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.: PACTR201908783085618 Date of Approval: 13/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Periodic Transcranial Direct Current Stimulation in the Management of Individuals with Fibromyalgia Syndrome: Design of a Randomized Clinical Trial with 1 Year Follow-up
Official scientific title Effects of Periodic Transcranial Direct Current Stimulation in the Management of Individuals with Fibromyalgia Syndrome: Design of a Randomized Clinical Trial with 1 Year Follow-up
Brief summary describing the background and objectives of the trial Recently, FMS is thought to be a central pain state suggesting that while peripheral input may be playing a role, central factors (e.g., central sensitization) also likely account for much of the problem (5). In FMS, abnormal firing in both central afferent and descending modulatory mechanisms contribute to symptoms and can be targeted therapeutically with some success (4). In this regard, non-invasive brain stimulation involving transcranial Direct Current Stimulation (tDCS) has evolved to help ameliorate the symptoms of the condition. However, there are to date no optimal stimulation parameters for tDCS and most of the published studies lacked standardized reporting outcomes and are of short duration which suggest that more studies are needed to be done (13). For these reasons, this study would like to examine the effects of long-interval tDCS (usual care) in comparison to periodic tDCS on patients’ self-report and objective outcomes in the management of fibromyalgia syndrome. The major hypothesis of the study was stated as, there will be significant differences in the mean effects of long-interval and periodic tDCS on self-report and objective outcomes in the management of individuals with fibromyalgia syndrome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) tDCS
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/12/2019
Actual trial start date 02/12/2019
Anticipated date of last follow up 07/12/2020
Actual Last follow-up date 07/12/2020
Anticipated target sample size (number of participants) 26
Actual target sample size (number of participants) 26
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 Long interval tDCS 2 times in a week for 20 minutes each for 12 weeks this group will receive long interval tDCS and manual therapy 13
Control Group periodic tDCS 2 times in a week for 20 minutes each for 12 weeks this group will receive periodic tDCS plus manual therapy program 13 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria will be participants; 1) who fulfilled the American College of Rheumatology criteria for fibromyalgia (20), 2) adults aged from 19 to 44 years old and, 3) able to provide informed consent. The exclusion criteria will be participants; 1) with psychiatric or behavioral conditions, 2) with severe cardio-respiratory problems and, 3) who have red flags (history of significant trauma, cancer, constitutional symptoms; fever, malaise, weight loss, recent infection, bladder and/or bowel dysfunction). Adult: 19 Year-44 Year 19 Year(s) 44 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 14/08/2019 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 self report measures including pain, disability, sleep disturbance, mood disturbance, quality of life at baseline, weeks 6, 12 and months 6, 9 and 12
Secondary Outcome objective measures including timed up and go test, lower back and harmstring flexibilities at baseline, weeks 6, 12 and months 6, 9 and 12
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 SELF SPONSORSHIP
COLLABORATORS
Name Street address City Postal code Country
SHEHU USMAN IBRAHIM 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 SHEHU USMAN IBRAHIM umanik28@gmail.com +2347030433882 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria ORTHOPEDIC AND SPORTS PHYSIOTHERAPIST
Role Name Email Phone Street address
Scientific Enquiries AUWAL BELLO HASSAN auwalbello0907@gmail.com +2349065867707 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 Participants' demographic data, both self report and objective outcomes Informed Consent Form,Statistical Analysis Plan,Study Protocol December 2020 through 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