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.: PACTR202003504433002 Date of Approval: 18/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The immediate effects of thoracic spine grade III mobilisation on the muscle activity of the middle and lower trapezius muscles.on muscle activity of the middle and lower trapezius muscles
Official scientific title The immediate effects of thoracic spine grade III mobilisation on the muscle activity of the middle and lower trapezius muscles.on muscle activity of the middle and lower trapezius muscles
Brief summary describing the background and objectives of the trial According to the International Association for the study of Pain,Thoracic spine dysfunction is frequently caused by skeletal muscles. The muscles that areulature bulk associated with thoracic spine dysfunction are the trapezius,levator scapulae,rhomboids and erector spinae.Overactivity of these muscles can cause hypomobility in the thoracic spine. Manual therapies, such as joint mobilisation, are frequently used to treat these abnormalities in the thoracic spine.Joint mobilisation improves joint mobility, alters muscle activity and achieves hypoalgesia. It further provokes improvesd stability, postural sway, range of motion and joint proprioception . systematic review on the immediate neurophysiological effects of a single session of spinal mobilisation and revealed that mobilisation elicited: increased pain pressure threshold and changes in skin conductance, skin temperature and neuro-tensioning.These effects were local and remote to the site of the mobilisation. However, the benefits of mobilisation on muscle activity is not well understood because few studies have evaluated the direct neurophysiological effects of spinal mobilisation on asymptomatic patients that are asymptomatic, in terms of pain, in the thoracic region.This study will will be a quantitative, experimental study with a pre-test post-test design.This is an efficient way of measuring the effects of mobilisation compared to a control group.Surface electromyography will be used to measure the muscle activity of the trapezius muscles prior to- and after the intervention.A sample size of 48 asymptomatic participants will be chosen. Within-group comparison of pre and post muscle activity will be achieved using paired T Tests. Objectives:To determine the immediate effects of thoracic spine grade III mobilisation on the muscle activity of the trapezius muscles through sEMG,To determine the immediate effects of a control on the muscle activity of the trapezius through sEMG and to compare these results.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Data Collection
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 02/04/2020
Actual trial start date 02/04/2020
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date 01/06/2020
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Durban University of Technology: Institutional Research Ethics Committee
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 Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Grade III thoracic spine mobilisation once off treatment 3 minutes Group A (Intervention group) will receive a Grade III Maitland mobilisation; this is a mobilisation of high amplitude, within the restricted range of motion and only slightly engages the elastic barrier (Ward et al. 2018). The mobilisation will be performed at vertebral levels T2 – T5 because this is where the upper- and lower trapezius fibres mainly attach. This is done for the purpose of standardisation. Studies have revealed that clinical effects of spinal mobilisation are systemic; whether they are performed at dysfunctional segments or not (Pecos-Martin et al. 2017). The mobilisation will be performed in the following way: The patient will be lying prone with the head piece slightly lowered and the pelvis firm on the chiropractic bed. The pads of the doctor’s thumbs are placed on the spinous process, pointing transversely across the vertebral column. The remaining fingers are spread out over the posterior chest wall and the mobilisation is performed in a posterior to anterior direction. The purpose of this form of contact is to achieve the best control of the mobilisation movement and to attain minimal discomfort. It is important to note that the pressure passing through the thumbs should not be as a result of the intrinsic muscles of the hand, the pressure should come from the doctor’s body weight and will be variable dependant on the degree of the fixation and patient tolerance (Cho et al. 2017). All fixated levels will be mobilised. 24
Control Group Control Group There is no intervention applied to this group 3 minutes Group B (Control group) will receive a control procedure. The patient will lie prone for 3 minutes. This control has been chosen because it replicates the procedure of the spinal mobilisation – the patient gets into the position for treatment and stays in this position for the duration of the treatment. This allows for the effects of time and repeated testing to be accounted for (Goodsell et al. 2000). 24 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Participants need to present with fixations in the region of the thoracic spine (Nyberg and Russel-Smith 2013). - The participants cannot be younger than 18 years of age as this eliminates the requisite for consent from a parent or legal guardian. - Participants cann\ot be older than 45 years of age because there is an increased likelihood of pathologies such as degeneration and, consequently, may alter the outcomes of the study (Walker et al. 2014). - Participants experiencing any pain in the region of the thoracic spine (Minarini et al. 2018). - Individuals who have taken any drugs that alter skeletal muscles in the last four weeks need to be excluded because it may skew results recorded by the surface electromyography (sEMG) instruments. For example, Norflex (Kruk and Pycock 1991). - Exclude participants who have receive manual therapy (i.e. manipulation, mobilisation or any soft tissue treatment) on the thoracic spine in the last 4 weeks. This avoids the effects of previous interventions from altering results recorded during the study. - Individuals who have been diagnosed with clinical contraindications to spinal joint mobilisation identified during a case history and/or physical exam need to be excluded from the study and referred to an appropriate medical discipline to assist with the condition. These contraindications include acute inflammation, Pott’s Disease, malignancy, hypermobility, neurological deficits, fractures, osteoporosis, rheumatoid arthritis during the acute phase, Paget’s Disease, Ankylosing Spondylitis during the inflammatory phase, Sheuermann’s Disease during phase 1 (Duarte et al. 2014), vertebral artery insufficiency, scoliosis, history of surgery and trauma and spinal cord insufficiency (Konin and Jessee 2012). - Individuals with contraindications to sEMG at the region of electrode placement need to be excluded as well. These contraindications include psoriasis, skin rashes, open wounds or any skin irritations - Exclude individuals with a skinfold thickness that is higher than 19mm. The presence of adipose tissue alters the ability to take accurate muscle activity readings (Baniqued et al. 2016). - If participants cavitate when receiving the spinal mobilisation, they will not be excluded from the study. Bergmann and Peterson (2011) established that any form of manual therapy that causes joint separation to overcome the fluid tension in to produce a joint cavitation.. Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
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 26/02/2020 DUT IREC
Ethics Committee Address
Street address City Postal code Country
11 Ritson Road Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Muscle Activity pre- and post intervention
Secondary Outcome comparison of results between control- and intervention groups at the end of the data collection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Durban University of Technology 11 Ritson Road Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Durban University of Technology 5 Ritson Road, Berea Durban 4000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Durban University of Technology 11 Ritson Road Durban 4001 South Africa University
Secondary Sponsor De Villiers Smit 11 Ritson Road Durban 4001 South Africa Father
COLLABORATORS
Name Street address City Postal code Country
Dr Ashura Abdul Rasheed 11 Ritson Road Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shinay Smit shinay123@gmail.com +27836371182 8 Broadview, 11 Wallace Road
City Postal code Country Position/Affiliation
Durban 4001 South Africa Student
Role Name Email Phone Street address
Scientific Enquiries Ashura Abdul Rasheed ashuraa@dut.ac.za +27761144203 11 Ritson Road
City Postal code Country Position/Affiliation
Durban 4001 South Africa Research Supervisor
Role Name Email Phone Street address
Public Enquiries Laura O Connor lauraw@dut.ac.za +27848480620 11 Ritson Road
City Postal code Country Position/Affiliation
Durban 4001 South Africa Department of Health Sciences HOD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Hard bound dissertation at the DUT library Online access via DUT library (Open Access) Publication in a peer-reviewed journal Informed Consent Form Once the dissertation is back from examination, all data will be loaded. In approximately the next 9 - 10 months The dissertation is available by Open Access URL and hardbound copy in the DUT library. However, due to anonymity, raw data of the research is only available to the researcher and collaborator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://library.dut.ac.za/ 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