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.: PACTR202004508185844 Date of Approval: 08/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Comparative Effect of the Posture Pump® versus Mechanical Cervical Traction in the Treatment of Chronic Mechanical Neck Pain
Official scientific title The Comparative Effect of the Posture Pump® versus Mechanical Cervical Traction in the Treatment of Chronic Mechanical Neck Pain
Brief summary describing the background and objectives of the trial Cervical traction is a therapeutic technique that applies a pulling or drawing force along the long axis of the spine, by use of a machine, other apparatus, or by manual techniques. The purpose of this technique is to stretch soft tissues, separate joint surfaces, and separate any bony fragments. The Posture Pump® is a mechanical device that applies ellipsoidal traction, to the spine rather than the conventional linear form of traction. The aim of this study is to explore the comparative effect of these two different techniques, by determining the effectiveness of The Posture Pump® in comparison to mechanical cervical traction in the treatment of chronic mechanical 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: Devices
Anticipated trial start date 15/04/2020
Actual trial start date
Anticipated date of last follow up 08/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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 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
Experimental Group Cervical traction by use of The Posture Pump 7 treatments 10 minutes per treatment The Posture Pump® is a manual, inflatable device that uses expanding ellipsoidal decompression to traction the cervical spine. Ellipsoidal air cells expand and contract from within the lordotic spinal concavity. The anterior and posterior aspects of the vertebral bodies and the vertebral discs are tractioned during this process. The device is a standard size for all patients 15
Experimental Group Mechanical Cervical Traction 7 treatments 10 minutes per treatment Cervical traction is a therapeutic technique that applies a pulling or drawing force along the long axis of the spine to the body segments, by use of a machine, other apparatus, or by manual techniques. The purpose is to stretch soft tissues, separate joint surfaces, and separate any bony fragments. Cervical traction leads to muscle relaxation and may decrease pain caused by muscular origin as the muscles normal resting length is restored. Cervical traction has been shown to be effective in the treatment of mechanical neck pain, by decreasing pain and increasing range of motion in patients with mechanical neck pain. Cervical traction will be applied with the use of the Saunders Cervical HomeTrac® Device. 15
Control Group Not Applicable Not Applicable Not Applicable Not Applicable 0 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Males and females Persons 18-45 years. Excluding minors for ethical concern; and excluding patients over 45 due to the increased prevalence of osteoarthritis. Persons must have chronic mechanical neck pain i.e. the absence of radiculopathy, myelopathy, or an underlying disease Patients who have acute neck pain Participants who present with any contra-indications to cervical spine traction (Appendix F) Participants who are involved in other studies that could interfere with the results of the study Participants who are currently using muscle relaxants, pain medication, or anti-inflammatory medication during the course of the study Participants who have neck pain of non-musculoskeletal origin Adult: 19 Year-44 Year 18 Year(s) 45 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 27/03/2020 University of Johannesburg Faculty of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
55 Beit Street, Doornfontein, Johannesburg, 2028 Johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Numerical pain rating scale, Vernon-Mior neck pain and disability index, Cervical range of motion Treatments 1, 4, and 7
Secondary Outcome N/A N/A
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Chiropractic Clinic Sherwell Street, Doornfontein Johannesburg 2094 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg Chiropractic Supervisor linked bursary Sherwell street, Doornfontein Johannesburg 2094 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UJ Chiropractic Department Sherwell Street, Doornfontein Johannesburg 2094 South Africa Supervisor-linked bursary
COLLABORATORS
Name Street address City Postal code Country
Dr Fatima Ismail Sherwell Street Doornfontein Johannesburg 2094 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shannon Lee Henderson shanzhenderson8@gmail.com 27824589595 31 Kramer Street, Beyers Park
City Postal code Country Position/Affiliation
Boksburg 1459 South Africa Researcher
Role Name Email Phone Street address
Public Enquiries Fatima Ismail fismail@uj.ac.za 27115596936 Sherwell Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2094 South Africa Research Supervisor
Role Name Email Phone Street address
Scientific Enquiries Fatima Ismail fismail@uj.ac.za 27115596936 Sherwell Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2094 South Africa Research Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date. Anyone, including participants who wish to access the data can contact the researcher. The results of the study will be written into a research report. Analysis for any purpose may be done. Data will be made available at request by contacting the researcher. Once approval has been given, access to the data will be given.
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