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.: PACTR201903910973688 Date of Approval: 01/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Manual compression versus device-assisted massage on active hamstring myofascial trigger points.
Official scientific title Ischaemic compression versus therapeutic massage with a percussive device on active hamstring myofascial trigger points.
Brief summary describing the background and objectives of the trial Soft tissue manipulation, which is a form of manual therapy, is used frequently by clinicians in the treatment of musculoskeletal conditions. These can be applied manually or with a device. This study would compare manual therapy with that of a device. Furthermore, the biological mechanisms associated soft tissue manipulation and its effects on clinical outcomes require further investigation.
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 Education /Training
Anticipated trial start date 26/03/2019
Actual trial start date 26/03/2019
Anticipated date of last follow up 26/04/2019
Actual Last follow-up date 26/04/2019
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Active, not 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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ischaemic compression Two treatments twice a week for three weeks One minute at a time Manual compression (pressing with the finger/thumb) into a knot in the hamstring muscle. To initiate blood perfusion into the area. 15
Experimental Group Percussive device Two treatments twice a week for three weeks One minute at a time A thumper massage device will be used to administer massage to the painful muscle. 15
Control Group There is no control group There is no control group There is no control group 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Must present with diagnostic criteria of an active hamstring muscle trigger point Contraindications to soft tissue massage Hamstring muscle tears Contraindications to ischaemic compression Participants using any conventional medical treatment - analgesics, anti-inflammatories etc Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 06/08/2018 University of Johannesburg REC
Ethics Committee Address
Street address City Postal code Country
55 Beit Street, Doornfontein Johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the effectiveness of manual soft tissue therapy versus a soft tissue therapy with a device 1st, 4th and 7th consult
Secondary Outcome To gain further understanding of the clinical effects of soft tissue therapy. 1st, 4th and 7th consults
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Chiropractic clinic situated on campus that services the general public and students on the campus 55 Beit Street, Doornfontein Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg 55 Beit Street, Doornfontein Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg 55 Beit Street, Doornfontein Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Anesu Kuhudzai 20 Chiselhurst Drive, Auckland park Johannesburg 2092 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charlize Jonker chrisy@uj.ac.za +27115596546 55 Beit Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Masters Student
Role Name Email Phone Street address
Public Enquiries Christopher Yelverton chrisy@uj.ac.za +27115596546 55 Beit Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Head of Department
Role Name Email Phone Street address
Scientific Enquiries Christopher Yelverton chrisy@uj.ac.za +27115596546 55 Beit Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data can be obtained be requesting it from the supervisor. Informed Consent Form,Study Protocol Up to 5 years after completion of study. Anyone can request access. All access requests will have to receive permission from the HOD. A reason for access request must be given.
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