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.: PACTR202209502771025 Date of Approval: 07/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF ALGOMETRIC PRESSURE RELEASE VERSUS POST ISOMETRIC RELAXATION ON MYOFASCIAL TRIGGER POINTS OF UPPER TRAPEZIUS
Official scientific title EFFECT OF ALGOMETRIC PRESSURE RELEASE VERSUS POST ISOMETRIC RELAXATION ON MYOFASCIAL TRIGGER POINTS OF UPPER TRAPEZIUS
Brief summary describing the background and objectives of the trial Myofascial pain syndrome (MPS) refers to pain of the muscle and fascia surrounding it (Sharan et al. 2014). It is common diagnosis that usually responds satisfactorily to manual therapy in the short term (Rickards 2006). This syndrome is characterized by the presence of active myofascial trigger points (MTrPs) (Ruiz-Sáez et al. 2007). MTrPs are hyperirritable and tender nodules located within a taut muscle band (Simons 2004). The purpose of this study is to investigate and compare effect of algometric pressure release versus post isometric relaxation on pain intensity level, pain threshold, ROM, proprioception, CVA, electromyographic activity and neck functional abilities on myofascial trigger points of upper trapezius.
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 Rehabilitation
Anticipated trial start date 25/07/2022
Actual trial start date 17/09/2022
Anticipated date of last follow up 02/01/2023
Actual Last follow-up date 20/12/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Experimental 1 Each patient will be subjected to the selected program for 12 sessions through four consecutive weeks (3 sessions/week) patients with upper trapezius myofascial trigger points will receive algometric pressure release and conventional treatment. Ultrasound device Postural advices will be given to all the participants Isometric strengthening exercises of neck muscles: 20
Experimental Group Experimental 2 Each patient will be subjected to the selected program for 12 sessions 12 sessions through four consecutive weeks (3 sessions/week) Patients with upper trapezius myofascial trigger points will receive post isometric relaxation and conventional treatment (Ultrasound therapy, Isometric strengthening exercises of neck muscles, Postural advices will be given to all the participants) 20
Control Group control Each patient will be subjected to the selected program for 12 sessions 12 sessions through four consecutive weeks (3 sessions/week) 1- Ultrasound therapy 2- Isometric strengthening exercises of neck muscles 3- Postural advices will be given to all the participants 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age ranged from 18-30 years (Kashyap et al. 2018). . • Both gender will be included. • Patients with body mass index 18.5 – 25 kg/m2 • Patients have forward head posture. • All patients complain of local pain in upper trapezius. • The presence of MTrPs will be diagnosed based on the presence of at least two essential criteria and at least one of the confirmatory manual examination criteria proposed by Simons et al. (1999). • Essential Criteria; Palpable taut band, spot tenderness of a nodule in a taut band, Pain pattern recognition by the patient, Painful limitation of full stretch ROM and EMG spontaneous activities. • Confirmatory Criteria; Visual or tactile identification of local twitch response (LTR), Visualization of an LTR induced by a needle, Pain or altered sensation [in the expected MTrP distribution] with pressure. • Fibromyalgia and other systemic rheumatic conditions. History of a whiplash injury (Okhovatian et al. 2012). • Other musculoskeletal diseases or comorbidities such as: cervical trauma or surgeries, cervical spondylosis, spondyliosthesis with radiculopathy (Fernández-de-las-Peñas et al. 2006). • Long-term steroid use, or administration of anti-inflammatory analgesics over the preceding 24 hours (Kostopoulos et al. 2008; Montañez-Aguilera et al. 2010). • Previous MTrPs therapy over the preceding 3 months (Ruiz-Sáez et al.2007). The main materials and methods that used in the current study were classified into two main categories Evaluation and Therapeutic materials and methods. Adult: 19 Year-44 Year 19 Year(s) 44 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 12/09/2021 Cairo University
Ethics Committee Address
Street address City Postal code Country
1 Gamaa Street, Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • VAS will be used to measure the pain severity level. • Algometer will be used to measure the pain pressure threshold. • Cervical range of motion (CROM) will be used to measure side bending on both sides, rotation and forward head. • Surface electromyography (EMG) will be used to measure the root mean square (RMS) value. 1 month
Secondary Outcome Arabic version of NDI will be used to assess self-rated disability in patients with neck pain. 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafr elsheikh University Faculty of physical therapy Sakha Road, Kafr Elsheikh, Egypt Kafr Elsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mai Ezzat Kafr Elsheikh Kafr Elsheikh Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kafr Elsheikh University Skha Road Kafr Elsheikh 33511 Egypt Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Nabil Mahmoud AbdelAal 7 Ahmed Elzayat street - Dokki Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nabil Mahmoud nabil.mahmoud@Cu.edu.eg 01200133613 Otman ibn Affan
City Postal code Country Position/Affiliation
Cairo 12613 Egypt Ass. Prof Basic Science department
Role Name Email Phone Street address
Public Enquiries Nabil Mahmoud nabil.mahmoud@Cu.edu.eg 01200133613 othman ibn affan
City Postal code Country Position/Affiliation
Giza 12613 Egypt Ass prof
Role Name Email Phone Street address
Scientific Enquiries nabil mahmoud nabil.mahmoud@Cu.edu.eg 01200133613 othman ib affan
City Postal code Country Position/Affiliation
Giza 12613 Egypt Ass. prof
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 Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after 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