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.: PACTR202003801190773 Date of Approval: 18/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of cervical spine manipulation on laterality-judgement-ability in participants with persistent neck pain
Official scientific title The effect of cervical spine manipulation on laterality-judgement-ability in participants with persistent neck pain
Brief summary describing the background and objectives of the trial Pain induces neuroplastic changes within the cerebral cortex which are known to contribute to the persistence of pain (Pelletier, Higgins and Bourbonnais 2015: 2). One possible maladaptive change is a decrease in body schema integrity (Moseley and Vlaeyen 2015) the consequence of which is an impaired laterality judgment ability (Bray and Moseley 2009: 121). Previous research has demonstrated that cervical spinal manipulation (CSM) is able to improve mental rotation ability with regard to alphabetical characters (Kelly, Murphy and Backhouse 2000: 249) however this in-volves a distinct mechanism to that involving laterality judgements of body part images (Dalecki, Hoffmann and Bock 2012). Further investigation is warranted into the effects of spinal manipula-tion on egocentric mechanisms of laterality judgement ability in participants with persistent neck pain. Findings may suggest whether CSM has potential as an adjunct tool for addressing cortical maladaptive changes which result from and contribute to persistent pain. Aim: To determine the immediate effect of cervical spinal manipulation on laterality judgement reac-tion time (LJRT) and laterality judgement accuracy (LJA) in participants with persistent neck pain.
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 25/03/2020
Actual trial start date
Anticipated date of last follow up 23/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants)
Recruitment status Not yet 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
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cervical Spinal Manipulation A single manipulation once off Single manipulation once off Intervention group: Spinal Manipulation: Participants which are allocated to the intervention group will receive cervical spinal manipulation (CSM) to those dysfunctional spinal segments which are indicated by motion palpation. This will be done by the student under the supervision of a qualified clinician according to the diversified technique described in Bergmann and Peterson (2011). A high velocity low amplitude (HVLA) thrust will be applied at the level of dysfunction and the line of thrust will be in accordance with the direction in which the fixation is manifested. All adjustments will be done in the supine position 34
Control Group Set up for spinal manipulation without thrust Single set up once off Single set up once off Participants allocated to the control group will be set up as though CSM were to be delivered (as indicated by motion palpation), however no thrust will be applied. The joint will be taken to the point from which the HVLA thrust would be applied (end range of motion), held for a period of 5 seconds and then returned to neutral position. 34 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants allocated to the control group will be set up as though CSM were to be delivered (as indicated by motion palpation), however no thrust will be applied. The joint will be taken to the point from which the HVLA thrust would be applied (end range of motion), held for a period of 5 seconds and then returned to neutral position. Due to the possibility of participants being familiar with spinal manipulation- this con-trol intervention is not expected to act as a form of placebo but rather to control for any potential physiological effects of the set up and tactile contact that occurs with CSM. • Participants will be excluded if they have previously received cervical spine manipulation in order to ensure participants are naïve to spinal manipulation. • Any patients presenting with contraindications to Spinal Manipulation will be excluded. • Any patients with neck pain of traumatic origin or whiplash associated disorders will be ex-cluded as research has shown this group not to have impaired laterality judgment (Ravat 2017 & Breckeridge et al 2019). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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
No 09/03/2020 Durban Universtiy of Technology Institutional Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ritson Road, Berea Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Laterality Judgement Reaction Time Immediately before and after the intervention
Secondary Outcome Laterality judgement Accuracy Immediately before and after intervention/control
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Durban University of Technology Ritson Road Berea Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Durban University of Technology Ritson Road, Berea Durban 4051 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Durban University of Technology Ritson Road, Berea Durban 4001 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr A Docrat Ritson Road, Berea Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Benjamin Bradford benbradfrd@gmail.com 0832292057 4 Humber Crescent, Durban North
City Postal code Country Position/Affiliation
Durban 4051 South Africa Student at Durban University of Technology
Role Name Email Phone Street address
Public Enquiries Lavisha Deonarian lavishad@dut.ac.za 0313732375 Ritson Road, Berea
City Postal code Country Position/Affiliation
Durban 4001 South Africa IREC Administrator
Role Name Email Phone Street address
Scientific Enquiries Aadil Docrat aadild@dut.ac.za 0313732589 Ritson Road, Berea
City Postal code Country Position/Affiliation
Durban 4001 South Africa Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The dissertation will be available in hard copy at the DUT library as well as in digital form on the DUT library website (www.dut.ac.za). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol This will be done within 12 months of the conclusion of the study completion date. Open access via the DUT library website
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