has been designed with reference to the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) criteria for insomnia and is a reliable and valid measure containing seven items to quantify perceived insomnia severity (initial, middle, terminal), dissatisfaction with current sleep pattern, interference with daily functioning, noticeability of sleep impairment attributed to the sleep problem, and degree of distress or concern raised by the sleep problem (Morin 1993; Bastien et al, 2001). The statements are scored on 4-point likert-scales (‘0’ not at all ‘4’ extremely) generating a total score (range 0-28), indicating clinical insomnia severity (0-7 points no clinically significant insomnia; 8-14 points sub threshold insomnia (mild); 15-21 points clinical insomnia (moderate); 22-28 points clinical insomnia (severe). Evaluation indicates that the Insomnia Severity Index is a reliable and valid instrument to quantify perceived insomnia severity and it is likely to be a clinically useful tool as a screening device or outcome measures in insomnia treatment research, internal consistency is 0.90 (Cronbach alpha rating). pre-intervention, baseline 2 weeks and baseline 4 weeks
Secondary Outcome OSWESTRY DISABILITY QUESTIONNAIRE This is a questionnaire designed to give information on how the back or leg is affecting ability to perform everyday life and it was designed to assess the functional disability level of the low back pain patients. The subscales consist of ten sections. Section 1 measures pain severity, section 2 measures personal care, section 3 measures lifting, section 4 measures walking, sections 5,6,7,8,9,10 measures sitting, standing, sleeping, sex life, social life and travelling respectively. For each section the total possible score is 5. If the first section is marked, the section score = 0, if the last statement is marked, the section is scored 5 and total score is calculated. pre-intervention, baseline 2 weeks and 4 weeks
Secondary Outcome SF- 36 QUALITY OF LIFE QUESTIONNAIRE The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The SF-36 is a standardized questionnaire derived from a larger set of questions used in the US Medical Outcomes Study in the mid-1980s (Ware and Sherbourne 1992). The SF-36 has become one of the most widely used of the health-related quality of life measures. These are generic, multi-dimensional measures of self-reported health status. Self-reported health measures, based on individuals’ own perception of their health status and functioning, are an alternative measure to the more traditional objective measures of health, such as mortality rates and hospitalization records. Self-reported health measures introduce an element of subjectivity into health status measurement. Quality of life measures such as the SF-36 have become increasingly important with the changing pattern of ill-health, particularly in developed countries. The rise in chronic, nonfatal disease and reduction in mortality from infectious diseases meant that traditional mortality based measures of population health status do not provide a full picture of the extent of ill-health (the ‘burden of disease’) in a society. pre-intervention, baseline 2 weeks and 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos university Teaching Hospital LUTH LUTH road, idi-araba, lagos. lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mrs odunfa f.o block N55 flat 5 lche isolo, lagos. lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Ashiyat Kehinde Akodu college of medicine, university of lagos lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AKODU ASHIYAT KEHINDE akoduashiyat@gmail.com +2348034269053 CMUL, IDI-ARABA
City Postal code Country Position/Affiliation
LAGOS Nigeria SENIOR LECTURER
Role Name Email Phone Street address
Public Enquiries AKODU ASHIYAT KEHINDE akoduashiyat@gmail.com +2348034269053 physiotherapy department, university of lagos
City Postal code Country Position/Affiliation
lagos Nigeria senior lecturer
Role Name Email Phone Street address
Scientific Enquiries odunfa kolawole sulaimon wolemagnum@gmail.com +2347015457319 block N55 flat 5, l.c.h.e isolo, lagos.
City Postal code Country Position/Affiliation
lagos Nigeria Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes it is a consort form, which reveals the participants and their informed participation in this research Informed Consent Form 4 weeks participants recruited and participants that participated in the study, participants that were analysed
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