DETERMINING THE EFFECT OF ESWT ON TREATMENT OF POST-SURGICAL PILLAR PAIN IN PATIENTS WITH CARPAL TUNNEL SYNDROME
Design
In this research, 32 eligible patients referring from a single orthopedist were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
Referred patients divided in either shockwave or sham group blindly(after being informed about the process and the blindness) and then enrolled for 4 sessions of ESWT in Isfahan Kashani hospital.
Participants/Inclusion and exclusion criteria
patients with persistent palmar pain for at least one month after surgery(visual analogue score (VAS) more than 5 points) and not improved after 10 sessions of physical therapy will be included. pregnancy, infection at the site or coagulopathy exclude the patients from the study.
Intervention groups
Half of the patients undergo four treatments of ESWT, performed at weekly intervals using Duollith sd1 shockwave equipment with an average of 2800 shocks and very low EFD of 0.03 mJ/mm2 at first session.The energy will be increased during the next three sessions according to patients` tolerance. The pulse repetition frequency is 4 Hz.
The other half undergo four sessions of sham shockwave with the same number of shocks and session intervals as the case group but with no energy.
Main outcome variables
Reduction in pillar pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171109037338N1
Registration date:2018-01-07, 1396/10/17
Registration timing:retrospective
Last update:2018-01-07, 1396/10/17
Update count:0
Registration date
2018-01-07, 1396/10/17
Registrant information
Name
Adele Oreizi
Name of organization / entity
isfahan univesity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 8194
Email address
a.oreizi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
2016-07-31, 1395/05/10
Actual recruitment end date
2017-11-01, 1396/08/10
Trial completion date
empty
Scientific title
Extracorporeal shockwave effect on treatment of post-surgical pillar pain in patients with carpal tunnel syndrome
Public title
Extracorporeal shockwave effect on post-surgical pain carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have persistent palmar pain for at least one month after carpal tunnel release surgery
Visual Analog Scale >5
Pain has not been improved with physical therapy.
Exclusion criteria:
Infection at the site of treatment
Pregnancy
Patients who have history of coagulopathy.
Patients who have systemic disease with joint involvement such as gout, rheumatoid arthritis.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
32
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are divided to two groups using table of random numbers with the simple randomization method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were explained about the process initially and told that they may be either in shockwave or sham group but they would not know it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
The intensity of pain in patients with pillar pain
Timepoint
before intervention and 1 and 3 months after intervention
Method of measurement
Visual Analogue Scale
2
Description
Evaluation of patients hand function
Timepoint
before intervention and 1 and 3 months after intervention
Method of measurement
Brief-Michigan hand questionairre
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: four treatments of extracorporeal shockwave therapy (ESWT), performed at weekly intervals using Duollith sd1 shockwave equipment with an average of 2800 shocks and very low EFD of 0.03 mJ/mm2 at first session.The energy will be increased during the next three sessions according to patients` tolerance. The pulse repetition frequency is 4 Hz.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Adele Oreizi
Street address
Kashani hospital, Kashani St.
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 3233 0091
Email
a.oreizi@resident.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian attar
Street address
Esfahan University of Medical Sciences, Hezar jarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
Email
a.oreizi@resident.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Adele Oreizi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Esfahan university of medical sciences, Hezar jarib St.
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
Email
a.oreizi@resident.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Adele Oreizi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Esfahan University of Medical Sciences, Hezar jarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
a.oreizi@resident.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Adele Oreizi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Esfahan University of Medical Sciences, Hezar jarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
a.oreizi@resident.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual participant data
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Available for people working in academic institutions
What processes are involved for a request to access data/document
The applicant should send by E-mail the request accompanied with a certificate of the university or institute where he works and the field of study. If approved, data will be sent in 1 week.