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.: PACTR202309751113430 Date of Registration: 12/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dryneedling versus magnesium to release trigger points in myofascial pain syndrome: a randomized controlled study.
Official scientific title Dryneedling versus magnesium to release trigger points in myofascial pain syndrome: a randomized controlled study.
Brief summary describing the background and objectives of the trial Myofascial pain syndrome (MPS) is one of the most common clinical musculoskeletal disorders, characterized by the existence of one or more myofascial trigger points (MTrPs) . The conventional definition of myofascial pain syndrome (MPS) is characterized by regional pain originating from hyperirritable spots located within taut bands of skeletal muscle (MTrPs) . Clinically, about 85% of patients who attend pain clinics have MTrPs. The highest prevalence is in trapezius muscles (93.75%), then in the levator scapulae (82.14%), and finally in the multifidi (77.68%) . The mechanism of pain in myofascial syndrome is complex. The pains are said to be referred, often accompanied by functional disorders. Also this syndrome remains unknown for the first line doctors, and will be considered as neck pain of degenerative origin or a painful shoulder. Lack of good treatment for a long period may result in headaches, dizziness or vertigo, neck and shoulder pain, sleep disorders, autonomic dysfunction, sensory abnormality, and limited neck and shoulder range of motion (ROM). Many treatment have been tried without evidence of efficacy: NSAID, anticonvulsivant… Injections into MTrPs are a common and effective treatment: Magnesium, TB, xylocaine Some authors Presume that this effect is due to mechanical disruption by the needle and termination of the dysfunctional activity of involved motor endplates. Yet, they use dryneedle to release trigger point. Our research question is: does dryneedle without active substance sufficient to release trigger point compared to a local injection of magnesium? We will compare the efficacy of a dryneedle versus magnesium in reducing pain in MPS
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: Drugs
Anticipated trial start date 01/07/2023
Actual trial start date 01/07/2023
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants)
Recruitment status 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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dryneedling 1 session of dryneedling each week 3 weeks an assistant professor and physical and rehabilitation doctor certified in dryneedlingr will localize the trigger point and insert the needle into the skin above a trigger point just 5 millimeters to 10 deep for 30 seconds. the same intervention will be repeated in three weeks. 22
Control Group magnesium infiltration 0.15 g/mL of magnesium sulfate will be injected in the trigger point each week 3 weeks a doctor will prepare the materiel wich is composed of : sterilized compress and antibacterial solution then he will sterilize the site of injection and will inject 1 mL of magnesium in the trigger point . the same procedure will be repeated 3 times . 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Patients with MtrPs diagnostic. o Infectious disease in cervico-scapular region o Wounds o Communication disorder o Non consultant patient o Anti coagulant treatment o Pregnancy o patients who take other treatments : , myorelaxant , analgesic Adult: 18 Year(s)-44 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 17/07/2023 ETHICS COMMITTEE UNIVERSITY OF MEDECINE SOUSSE
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui Sousse Tunisie sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduced Visual analogical scale by 3 points and diseappearance of the trigger point at first evaluation, each week before intervetion, at 3 months and at 6 months
Secondary Outcome improvement of neck range of motion and quality of life at first evaluation, each week before intervention, at 3 months and at 6 months from the first intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
physical and rehabilitaion departement route ceinture sahloul sousse 4054 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
hospital Sahloul of Sousse route ceinture hospital Sahloul of Sousse Soussse 4054 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor department of pharmacy Sahloul hospital route ceinture Sahloul hospital of Sousse Sousse 4054 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rihab Moncer rihabmoncer@hotmail.com 0053911717 route ceinture sahloul
City Postal code Country Position/Affiliation
sousse 4054 Tunisia assistant professor in physical and rehabilitation departement in sahloul hospital of Sousse Faculty of medicine of Sousse
Role Name Email Phone Street address
Scientific Enquiries Jaouher Dhouibi jaouherdhouibi@gmail.com 0021625336363 route ceinture Sahloul hospital of Sousse
City Postal code Country Position/Affiliation
Sousse 4054 Tunisia resident in physical and rehabilitation medicine
Role Name Email Phone Street address
Public Enquiries sonia jemni jemnisonia@hotmail.com 0021699999169 route ceinture Sahloul hospital of Sousse
City Postal code Country Position/Affiliation
Sousse 4054 Tunisia professor in physical medicine and rehabilitation
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data , after deidentification (text, tables, figures, and appendices) will be available and will be shared from one year following the publication without end date. individuals and organizations who are engaged in scientific or scholarly research can request these details from jaouherdhouibi@gmail.com or rihabmoncer@hotmail.com to achieve aims in the approved proposal. Clinical Study Report,Study Protocol As part of our IPD sharing plan, we will make the data collected in the study available in the protocol. Once the data collection phase is complete, interested researchers will have access to the raw, unprocessed data through the provided protocol. Additionally, we will share the statistical details related to the data analysis. The statistical details will be shared one year after publication. Access to the IPD and documents may be granted to individuals or entities engaged in scientific or scholarly research. Interested researchers or organizations must formally submit a request to jaouherdhouibi@gmail.com or rihabmoncer@hotmail.com The request should include the purpose of the data usage, a detailed description of the proposed analyses, and any specific requirements. the request will be evaluated to assess the qualifications of the requester, the scientific merit of the proposed analyses, the potential benefits of sharing the data, and the adherence to ethical considerations, data protection, and privacy guidelines. qualifications of the requester, the scientific merit of the proposed analyses, the potential benefits of sharing the data, and the adherence to ethical considerations, data protection, and privacy guidelines. The documents, including study protocols, statistical details, and other relevant materials, will be made available as agreed upon.
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