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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201912834190028 Date of Registration: 12/12/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title physical therapy for rehabilitation of rheumatoid arthritis patient.
Official scientific title Siwa sand bath versus sulphurous water bath in management of rheumatoid arthritis patients
Brief summary describing the background and objectives of the trial To compare between the effect of siwa sandbath and sulphurous water bath on 1-ESR,CRP and RF in blood sample of rheumatoid arthritis patients. 2- range of motion of wrist. 3- health assessment questionnaire for rheumatoid arthritis patient.
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 Rehabilitation
Anticipated trial start date 20/05/2019
Actual trial start date 20/05/2019
Anticipated date of last follow up 20/06/2019
Actual Last follow-up date 30/06/2019
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
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
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group physical therapy program two session one month moist heat , exercise 15 Active-Treatment of Control Group
Experimental Group siwa sand bath 10-15 min one week patient is buried in hole in hot sand and covered also by hot sand 15
Experimental Group sulphrous water bath one week 10-15 minute the patient is fully immersed in sulphrous water bath except head 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- age range from 35- 50 . 2- subjects in chronic stage of rheumatoid arthritis. 3- morning stiffness lasts more than one hour. duration of arthritis lasts more than six months 1- open wounds. 2- pregnancy. 3- hypertension. 4- cardiac patients. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 50 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 06/06/2017 faculty of physical therapy research ethical committee
Ethics Committee Address
Street address City Postal code Country
Doky Giza 33804762 Egypt
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 06/06/2017 faculty of physical therapy research ethical committee
Ethics Committee Address
Street address City Postal code Country
ahmed el zaiat st Giza 99999 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome siwa sand bath has an effect on rheumatoid arthritis patient pre-treatment, post treatment, and after one month.
Secondary Outcome siwa sand bath has more effect on the long run after one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National institute of neuromotor system Eltayar street, Embaba Giza 33804762 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
rasha mohamed samy hadbet elahram.3001.Egypt.self funded 122 k hadabet el ahram giza 3001 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy Doky Giza 33804762 Egypt University
COLLABORATORS
Name Street address City Postal code Country
prof.dr.Maher Elkablawy doky giza 2001 Egypt
rasha mohamed samy hadabet elahram, giza 2001 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator rasha mohamed samy rashasamy660@gmail.com 01099945471 122k hadabet el ahram
City Postal code Country Position/Affiliation
Giza 99999 Egypt researcher
Role Name Email Phone Street address
Scientific Enquiries Maher ahmed Elkabalawy maherkabalawy-2000@yahoo.com 01001410544 Doky
City Postal code Country Position/Affiliation
Giza 99999 Egypt main supervisor
Role Name Email Phone Street address
Scientific Enquiries Marwa Shafiek Marwa-shafiek2000@yahoo.com 01008342466 haram
City Postal code Country Position/Affiliation
Giza 99999 Egypt lecturer of physical therapy basic science department physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries Mohamed ELbatanony elbatanony60@yahoo.com 01222174324 Doky
City Postal code Country Position/Affiliation
Giza Egypt supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes there will be patient data sheet and informed consent form before beginning of the study also, there will be statistical analysis plan by data collection during study Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol during study participation all samples will participates and complete the study
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://pactr.samrc.ac.za/Researcher/TrialRegister.aspx 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