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.: PACTR201806003443167 Date of Approval: 02/06/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title High Intensity Laser versus Low Intensity Pulse Ultrasound on Pain, Range of motion, Posi-tion Sense and Function in Knee Osteoarthritis: Randomized c
Official scientific title High Intensity Laser versus Low Intensity Pulse Ultrasound on Pain, Range of motion, Position Sense and Function in Knee Osteoarthritis: Randomized controlled trial
Brief summary describing the background and objectives of the trial High intensity laser therapy is used recently instead of low intensity laser for treating musculoskeletal disorders because its greater depth of penetration and its effectiveness in pain alleviation and inflammatory release. Ultrasound was seen to have better therapeutic effects than low intensity laser therapy on knee osteoarthritis. This study was conducted to compare the effects of high intensity laser therapy to ultrasound on knee osteoathritis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics,Osteoarthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 09/04/2017
Actual trial start date 24/04/2017
Anticipated date of last follow up 15/07/2017
Actual Last follow-up date 30/07/2017
Anticipated target sample size (number of participants) 85
Actual target sample size (number of participants) 70
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Selected exercise program 12 sessions, 2 sessions per week for 6 consecutive weeks flexibility exercises for the posterior thigh and leg muscles, straight leg raising (SLR) exercise, and isometric strengthening exercises for the quadriceps muscles. 22
Experimental Group High intensity laser plus a selected exercise program 12 sessions, 2 sessions per week for 6 consecutive weeks High intensity laser therapy was applied with 1,250 J/session divided in three phases of laser application. The 1,250 J were divided to: 500J was provided in the first part by quick manual scanning.The selected exercise program consisted of flexibility exercises for the posterior thigh and leg muscles, straight leg raising (SLR) exercise, and isometric strengthening exercises for the quadriceps. 25
Experimental Group Low intensity pulsed ultrasound plus a selected exercise program 12 sessions, 2 sessions per week for 6 consecutive weeks Pulsed ultrasound was used with the following parameters: 1 MHz, 2 W/cm2, and a duty cycle of 1:4 with the applicator diameter 5 cm for 5 minutes/session. The selected exercise program consisted of flexibility exercises for the posterior thigh and leg muscles, straight leg raising (SLR) exercise, and isometric strengthening exercises for the quadriceps muscles. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
We recruited 84 participants who visit the outpatient clinic regularly for physical therapy treatment, 10 of them were not matched to the inclusion criteria and 4 did not agreed to be continue participation in the study. 70 participants were eligible; 30 male and 40 female, their ages ranged from 25 to 45 years. They were simply randomized and assigned to three groups; randomization was implemented by means of a computer-generated randomized table using the SPSS program (IBM, USA) prepared in advance to data collec¬tion. A certain identification number was assigned for every participant. These numbers were randomized into three groups. Individual and sequentially numbered index cards were secured in opaque envelopes. Each participant was given a hand-picked envelope and was relocated accordingly to their treatment groups. The 3 groups were: HILT group consisted of 25 participants (13 females and 12 males) received HILT plus selected exercises, the LIPUS group consisted of 23 participants (14 females and 9 males) received LIPUS and the selected exercises, or the control group consisted of 22 participants (13 females and 9 males) received exercises only. Subjects were excluded if they had: acute infective arthritis rheumatoid arthritis any other type of arthritis history of recent knee trauma unreliable patients mentally or physically metabolic disorders fibromyalgia or other chronic pain syndromes; patient put on anti-coagulant/anti-platelet therapy; arthroscopy or invasive knee surgeries in the previous 3 months. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 45 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 18/03/2017 School of physical therapy, Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayyat st., Dokki Giza 11672 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS scores (pain), range of motion and proprioceptive accuracy. Baseline (before treatment) and 6 weeks after treatment.
Secondary Outcome Functional disability of the knee joint Baseline (before treatment) and 6 weeks after treatment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
School of physical therapy, Cairo University 7 Ahmed Elzayyat st., Dokki, Giza. Cairo 11672 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self 11 Ahmed Eltayeib st., from Elwarsha st., Saint Theresa, Shoubra.A.R.E Cairo 11672 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Soheir Shehata Samaan 11 Ahmed Eltayeib st., from Elwarsha st., Saint Theresa, Shoubra.A.R.E Cairo 11672 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Soheir Shehata Samaan 11 Ahmed Eltayeib st., from Elwarsha st., Saint Theresa, Shoubra.A.R.E Cairo 11672 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Soheir Samaan soheirsamaan@yahoo.com 01224003374 11 Ahmed Eltayeib st., from Elwarsha st., Saint Theresa, Shoubra.A.R.E
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Assistant professor, Basic science department, faculty of physical therapy, Cairo University.
Role Name Email Phone Street address
Public Enquiries Soheir Samaan soheirsamaan@yahoo.com 01224003374 11 Ahmed Eltayeib st., from Elwarsha st., Saint Theresa, Shoubra.A.R.E
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Assistant professor, Basic science department, faculty of physical therapy, Cairo University.
Role Name Email Phone Street address
Scientific Enquiries Soheir Samaan soheirsamaan@yahoo.com 01224003374 11 Ahmed Eltayeib st., from Elwarsha st., Saint Theresa, Shoubra.A.R.E
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Assistant professor, Basic science department, faculty of physical therapy, Cairo University.
REPORTING
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Result URL Hyperlinks Link To Protocol
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