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.: PACTR202009911403492 Date of Approval: 14/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effects of Chiropractic Manipulation on Pressure Pain Threshold and Pinprick Sensitivity
Official scientific title The Effects of Cervical Spine Manipulation on Pressure Pain Threshold and Pinprick Sensitivity
Brief summary describing the background and objectives of the trial Purpose: Chiropractic plays an integral role in the conservative treatment and management of neuro-musculoskeletal conditions that cause pain. Clinically, the benefit of spinal manipulative therapy (SMT) for pain relief related to neuro-musculoskeletal causes is apparent, yet the underlying mechanisms responsible are still not clearly understood. A paucity of clinical research defining the neurophysiological effects of SMT leaves room for investigation. Several studies using experimentally induced pain have proposed that there are central and peripheral nervous system aspects involved in afferent input and modulation of pain. Therefore, this study assessed the potential role of SMT on the mechanisms of the nervous system that mediate pain. As the responses to mechanical stimuli were examined, both locally and remotely using pinprick sensitivity and pressure pain threshold with spinal manipulation applied, central modulation could be assessed. Objectives: The aim of this study was to analyse the effects of cervical SMT on experimental mechanical pain, locally and remotely, in asymptomatic individuals. Mechanical pain was tested using a Wagner's pressure algometer for pressure pain threshold and an Owen Mumford's Neuropen and tip for pinprick sensitivity, both before and after left- or right-sided chiropractic manipulation was applied to the cervical spine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 28/02/2019
Actual trial start date 08/03/2019
Anticipated date of last follow up 24/04/2019
Actual Last follow-up date 24/04/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
REC 01 186 2018 Faculty of Health Sciences Research and Ethics Committee and Higher Degrees 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 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 spine manipulation Only one chiropractic manipulation was applied to the cervical region of the joint that was identified as restricted on motion palpation. All manipulations cavitated and movement was felt under the researchers contact where the thrust was applied. One session (40 minutes) Spinal manipulation applied to the lower cervical spine. The researcher used cervical break and rotary thumbs chiropractic manipulative techniques (patient dependant), with all participants supine. 50
Control Group None None One session None applied 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Male or female; age ranges from 18 – 65 years • Cervical spine motion restriction of a minimum of one spinal segment between and inclusive of C4-C7 spinal levels, right or left sided, identified by motion palpation • Asymptomatic, pain-free, no current complaint. • Complaint of acute, subacute or chronic neck pain • History of trauma that may have resulted in nerve damage (i.e. hypoalgesia/hyperalgesia) • History of spinal surgery or lower limb surgery causing nerve damage • Contra-indications or red flags prohibiting SMT (Appendix D), where applicable to lower levels of the cervical spine • Intake of CNS depressants in past 24 hours thus suppressing neurotransmission (i.e. ethanol, barbiturates or benzodiazepines) • Neurological disease causing abnormal sensory perception such as central nervous system diseases (Huntington’s disease, multiple sclerosis, Parkinson’s disease), or peripheral nervous system diseases (peripheral neuropathies) • Complaint of chronic illness/pathology such as cancer and HIV Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 01/02/2019 University of Johannesburg Faculty of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P O Box Auckland Park Johannesburg 2006 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome was the assessment of spinal manipulation of the cervical spine on pain receptors locally. Bilaterally articular pillars were identified and stimulated using 2 mechanical stimuli. Pinprick sensitivity that stimulated superficial A-delta nociceptive fibres and pressure pain threshold which stimulated A-delta as well as deep C nociceptive fibres. Devices tested over 3 time periods, for a control group that did not receive spinal manipulation and an experimental group that received spinal manipulation of the cervical spine and measure pre and post-intervention to determine if the manipulation influenced these pain receptors. 0 minutes, 2 minutes and 10 minutes
Secondary Outcome The secondary outcome was assessing the remote effects of the spinal manipulation on bilateral calf regions using the 2 devices. Readings were taken at the same times as local areas. The remote testing sites assessed for the same potential effects on the pain receptors with the same fibres stimulated. Ultimately these remotes effects would determine if the spinal manipulation affected the central nervous system and afferent input from the peripheral nerves, possibly due to central modulation such as the descending inhibitory pathways. Again, both groups tested at the identified time intervals at the same locations throughout but group B received the intervention, immediately after the initial reading was done, group A did not have an intervention applied. 0 minutes, 2 minutes, 10 minutes.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Doornfontein Campus Chiropractic Day Clinic. 66 Sherwell Street Johannesburg South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg 25 Louisa St, Doornfontein Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg 66 Sherwell Street JHB South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr DM Landman 66 Sherwell Street Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kerry Murtagh kmurtagh15@gmail.com +27825684155 50 West Meath Road
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Researcher
Role Name Email Phone Street address
Scientific Enquiries Irmarie Landman dirkiel@uj.ac.za +27115596820 66 Sherwell Street
City Postal code Country Position/Affiliation
Johannesburg South Africa Supervisor
Role Name Email Phone Street address
Public Enquiries Raihaanah Pieterse rpieterse@uj.ac.za 0115596073 66 Sherwell Street
City Postal code Country Position/Affiliation
Johannesburg South Africa Senior Faculty Officer Post Graduate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The independant patient data is available for persons in hard copies with the administrator of the University of Johannesburg Chiropractic Clinic. It is available only to persons with authority due to patient confidentiality of patient details being of utmost importance. All data pertaining to the research protocols as well as research results are available indefinitely in the University repository at this link: http://hdl.handle.net/10210/412854. There is also a research article that is available. It has been attached below as a summary of the research trial with all protocols, results, clinical analysis and conclusion. The type of analysis was to achieve the aim described within the research outline. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol All documents are now available at the above listed hyperlink Patient confidentiality limits access to all results. The data analysis and clinical analysis are available to anyone who may wish to see it at the above listed hyperlink.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://ujcontent.uj.ac.za/vital/access/manager/Repository?view=null&f0=sm_identifier%3A%22http%3A%2F%2Fhdl.handle.net%2F10210%2F412854%22&sort=null Yes 12/09/2020 12/09/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/09/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information