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.: PACTR202008842095447 Date of Approval: 12/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Integrated neuromuscular inhibition for neck pain
Official scientific title Efficacy of integrated neuromuscular inhibition versus muscle energy technique on rhomboid latent myofascial trigger point: a randomized blinded trial
Brief summary describing the background and objectives of the trial Neck and shoulder pain linked to latent trigger points (LTrPs) in the scapular muscles are common complaints. Manual therapy is an important treatment category for such conditions. this study will be conducted to examine the efficacy of integrated neuromuscular inhibition versus muscle energy technique on rhomboid latent myofascial trigger point: a randomized blinded trial
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 04/08/2020
Actual trial start date
Anticipated date of last follow up 04/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional program 3 sessions per week 4 weeks infra red radiation TENS ultrasound therapy 25 Active-Treatment of Control Group
Experimental Group MUSCLE ENERGY TECHNIQUE 3 sessions per week 4 weeks MUSCLE ENERGY technique added to traditional program composed of application infra red radiation, ultrasound, and TENS 25
Experimental Group integrated neuromuscular inhibition technique 3 sessions per week 4 weeks integrated neuromuscular inhibition technique (composed of ischemic compression, strain counter strain, muscle energy technique) added to traditional program (composed of TENS, US, IR) 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
neck or shoulder pain disability rhomboid muscles trigger points radiculopathy visual or auditory problems current participation in physical or medical treatmentr Adult: 19 Year-44 Year 20 Year(s) 40 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 28/07/2020 research ethics committe of faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzayat street cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity immediatly before and after the treatment program
Secondary Outcome pressure pain threshold of rhomboid muscle immediatly before and after the treatment program
Secondary Outcome neck disability measured by neck disability index immediatly before and after the treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
clinic of faculty of physical therapy pharos university elmahmoudeya street alexandria 36741 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aliaa M Elabd Sabry aboallam street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor aliaa elabd sabry aboallam street alexandria 25907 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Omar M Elabd Hamdy Kandil Shebin Elkom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliaa Elabd aliaelabd88@gmail.com 00201069352446 sabry aboallam street
City Postal code Country Position/Affiliation
alexandria Egypt pharos university faculty of physical therapy lecturer
Role Name Email Phone Street address
Public Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 sabry aboallam street
City Postal code Country Position/Affiliation
alexandria Egypt pharos university faculty of physical therapy lecturer
Role Name Email Phone Street address
Scientific Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 sabry aboallam street
City Postal code Country Position/Affiliation
alexandria Egypt pharos university faculty of physical therapy lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All participant data Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediatly after publication Any body can access
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