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.: PACTR201911569413211 Date of Approval: 12/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dry Needling versus Integrated Neuromuscular Inhibition Techniques on Upper Trapezius in Myofascial Pain Syndrome
Official scientific title Dry Needling versus Integrated Neuromuscular Inhibition Technique on Upper Trapezius in Myofascial Pain Syndrome on Pain Intensity and Neck Disability Function
Brief summary describing the background and objectives of the trial The incidence of myofacial pain syndrome with associated trigger points appears to vary between people of any age, but the greatest number were between the ages of 21-50 years old . MTrPs occur in both sexes although it appears to be more common in females than males .. Myofascial trigger points are the primary source of musculoskeletal pain in 21-85% of patients Dry needling (DN) is one of physical therapy treatment for MTrPs which is safe and settled by several studies . The effect of DN on MTrPs of the upper trapezius muscle have demonstrated reduced pain intensity and pain pressure threshold (PPT). It can disrupt the neuromuscular activity dysfunctional in the muscles, decrease muscle tone and normalize the neurochemical pathways of muscles, increased local blood flow, restored range of motion at the neck, and improved quality of life Integrated neuromuscular inhibition technique(INIT) is a manual therapy technique consisted of muscle energy techniques (MET), ischemic compression (IC) and strain-counterstrain (SCS). It was settled and found to be effective in treatment of MTrPs and more beneficial in relieving pain , reducing stiffness, and improving functional ability .So The study will be conducted to answer the following research question: Which will be more effective dry needling or integrated neuromuscular inhibition technique in treatment of active MTrPs of upper trapezius muscle.?
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MTrPs DN INIT IC MET SCS
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 01/10/2019
Actual trial start date 05/10/2019
Anticipated date of last follow up 01/12/2019
Actual Last follow-up date 19/12/2019
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 60
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 a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dry Needling Group 3 sessions per week 4weeks will be received dry needlig with passive stretch on upper fiber of trapezius 30
Control Group Integrated Neuromuscular Inhibition group 3 session per week 4 weeks will be recieved integrated neuromuscular inhibition technique with passive stretch on upper fiber of trapezius 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All patients will have active trigger myofascial trigger points (MTrPs) in upper trapeziues muscle in unilateral dominant side. • The patients age will be ranged from 18-35years • The patients will be choosen from both gender. • All patients medically stable and don’t suffer from any other diseases and their psychological state is stable which may affect trial results. • Pressure algeometer will be calibrated to an accuracy of + 0.3% ,+ 1 least significant digit (LSD) • History of whiplash injury • History of cervical spine surgery • Cervical radiculopathy or myelopathy • Having undergone physical therapy within the past 3 months before the study. • Non –rheumatologic diseases as multiple sclerosis ,thyroid dysfunction and chronic infection. • Rheumatologic condition as mild systemic lupus erythematosus , poly articular osteoarthritis ,rheumatoid arthritis and advanced cervical spine degenrative diseases. Adult: 19 Year-44 Year 18 Year(s) 35 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 01/09/2019 Faculty of physical therapy .cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed el zayat street.dokki .Giza Giza 37617692 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pressure pain threshold before treatment and after completion of the intervention
Secondary Outcome Neck disability index before treatment and after completion of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy cairo university 7 Ahmed el zayad street, Dooki,Giza,Egypt Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university 1 Gamaa street,Giza Giza 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy cairo university 7 Ahmed El zayad street, Dooki Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shimaa taha abuelkasem 7st Ahmed el zayat .doki.giza Giza 12651 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yassmin Mamdouh Dryassminmamdouh@gmail.com 00201273131156 1243 1st district 6 october
City Postal code Country Position/Affiliation
Giza Egypt doctor in minisrty of health
Role Name Email Phone Street address
Public Enquiries Abeer Abd El Rahman abeer.yamany@pt.cu.edu.eg 01006899872 1 Gamaa street
City Postal code Country Position/Affiliation
Giza Egypt professor Doctor of Basic science Departement Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Shimaa Taha abu el kasem dr.shymaelshazly@yahoo.com 01229823327 7 Ahmed el Zayad street,Dooki
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of Basic Science Department .Faculty of physical therapy Cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All patients will have active trigger myofascial trigger points (MTrPs) in upper trapeziues muscle in unilateral dominant side. • The patients age will be ranged from 18-35years • The patients will be choosen from both gender. • All patients medically stable and don’t suffer from any other diseases and their psychological state is stable which may affect trial results. • Pressure algeometer will be calibrated to an accuracy of + 0.3% ,+ 1 least significant digit Study Protocol 6 months Open access
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