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.: PACTR201909918179551 Date of Approval: 18/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Comparative Effectiveness of Chiropractic Manipulation versus TENS in the treatment of Temporomandibular disorders.
Official scientific title The Comparative Effectiveness of Chiropractic Manipulation versus TENS in the treatment of Temporomandibular disorders.
Brief summary describing the background and objectives of the trial Temporomandibular disorder (TMD) is the collective term used to describe various clinical problems involving the temporomandibular joint (TMJ), the masticatory musculature, and the associated structures. Symptoms commonly associated with TMD include pain and/or tenderness in the region of the TMJ or the masticatory musculature, limitation or deviation in mandibular range of motion and clicking or grating sounds in the TMJ during mandibular function. Recent studies show the effectiveness of using Transcutaneous Electrical Nerve Stimulation (TENS) in the treatment of TMD. It is very common for Chiropractors to use manual therapy in the treatment of TMD, but the use of TENS in combination with manual therapy has not been well established. The purpose of this study is to explore the comparative effect chiropractic manipulation of the TMJ versus TENS, and the combination thereof in the treatment of TMD.
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 Education /Training
Anticipated trial start date 03/02/2020
Actual trial start date
Anticipated date of last follow up 28/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Control Group Chiropractic Manipulation 2 times a week 3 weeks Group 1 will receive Chiropractic Manipulation. Temporomandibular disorders (TMD) can be caused by restrictions in either the Temporomandibular joint (TMJ) itself or in the Cervical spine or both. Depending on which restrictions are found in the patient during examination will determine which segments will be manipulated. Restrictions in these areas form part of the diagnostic criteria for TMD and will therefore be included in the inclusion criteria. 10 Active-Treatment of Control Group
Experimental Group TENS 4 times a week 3 weeks Group 2 will receive TENS (Transcutaneous Electrical Nerve Stimulation) that will be applied via electrodes to the surface of the skin which will deliver a stimulus to the trigeminal and facial nerves. 10
Experimental Group Chiropractic Manipulation and TENS Participants will receive 2 chiropractic manipulative treatments a week and 4 TENS therapy treatments a week. 3 weeks Group 3 will receive Chiropractic Manipulation depending on their presentation, either of the temporomandibular joint or in the Cervical spine, or both. And they will receive TENS (Transcutaneous Electrical Nerve Stimulation) that will be applied via electrodes to the surface of the skin and that will deliver a stimulus to the trigeminal and facial nerves. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Potential participants must comply with the following to be included in the trial: • Both male and females will be included in this study. • Participants need to be between the ages of 18 – 45 years old. This is because the mean age of TMD falls within this age range and the mean age of onset of osteoarthritis in patients was 45.67 years for the right TMJ and 46.03 years for the left TMJ. • Participants must present with the correct diagnostic criteria for TMD. Potential participants will be excluded from the trial if they present with any of the following criteria: • Participants with contraindications to either chiropractic manipulation or TENS. • Participants who are already being treated for TMD at the time of the study that may interfere with the results of this study. • Participants who are taking any form of non-steroidal anti-inflammatory drugs (NSAIDS) or analgesics that may interfere with the study results or lead to any side effects. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 11/10/2019 Faculty of Health Sciences Research Ethics Committee at the University of Johannesburg.
Ethics Committee Address
Street address City Postal code Country
University of Johannesburg, Doornfontein Campus, Sherwell Road, Doornfontein. Johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Subjective data will include the TMJ Scale. Subjective and objective measurements will be taken for Group 1 and 3 at visits one, four and seven, and for Group 2 at visits one, eight and thirteen.
Secondary Outcome Objective data will include the Pain Pressure Algometer and measuring the opening capability of the Mandible. Subjective and objective measurements will be taken for Group 1 and 3 at visits one, four and seven, and for Group 2 at visits one, eight and thirteen.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg University of Johannesburg, Doornfontein Campus, Sherwell Road, Doornfontein. Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Student Linked Bursary University of Johannesburg, Doornfontein Campus, Sherwell Road, Doornfontein. Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Student Linked Bursary University of Johannesburg, Doornfontein Campus, Sherwell Road, Doornfontein. Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Fatima Ismail University of Johannesburg Doornfontein Campus, Sherwell Road, Doornfontein Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Berle Schoeman berle.schoeman@gmail.com +27828279132 35 Ruby Corner, Winglen Estate, Falls Road, Homes Haven, Krugersdorp.
City Postal code Country Position/Affiliation
Krugersdorp 1746 South Africa Researcher
Role Name Email Phone Street address
Public Enquiries Berle Schoeman berle.schoeman@gmail.com +27828279132 35 Ruby Corner, Winglen Estate, Falls Road, Homes Haven, Krugersdorp.
City Postal code Country Position/Affiliation
Krugersdorp 1746 South Africa Researcher
Role Name Email Phone Street address
Scientific Enquiries Berle Schoeman berle.schoeman@gmail.com +27828279132 35 Ruby Corner, Winglen Estate, Falls Road, Homes Haven, Krugersdorp.
City Postal code Country Position/Affiliation
Krugersdorp 1746 South Africa Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Anyone who wishes to access the data.
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