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.: PACTR202006491989074 Date of Approval: 18/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cervical spinal manipulation for neck pain - effect on muscle recruitment patterns, spinal kinematics, pain and disability in participants in KwaZulu-Natal
Official scientific title Cervical spinal manipulation for neck pain - effect on muscle recruitment patterns, spinal kinematics, pain and disability in participants in KwaZulu-Natal
Brief summary describing the background and objectives of the trial Spinal manipulation (SMT) is a commonly used therapeutic modality in the treatment of neck and back pain. In the context of this research, SMT is the application of a high velocity, low amplitude thrust applied to the joint/s of the spine to induce healing, resulting in decreased pain and disability. Although well utilised, the specific mechanism through which it exerts its reported clinical effects are not well understood. Patients with neck pain (NP) patients have been shown to have altered cervio-thoracic kinematic and muscle activity patterns during a sitting functional task (Tsang, Szeto and Lee, 2014) when compared to healthy controls. The particular task investigated is more often performed in a standing position. By changing the task from sitting to standing, the motor recruitment and the cervical and thoracic spine kinematic pattern may be altered. This requires further investigation. In addition it is not clear if the application of cervical SMT in NP patients would alter the cervico-thoracic kinematic and muscle activity patterns observed during this functional task and if these changes are associated with changes in pain and disability. Thus this study aims to determine the effect of cervical spine manipulation compared to a control intervention in participants with non-specific neck pain in terms of both objective and subjective measures: Objective measures: - Cervical spine range of motion (ROM), - Cervico-thoracic muscle recruitment patterns (timing onset relative to phase of movement and percentage activation), and - Kinematics for the cervical and thoracic spine (angular displacement, velocity and acceleration) during two functional tasks. Subjective measures: - Pain, - Disability, and - Global impression of change - Level of satisfaction
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 25/06/2020
Actual trial start date 01/09/2022
Anticipated date of last follow up 30/03/2021
Actual Last follow-up date 15/12/2023
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 39
Recruitment status Completed
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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Statics head hold 4 sessions over 3 weeks approximately 10 sec Their head will be passively moved into lateral flexion, slight extension and rotation, mimicking the position used to preform cervical spine manipulation however no thrust impulse will be utilised. This will allow for the sensory input without the effect of HVLA thrust 40 Placebo
Experimental Group Cervical spine manipulation 4 treatments over 3 weeks 10 sec The participant will lie supine, the dysfunctional cervical motion segment will be brought to end range and a high velocity low amplitude thrust will be administered in the direction of restricted motion. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Diagnosed with non-specific NP through case history and physical examination. 2. Experienced neck pain for more than three months or mostly over the last twelve months 3. Between the age of 18 and 50 years of age, excluding minors and those who may potentially have age related changes. 4. The severity of the neck pain should require them to seek medical care. 1. Any known neurological/orthopaedic disorder, previous severe trauma or surgery to the brain or spine, sensory or vestibular deficits, bony abnormalities or deformities of the trunk, suffering from rheumatic disease, or had dysfunction of the temporomandibular joint. 2. Contraindications to surface electromyography (sEMG) such as open wounds 3. Contraindications to cervical spinal manipulation such as osteoporosis, rheumatoid arthritis and spinal fractures these will be assessed via thorough case history and physical examination. 4. History of whiplash disorder or other chronic pain syndromes. 5. If they present with signs of central sensitization as determined by the Central Sensitization Inventory (Appendix D) and Fear Avoidance Behaviours (FAB) as determined by the Tampa scale of kinesiophobia (TSK) questionnaire (Appendix E). 6. If the participant’s skin fold thickness is greater than 19mm they will be excluded as adiposity can interfere with sEMG readings 7. Failure to give informed consent. 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 22/06/2020 Institutioanl Research Ethcis Committee of the Durban University of Technology
Ethics Committee Address
Street address City Postal code Country
Gate 1, Steve Biko, Durban University of Technology Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Cervico-thoracic kinematics – angular displacement, velocity and acceleration - Cervical range of motion - Cervico-thoracic spinal muscle activity - SCM, anterior scalene, upper trapezius, posterior cervical muscles and thoracic erector spinae, anterior deltoid bilaterally - Pain rating - Self reported disability following the first and fourth visits
Secondary Outcome - Global impression of change score - Level of satisfaction with the treatment following the first and fourth visits
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chiropractic Clinic at the Durban University of Technology 11 ritson rd Berea Durban 4000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation NRF building, South Gate, CSIR complex, Meiring Naude Road, Brummeria Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NA N/A NA South Africa N/A
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Laura OConnor lauraw@dut.ac.za +2737372923 11 Ritson rd Berea
City Postal code Country Position/Affiliation
Durban 4000 South Africa Durban University of Technology
Role Name Email Phone Street address
Public Enquiries Laura OConnor lauraw@dut.ac.za +273732923 11 Ritson rd Berea
City Postal code Country Position/Affiliation
Durban 4000 South Africa Durban University of Technology
Role Name Email Phone Street address
Scientific Enquiries Laura OConnor lauraw@dut.ac.za +273732923 11 Ritson rd Berea
City Postal code Country Position/Affiliation
Durban 4000 South Africa Durban University of Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified data of all participants collected during this study will be shared. Those seeking the data from the researcher will be required to sign a data access agreement. Analytic Code,Statistical Analysis Plan,Study Protocol This information will be made available after publication of the study results for a period of 5 years. The data will be available for researchers to access, for any purpose, by being included into a data base (still being developed) or via direct contact with the researcher lauraw@dut.ac.za.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
still under development 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 04/02/2025 Delays in setting up lab and starting trial due to COVID-19 01 Sep 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 04/02/2025 Delays in starting the trial due to COVID-19 15 Dec 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 04/02/2025 Sample size changed due to pilot study data 39
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 04/02/2025 Trail completed Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 18/06/2020 edit Chiropractic Clinicat the Durban University of Technology, 11 ritson rd Berea, Durban , 4000, South Africa Chiropractic Clinic at the Durban University of Technology, 11 ritson rd Berea, Durban , 4000, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 04/02/2025 Apologies I did not realise I had not uploaded this document FALSE, Institutioanl Research Ethcis Committee of the Durban University of Technology, Gate 1, Steve Biko, Durban University of Technology, Durban , 4000, South Africa, 12 May 2020, , +273732375, lavishad@dut.ac.za, TRUE, Institutioanl Research Ethcis Committee of the Durban University of Technology, Gate 1, Steve Biko, Durban University of Technology, Durban , 4000, South Africa, 12 May 2020, 22 Jun 2020, +273732375, lavishad@dut.ac.za, 11102_11389_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 18/06/2020 When initially completing this submission I had indicated undecided as I was not aware that I needed an IPD statement. Thus I have changed the response to 'yes' and provided the necessary information. Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 18/06/2020 No comment previously De-identified data of all participants collected during this study will be shared. Those seeking the data from the researcher will be required to sign a data access agreement.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 18/06/2020 No comment previously This information will be made available after publication of the study results for a period of 5 years.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 18/06/2020 No comment previously The data will be available for researchers to access, for any purpose, by being included into a data base (still being developed) or via direct contact with the researcher lauraw@dut.ac.za.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 18/06/2020 No comment previously still under development
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 18/06/2020 No comment previously Study Protocol, Statistical Analysis Plan, Analytic Code