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.: PACTR202005827347437 Date of Approval: 19/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Instrument Assisted Soft Tissue Mobilization on Hand Grip Strength in Patients with Subacromial Impingement Syndrome
Official scientific title Effect of Instrument Assisted Soft Tissue Mobilization on Hand Grip Strength, Upper Limb Functions, and Pain in Patients with Subacromial Impingement Syndrome
Brief summary describing the background and objectives of the trial It is widely accepted that grip strength provides an objective index of the functional integrity of the upper extremity. The muscles surrounding the scapula provide proximal stability for the upper extremity and act as a fix when the distal part is moving (Devika et al., 2018). Subacromial Impingement Syndrome (SIS) may account for as much as 30% of patients presenting with shoulder complex pain and dysfunction (Diercks et al., 2014). Common examination findings associated with SIS include abnormalities with scapular kinematics such as displacing the scapula laterally, decreased upward rotation and posterior tilting of the scapula that can contribute to the cause of SIS (Ludewig and Reynolds, 2009). It is hypothesized that SIS presenting with decreased upward scapular rotation may be the result of soft tissue restrictions (Surenkok et al., 2009). Instrument assisted soft tissue mobilization (IASTM) is a popular treatment for myofascial restriction which is applied using specially designed instruments to provide a mobilizing effect to soft tissue (e.g., scar tissue and myofascial adhesion) to decrease pain and improve range of motion and function (Scott et al., 2016). This study was conducted to Investigate the effect of adding instrument assisted soft tissue mobilization to the scapular stabilization exercises on hand grip strength, upper limb functions, and pain in patients with subacromial impingement syndrome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SIS HG
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date 01/04/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
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 the conventional treatment of subacromial impingement syndrome. 3 times per week 4 weeks 1-Transcutaneous electrical nerve stimulation (TENS) b- Ultrasound c- Exercise including (Range of motion exercises, stretching exercises, and strengthening exercises (Scapular stabilization exercises and rotator cuff strengthening exercises)). 30 Active-Treatment of Control Group
Experimental Group IASTM in addition to the conventional treatment. 3 times per week 4 weeks 1-Transcutaneous electrical nerve stimulation (TENS) 2- Ultrasound 3- Exercise including (Range of motion exercises, stretching exercises, and strengthening exercises (Scapular stabilization exercises and rotator cuff strengthening exercises)). 4- Instrument assisted soft tissue mobilization (IASTM) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients with subacromial impingement syndrome from both genders. 2- Age range from 25-40 years 3- Shoulder impingement symptoms lasting at least 6 weeks Patients will be excluded if they have any of the following: 1- Hand truma, present pain or other kinds of complaints in the hand area. 2- History of deformities, fractures, or surgery of the tested upper extremity joints affecting hand grip strength within the last 6 months. 3- Presence of cardiopulmonary, hormonal disorder, central or peripheral neurological deficits or any condition that can influence the results. 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 05/05/2019 faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayyat Street, between Al-Sarayat in front of Giza Traffic Department giza 12618 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hand Grip Strength before and after 2 weeks , 4 weeks
Secondary Outcome Upper limb functions by Disabilities of the Arm, Shoulder, and Hand (DASH) Before, after 2 and 4 weeks
Secondary Outcome Pain by visual analogue scale before, after 2 and 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Elmanial Kasr Al-Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nancy Shehta Ali Ahmed Khedr 39 Nossier Saber St,Elmattarya Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo University 7 Ahmed Elzayat st, Ben El- Sarayat- in front of Giza Traffic Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fatma Sedeek Amin 7 Ahmed Elzayat st, Ben El- Sarayat- in front of Giza Traffic Giza Egypt
Nabil Mahmoud Ismail 7 Ahmed Elzayat st, Ben El- Sarayat- in front of Giza Traffic Giza Egypt
Ashraf Nihad Moharram 92 Eltahrir St, Saridar Medical Tower Dokki Square, giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatma Amin nancyshehta47@gmail.com 01223417697 7 Ahmed Elzayat st, Ben El- Sarayat- in front of Giza Traffic
City Postal code Country Position/Affiliation
Giza Egypt Professor of physical therapy
Role Name Email Phone Street address
Public Enquiries Nabil Ismail nabil.mahmoud@cu.edu.eg 01200133613 7 Ahmed El Zayyat Street, between Al-Sarayat in front of Giza Traffic Department
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Ashraf Moharram dr.amoharram@gmail.com 01001420049 92 Tahrir Street Saridar Medical Tower Dokki Sq
City Postal code Country Position/Affiliation
Giza Egypt Professor of Orthopaedic Surgery
Role Name Email Phone Street address
Principal Investigator Nancy Shehta nancy_shehta89@yahoo.com 01286221886 39 nossier saber st, Elmattarya
City Postal code Country Position/Affiliation
Cairo Egypt Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) Statistical Analysis Plan 6 months following publication Anyone who wishes to access the 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