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.: PACTR201805003408271 Date of Approval: 23/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Okonkwo TENS trial
Official scientific title Effects of Transcutaneous Electrical Nerve Stimulation in the Management of Post-Injection Sciatic Pain in Nnewi, Nigeria
Brief summary describing the background and objectives of the trial The proposed study will be a non-randomized controlled study that will involve 250 participants. The participants will be blinded to the treatment they shall receive and conveniently assigned to either Test group (TG) or Control group (CG). The purposive sampling technique will be applied since all the subjects will require meeting certain selection criteria before participation in the study. Participants will be recruited from Department of Physiotherapy, Nnamdi Aziliwe University Teaching Hospital, Nnewi and Landmark Physiotherapy Services, Nnewi. Ethical approval was obtained from Nnamdi Azikiwe University Teaching Hospital Ethics Committee, (NAUTHEC) Nnewi. Informed consent will be obtained before enrolling participants in the study. The visual analogue scale will be used in determining the subjects¿ level of pain. The baseline VAS scores will be recorded for all the participants because it will constitute the basis of comparison with subsequent VAS scores. By this procedure the mean pre and post VAS scores will be obtained for the TG and CG for 2nd, 4th, 6th, 8th, and 10th weeks. The same data collecting procedures will apply to the TG and CG throughout the period of study.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases,sciatica
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 12/06/2018
Actual trial start date
Anticipated date of last follow up 19/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 250
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group non-invasive transcutaneous electrical nerve stimulation one hour per session three times per week 10 weeks TENS was along painful parts of sciatic route 125
Control Group sham TENS one hour per session three times per week 10 weeks the sham TENS is set on the patient but switched off throughout the intervention period 125 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. post injection sciatic pain of not more than one year 2. participants that stopped medication for two weeks before intervention 3. participants without foot drop 4. age range of 20 to 50 1. spondylosis 2. osteoarthritis of the knee 3. metallic implant 4. mentally unbalanced participants 5. participants that refused to stop medication 6. very elderly people Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 Year(s) Male
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 11/05/2010 Nnamdi Azikiwe University Teaching Hospital Ethics Committee (NAUTHEC)
Ethics Committee Address
Street address City Postal code Country
Old Onitsha/NNewi Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual analogue scale every three intervention
Secondary Outcome Effects of TENS on gender every three intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Landmark Physiotherapy Services Anaedo Social Club Headquarters premises Nnewi 435101 Nigeria
Nnamdi Azikiwe University Teaching Hospital, Nnewi old onitsha/Nnewi road Nnewi 435101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor the authors Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibeneme Chidi Sam Okofia Village Nnewi 435101 Nigeria
Ihegihu Yvonne Ebere old onitsha/Nnewi road Nnewi 435101 Nigeria
Egwuonwu Afamefuna Victor Okofia Village Nnewi 435101 Nigeria
Ezema Ikechukwu Charles Okofia Village Nnewi 435101 Nigeria
Fatai Adesina Maruf Okofia Village Nnewi 435101 Nigeria
Ibikunle Olanrewaju Peter Okofia Village Nnewi 435101 Nigeria
Ezekwu Atoninus Obinna Okofia Village Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Uchenna Prosper Okonkwo drchiefprosper@gmail.com 08033611851 64 old onitsha/Nnewi Road
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Assistant Director of Physiotherapy, Nnamdi Azikiwe University Teaching Hospital Nnewi
Role Name Email Phone Street address
Public Enquiries Afamefuna Victor Egwuonwu va.egwuonwu@unizik.edu.ng 08037791461 Okofia Village
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Lecturer 1, Nnamdi Azikiwe University, Nnewi campus
Role Name Email Phone Street address
Scientific Enquiries Chidi Sam Ibeneme sam.ibeneme@unn.edu.ng 07038138435 Okofia Village
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Adjunct Senior Lecturer, Nnamdi Azikiwe University Nnewi Campus
REPORTING
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