Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008911789002 Date of Approval: 31/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Diode Laser 905NM and Fascial Distortion Model on Groin Adductor Strain in Handball Athletes
Official scientific title Effect of Diode laser 905 nm and Fascial Distortion Model on Groin adductor strain in Handball Athletes
Brief summary describing the background and objectives of the trial this study will be conducted to determine the impact of low level laser (Diode 905nm) and Fascial Distortion Model on groin adductor strain ( second degree strain) in Handball males and females athletes with their ages ranged from ( 12 to 24 years old) and 40 patients will subdivided into 2 groups ( group A) will receive Diode laser 905 nm and Fascial Distortion Model and (group B) will receive Fascial Distortion Model and sham laser • Patients received Low Laser Therapy in form of Gallium Aluminum Arsenide Laser (905 nm / 6 HZ / 30 seconds) .patients received Fascial Distortion Model which is approach to treating distorted fascial bands in which the distortion is located and corrected along its entire pathway by using physical force from the physician's thumb Twist . patients received 3 sessions per week as 6 sessions as total number of sessions for 2 weeks (treatment period) using in evaluation (1) pressure algometry to assess pain (2) HAGOS (The Copenhagen Hip and Groin outcome scores): to assess patient daily activities , sport activities and level of pain. (3)CK-MM test (Creatine Kinase for muscle test): it is biomarker serum enzyme test and was used to detect muscle injury due to damage, crush injuries (4) LDH5 test (Lactate Dehydrogenase for muscle test) :itis biomarker serum enzyme test and was used to detect tissue damage such as muscle.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 12/02/2019
Actual trial start date 02/03/2019
Anticipated date of last follow up 30/04/2019
Actual Last follow-up date 16/04/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 42
Recruitment status Completed
Publication URL No 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
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Diode laser 905nm and Fascial Distortion Model and pressure algometry 3 sessions per week as total number of sessions ( 6 sessions) 2 weeks Chattanooga Gallium Aluminum Arsenide Diode Laser (Italy).((905 nm / 6 HZ / 30 seconds) Average power: 70.5 mw. Maximum frequency: 30000HZ. Energy per pulse: 2.35mJ. Peak power: 13.5W. Beam surface at laser aperture: 12.5 mm2. Pulse width at 50% of peak power: 155ns The Wagner FPIX™ Digital Algometer which detect the minimum pressure that induces pain in tender and trigger points of tissue CK-MM test (Creatine Kinase for muscle test) LDH5 test (Lactate Dehydrogenase for muscle test) HAGOS (The Copenhagen Hip and Groin outcome scores): HAGOS is self-explanatory, takes 10 min for the athletes to fill . It is consisting of 37 items distributed in six subscales:1) Pain (10 items) 2) Symptoms (7 items) 3) Physical function in ADL( 5 items) 4) Physical function in sports and recreation (8 items) 5) Participation in physical activities (2 items) 6) Hip or groin related QOL ( 5 items) and Fascial Distortion Model which Patient was in comfortable position ( supine lying position) then determine with palpation the points of pain through verbal expression of patient which the distortion is located which described as a “burning” or “pulling” pain along a linear course. The accompanying body language is a sweeping motion with one or more fingers along trigger band pathway. It is approach to treating distorted fascial bands in which the distortion is located and corrected along its entire pathway by using physical force from the physician's thumb Twist 20 Active-Treatment of Control Group
Experimental Group sham diode laser 905nm and Fascial distortion 3 sessions per week and total number of session 6 sessions 2 weeks • Patients received sham Low Laser Therapy which it is not work in form of Gallium Aluminum Arsenide Laser (905 nm / 6 HZ / 30 seconds) Average power: 70.5 mw. Maximum frequency: 30000HZ. Energy per pulse: 2.35mJ. Peak power: 13.5W. Beam surface at laser aperture: 12.5 mm2. Pulse width at 50% of peak power: 155ns CK-MM test (Creatine Kinase for muscle test): it is biomarker serum enzyme test and was used to detect muscle injury due to damage, crush injuries LDH5 test (Lactate Dehydrogenase for muscle test) :itis biomarker serum enzyme test and was used to detect tissue damage such as muscle HAGOS (The Copenhagen Hip and Groin outcome scores): HAGOS is self-explanatory, takes 10 min for the athletes to fill . It is consisting of 37 items distributed in six subscales: 1) Pain (10 items) 2) Symptoms (7 items) 3) Physical function in ADL( 5 items) 4) Physical function in sports and recreation (8 items) 5) Participation in physical activities (2 items) 6) Hip or groin related QOL ( 5 items) Pressure Algometry: was used to assess pain(The Wagner FPIX™ Digital Algometer which detect the minimum pressure that induces pain in tender and trigger points of tissue) Fascial Distortion Model (Patient was in comfortable position ( supine lying position) then determine with palpation the points of pain through verbal expression of patient which the distortion is located which described as a “burning” or “pulling” pain along a linear course. The accompanying body language is a sweeping motion with one or more fingers along trigger band pathway. It is approach to treating distorted fascial bands in which the distortion is located and corrected along its entire pathway by using physical force from the physician's thumb Twist ) 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Patients with ages ranged from (12-24) years of both sex 2) They were diagnosed as acute second stage groin adductor muscles strain. 3) All patients play handball sport. 1)Athletic injuries : such as sport hernia and osteitis pubis 2) Hip joint injury: such as Avulsion or stress fracture Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 12 Year(s) 24 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 11/12/2018 Scientific Research Ethics Committee at the Laser Institute
Ethics Committee Address
Street address City Postal code Country
Orman Street Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity level and scores of blood creatine kinase for muscles enzyme (CK-mm) and lactate dehydrogenase for muscles enzymes (LDH5) 30 secondes
Secondary Outcome Low level Laser (Diode Laser) and Fascial Distortion Model 30 seconds
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
shubra public hospital shubra cairo 11567 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dina said Ali elkrdasy cairo 11772 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor dina Ali Al-Kordasi Street cairo 11772 Egypt no
COLLABORATORS
Name Street address City Postal code Country
Doctor Essam Rashwan Wezaret Al Zeraa, Al Agouzah, Dokki Giza 12618 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dr.Ahmed Kharbutli kharbotly98@gmail.com 01001640946 Orman Street
City Postal code Country Position/Affiliation
Giza 12612 Egypt Professor Of Laser Application In Otorhinology in Laser Institute Cairo University
Role Name Email Phone Street address
Public Enquiries Dina said dinaahly262684@gmail.com 01224625772 Ali al-Kordasi
City Postal code Country Position/Affiliation
cairo 11772 Egypt Physiotherapist in Shubra General Hospital
Role Name Email Phone Street address
Scientific Enquiries Dr. ENAS ABU TALEB enas_abutaleb@yahoo.com 01001468054 Abdul Hafez Ahmed Street
City Postal code Country Position/Affiliation
Cairo 11762 Egypt Assistant Lecturer in Department of Basic Sciences in Faculty of Physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Paired “t” test will be used to assess the significance of changes in the study variables before and after treatment in each group - Unpaired "t" test will be done between the 2 groups to detect significant differences between variables pre and post treatment Statistical Analysis Plan (When to start / when expected to finish/ when to publish) Each athletes have the same diagnosis of acute second stage groin adductor strain. 2) The same age (12-24) years old 3) Male and female handball athletes 4) Consent to participate in the study and follow the treatment schedule.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes It was the first study to determine effect of Diode laser (905nm) and Fascial Distortion on acute Groin Adductor Strain on Handball Athletes and investigate their effects on pain and Creatine Kinase (CKmm) and Lactate Dehydrogenase (LDH5) level scores. Forty patients diagnosed as adductor strain grade II participated in the study .their ages ranged from 12- 24 years. Patients subdivided randomly into two groups ,each group consisted of 20 patients ,patients in group (A) received a program of Chattanooga Gallium Aluminum Arsenide Diode Laser (Italy) (wavelength 905nm, 6 HZ / 30 seconds and average power 70.5mw) and Fascial Distortion Model in form of (Trigger band technique), while patients in group (B) received a program of (Shame Laser and Fascial Distortion Model in form of (Trigger band technique). Data obtained from both groups prior and following the treatment program (at 2 weeks) regarding Creatine Kinase level(CKmm) , Lactate Dehydrogenase level (LDH5),HAGOS scores and Pressure algometry (point 1 and point 2) were statistically analyzed and compared between two groups. The data collected was statistically analyzed using Paired “t” test to assess the significance of changes in the study variables before and after treatment in each group and the independent t-test between both groups to detect significant differences between variables pre and post treatment. 16/04/2019 30/04/2020
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks not yet published
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