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.: PACTR201803003126291 Date of Approval: 21/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title LOW LEVEL LASER VERSUS TRUNK STABILIZING EXERCISES ON STERNOTOMY HEALING AFTER CORONARY ARTERY BYPASS GRAFTING
Official scientific title efficacy of low level laser versus trunk stabilizing exercises on sternal separation, pain, activity of daily living and phogotography of incisional site
Brief summary describing the background and objectives of the trial Coronary artery bypass graft (CABG) surgery is a well-accepted treatment in patients with severe angina since the 1970s. Relief of angina symptoms is still the major goal of CABG to obtain better quality of life, as well as increase of life expectancy (LE). Today, several different grafting techniques are used, but in the beginning only venous conduits were used. Although nowadays arterial grafts are preferred, venous grafts are still being used extensively (van Domburg et al., 2009).The sternotomy incision during cardiac surgery is oriented in the sagittal plane and lies in a similar direction to the sacroiliac joint. Contraction and activation of the abdominal and anterior thoracic cage muscles may assist in stabilizing the divided sternum, thereby achieving reductions of excessive motion in the anteroposterior and cephalocaudal planes during movement of the trunk. Minimising the degree of excessive motion between the two sternal edges in the patient with an unstable sternum may reduce the associated pain and discomfort reported by individuals, and thus provides a conservative option for sternal instability (El-Ansary et al., 2007c). Low-level laser therapy (LLLT) can promote tissue repair by numerous mechanisms that have been validated both in vitro and in vivo. Many studies have reported that LLLT can induce fibroblast proliferation and mast cell degranulation and increase the tensile strength of the tendons and skin. Recent studies have described other positive effects of LLLT, such as an increase in angiogenesis, alignment of collagen fibers, and the prevention of oxidative stress (Fernandes et al. 2016).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LLLT CABG ADL
Disease(s) or condition(s) being studied Cardiology,Circulatory System,coronary artery disese
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 22/02/2018
Actual trial start date
Anticipated date of last follow up 19/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
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)
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)
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 low level laser therapy 3 times/ week four weeks The laser group consist of (15) patients, who will receive the irradiation immediately after surgery and on postoperative days 3 times /week The irradiation will be performed at spots along the incision that will be 2 cm from each other, for a total of eight points. During the irradiation, the probe will be positioned perpendicularly to the sternum and in contact with the skin; it will be protec 15
Experimental Group trunk stabilizing exercises 3 times/ week four weeks The exercise group consist of (15) patients, who will receive trunk stabilizing exercises (which will begin from the 7th day post CABG surgery) for 20-40 minutes (min), three times per week for four consecutive weeks 15
Control Group traditional treatment 3 times/ week four weeks routine physiotherapy program (incentive spirometer, shoulder active range of motion exercises, walking training, and therapeutic modalities such as TENS, IR and vibrator) that will begin from the 1st day post CABG surgery, two sessions daily, three times per week until discharge. Post discharge, the patients will continue this routine physiotherapy program as an outpatient CR program for 40-60 mi 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Forty patients male who will undergo CABG surgery through a median sternotomy and have sternal instability. 2-Their age will be ranged from 45-65 years old. 3-Patients will be included as they have acute sternal instability that will be assessed clinically by sternal instability testing (from sitting position with both index and middle fingers of the investigator at both sides of sternal incision, the patient rotate the head to the right then the left sides. There will be a palpable sternal motion and separation with audible clicking sound, indicating a patient with sternal instability). Sternal separation assessment will be confirmed through ultrasound unit that will be done by a specialist radiologist. 4-Body mass index from 25 to 29.9 kg/m2 5-Patients with hemodynamic stability. Patients who will meet one of the following criteria will be excluded from the study: 1- Previous thoracic surgery. 2- Emergency or urgent coronary artery bypass surgery. 3- Respiratory insufficiency after surgery manifesting hypoxemia with partial pressure of oxygen in arterial blood <60 mmHg. 4- Renal insufficiency with serum creatinine ¿1.8 mg/dl after surgery. 5- Low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads, cardiac arrhythmias, or hypotension according to the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) (Hillis et al., 2011). 5- Other medical conditions such as diabetes, uncontrolled hypertension and obesity. 6- Past medical history included conditions that may have influenced the provision of physiotherapy interventions such as (severe asthma, chronic airflow limitation, bronchiectasis, ankylosing spondylitis or lumbar disc prolapse). 45 Year(s) 65 Year(s) Male
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 27/02/2018 Faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El zyad street, dooki, giza, egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome activity of daily living pre and post completion of study
Secondary Outcome photography of sternotomy site pre and post completion of study
Primary Outcome sternal separation pre and post completion of study
Primary Outcome pain intensity pre and post completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Heart Institute 5 Ibn El Nafees Sq.¿ AL KIT KAT 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
zeinab mohamed helmy 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
sherin hassan mohammed 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
basant hamdy elrefaey 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
eman hassan abd elsalam 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator zeinab helmy elsayedessam22@yahoo.com 01114773311 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt professor
Role Name Email Phone Street address
Public Enquiries eman abd elsallam elsayedessam22@yahoo.com 01002771626 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries basant el refaey bassanthamdy@yahoo.com 01001224979 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries sherin mohammed sherinhassin@yahoo.com 01003378217 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt assistant professor
REPORTING
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