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.: PACTR202001804595903 Date of Approval: 28/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Core Stabilization Exercises and Electrical Muscle Stimulation in Patients with Non-Specific Chronic Low Back Pain
Official scientific title Efficacy of Core Stabilization Exercises and Electrical Muscle Stimulation 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 common cause of disability, is ranked as the most burden- some disease globally and has become an increasing problem around the world (Vos et al, 2010; Murray et al, 2012). It is the fourth most common diagnosis seen in primary care and approximately every fifth adult suffers from chronic LBP (Hoy et al, 2012; Wandell et al, 2013). The years lived with disability from low back pain have gone up by more than 50% since 1990, particularly in low-income and middle-income countries (Clark and Hartvigsen, 2018). Studies by Gatti et al, 2011; Mannion et al, 2012; Brumitt et al, 2013; Akodu et al, 2014 and Venkata et al, 2015 reported that core stabilization exercise was found to be effective in reducing pain and disability in patients with CLBP. Although there are increasing reports about the effectiveness of Electrical Stimulation (ES) in these patients, the studies are limited. It is therefore hypothesized that a combination of ES and core stabilization exercises may result in more therapeutic benefits in the management of non-specific chronic low back pain. ES may also become a valuable treatment modality for patients with CLBP before the exercise and conditioning programs are implemented when further clinical trials are carried out. Also in line with the suggestion by Odebiyi et al (2012), that a treatment guideline is needed for proper management of the patients with CLBP, this therapeutic combination is foreseen to be of immense clinical importance in that direction and thus, demands further elucidation. This study therefore aims to determine the effect of stabilization exercises and electrical muscle stimulation on muscle mass, visceral fat, pain, functional disability, physical activity, 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)
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 23/01/2020
Actual trial start date
Anticipated date of last follow up 20/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 48
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 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 exercises and electrical muscle stimulation 2 times a week For 4 weeks Patients in this group will receive electrical muscle stimulation for 20 minutes and back care advice two times per week for four weeks (8 sessions). Four electrodes will be attached on bilateral L2 and L4 paraspinal muscles; anodes placed on both L2 and cathodes placed on both L4. The pulse width is to be set at 300 s and frequency at 80Hz. participants will also perform the exercises stated below. Abdominal bracing: Subjects will be instructed in supine lying position to perform drawing-in manoeuvre of the abdomen, holding it for 8 seconds, doing 30 repetitions. Bracing with heel slides: Subjects will be instructed in supine lying to perform drawing-in manoeuvre of the abdomen, holding it for 8 seconds, doing 20 repetitions with sliding of each heel for 4 seconds. Bracing with bridging: Subjects 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. Bracing with leg lift: Subjects 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. Bracing with bridging and leg lift: Subjects 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. Bracing with standing: Subjects will be instructed while standing to perform drawing-in manoeuvre of the abdomen for 8 seconds, doing 30 repetitions. Quadruped arm lift with bracing (one upper limb flexed): Subjects 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. Quadruped leg lift with bracing (one lower limb is extended and lifted off the supporting surface): Subjects 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. Quadruped alternate arm and leg lift with bracing (contralateral upper and lower limbs are extended alternately): 16
Control Group Core stabilization exercises Two times a week For four weeks The exercise protocol will be explained to the participants and is stated below. Abdominal bracing: Subjects will be instructed in supine lying position to perform drawing-in manoeuvre of the abdomen, holding it for 8 seconds, doing 30 repetitions. Bracing with heel slides: Subjects will be instructed in supine lying to perform drawing-in manoeuvre of the abdomen, holding it for 8 seconds, doing 20 repetitions with sliding of each heel for 4 seconds. Bracing with bridging: Subjects 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. Bracing with leg lift: Subjects 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. Bracing with bridging and leg lift: Subjects 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. Bracing with standing: Subjects will be instructed while standing to perform drawing-in manoeuvre of the abdomen for 8 seconds, doing 30 repetitions. Quadruped arm lift with bracing (one upper limb flexed): Subjects 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. Quadruped leg lift with bracing (one lower limb is extended and lifted off the supporting surface): Subjects 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. 16 Active-Treatment of Control Group
Experimental Group Electrical muscle stimulation Twice a week For four weeks Patients in this group will receive electrical muscle stimulation for 20 minutes and back care advice two times per week for four weeks (8 sessions). Four electrodes will be attached on bilateral L2 and L4 paraspinal muscles; anodes placed on both L2 and cathodes placed on both L4. The pulse width is to be set at 300 s and frequency at 80Hz. 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following were included in the study: I. Patients with history of LBP of not less than 3 months. II. Patients with history of non-specific chronic with or without pain radiating to one or both lower limbs. The following were excluded from the study: I. Patients with previous spinal surgeries. II. Patients with history of trauma to the back III. Patients with spinal deformity IIII. Unexplained weight loss of more than 4.5 kg in the past 6 months V. Patients with specific LBP Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 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 04/11/2019 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria. Lagos 10234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Baseline, mid intervention and post intervention
Primary Outcome Functional disability Baseline, mid intervention and post intervention
Primary Outcome Quality of life Baseline, mid intervention and post intervention
Secondary Outcome Muscle mass Baseline, mid intervention and post intervention
Secondary Outcome Visceral fat Baseline, mid intervention and post intervention
Primary Outcome Anxiety and depression Baseline, mid intervention and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy Department College of Medicine University of Lagos Idi-Araba Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adebisi Oluwadamilola Physiotherapy Department, College of Medicine, University of Lagos, Idiaraba Lagos Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adebisi Oluwadamilola B. 1, Fatai Salami Street, Ikorodu GRA 2, Lagos Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. A I Aiyegbusi Physiotherapy Department, College of Medicine, University of Lagos Lagos Nigeria
Dr O A Fapojuwo Physiotherapy Department, College of Medicine, University of Lagos Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwadamilola Adebisi adebisi.oluwadamilola@yahoo.com +2347084298294 Physiotherapy Department, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 10234 Nigeria Master of Physiotherapy In view
Role Name Email Phone Street address
Scientific Enquiries Ayoola Aiyegbusi aaiyegbusi@unilag.edu.ng +2348023212513 Physiotherapy department, College of Medicine, University of Lagos.
City Postal code Country Position/Affiliation
Lagos 10234 Nigeria Head of Department and Senior lecturer
Role Name Email Phone Street address
Public Enquiries Oluseun Fapojuwo ofapojuwo@unilag.edu.ng +23480600813822 Physiotherapy Department, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 10234 Nigeria Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Patients will be assessed by obtaining a detailed history and carrying out physical examination. Information such as age, sex, weight, height, duration of back pain will also be obtained. Participants will be questioned about past and present medications. The purpose of the study will be explained to them to help determine those who meet the criteria to partake in the study. Participants will be assigned into three groups; one control group and two experimental groups. Pain will be measured using Numerical rating scale, muscle mass and visceral fat will be measured using the body composition monitor, Rolland-Morris Disability Questionnaire will be used to assess disability while WHOQoL and HADS will be used to measure Quality of life and anxiety and depression respectively. Informed Consent Form Within 12 months of study completion No key access
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