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.: PACTR201804003293116 Date of Approval: 05/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of extracorporeal shock wave therapy on different severities of carpal tunnel syndrome
Official scientific title Effect of extracorporeal shock wave therapy on different severities of carpal tunnel syndrome
Brief summary describing the background and objectives of the trial To determine the Effect of extracorporeal shock wave therapy (ESWT) as a non- invasive technique on different severities of carpal tunnel syndrome. assessment of the effect of ESWT was done by measurent the degree of lateral pinch power, Visual Analogue Scale (VAS), by nerve conduction studies and by cross sectional area of the median nerve at the wrist using high resolution ultrasound
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied carpal tunnel syndrome,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 06/11/2016
Actual trial start date 06/11/2016
Anticipated date of last follow up 16/07/2017
Actual Last follow-up date 16/07/2017
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
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 Non-randomised Open-label(Masking Not Used)
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Extracorporeal shock wave therapy for mild carpal tunnel syndrome 2000 pulses at energy flux density of 0.03 mJ/mm2, 1.6 bar therapy one session per week, for six weeks Extracorporeal shock waves (ESWs) are non invasive sequence of acoustic pulses characterized by a high peak pressure , fast pressure increase and short duration 20
Experimental Group Extracorporeal shock wave therapy for severe carpal tunnel syndrome followed by assessment 2000 pulses at energy flux density of 0.03 mJ/mm2, 1.6 bar therapy one session per week, for six weeks Extracorporeal shock waves (ESWs) are non invasive sequence of acoustic pulses characterized by a high peak pressure , fast pressure increase and short duration 20
Control Group mild carpal tunnel syndrome before shock wave therapy assessment: clinical, nerve conduction studies, ultrasound of median nerve 20
Control Group moderate carpal tunnel syndrome before shock wave therapy assessment: clinical, nerve conduction studies, ultrasound of median nerve 20
Control Group severe carpal tunnel syndrome before shock wave therapy assessment: clinical, nerve conduction studies, ultrasound of median nerve 20
Experimental Group Extracorporeal shock wave therapy for moderate carpal tunnel syndrome followed by assessment 2000 pulses at energy flux density of 0.03 mJ/mm2, 1.6 bar one session per week, for six weeks Extracorporeal shock waves (ESWs) are non invasive sequence of acoustic pulses characterized by a high peak pressure , fast pressure increase and short duration / assessment: clinical, nerve conduction studies, ultrasound of median nerve 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-clinically suspected to have carpal tunnel syndrome with duration of symptoms more than 3 months. -nerve conduction studies showed evidence of median neuropathy at the wrist -patients with other neuromuscular disorders, proven clinically or electrodiagnostically e.g. cervical radiculopathy, polyneuropathy. -patients with systemic diseases which may be associated with neuropathy e.g. diabetes -Patients with carpal bone fractures and joint injuries. -Presence of vascular disease at the wrist and/or the hand. Patients who received any previous local intervention.(e.g. surgery) -Patients who are receiving systemic corticosteroids 18 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 12/07/2015 ethics committee of department of Physical Therapy for Neuromuscular Disorder and Its Surgery, Faculty of Physical Therapy, Cairo University.
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayyat Street, Dokki, Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome extracorporeal shock wave therapy may be used as a conservative treatment in patients with mild and moderate carpal tunnel syndrome end of the study
Secondary Outcome nerve coduction studies and cross sectional area of median nerve by high resolution ultrasound may be used an objective measure to assess improvement of carpal tunnel syndrome end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Sahel Teaching Hospital 2 Yossef Karam Street Cairo 11697 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
El Sahel Teaching Hospital 2 Yossef Karam Street Cairo 11697 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor El Sahel Teaching Hospital 2 Yossef Karam Street Cairo 11697 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Waleed Talat Mansour Faculty of physical therapy ,Cairo University : 7 Ahmed Elzayyat Street Giza 11432 Egypt
Usama Mohammad Rashad Faculty of physical therapy ,Cairo University : 7 Ahmed Elzayyat Street Giza 11432 Egypt
Tarek Kamal Zayed El Sahel Teaching Hospital :2 Yossef Karam Street Cairo 11697 Egypt
Amani Mahmoud Nawito 27 Nafezet Sheem El Shafaey street, Kasr Alainy , faculty of medicine Cairo 11562 Egypt
Nirmeen Adel Kishk 27 Nafezet Sheem El Shafaey street, Kasr Alainy , faculty of medicine Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Zayed dr_tarek_kamal_aly@yahoo.com +201120855944 2 Yossef Karam Street
City Postal code Country Position/Affiliation
Cairo 11697 Egypt Physical therapist at El Sahel Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Usama Rashad usama_elsarty@yahoo.com +201001440053 7 Ahmed Elzayyat Street
City Postal code Country Position/Affiliation
Giza 11432 Egypt Professor at department of Physical Therapy, Faculty of Physical Therapy, Cairo University.
Role Name Email Phone Street address
Scientific Enquiries Tarek Zayed dr_tarek_kamal_aly@yahoo.com +201120855944 2 Yossef Karam Street
City Postal code Country Position/Affiliation
Cairo 11697 Egypt Physical therapist at El Sahel Teaching Hospital
REPORTING
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