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.: PACTR202009722252659 Date of Approval: 15/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of strain counter strain technique on electromyographic amplitude in subjects with upper trapezius trigger points. Randomized clinical trials
Official scientific title Efficacy of strain counter strain technique on electromyographic amplitude, pain, and function in subjects with upper trapezius trigger points. Randomized clinical trials
Brief summary describing the background and objectives of the trial myofascial pain syndrome is one of the common musculoskeletal pain disorders which affects almost 95% of people with chronic pain disorders and is a common finding in specially pain management Centre.It is characterized by trigger points, which are defined as hyperirritable spots within taut bands of skeletal muscle fibers. The syndrome is associated with tenderness in the muscle, referred pain, spasm and restriction of motion (Simons et al 1999). From different treatment methods on the Myo-fascial trigger points, Strain counterstrainis one of the treatment approaches whose effectiveness need an evaluation on scientific grounds. It is an osteopathic technique used by physical therapists and osteopaths, defined as ―the passive specific positioning of patient and affected region by the physical therapist for 90 seconds that would reduce the sensitivity of trigger point‖. The specific positioning of the upper trapezius is ipsilateral side flexion, contralateral rotation, ipsila-teral shoulder abduction and external rotation. The position is maintained for 90 seconds. In the present prospect and knowledge found in some databases i.e. PUBMED, Google Scholar, CIN-HAL and DOAJ, there is hardly any study found in the region addressing the effectiveness of strain counter-strain on muscle amplitude in subjects with upper trapezius trigger points, so this study was conducted.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) 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 01/10/2020
Actual trial start date 12/10/2020
Anticipated date of last follow up 30/12/2020
Actual Last follow-up date 30/12/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group strain counter strain technique three times a week six week from supine lying position. For SCS, The subjects were in a sitting position on the chair and upper extremities were relaxed. The the-rapist used ultrasound gel to liquefy the area and pin-cer palpation to localize the trigger point. Once MTrPs found, the researcher started applying pressure to the area until the sensation identified the Myofascial trig-ger point. The position of comfort for applying strain counterstrain technique was ipsilateral side flexion, contralateral rotation and slight ipsilateral upper limb abduction. This position was maintained for 90s. Fin-ally, the subject was slowly placed into a neutral position. 20
Control Group active range of motion and instruction three times per week six weeks range of motion exercise+ instruction 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Forty patients from both genders. 2-Their age between 19 and 38 years 3- patients is required to have active TrPs in the upper trapezius muscle unilaterally 1-they have History of whiplash injury 2- History of cervical spine surgery 3-Cervical radiculopathy or myelopathy 4-Having undergone physical therapy within the past 3 months before the study 5-Non- rheumatologic diseases as multiple sclerosis, thyroid dysfunction and chronic infection and Rheumatologic condition Adult: 19 Year-44 Year 19 Year(s) 38 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 23/09/2020 faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
7th el zayat street giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome muscle amplitude will be assessed by electromyographe. before and after completion of study
Secondary Outcome the pain will be assessed by visual analogue scale before and after completion of study
Secondary Outcome neck function will be assessed by arabic neck disability index before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic at faculty of physical therapy 7th el zayat street giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
al shaymaa shaaban 7th el zayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university el kasr el einy street giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
al shaymaa shaaban abd el azeim 7th el zayat street giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator al shaymaa shaaban alshaymaa.shaaban@pt.cu.edu.eg 01033771553 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer at physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries al shaymaa shaaban alshaymaa.shaaban@pt.cu.edu.eg 01033771553 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer at physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries al shaymaa shaaban alshaymaa.shaaban@pt.cu.edu.eg 01033771553 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer at physical therapy ciaro university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of the trial1-muscle amplitude 2- pain 3-function Study Protocol 6months the criteria will be accessed by the publication of trial in international journal
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