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.: PACTR202003474034933 Date of Approval: 18/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Acupuncture Compared with Transcranial Direct Current Stimulations in the Management of Central Post-stroke Pain: A Randomized Clinical Trial
Official scientific title Effects of Acupuncture Compared with Transcranial Direct Current Stimulations in the Management of Central Post-stroke Pain: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Central post-stroke pain (CPSP) is one of the sensory impairments after stroke. It is a neuropathic pain as a result of impairment in the spinothalamocortical pathway that is characterized by a spontaneous and/or evoked, persistent and/or paroxysmal pain or dysasthesia/paresthesia (Kumar and Soni, 2009). Management of CPSP includes the use of pharmacological agents such as opiods and amitriptyline (Frese et al., 2006; Kim, 2014). However, due to the persistent nature of the pain, pharmacological intervention may often be accompanied by dependency and adverse effects. Thus, scalp acupuncture and non-invasive brain stimulation (NIBS), such as the transcranial direct stimulation (tDCS) (Bae et al., 2014), is used as an alternative to the pharmacological treatment. However, there is the scarcity of studies comparing acupuncture and tDCS in the management of CPCP and this is the purpose of the study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Acupuncture and tDCS
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 04/05/2021
Actual trial start date 04/05/2021
Anticipated date of last follow up 04/05/2022
Actual Last follow-up date 04/05/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 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 Scalp Acupunture 3 times in a week 3 months Scalp acupuncture using disposable needles will be given 30
Control Group tDCS 3 times in a week 3 months tDCS delivered via dorsolateral prefrontal cortex will be given 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants diagnosed as having central post-stroke pain (CPSP) using brain CT will be included Participants with stroke but not having CPSP Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 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 08/04/2020 FEDERAL MEDICAL CENTER NGURU YOBE STATE NIGERIA
Ethics Committee Address
Street address City Postal code Country
MACHINA ROAD Nguru 630101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain AT BASELINE AND AFTER 4 WEEKS, 8 WEEKS AND AFTER 12 WEEKS
Secondary Outcome Doueleur Neuropathique 4 QuestDonnaire (DN4Q) and Beck depression inventory (BDI) AT BASELINE AND AFTER 4 WEEKS, 8 WEEKS AND AFTER 12 WEEKS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTER NGURU MACHINA ROAD NGURU 630101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
MUSA SANI DANAZUMI MACHINA ROAD, FEDERAL MEDICAL CENTER, NGURU, YOBE STATE, NIGERIA NGURU 630101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MUSA SANI DANAZUMI MACHINA ROAD NGURU 630101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
ABDULSALAM MOHAMMED YAKASAI MACHINA ROAD NGURU 630101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MUSA SANI DANAZUMI musadanazumisani@gmail.com +8145123496 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria ORTHOPEDIC AND SPORTS PHYSIOTHERAPIST
Role Name Email Phone Street address
Public Enquiries ABDULSALAM MOHAMMED YAKASAI abdulpeace1@gmail.com +8035307341 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria NEUROPHYSIOTHERAPIST
Role Name Email Phone Street address
Scientific Enquiries Auwal Bello Hassan auwalbello0907@gmail.com +8037019137 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria NEUROPHYSIOTHERAPIST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Outcomes including pain and depressive symptoms Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Publication
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