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.: PACTR201912698539774 Date of Approval: 03/12/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Low Level Laser Therapy on Intermittent Claudication and estimated Peak Oxygen Consumption in Peripheral Arterial Disease. A Randomized Controlled Study.
Official scientific title Effect of Low Level Laser Therapy on Intermittent Claudication and estimated Peak Oxygen Consumption in Peripheral Arterial Disease. A Randomized Controlled Study.
Brief summary describing the background and objectives of the trial The prevalence of PAD has been increased dramatically in the last decade with more than two-thirds of this global increase in PAD cases were found in low-income and middle-income countries [1]. Peripheral arterial disease (PAD) is the third leading cause of morbidity in people with atherosclerotic vascular disorders after coronary heart disease and stroke, yet it receives a relatively less research attention than the other two morbidities.The main purpose of this study was to assess the effect of Gallium Aluminium Arsenide (GaAlAs) laser therapy on intermittent claudication and estimated peak oxygen consumption in symptomatic patients with PAD
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/10/2018
Actual trial start date
Anticipated date of last follow up 15/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Medical treatment only 5 weeks patients in this group only received routine medical treatment for peripheral arterial disease 15 Active-Treatment of Control Group
Experimental Group low level laser therapy 5 weeks Patients in this group received GaAlAs laser therapy (655 nm) at 10 acupuncture points namely, LV2, ST41, UB25, UB40, UB60, UB61, GB30, GB34, GB38, and GB40. The power output was 41 mW, the spot size was 0.08 cm2, and the energy density was 2 J/cm2. The duration of laser application was 60 seconds/point, 2 days/week, and for 5 weeks 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The enrty criteria were male patients, aged from 60 to 70 years, with symptomatic PAD confirmed by a positive Edinburgh claudication questionnaire response and an ankle-brachial pressure index (ABI) of <0.9. Patients with co-existed diabetes or hypertension were also included. Patients excluded were women, patients with asymptomatic PAD, and/or patients who are contraindicated for laser therapy Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 70 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 03/11/2019 The ethics committee of human scientific research of the Faculty of Physical Therapy at Cairo University
Ethics Committee Address
Street address City Postal code Country
80 Ahmad Elzyat street-Dokki-Giza Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intermittent claudication and estimated peak oxygen consumption before and after the study
Secondary Outcome percentage predicted 6-MWD before and after the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Montaser el zyat street-Dokki-Giza Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cairo University Dokki-Giza Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abeer Ahmad Nasr City Cairo Egypt
Hasnaa Hosam Al fayoum Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abeer Farghaly abeer.phth@yahoo.com 002001116013302 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Professor of physical therapy
Role Name Email Phone Street address
Public Enquiries Hasnaa Ahmad hasnahosam6@yahoo.com 002001095557925 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Physiotherapist at the outpatient clinics of faculty of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Ahmad Mahdi Ahmed.mahdy@pt.cu.edu.eg 002001007056624 13 Darb El Mwahi-El Sakkayeen-Abdeen
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of physical therapy in Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Statistical Analysis Plan,Study Protocol immediately following publication Any one who wishes to access to 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