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.: PACTR202005669610759 Date of Approval: 07/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Integrated neuromuscular inhibition technique versus spray and stretch technique on upper trapezius trigger points:A randomised clinical trial
Official scientific title Efficacy of Integrated neuromuscular inhibition technique versus spray and stretch technique on pain, function and muscle activity at upper trapezius trigger points:A randomised clinical trial
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.Myofascial pain syndrome responds well when treatment is targeted at the trigger points.integrated neuromuscular inhibition(INIT)is a combination of three treatment technique: ischemic compression, positional release and muscle energy technique.this technique is effective in treatment of trigger points (Nagrale et al., 2010). Also, In treating trigger focuses Simons et al (1999) advocates spray and stretch technique as a non-intrusive strategy to deactivate active trigger point, musculoskeletal disorders and increase movement of different joints [9].
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INIT
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 02/06/2020
Actual trial start date 02/06/2020
Anticipated date of last follow up 22/08/2020
Actual Last follow-up date 22/08/2020
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
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 integrated neuromuscular inhibition technique 3time /week 4 weeks the patients will receive integrated neuromuscular inhibition technique: from supine lying position.we will perform ischemic compression at trigger points then positional release technique and finally muscle energy technique. 15
Experimental Group spray and stretch technique 3times /wekk 4 weeks The subjects were placed in a relaxed position on their homolateral hand for lying down the distal end of examined muscle (upper fiber of trapezius). At first, 3 to 5 parallel sweeps of ethyl chloride spray were connected covering the upper fiber of trapezius muscle. At that point, the muscle was placed in a maximal yet decent extend and protracted until the physical therapist felt the muscle tension hindrance. This method was rehashed 2 or 3 times 15
Control Group traditional treatment 3times/ week 4 weeks stretch for upper trapezius 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Forty five 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, 4- deļ¬ned as a tender nodule in a taut band that referred pain beyond the area of contact 1- Patients will be excluded if 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 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 12/05/2020 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 activity for upper trapezius by surface EMG for calculating the root mean square before and after completion of study
Secondary Outcome assessment of pain intensity by visual analogue scale before and after completion of study
Secondary Outcome assessment of nack function by arabic neck disability index before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therpay 7th elzayat street giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
al shaymaa shaaban 7th elzayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university cairo university street giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
al shaymaa shaaban 7th el zayat street giza 12511 Egypt
Ali Mohamed Ali Ismail 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 basic science department at faculty of physical therapy
Role Name Email Phone Street address
Public Enquiries ali ismail Ali.mohamed@pt.cu.edu.eg 01005154209 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt Lecturer in Department of Physical Therapy for Cardiovascular Respiratory Disorder and Geriatrics
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 basic science department at faculty of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of this trial as 1-pain 2- function 3-muscle activity Study Protocol after 6 months the criteria will be accessed by the publication of the results at 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