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.: PACTR201701001962265 Date of Approval: 05/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Integrated Neuromuscular Inhibition Technique Versus Kinesiotap On Upper Trapezius Myofascial trigger points: Randomised Clinical Trial
Official scientific title integrated neuromuscular inhibition technique versus kinesiotape on pain intensity, pressure pain threshold, range of motion,functional disability and electrical activity of muscle ( muscle amplitude and fatigue) in patient with myofascial trigger points
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). kinesiotape( KT) is a novel treatment method and its effect on trigger points must be taken seriously. the purpose of the study: to compare between INIT and KT at patients with active trigger points. pilot study will be conducted to detect sample size. the patients of both gender will participate in the study with age ranging from 19 to 38 years old.the patients will be assigned randomly into two equal group A and B.we will assess pain intensity by VAS, pressure pain threshold by algometer, ROM by CROM, functional disability by NDI and electrical activity by EMG.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INIT KT ROM NDI WMG
Disease(s) or condition(s) being studied myofascial trigger points
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2017
Actual trial start date
Anticipated date of last follow up 01/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised the patients were assigned randomly by random generator and by using permuted block of different size which was done by third person into two equal group A and B the allocation will be determined by a third person( the holder of the situated off site) 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 12 session four week from supine lying position.we will perform ischemic compression at trigger points then positional release technique and finally muscle energy technique 20
Experimental Group kinesiotape 12 session four weeks from sitting position:cervical vertebrae (CV) are tilted towards the opposite side, flexion and rotation to the same side. The base is affixed to the insertion site of the acromion in the resting state. The muscle is elongated and the base anchored with skin displacement, then the tape is affixed with 10% tension over the belly of the muscle to the point of origin. 20
Control Group advices 12 four week ¿ Be aware of your posture and change the neck position regularly. ¿ Avoid extreme postures of the neck. ¿ Avoid maintaining the neck in a fixed position (prolonged static work. ¿ Adjust the workbench to your height, eyesight, and task. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-All patients have active MTrPs in upper trapezius muscle unilaterally. 2-The patients have pain at rest, local twitch response, jump sign, limited ROM and referred (Fryer and Hodgson, 2005). 3-The patients aged will be ranged from 19 to 38 years. 4-The patients will be chosen from both sexes 5-All patients medically stable and do not suffer from any other diseases which might affect the trial results. 1-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. 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 09/01/2017 Faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El zyad street, dooki, giza, egypt GIZA Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity before treatment and after completion of treatment sessions
Primary Outcome pressure pain threshold before treatment and after completion of treatment sessions
Primary Outcome range of motion before treatment and after completion of treatment sessions
Primary Outcome functional disability before treatment and after completion of treatment sessions
Secondary Outcome electrical activity of the muscle before treatment and after completion of treatment sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the clinic of El-Qasr el einy hospital el Qasr el Einy street, Giza, EGYPT giza Egypt
the clinic of faculty of physical tharapy 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university giza Egypt University
Primary Sponsor faculty of physical tharapy 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
DR.Haytham el hafez el zayat street giza Egypt
Amira hussein draz 7 Ahmed el zayat street giza Egypt
Salah Eldin Bassit Ahmed 22 Amer street giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haytham el hafez elhafez@yahoo.com 01001909630 el zayat street
City Postal code Country Position/Affiliation
giza Egypt
Role Name Email Phone Street address
Public Enquiries salah Eldein bassit utcsalah@gmail.com 01115018299 22 amer street
City Postal code Country Position/Affiliation
giza Egypt
Role Name Email Phone Street address
Scientific Enquiries Amira Draz amira.draz@pt.cu.edu.eg 01149411373 7 el zayat street
City Postal code Country Position/Affiliation
giza Egypt
REPORTING
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