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.: PACTR201907862005869 Date of Approval: 04/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of a unilateral sacroiliac joint manipulation on muscle activity and force output in the posterior oblique sling muscles
Official scientific title The effect of a unilateral sacroiliac joint manipulation on muscle activity and force output in the posterior oblique sling muscles
Brief summary describing the background and objectives of the trial The posterior oblique slings (POS) (which include the gluteus maximus, contralateral latissimus dorsi and the thoracolumbar fascia between them) play a profound role in the stability of the trunk in extension and rotation during the gait cycle (Page, Frank and Lardner 2010; Shin, Kim and Yoo 2013). It assists with transmitting forces from the lower limb to the upper limb. The sacroiliac joint (SIJ) also plays a significant role of load transfer during the gait cycle (Liebenson 2004). The POS, due to its biomechanical connections, aids the stability of the SIJ in force closure. Thus any alterations to the mobility of the SIJ, such as joint dysfunction, can negatively affect the POS. This may result in fatigue of the sling muscles and abnormal recruitment patterns. These resultant muscle imbalances may cause a decrease in performance (strength/endurance) of the POS and predispose a person to lower back pain (Potter, McCarthy and Oldham 2005). Joint manipulation, through afferent bombardment of the dorsal horn, brings about neurophysiological changes in the joint and surrounding muscles. Little is understood about these effects, therefore this study aims to determine the effect of a unilateral SIJ manipulation on the muscle activity within the muscles of the POS, in comparison to a control intervention in asymptomatic participants residing in the eThekwini municipality. This will be a quantitative experimental study, utilizing a pre-test post-test design. This design is appropriate in order to compare the efficacy of SIJ manipulation compared to a control. A sample size of 34 pain-free participants will be selected for this study (Matthews, 2018), who will be randomly allocated into one of two groups. Informed consent will be obtained and then a pre-test and post-test will be performed measuring muscle activity and force output of the POS. Objectives: 1. To determine the effect of the SIJ manipulation on the muscle activity and force output of the gluteus maximus and contralateral latissimus dorsi during maximum voluntary contraction measured before and after the intervention. 2. To determine the effect of time (i.e. the control) on the muscle activity and force output of the gluteus maximus and contralateral latissimus dorsi during maximum voluntary contraction measured before and after the control. 3. To compare the muscle activity and force output readings between the control and intervention groups.
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 Early detection /Screening
Anticipated trial start date 23/04/2019
Actual trial start date 14/05/2019
Anticipated date of last follow up 26/07/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 34
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
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention 3 times in succession Approximately 10 seconds The sacroiliac joint will be placed over the drop segment of the table, with the contact hand placed over the posterior superior iliac spine and a force will be applied to that joint. It can best be described as follows: Doctor position: Ipsilateral fencer stance Patient position: Prone with ASIS over edge of lumbar drop piece Contact point on patient: Ipsilateral sacroiliac joint, medial to PSIS Contact point on doctor: Reinforced pisiform Vector of the thrust: Posterior to anterior and inferior to superior Special requirements: The lumbar drop section will be raised and the tension in the drop section set so that it will not drop with the patient’s body weight, but will be able to drop with the addition of minimal force, beyond that of the patient’s weight. Procedure applied once all the above are in place: contact will be taken and skin slack removed. A high velocity, low amplitude with toggle recoil adjustment will then be applied to the affected SIJ. 17
Control Group Control 3 times in succession Approximately 10 seconds The femur will be placed over the drop section of the table, with no contact applied to the SIJ, but on the table only (i.e. neither the contact nor the indifferent hands will contact the patient). The thrust is then applied to the table. It can best be described as follows: Doctor position: Ipsilateral fencer stance Patient position: Prone with femur over edge of lumbar drop piece Contact point on patient: None Contact point on doctor: Pisiform Vector of the thrust: Posterior to anterior and inferior to superior Special requirements: The lumbar drop section will be raised and the tension in the drop section set so that it will not drop with the patient’s body weight, but is able to drop with the addition of minimal force, beyond that of the patient’s weight. Once all the above are in place, with the contact taken on the drop section of the table and not on the patient – thus there is no subject contact - a high velocity low, amplitude with toggle recoil adjustment will be applied to the table to activate the drop piece, with no thrust being applied to the participant. 17 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria • All participants will be required to read and sign the participant information and consent form (Appendix B) prior to being admitted into the study. Consent must be received both on paper as well as verbally. • The participants must be 18 years of age or older in order to negate the necessity for consent from a parent, but not older than 45 years of age as people older than 45 have an increased prevalence of degeneration as seen on radiographs. Walker and Colledge (2013) said that the increased incidence of pathology in older individuals may also influence the results of the study. • The participants must present with a sacro-iliac joint fixation. The upper sacro-iliac joint mobility test will be used to identify the existence of a fixation (Bergmann and Peterson 2010). Exclusion Criteria • Individuals having received a chiropractic manipulation on the lumbar/sacral region four weeks prior to the study. This will prevent the possible effects of previous treatment on the outcome of the results and the readings taken. • Any patient with SIJ syndrome or pain experienced in the SIJs in the three weeks prior to the study (i.e. the participants must be asymptomatic)(Lamoth et al. 2006). • Exclude participants taking any drugs which have effects on the skeletal muscles (e.g. statins and spasmed), as this will affect the results of the sEMG (Kruk 2014). • Individuals presenting with identified clinical contraindications to spinal manipulative therapy, which would require further testing, will be excluded from the study as per the case history and physical examination (Gatterman 1991). Should any of the above mentioned conditions be suspected after carrying out the case history or physical examinations, the participant will be sent for the appropriate investigative procedures and/or referred to the appropriate practitioner for treatment. • Contraindications to surface electromyography (sEMG) including, but not limited to: open wounds, rashes, psoriasis, skin irriattions, or skin conditions of any kind in the region of electrode placement. • Patients with a Body Mass Index (BMI) of 30 or higher (due to the potential influence of adipose tissue on the ability to take muscle activity readings) (Kim, Kang and Oh 2014). • Any lower extremity pain or shoulder pain as any dysfunction in these areas may predispose the POS to imbalances unrelated to the SIJ (due to the attachments of the POS muscles). 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 26/03/2019 Institutional Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Steve Biko campus, Durban University of Technology Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ho: A unilateral SIJ manipulation will result in differences in mean muscle activity and mean force output of the ipsilateral gluteus maximus and contralateral latissimus dorsi when compared to the control group. Immediately after intervention/control
Secondary Outcome Ha: The intervention group receiving unilateral SIJ manipulation will have no change in mean muscle activity and mean force output of the ipsilateral gluteus maximus and contralateral latissimus dorsi when compared to the control group. Immediately after the intervention/control
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chiropractic Day Clinic at Durban University of Technology 8 Ritson road, Musgrave, Berea Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NRF Steve Biko road, Berea Durban 4001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NRF grant Berea Durban 4001 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Ashura Abdul Rasheed and Dr Laura OConnor 8 Ritson road, Berea Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aimee McNally aimeemcnall@gmail.com 0027810108517 567 Currie road, Berea
City Postal code Country Position/Affiliation
Durban 4001 South Africa Student
Role Name Email Phone Street address
Public Enquiries Lavisha Deonarain lavishad@dut.ac.za 0313732375 Steve Biko Campus, DUT
City Postal code Country Position/Affiliation
Durban 4001 South Africa IREC
Role Name Email Phone Street address
Scientific Enquiries Laura OConnor lauraw@dut.ac.za 0027313732923 8 Ritson road, Berea
City Postal code Country Position/Affiliation
Durban 4001 South Africa Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Raw data will be stored for five years and will be available for other students. Dissertation will be available at the DUT library. Dissertation will be available online at the DUT repository. Publication will be done in peer-reviewed DHET accredited journal. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Repository and dissertation has permanent online open access. Full study and results of dissertation.
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