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.: PACTR201805003234227 Date of Approval: 21/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title focus versus radial shockwaves therapy in tennis elbow
Official scientific title Focused extracorporeal Shock Waves Therapy versus Radial Shock Waves Therapy in Chronic Lateral Epicondylitis
Brief summary describing the background and objectives of the trial This study to investigate the effects of focused shock waves versus Radial shock waves therapy on pain level, muscle strength and MRI changes of CET (common extensor tendon) in patients with lateral epicondylitis. Patients will randomly assign into three equal groups,their age ranged from 30 ¿ 60 years The first experimental group consisted of 20 patients will receive Focused shock waves therapy (1500 shock, only one session in alternative week of maximum 3 session, energy flux density 0.32 mj / mm , energy level 4 ¿ 7 and puls rate 160 / min, 2-3 HZ)plus traditional physical therapy modalities . The second experimental group consisted of 20 patients will receive Radial shock waves therapy (2000 shock, only one session in alternative week of maximum 3 session plus traditional physical therapy modalities. The third group (controlled group) consisted of 20 patients will receive traditional physical therapy modalities only which include (ultrasound therapy, deep friction massage and physical -Exercises) this study To compare the effect of FSWT versus RSWT on pain level, muscle strength of elbow joint and MRI changes of CET (common extensor tendon) in patient with chronic lateral epicondylitis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FSW RSW MRI CET
Disease(s) or condition(s) being studied Chronic lateral epicondylitis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/04/2017
Actual trial start date 01/05/2017
Anticipated date of last follow up 05/10/2017
Actual Last follow-up date 09/11/2017
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 60
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 randomisation Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group focused shock waves 3 month and two weeks focused extracorporeal shock wave plus traditional physical therapy program 20
Experimental Group radial shock waves 3-5 2 monthes radial shock waves plus traditional physical therapy 20
Control Group traditional physical therapy program 12 sessions one monthe ultrasound , friction massage and exercises 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria: 1-Patients¿ age varies between 30 ¿ 60 years. 2-Patients reported pain over lateral epicondyle for at least 3 months. 3-Patients will not involve in a regular exercise program 4 weeks prior to the study. exclusion criteria: 1-Patients with polyarthritis, carpal tunnel syndrome, rotator cuff tendonitis, cervical spondylosis and neurological abnormalities in affected area (Nirchl et al, 2003). 2-Patients with cardiac pacemakers or metal implants 3-Osteoporotic and rheumatoid arthritis patients. 4-Pregnant women with lateral epicondylitis 30 Year(s) 60 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 04/10/2016 Cairo university , faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
el tahrir street , ben el sarayat - dokki Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain level (visual analogue scale) before treatment after treatment after 3 months after 6 months
Secondary Outcome handheld dynamometer before treatment after treatment after 3 months after 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
al sahel educational hospital 2 yossif karam street , al sahel , shobra cairo 11672 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 52 sefarat distinct - nasr city cairo 11787 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university,faculty of physical therapy El_Tahrir st ,Ben El sarayat,Dokki Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
soheir shehata shobra street cairo 11672 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haidy Henry Hadhoood2005@hotmail.com 01287238800 el sefarat district - nasr city
City Postal code Country Position/Affiliation
cairo 11765 Egypt physical therapist
Role Name Email Phone Street address
Public Enquiries sohier shehata soheirsamaan@yahoo.com 012 240 03374 shobra street
City Postal code Country Position/Affiliation
cairo 11672 Egypt assistant professor of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Haidy Henry Hadhoood2005@hotmail.com 01287238800 el sefarat district - nasr city
City Postal code Country Position/Affiliation
cairo 11765 Egypt Physical therapist
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information