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.: PACTR202004888024754 Date of Approval: 22/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Analgesic effect of Transcutaneous Electrical Nerve Stimulation on patients with chronic back pain
Official scientific title Serial correlation of temporal pain intensities with beta-endorphin and meta-enkephalin concentrations, following Transcutaneous Electrical Nerve Stimulation among patients with chronic low back pain: a randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Chronic low back pain (CLBP) is a well-recognised cause of disability and loss of working hours. The efficacy and mode of action of transcutaneous electrical nerve stimulation (TENS) in the management of CLBP remain controversial. Objective: To evaluate the responses of plasma beta-endorphin (βE), met-enkephalin (ME) and pain intensity (PI) among patients with CLBP exposed to TENS or sham TENS.
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: Devices
Anticipated trial start date 06/11/2012
Actual trial start date 06/10/2016
Anticipated date of last follow up 28/05/2013
Actual Last follow-up date 08/06/2018
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 62
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
IRB00002323 Health Research and Ethics Committee of the University of Nigeria Teaching Hospital, Enugu
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TENS The machines were operated for 30 min (duration), at 100 Hz frequency, of 2 Hz burst rate, 150 μS burst width at 10 μS per step, and 40 mA output intensity. 30 min one-off treatment The patients in the trial group were treated with the bi-channel burst modulation TENS (MediHightec Medical–MH6200 Combo; made in Taiwan) delivered through four (50 mm by 50 mm) self-adhesive electrodes. The electrodes were positioned paraspinally at the surface landmark of L1 and L5. All subjects were treated on side-lying, under aseptic conditions (skin toileting, personal electrodes). 30
Control Group Sham TENS The machines were operated for 30 min (duration), at 0 Hz frequency, and 0 mA output intensity (none functional). 30 min, one-off treatment The patients in the trial group were treated with the bi-channel burst modulation TENS (MediHightec Medical–MH6200 Combo; made in Taiwan) delivered through four (50 mm by 50 mm) self-adhesive electrodes. The electrodes were positioned paraspinally at the surface landmark of L1 and L5. All subjects were treated on side-lying, under aseptic conditions (skin toileting, personal electrodes). 32 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ambulatory male or female patients aged 20–70 years who had been clinically diagnosed of CLBP resulting from lumbar spondylosis of not less than six months duration with pain intensity NRS ≥ 5 who were referred for physiotherapy, previous use of therapeutic electrical stimulation modality pregnancy diabetes prior lumbar spine surgery history of cancer, cardiovascular, gynaecological, urological, and neurologic conditions severe spinal orthopaedic conditions such as pott’s disease, disc protrusion, lumbar (spinal and foramina) stenosis, radiculopathy, and spondylolisthesis > 1 cm skin lesions between L1 to L5 pain on vertical oscillatory thrust of any spinal vertebrae beyond L1 to L5 pain from hips and sacroiliac joints implanted electronic device (pacemaker) use of steroids and central nervous system stimulants Middle Aged: 45 Year(s)-64 Year(s) 47 Year(s) 64 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 22/08/2012 Health Research and Ethics Committee of the University of Nigeria Teaching Hospital Enugu
Ethics Committee Address
Street address City Postal code Country
Itukwu/Ozalla Enugu 01129 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity of Numeric Rating Scale Baseline, immediately after treatment, one hour, twenty-four hours, and forty-eight hours after
Secondary Outcome plasma concentrations of beta-endorphin and met-enkephalin Baseline, immediately after treatment, one hour, twenty-four hours, and forty-eight hours after
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Itukwu/Ozalla Enugu Nigeria
National Orthopaedic Hospital Abakpa-Nike Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Charles Ikechukwu Ezema Department of medical Rehabilitation, Faculty of Health Sciences and Technology, University of Nigeria Nsukka Enugu Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Charles Ikechukwu Ezema Department of Medical Rehabilitation, Faculty of Health Sciences and Technology, University of Nigeria Enugu Campus Enugu Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Goddy Chuba Okoye Department of Medical Rehabilitation, Faculty of Health Sciences and Technology, University of Nigeria, Enugu Campus Enugu Nigeria
David Morse Mississippi State University, Starkville, United States Starkville United States of America
Ogochukwu Onyeso Department of Medical Rehabilitation, Faculty of Health Sciences and Technology, University of Nigeria Enugu Campus Enugu Nigeria
Emmanuel Nna Safety Molecular Pathology Laboratory, Rangers Avenue Enugu Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Ezema charles.ezema@unn.edu.ng +2348037494795 Department of Medical Rehabilitation, Faculty of Health Sciences and Technology, University of Nigeria, Enugu Campus
City Postal code Country Position/Affiliation
Enugu Nigeria Senior Lecturer University of Nigeria Nsukka
Role Name Email Phone Street address
Public Enquiries Ogochukwu Onyeso kzetfrank@yahoo.com +2348060905846 Department of Medical Rehabilitation, Faculty of Health Sciences and Technology, University of Nigeria, Enugu Campus
City Postal code Country Position/Affiliation
Enugu Nigeria Research Associate Department of Medical Rehabilitation University of Nigeria
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Nna emmanuelnna@gmail.com +2349080119094 Safety Molecular Pathology Laboratory, Rangers Avenue
City Postal code Country Position/Affiliation
Enugu Nigeria CEO Safety Molecular Pathology Laboratory
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Dataset Statistical Analysis Plan Dataset was published in a public repository Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://doi.org/10.5281/zenodo.3739775 Yes The results showed that the reported PI values were significantly lower for TENS patient than sham-TENS patients at immediate post-treatment (M.D = -3, t = -6.616, p = 0.000) and 1 hr times (M.D = -3, t = -6.893, p = 0.000). However, there were no significant differences at 24 hrs or 48 hrs (or at baseline). The correlation between PI, βE and ME was not significant. It was concluded that TENS application significantly reduces PI but does not cause any significant change in plasma concentration of βE and ME in patients with CLBP. 06/04/2020 06/04/2020
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks None
Changes to trial information