Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202212704638101 Date of Approval: 02/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) on low back pain among stroke survivors in University of Benin Teaching Hospital.
Official scientific title Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) on low back pain among stroke survivors in University of Benin Teaching Hospital.
Brief summary describing the background and objectives of the trial Low back pain (LPB) is one of the common disorders seen by health providers today; it is often chronic and recurrent in nature. LBP has been regarded as the most common musculoskeletal problem globally, and it affects people across various strata of the society from laymen in the street to health care providers in the health institution. It has been reported that from adolescence to adulthood, 80-85% of people suffer from this ailment in the modern world. Low back pain is a common symptom of various clinical entities because it can occur alone or in association with other somatic complaints. Anecdotally, it has been observed that some stroke survivors tend to have LBP prior the occurrence of stroke. To the best knowledge of researcher, the best modality of choice to address such LBP among stroke survivors is unknown. Thus, the present study will seek to investigate the effect of the various modes of Transcutaneous Nerve Stimulation TENS (convectional and acupuncture-like mode) on low back pain among stroke survivors.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 31/01/2022
Actual trial start date 02/03/2022
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date 03/03/2023
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Convectional TENS Frequency = 50 - 100 Hertz, Pulse width = 50-200μs, 15 minutes, twenty four sessions of intervention (three times/week). Participants in this category would be given a proper explanation on the procedure, then an assessment and a clarification from their case file would be done to check for contraindication to the application of TENS, i.e., altered blood flow, epilepsy, presence of cardiac pace maker etc. The area to be stimulated would be skin toileted before the electrodes would be placed on the specific lumbar area. Prior to the intervention, the participants would be required to grade their pain using 0-10 Visual Analogue Scale. Participants would receive convectional Transcutaneous Nerve Stimulator (TENS) - [Roscoe Medical, Model Number DS2202-OTC] for a period of 8 weeks. Each TENS pad has an adhesive backing and is positioned on the skin in specific area along nerve pathways in the area to be treated. A frequency of 50 to 100 Hz and a pulse width of 50 to 200μs would be used for 15 minutes for the twenty four sessions of intervention (three times/week). Parameters to be used would be used on a continuous mode pattern. Participants would be asked to grade their pain using 0-10 Visual Analogue Scale. The graded pain would be recorded by the researcher weekly. Further, participants would need to complete the Oswestry Low Back Pain Disability Index and Functional Independence Measure to assess functional disability and performance level pre-intervention and post-intervention. 10 Dose Comparison
Experimental Group Acupuncture like TENS Frequency = 2-4Hertz; Pulse width = 100-400μs 15 minutes, twenty four sessions of intervention (three times/week). Participants in this category would be given a proper explanation on the procedure, then an assessment and a clarification from their medical case note would be done to check for contraindication to the application of TENS, i.e., altered blood flow, epilepsy, presence of cardiac pace maker etc. The area to be stimulated would be skin toileted before the electrodes would be placed on the specific lumbar area. Prior to the intervention, the participants would be required to grade their pain using 0-10 Visual Analogue Scale. Participants would receive acupuncture like Transcutaneous Nerve Stimulator (TENS) - [Roscoe Medical, Model Number DS2202-OTC] for a period of 8 weeks. Each TENS pad has an adhesive backing and would be positioned on the skin in specific area along nerve pathways in the area to be treated. A frequency of 2 to 4 Hz and a pulse width of 100 to 400μs would be used for 15 minutes for the twenty four sessions of intervention (three times/week). Parameters to be used would be used on a continuous mode pattern. Participants would be asked to grade their pain using 0-10 Visual Analogue Scale. The graded pain would be recorded by the researcher weekly. Further, participants would need to complete the Oswestry Low Back Pain Disability Index and Functional Independence Measure to assess functional disability and performance level pre-intervention and post-intervention. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male and female patients. 2. Patients diagnosed with stroke, treated and survived stroke (stroke survivors), shown in medical case notes. 3 Patients who were able to communicate in English and pidgin English. 4. Patients with previous history of low back pain and can still feel the pain after stroke survival. 5. Patients who are 30 to 65 years old. 1. Individuals with no diagnosis of stroke in medical case note. 2. Stroke survivors with no history of low back pain. 3. Patients with major mental health condition (i.e. schizophrenia). 4. Patients with history of low back pain but no longer suffer from the low back pain. 5. Patients with no previous history of low back pain symptoms prior to the stroke. Adult: 19 Year-44 Year,Aged: 65+ Year(s),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
No 06/02/2022 University of Benin teaching Hospital Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
University of Benin teaching Hospital, PMB 1111, Benin Lagos Express Road, Uselu Benin City 300213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Pre intervention, weekly post intervention for 8 weeks
Secondary Outcome Functional disabilty Pre and post intervention
Secondary Outcome Daily functional performance Pre-intervention and post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital University of Benin teaching Hospital, PMB 1111, Benin Lagos Express Road, Uselu Benin City 300213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
ORIBHABOR JOEL Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Joel Oribhabor Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Opeyemi Idowu Department of Physiotherapy, Redeemers University Ede 230001 Nigeria
Dr Hammed I. Adebisi Department of Physiotherapy, University of Benin Teaching Hospital Benin City 300213 Nigeria
Rev Sister Dr Henrietta Fawole Deaprtment of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joel Oribhabor joeloribhabor1@gmail.com 08131837513 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries Opeyemi Idowu idowuope@run.edu.ng 07036872825 Department of Physiotherapy, Redeemers University
City Postal code Country Position/Affiliation
Ede 230001 Nigeria Physiotherapist
Role Name Email Phone Street address
Public Enquiries Henrietta Fawole henrietta.fawole@uniben.edu 08160580905 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification would be available Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researcher who provide a methodologically sound proposal will be given access to the data for individual participant meta-analysis. Proposal should be directed to idowuope@run.edu.ng to gain access, data requestors will need to sign a data access agreement which will be provided through the email provided above. Data would be available for 5 years and would be sent on request.
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