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.: PACTR202003521569108 Date of Approval: 13/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Chiropractic Spinal Manipulation on the Grip strength and Free Throw Accuracy in Symptomatic Netball Players
Official scientific title The Effect of Chiropractic Spinal Manipulation on the Grip strength and Free Throw Accuracy in Symptomatic Netball Players
Brief summary describing the background and objectives of the trial in netball neck pai is quite prevalent in netball players and if this could be reduced the players passes could theoretically be more accurate.
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: Other
Anticipated trial start date 01/05/2020
Actual trial start date
Anticipated date of last follow up 31/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Dynamic (adaptive) random allocation such as minimization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cervical Chiropractic Manipulation twice a week for three weeks Apply a chiropractic manipulation to the restricted levels found on the motion palpation completed 15
Control Group Motion palpation twice a week for three weeks Only motion palpation will be completed and no treatment 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
•Amateur netball players between the ages of 18-35. This will eliminate the need for parental/guardian consent and the risk of degenerative changes due to normal aging (Park, Moon & Lee, 2014). •Neck, shoulder and arm pain that can be attributed to the cervical spine. Amateur netball players include players that play netball recreationally, for a club or for university. • Elite, professional or Pro-am players • Previous cervical surgery • Systemic disease, (Gatterman, 1991). • Participants already receiving treatment for their symptoms e.g. Non-Steroidal Anti-inflammatories • Participants with contra-indications to SMT. • Participant receiving any other chiropractic treatment during the trial period. • Participant younger than 18 or older than 35. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 35 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 01/04/2020 Faculty of health sciences research ethics committee
Ethics Committee Address
Street address City Postal code Country
UJ doornfontein Johannesburg 2052 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome SMT has a positive effect on grip strength and throwing accuracy, or have no change in effect on grip strength and throwing accuracy. on the first, fourth and seventh visit
Secondary Outcome the control group will not increase throwing accuracy first, fourth and seventh visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
uj netball club kingsway road Johannesburg 2092 South Africa
Action sport arenas zambezi road pretoria 0150 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Christell Botha Montana Manor Pretoria 0151 South Africa
Supervisor linked bursary Beit street university of Johannesburg Johannesburg 2052 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Supervisor linked bursary Beit street johannesburg 2052 South Africa University
Secondary Sponsor Christell Montana manor prretoria 0151 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dr DM Landman Beit stret University of Johannesburg Johannesburg 2052 South Africa
Dr S Smilkstein Beit street university Johannesburg Johannesburg 2052 South Africa
Christell Botha Montana Manor 1346 Pretoria 0151 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Christell Botha stellie0@gmail.com +27713270121 Montana manor 1346
City Postal code Country Position/Affiliation
pretoria 0151 South Africa researcher
Role Name Email Phone Street address
Public Enquiries christell botha stellie0@gmail.com +27713270121 montana manor 1346
City Postal code Country Position/Affiliation
pretoira 0151 South Africa researcher
Role Name Email Phone Street address
Scientific Enquiries Christell botha stellie0@gmail.com +27713270121 Montana Manor 1346
City Postal code Country Position/Affiliation
Pretoria South Africa Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The personal information of the participant will confidential while the data collected during the study will be published with the trial but not allocated to the participant's name Clinical Study Report 2 years controlled
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