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.: PACTR201801002980602 Date of Approval: 16/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lumbar stabilization exercise with real–time ultrasound imaging biofeedback in individuals with chronic low back pain
Official scientific title Effect of lumbar stabilization exercise with real–time ultrasound imaging biofeedback on lumbar multifidus muscle cross–sectional area, pain, disability, and quality of life in individuals with non–specific chronic low back pain
Brief summary describing the background and objectives of the trial Impairments in the lumbar multifidus muscle such as decrease cross-sectional area or size is prevalent in individuals with low back pain. Real-time ultrasound imaging (RUSI) biofeedback has been reported to improve preferential activation of as well as retention in the ability to activate the lumbar multifidus muscle during lumbar stabilization exercises (LSE). However, evidence of effectiveness of this treatment approach in individuals with non-specific chronic low back pain (NCLBP) is scarce. Therefore, this study will be conducted to investigate the effect of LSE with RUSI biofeedback on lumbar multifidus muscle cross-sectional area, pain, functional disability, and quality of life in individuals with NCLBP. Outcome of this study may provide an insight whether RUSI biofeedback can be used clinically to enhance recovery of lumbar multifidus muscle which is commonly associated with low back pain and reoccurrence.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Non-specific chronic low back pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/03/2018
Actual trial start date 01/04/2019
Anticipated date of last follow up 08/06/2018
Actual Last follow-up date 30/09/2021
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 90
Recruitment status Closed to recruitment,follow-up continuing
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lumbar stabilization exercise with RUSI biofeedback imaging twice/week 30 minutes carrying out stabilization exercises and watching the way and manner their multifidus muscle swells up in response to exercises 30
Experimental Group Lumbar stabilization exercise without RUSI biofeedback imaging twice/week 30 minutes individuals will be instructed to carry out the exercises as taught by the health care provider 30
Control Group Minimal intervention twice/week 30 minutes individuals will be instucted to carry out bridging, double knee to chest and lumbar rotation. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants will be included if they: 1. Are male or female between the age of 18 and 60 years 2. Have a primary complain of non-specific LBP with or without leg pain for 12 weeks or more, and 3. Are able to read and understand Hausa or English language or both. The participants will be excluded if they: 1. Have history of spine surgery 2. Obvious deformities affecting the trunk or upper and lower extremities 3. Serious spinal pathology such as infection, fracture, metastases, and cauda equine syndrome 4. Have history of medical or surgical conditions that might hinder exercise performance, and 5. Pregnant or lactating women. 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 17/01/2018 National Orthopaedic Hospital ethics committee
Ethics Committee Address
Street address City Postal code Country
Dala kano 70000 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lumbar multifidus cross sectional area at the baseline, the end of six week and three month follow up
Secondary Outcome Numerical pain rating scale, Rolland-Morris disability questionnaire, and Quality of life at the baseline, end of six week and three month follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National ortopaedic hospital Dala Kano 70000 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Dala kano 70000 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Professor Ganiyu O. Sokunbi zaria road kano 70000 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr Anas zaria road Kano 70000 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator RAHEEM SARAFADEEN raheemsarafadeen@yahoo.com +2348033727306 DALA
City Postal code Country Position/Affiliation
KANO 70000 Nigeria Assistant Director
Role Name Email Phone Street address
Public Enquiries Olanrewaju Olawoyin, O lanreyinka62@yahoo.com +2348053141467 DALA
City Postal code Country Position/Affiliation
KANO 70000 Nigeria deputy director
Role Name Email Phone Street address
Scientific Enquiries Sokunbi Ganiyu, O. ganiyusokunbi@gmail.com +23480138468412 Zaria road
City Postal code Country Position/Affiliation
KANO 70000 Nigeria Professor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information