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.: PACTR202010727816326 Date of Approval: 26/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Photobiomodulation Therapy on Trunk Flexor Performance after Incisional Hernia Repair: A Double-Blinded, Parallel Groups, Randomized Controlled Trial
Official scientific title Effect of Photobiomodulation Therapy on Trunk Flexor Performance after Incisional Hernia Repair: A Double-Blinded, Parallel Groups, Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Technical errors in surgery may play a part in the formation of incisional hernias ( Hesselink et al., 1993; Grevious et al.,2006). As the hernia defect widens, the respiratory functions of the abdominal wall may be disrupted (Flament et al., 1997). Maintaining posture and supporting the lumbar spine are significant functions of the abdominal wall, and these may also be affected by the presence of large incisional hernias (Lam, and Mehdian,1999). Whatever the type of operation and technique for the treatment of hernia, all are associated with complications and potential abdominal weakness. Post-surgical rehabilitation protocols should be taken into consideration to help patients return to an active life (Balogh et al., 2002). A photobiomodulation with a power range of 1–500 mW is usually applied in the treatment of disease or a health disorder. It has a narrow width spectrum within the near infra-red or red spectrum ranging from 600 to 1,000 nanometres with an power range of between one mWatt and five Watt/cm2 (Huang et al., 2009). Photobiomodulation therapy has been used to promote tissue healing and reduce pain through direct interaction with tissues (Enwemeka et al., 2004). Muscle resistance to fatigue can be increased with photobiomodulation therapy when applied pre-exercise for muscular preconditioning (Huang et al., 2011). The purpose of the study will be directed to investigate the effect photobiomodulation approaches (infrared laser 830 nm and red laser 660 nm) on trunk flexor performance after incisional hernia. It has been suggested that light wavelengths between 600 and1000 nm are the most effective optical window for low enough levels of light absorption (Huang et al., 2009) and due to infrared laser (830 nm) and red laser (660 nm) are located within this range.Thus, our study specifically will aim to compare the effects of both photobiomodulation approaches with different wavelengths on the performance of trunk flexors after incisional hernia repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 25/10/2020
Actual trial start date
Anticipated date of last follow up 25/12/2020
Actual Last follow-up date 25/01/2021
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Study group B 3 sessions per week for laser therapy and daily sessions for traditional physiotherapy 4 weeks Study group B (red laser group ) will receive red laser light (660 nm) as four areas in both recti muscles will be defined and arranged in order from above to below in 4 levels. At each level, 3 points will be evenly distributed to deliver the laser radiation to most of the rectus muscle belly; this distribution will be allowed a total of 24 points (12 points for each abdominal side) to be irradiated in each session with the following parameters as the laser probe will be applied perpendicular to the skin; 0.6 joules as energy per point,21.42 W/cm2 as power density,214.28 J/cm2 as energy density per point,10 seconds as exposure time per point and 14.4 joules as total energy to be delivered, then after laser application, study group A will immediately recieve traditional physiotherapy program in form of : 1.Pelvic rocking exercises: 2.Abdominal sit up exercises: 15
Control Group Control group C 3 sessions per week for placebo treatment and daily sessions for traditional physiotherapy 4 weeks Group C will recieve placebo group as (laser device in switch-off mode) followed by a traditional physiotherapy program in form of : 1.Pelvic rocking exercises: 2.Abdominal sit up exercises: 15 Placebo
Experimental Group Study group A 3 sessions per week for laser therapy and daily sessions for traditional physiotherapy 4 weeks Study group A (Infra-red laser group ) will receive red laser light (830 nm) as four areas in both recti muscles will be defined and arranged in order from above to below in 4 levels. At each level, 3 points will be evenly distributed to deliver the laser radiation to most of the rectus muscle belly; this distribution will be allowed a total of 24 points (12 points for each abdominal side) to be irradiated in each session with the following parameters as the laser probe will be applied perpendicular to the skin; 0.6 joules as energy per point,21.42 W/cm2 as power density,214.28 J/cm2 as energy density per point,10 seconds as exposure time per point and 14.4 joules as total energy to be delivered, then after laser application, study group A will immediately recieve traditional physiotherapy program in form of : 1.Pelvic rocking exercises: 2.Abdominal sit up exercises: 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patients had undergone postoperative (open or laparoscopic technique) midline incisional hernia repair -Time since operation ranged from six to twelve months -They ranged in age from thirty to fifty-five years -Participating in any physical therapy program or treatment post hernia operation. -Patients with cardiopulmonary disease; diabetes; neuromuscular disease and a history of previous abdominal surgeries not attributed to incisional hernia. -If they were smokers. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 55 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
Yes 15/07/2020 Faculty of Physical Therapy Ethical Comitte Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat street Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The amount of trunk flexor muscle strength will be measured before fatigue test as 3 repetitions of isokinetic flexion-extension movements will be executed, the greatest torque will be selected from the 3 repetitions and peak torque per bodyweight will be considered a study outcome measure. Baseline, and after 4 weeks of intervention
Secondary Outcome The amount of trunk flexor fatigue resistance will be measured post fatigue test as one repetition of isokinetic flexion-extension movement will be executed, and peak torque per bodyweight will be considered a study outcome measure. Baseline, and after 4weeks of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University 7 Ahmed ELzayat St. Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hesham Galal Mahran 7 Ahmed Elzayat st. Giza 11432 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. Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohamed Ibrahim Ali 7 Ahmed Elzayat st. Giza 11432 Egypt
Mansour Abdullah Alshehri Al-Safa District, Ash Shakirin Street. Jeddah 21493 Saudi Arabia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hesham Mahran heshammahran75@yahoo.com +201030792492 7 Ahmed Elzayat st.
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Hesham Mahran heshammahran75@yahoo.com 00201030792492 7 Ahmed Elzayat st.
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Mohamed Ali mmsalem@uqu.edu.sa 00966545919520 7 Ahmed Elzayat st.
City Postal code Country Position/Affiliation
Giza 11432 Egypt Professor
Role Name Email Phone Street address
Public Enquiries Mansour Alshehri mamshehri@uqu.edu.sa 00966569693637 Al-Safa District, Ash Shakirin Street
City Postal code Country Position/Affiliation
Jeddah 21493 Saudi Arabia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the results of this study within 6 months of the study completion regarding amount of trunk flexor muscle strength and trunk flexor muscle fatigue resistance (isokinetic assessment results ) Clinical Study Report 6 month after the study completion The criteria will be accessed by the publication of the trial in an 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