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.: PACTR202008747287742 Date of Approval: 12/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Instrument Assisted Soft Tissue Mobilization versus Myofascial Release on Mechanical Neck Pain
Official scientific title Instrument Assisted Soft Tissue Mobilization versus Myofascial Release on Mechanical Neck Pain
Brief summary describing the background and objectives of the trial This study conducted to compare between instrument assisted soft tissue mobilization versus myofascial release on mechanical neck pain with traditional treatment with 45 patients divded into 3 groups. Evaluation by vas ,inclinometer, algometer and neck disability index
Type of trial RCT
Acronym (If the trial has an acronym then please provide) zeinab
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 05/05/2019
Actual trial start date 20/12/2019
Anticipated date of last follow up 05/05/2019
Actual Last follow-up date 20/03/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 45
Recruitment status Closed to recruitment,follow-up continuing
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group myofascial release. instrument assisted soft tissue mobilization and traditional treatment 3 sessions per week 12 sessions for 1 month 12 sessions for 1 month 45 patients divided into 3 groups 15 patients received myofascial release with traditional treatment 15 patients received assisted soft tissue mobilization with traditional treatment 15 patients received traditional treatment only 15
Experimental Group myofascial release and conventional treatment 3 times per week 3 sessions per week 12 sessions for 1 month 3 groups 45 patients 15 received myofascial release and traditional treatment 15 received IASTM and traditional treatment 15 received traditional treatment only 15
Control Group conventional treatment only 3 sessions per week 12 sessions for 1 month 3 sessions per week 12 sessions for 1 month conventional treatment only (hot packs , TENS and U.S)plus proprioceptive exercises and strengthening exercises. 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 with mechanical neck pain (no radiculopathy ,spondylosis and disc prolapsed) of both sexes. 2) Age ranged between 25-40 year) 3 All subjects who participated in this study read, signed and dated an informed consent form which required by the ethical committee of Faculty of Physical Therapy, Cairo University 1) Pregnant women. 2) Stroke patients. 3) Cancer patients Adult: 19 Year-44 Year 25 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
Yes 31/03/2019 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat st. bein srayyat giza ,Egyp Giza 11421 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome vas for pain measurement ,inclinometer for range of motion, pressure algometer for trigger points and neck dis ability index to measure ADL 1 month
Primary Outcome pain , range of motion, trigger points and activity daily living 1 month
Primary Outcome pain 1 month
Secondary Outcome range of motion 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
el shrouk hospital 5 baher elghazal el mohandeseen giza Egypt
el shrouk hospital el mohandessen giza 330440901 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof Neveen Abdelraouf 7 ahmed elziat st. bein srayyat giza ,Egypt Giza 11411 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor zeinab salah eldeen mohamed el haram giza 35608817 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries zeinab abdel aziz zizisalah98@gmail.com 00201281482491 el haram
City Postal code Country Position/Affiliation
giza 35608817 Egypt physiotherapist
Role Name Email Phone Street address
Public Enquiries mohamed mahgoub drsergany_79@hotmail.com 00201140974442 october
City Postal code Country Position/Affiliation
giza 002356088 Egypt associate professor faculty of physical therapy cairo university
Role Name Email Phone Street address
Principal Investigator neveen abdelraouf dr_neveen_69@yahoo.com 002100768902 eiharam
City Postal code Country Position/Affiliation
giza 002356088 Egypt professor of physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data summary of results Study Protocol 5 month period of time after publication Controlling access to data
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