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.: PACTR202003774700847 Date of Approval: 19/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effectiveness of Dry Needling Compared to Myofascial Decompression Therapy on Upper Trapezius Myofascial Trigger points
Official scientific title The Effectiveness of Dry Needling Compared to Myofascial Decompression Therapy on Upper Trapezius Myofascial Trigger points
Brief summary describing the background and objectives of the trial Active myofascial trigger points located in the upper trapezius is often the cause of upper back and neck pain and is frequently experienced by the general public. This can lead to a lot of discomfort and ultimately a loss in working hours leading to financial implications making it a social and medical problem. The treatment of myofascial trigger points has become a popular topic in literature over the years and several treatment methods have developed as a result. The aim of the study is to compare the effectiveness of myofascial decompression therapy versus dry needling in treatment of active myofascial trigger points of the upper trapezius muscle.
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 20/05/2020
Actual trial start date
Anticipated date of last follow up 10/06/2020
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 Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Myofascial decompression therapy 2 times a week, 10 minutes per session 3 weeks Myofascial decompression over the upper Trapezius muscle using silicone cups known as Pods from Rocktape 15
Experimental Group Dry needling 2 times per week for 10 minutes 3 weeks Dry needling into an active trapezius trigger point, either Tp1 or Tp2/ both 15
Control Group NA NA NA 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Participants must be between the age of 18 and 50 years as degenerative cervical diseases are common among people over the age of 50 and this limits the possibility of degenerative changes in the participant • Present with active myofascial trigger points, unilateral or bilateral, of the upper trapezius muscle (Trp1 and Trp2). • The diagnostic criteria of TrPs on examination are: - A palpable, taut band present in a muscle - Pain elicited by digital pressure - A characteristic pattern of referred pain specific to individual muscles - The occurrence of a LTR as a result of needle insertion - Limited stretch range of motion • Must be able to attend all treatments • Participants cannot be on anti-inflammatories or other drugs which might alter their pain during the study • Contra-indicated for Myofascial decompression therapy • Contra-indicated for myofascial dry needling • Received any form of treatment which may interfere with the results of the study such as massage therapy, physiotherapy, medications in the form of analgesics or anti-inflammatories. • Have no active myofascial trigger point in the upper trapezius muscle Adult: 19 Year-44 Year 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
No 27/03/2020 Faculty of Health Sciences Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
55 Beit Street Johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The result of this study may offer clarity on which treatment approach might be more beneficial for this particular condition. It will hopefully offer a better understanding of which treatment group had the most beneficial results and might aid as a guide for future management of upper trapezius myofascial trigger points. Before the first, fourth and during the seventh consultation
Secondary Outcome MFD if as effective as myofascial dry needling could be a superior treatment approach as it is not as invasive and might be more comfortable. Before the first and fourth and during the seventh consultation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Chiropractic Clinic 55 Beit Street Jojannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg Health science ethics committee 55 Beit Street Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg Health Science Ethics Committee 55 Beit Street Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr M Moodley 55 Beit Street Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marthinus Louis du Plessis mduplessis.chiro@gmail.com 0799417599 14A 7th Street, Linden
City Postal code Country Position/Affiliation
Johannesburg 2195 South Africa Student
Role Name Email Phone Street address
Public Enquiries Marthinus Louis du Plessis mduplessis.chiro@gmail.com 0799417599 14A 7th STreet, Linden
City Postal code Country Position/Affiliation
Johannesburg 2195 South Africa Student
Role Name Email Phone Street address
Scientific Enquiries Marthinus Louis du Plessis mduplessis.chiro@gmail.com 0799417599 14A 7th STreet, LInden
City Postal code Country Position/Affiliation
Johannesburg 2195 South Africa Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data Capturing Sheet Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 years Anyone can request it but it must be requested from the Head of department (HOD)
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