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.: PACTR202008598885040 Date of Approval: 31/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DEEP NECK FLEXOR STABILIZER BIOFEEDBACK EXERCISE VERSUS INTGREATED NEURO MUSCULAR INHIBITION TECHNIQUE ON CHRONIC MECHANICAL NECK PAIN
Official scientific title DEEP NECK FLEXOR STABILIZER BIOFEEDBACK EXERCISE VERSUS INTGREATED NEURO MUSCULAR INHIBITION TECHNIQUE ON CHRONIC MECHANICAL NECK PAIN
Brief summary describing the background and objectives of the trial Deep cervical flexor (DCF): play a major role in supporting and straightening the cervical spine also suggested that the proper use of DCF, before beginning the strengthening of the global cervical muscles, is an effective rehabilitation strategy for cervical disorders,Integrated Neuromuscular Inhibition technique: It includes the sequence of the ischemic compression technique, the strain counter strain technique, and the muscle energy technique combination of the INIT and specific strength exercises aiming to reducing pain, decreasing disability, and improving range of motion ,The main contributing factor seems to be the muscular imbalance between the neck muscles and specifically between the deep and superficial neck flexors Stabilizer pressure biofeedback unit: An inflatable air pressure sensor that is placed behind the neck and is inflated to 20 mmHg, which is sufficient to fill the space between the testing surface and the neck without pushing the neck into a lordosis. The pressure sensor monitors the slight flattening of the cervical lordosis which occurs with the contraction of the deep neck flexors, particularly the longus colli and registers as an increase in pressure The pressure that can be achieved and held in a steady manner for 10 set has been called the activation score. (lee et al., 2014) Several authors have attempted to investigate the combined effect of exercise and manual techniques on neck muscle strength and neck muscle endurance in individuals with chronic neck pain,as well as the relationship between exercise adaptation and improvement in pain and disability (Beltran-Alacreu et al., 2015); )Integrated Neuromuscular Inhibition technique( INIT): It includes the sequence of the ischemic compression technique, the strain counter strain technique, and the muscle energy technique combination of the INIT and specific strength exercises aiming to reducing pain, decreasing disability, and improving range of motion
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DCF
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 30/08/2020
Actual trial start date
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Active, not 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group DCF 3 session per week over 3 weeks long 3 weeks DEEP NECK FLEXOR STABILIZER BIOFEEDBACK UNIT EXERCISE 15
Experimental Group INIT 3 SESSIONS PER WEEKS 3 WEEKS INTGREATED NEURO MUSCULAR INHIBITION TECHNIQUE 15
Control Group traditional treatment 3 sessions per week 3 weeks (Infrared, Ultrasonic, and massage) 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o mechanical neck pain as neck pain with a duration of symptoms longer than 3 months o The patients’ ages ranged from 19 to 38Years o History of previous neck surgery. o Acute and sever inflammatory conditions o Patients with radicular symptoms (radiating pain, loss of sensation, muscle dysfunction, or loss of reflexes), disc prolapse, severe scoliosis, and other specific and serious causes of neck pain. o Neurological deficit. o The patients who had history of diabetes, circulatory or sensory disorders. o Symptoms of vertigo or dizziness. o Cardiopulmonary disease with decreased activity tolerance. o Neck pain due to spondylosis or inflammatory diseases. Adolescent: 13 Year-18 Year,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
Yes 06/06/2019 IRB FOR faculty of physiotherapy cairo university
Ethics Committee Address
Street address City Postal code Country
7th el zayaat st giza 12511 Egypt
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 26/06/2019 IRB of cairo university
Ethics Committee Address
Street address City Postal code Country
7 th el zayat st doki giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ROM range of motion by incliniometer degrees pre ttt and post ttt
Secondary Outcome pain VAS SCALE pre tt and post ttt
Secondary Outcome FUNCTION neck pain disability index index pre ttt and post ttt
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
recruitment center of cairo university faculty of physiotherapy 7th el zayaat st giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator 12 th mohamed selim st from el jomherya ahamed zaki st maadi cairo cairo 11728 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor profdr amira deraz 7 th el zayat st giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr amira deraz 7th el zayat st doki giza giza 12511 Egypt
dr Ghada Esmail 7th el zayat st doki giza doki giza 12511 Egypt
dr Rajga kamel 7th el zayat st doki giza giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eman fahmy eman_pt88@yahoo.com +201025806209 12 th mohamed seilm from jomhoria from ahmed zaki el maadi cairo
City Postal code Country Position/Affiliation
cairo 11728 Egypt phd student
Role Name Email Phone Street address
Scientific Enquiries prof amira deraz deraz amira.draz@pt.cu.edu.eg +1149411373 7th el zayat st
City Postal code Country Position/Affiliation
giza 12511 Egypt professor
Role Name Email Phone Street address
Public Enquiries eman mohamed eman_pt88@yahoo.com +01110353193 7th el zayaat st
City Postal code Country Position/Affiliation
giza 12511 Egypt researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes YES we will share the results of the trail 1 pain 2 function 3 range of motion parameters Study Protocol as soon as the trail finished form one to 3 months the criteria will be accessed by publication of 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