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.: PACTR201906557214661 Date of Approval: 10/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of cervical spine manipulation compared to muscle energy technique on neck muscle activity and range of motion in asymptomatic participants
Official scientific title The effect of cervical spine manipulation compared to muscle energy technique on neck muscle activity and range of motion in asymptomatic participants
Brief summary describing the background and objectives of the trial Chiropractors utilise spinal manipulative therapy (SMT) as their primary treatment tool,however,when SMT is contraindicated,techniques,such as muscle energy technique (MET),are utilised.These interventions differ in application,however,both target restricted joints,the presence of which produces hypertonicity of the segmentally related muscles.Evidence in the literature demonstrates a reduction in muscle activity,in previously hypertonic muscles,following the application of these interventions in healthy individuals.However,the literature describing&comparing the effect of SMT and MET on neck muscle activity is limited. Neck pain(NP) is a common&disabling problem that has been associated with cervical muscle dysfunction due to the presence of altered muscle activity & impaired kinematics demonstrated in NP patients.This includes the upper trapezius&posterior cervicals,whose dysfunction can be a source of NP.Numerous individuals with NP seek chiropractic care. Spinal manipulative therapy and MET have shown to be effective in the conservative management of NP.Despite this clinical evidence, the mechanism behind their effectiveness is not well understood.Studying the effects of these interventions on asymptomatic individuals may provide additional insight into their neurophysiological muscle response without the confounding,uncontrolled effects of altered muscle activation related to pain.This may assist an evidence-informed approach to technique selection.Objective1.To determine the pre and post effects of cervical spine manipulation on surface electromyographic(sEMG) muscle activity of the posterior cervical and upper trapezius muscles &cervical range of motion(CROM). 2.To determine the pre and post effects of muscle energy technique on sEMG muscle activity of the posterior cervical and upper trapezius muscles and CROM. 3.To correlate the pre and post intervention findings in terms of the immediate effects of MET&as compared to manipulation asympyomatic participants.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Study completed
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 25/04/2019
Actual trial start date 25/04/2019
Anticipated date of last follow up 12/07/2019
Actual Last follow-up date 01/07/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
IREC 01219 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
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
Control Group Cervical spine manipulation Once off 2 mins • Participant position: - C0-C1: Supine, with the head turned away from the side of dysfunction. - C2-C7: Supine • Researcher’s position: Standing at the head of the table on the side of the adjustive contact, angled forty-five to ninety degrees to the participant. • Contact point: - C0-C1: Hypothenar of the hand corresponding to the side of segmental contact. Contact hand is arched to cup over the participant’s ear, with fingers resting on the angle of the jaw. - C2-C7: Ventrolateral surface of the index finger of the hand corresponding to the side of segmental contact. The thumb rests on the participants cheek as the remaining fingers reinforce the contact. • Segmental contact point on participant: - C0-C1: Occiput (posterior supramastoid groove), just posterior to the ear. - C1-C2: Posterior aspect of the transverse process. - C2-C7: Posterior articular pillar of superior vertebrae. • Indifferent hand: Cradles the participant’s head and supports the contralateral occiput. • Vector: - C0-C1: Posterior to anterior, superior to inferior and lateral to medial for extension. and lateral to medial and superior to inferior for lateral flexion. - C1-C7: Posterior to anterior, with clockwise or counter clockwise rotation to induce rotation. Posterior to anterior to induce ipsilateral extension. Medial to lateral to induce lateral flexion. • Procedure: - C0-C1: For lateral flexion, induce lateral flexion toward the side of adjustive contact. For extension, laterally flex the head toward the side of contact wile rotating it away and prestress into extension. For rotation, rotate the patient’s head away from the side of adjustive contact 25 Active-Treatment of Control Group
Experimental Group Muscle energy technique Once off 5 seconds, 3 times 1. The participant is supine on the table with the researcher sitting at the head. 2. The researcher’s fingertips of the right index and middle finger are placed on the right articular pillar of C6 to hold the segment so that C5 can be moved upon it. 3. The researcher’s left hand controls the left side of the patient’s head and neck. ‘ 4. The researcher’s right fingers translate the segment anteriorly introducing motion to the backward-bending barrier. 5. The researcher’s left hand introduces side bending and rotation of the head and neck to the right by right-to-left translation engaging the right rotation and the right side bending barriers. 10 6. The participant exerts a small isometric effort against the researcher’s resisting left hand into forward bending, left side bending or left rotation. 7. After a three to five second muscle effort, the participant relaxes, and the researcher increases translatory movement in an anterior and a right-to-left direction engaging the backward bending, right side bending and right rotation barriers. The process is repeated three to five times. The technique will be applied in the same manner on both right and left restrictions for C2 to C7. However, if the restriction is on the left, then the researcher will use the right hand to move the participant’s cervical spine into th 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Participants aged 18 to 35 years. This is to exclude individuals in their fifth to seventh decade of life who are more likely to have osteoarthritis. • Participants with the presence of one or more cervical spine restrictions. • Participants will have to sign the letter of information and informed consent • Participants who have neck pain. • Any participant taking medication or receiving any other form of treatment for the duration of the study. • The presence of contra-indications to spinal manipulative therapy (Bergmann and Peterson 2011), such as: - Atherosclerosis of major blood vessels - Vertebrobasilar insufficiency - Aneurysm - Tumours - Fracturs - Late stage osteoarthritis - Uncarthrosis - Clotting disorders - Osteopenia - Space occupying lesions - Diabetic neuropathy • The presence of contra-indications to MET (Chaitow 2006; Fernández de las Peñas, Cleland and Huijbregts 2011), including but not limited to: - Tissue fragility - Hypermobility - Myositis - Tumours • Contra-indications to surface electromyography including, but not limited to: - Skin irritation - Open wounds, rashes, psoriasis or skin conditions of any kind in the region of the electrode placement 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
Yes 11/04/2019 Durban University of Technology Institutional Ethics Committee
Ethics Committee Address
Street address City Postal code Country
2nd Floor Berwyn Court, Gate 1 Steve Biko Campus, Durban University of Technology Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Surface electromyographic muscle activity of the posterior cervicals and upper trapezius muscles Before and after the intervention
Secondary Outcome Range of cervical spine extension and lateral flexion Before and after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Durban University of Technology Chiropractic Day Clinic 11 Ritson Road Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Funding Gate 1 Steve Biko Campus, Durban University of Technology Durban 4001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Not applicable Not applicable Not applicable South Africa Not applicable
COLLABORATORS
Name Street address City Postal code Country
Dr Ashura Abdul Rasheed Ritson Campus, Durban University of Technology Durban 4001 South Africa
Dr Aadil Docart Ritson Campus, Durban University of Technology Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sasha Lee King sashalee.splasha@gmail.com 0828964915 78 Marine Drive, Bluff
City Postal code Country Position/Affiliation
Durban 4052 South Africa Durban University of Technology chiropractic student
Role Name Email Phone Street address
Scientific Enquiries Aadil Docrat aadild@dut.ac.za 0313732589 Ritson Campus Durban University of Technology
City Postal code Country Position/Affiliation
Durban 4001 South Africa Durban University of Technology senior lecturer
Role Name Email Phone Street address
Public Enquiries Lavisha Deonarian lavishad@dut.ac.za 0313732375 Steve Biko Campus, Durban University of Technology
City Postal code Country Position/Affiliation
Durban 4001 South Africa Durban University of Technology Institutional Research Ethics Committee Administrator
Role Name Email Phone Street address
Scientific Enquiries Ashura Abdul Rasheed ashuraa@dut.ac.za 0313732102 Ritson Campus, Durban University of Technology
City Postal code Country Position/Affiliation
Durban 4001 South Africa Durban University of Technology Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The dissertation will be available online on the Durban University of Technology repository. Raw data will be available at the Durban University of Technology Chiropractic Day Clinic for five years. The article will also be published in an appropriate journal. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Due to the dissertation being made available online on the Durban University of Technology repository, the IPD-Sharing Time Frame is infinite. Open 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