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.: PACTR201903810877918 Date of Approval: 14/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A research study comparing the effects of two different chiropractic techniques (sacroiliac manipulation and pelvic blocking) on muscle spasms in the buttock.
Official scientific title The Effects of Sacroiliac Manipulation and Pelvic Blocking on Active Gluteus Medius Trigger Points: A Randomised Clinical Trial
Brief summary describing the background and objectives of the trial Active myofascial trigger points in the gluteus medius muscle are often a cause of low back, hip and/or buttock pain. Chiropractic techniques such as manipulation or pelvic blocking are tools utilised in the treatment of these trigger points by relieving muscle spasm and decreasing pain. The aim of this research study is to compare the effects of chiropractic manipulation of the sacroiliac joint, pelvic blocking or a combination of the two on active gluteus medius trigger points. The intention is to ascertain if restoring joint motion will influence the pressure pain threshold of an active trigger point, thereby relieving myofascial pain and discomfort.
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 01/04/2019
Actual trial start date
Anticipated date of last follow up 27/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Chiropractic sacroiliac manipulation 6 treatments with the 7th visit being a consultation for measurement only 2 x week for 3 weeks A thigh-ilio deltoid manipulation will be performed. This involves a low-amplitude, high-velocity thrust that will be delivered to restricted segments through the researcher’s contact hand. The aim of chiropractic manipulations is to restore normal range of motion to the joint. 15
Experimental Group Pelvic blocking 6 treatments with the 7th visit being a consultation for measurement only 2 x week for 3 weeks During this treatment, the patient will be prone, with a firm surface under the pelvis. A wedge will be placed under the anterior superior iliac spine on one side and under the greater trochanter on the other side. The wedges will be left under the patient for 5-8 minutes. 15
Control Group NO CONTROL 0 0 N/A 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Present with active gluteus medius trigger points that will be identified by flat palpation. The researcher will palpate for a taut, palpable band that elicits tenderness and possible referred pain. • Present with the following criteria associated with sacroiliac joint dysfunction: o sacroiliac joint motion restriction/s, as determined by motion palpation o altered end feel on motion palpation. • Be between the ages of 18 and 45 as degenerative changes are found in patients over 45. • Any contraindications to spinal manipulative therapy as determined by case history, physical examination and lumbar spine regional examination. • Any lumbar spinal manipulation within the last 6 weeks. • Currently receiving any other treatments for low back pain, including pain control medication such as anti-inflammatories (NSAIDS) or muscle relaxants. Anti-inflammatory, analgesic and narcotic medications are used for symptomatic control. These medications would alter a patient’s perception of pain. • Any neurological dysfunction as determined by case history, physical examination and regional examination. • Making use of any post-treatment home therapies for the duration of the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 45 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 04/04/2019 Professor Christopher Stein University of Johannesburg Faculty of Health Sciences Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
55 Beit Street, Doornfontein Johannesburg 2094 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The study will demonstrate a comparison between the two treatment modalities and identify whether one is more effective than the other in relieving active trigger points of the gluteus medius. 1st, 4th and 7th consultations
Secondary Outcome The study will also contribute to the link between joint dysfunction and myofascial trigger points and whether restoring normal joint function will effect the pressure pain threshold of myofascial trigger points. 1st, 4th and 7th consultations
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Chiropractic Clinic Sherwell Street, Doornfontein Johannesburg 2094 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Supervisory linked bursary Sherwell Street, Doornfontein Johannesburg 2094 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg Sherwell Street, Doornfontein Johannesburg 2094 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Irmarie Landman Sherwell Street, Doornfontein Johannesburg 2094 South Africa
Dr Fatima Ismail Sherwell Street, Doornfontein Johannesburg 2094 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rebecca Marsden rmarsden0112@gmail.com +27828897979 218 Komati Drive Helderfontein Estate Fourways
City Postal code Country Position/Affiliation
Johannesburg 2055 South Africa Masters student
Role Name Email Phone Street address
Scientific Enquiries Irmarie Landman dirkiel@uj.ac.za +27115596820 Sherwell Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2094 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Fatima Ismail fismail@uj.ac.za +27115596218 Sherwell Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2094 South Africa Cosupervisor
Role Name Email Phone Street address
Public Enquiries Chris Yelverton chrisy@uj.ac.za +27115596646 Sherwell Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2094 South Africa Head of Chiropractic Department at the University of Johannesburg
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The University of Johannesburg Chiropractic Department will make their data available to the public if they request it. Informed Consent Form 2 years Anyone who would like access to the results of the study, will have to request access to the data from Dr Chris Yelverton, the Head of the Chiropractic Department at the University of Johannesburg. They will need to state the reason for requesting the results and he will grant access.
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