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.: PACTR201712002842111 Date of Approval: 06/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Addition of integrated neuromuscular inhibition technique to a multimodal treatment program for chronic non-specific neck pain
Official scientific title Addition of integrated neuromuscular inhibition technique to multimodal program on pain intensity, pressure pain threshold, neck function and cervical range of motion in patient with chronic non-specific neck pain
Brief summary describing the background and objectives of the trial Neck pain (NP) causes pain and disability in approximately 30% of the adult population worldwide (O Riordan et al., 2014),Chronic non specific neck pain(CNSNP) is defined as neck pain persisting for more than 3 months without a specific systemic disease being identified as the underlying cause of the complaint (Tsakitzidis G et al., 2013. Multimodal treatment is the combination of at least 2 different therapy modalities, for example exercises combined with mobilization and medication. (Tsakitzidis G et al., 2013 )Integrated neuromuscular inhibition technique (INIT) consists of muscle energy techniques, ischemic compression and strain counterstrain (SCS)..
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INIT NAG SNAG PPT
Disease(s) or condition(s) being studied chronic non specific neck pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/03/2017
Actual trial start date 15/03/2017
Anticipated date of last follow up 20/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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 three equal group A&B&C 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 mulligan techniques+ isometric exercise 3 times/ week 2 week Mulligan Natural Apophyseal Glide (NaG),Sustained natural apophysial glide ( SNAG ) and Cervical SNAStrength exercise 1-Isometric exercises for muscle responsible for neck extension ,side bending ,deep neck flexors 10
Experimental Group integrated neuromuscular inhibition technique+mulligan technique+isometric exercise 3 times/ week 2 week Mulligan Natural Apophyseal Glide (NaG),Sustained natural apophysial glide ( SNAG ) and Cervical SNAStrength exercise 1-Isometric exercises for muscle responsible for neck extension ,side bending ,deep neck flexors+intrgrated neuromuscular inhibition technique 10
Control Group isometric exercise 3 times/ week 2 week isometric exercise 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-The patients aged ranged from 18 to 24 years (Nagrale et al., 2010) suffered from chronic nonspecific neck pain with active trigger point of upper fiber of trapezius and /or levator scapulae ) pain duration of more than 12 weeks referred by orthopaedist ) . 2-Neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with sufficient intensity ( 2 or more from 10 on visual analogue scale) to permit clinically worthwhile effect to be demonstrated. 3-Patients with neck stiffness and hypomobility involvement (unidirectional or multidirectional) (Hing W et al,.2015 ). 4-Symptoms provoked by maintained neck postures or by movement, or by palpation of the cervical muscles . neck pain associated with whiplash injuries . 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 scelerosis , thyroid dysfunction and chronic infection. 18 Year(s) 26 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 12/12/2017 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 and after completion of study
Primary Outcome pressure pain threshold before and after completion of study
Primary Outcome range of motion before and after comletion of study
Secondary Outcome neck disability index before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
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 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university giza Egypt University
Secondary 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. enas el sayed mohamed abou taleb 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
dr. reham mohamed diab 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator enas el sayed enas_abutaleb@yahoo.com 1001468054 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries mostafa mahmoud mesoo1855@gmail.com 01271105483 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt demonstrator
Role Name Email Phone Street address
Scientific Enquiries dr. reham diab reham.diab@yahoo.com 01006195473 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt assistant professor
REPORTING
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