Compare the effect of extarcorporeal radial shockwave and corticosteroid injection in patients with coccydynia
Design
Randomized, with control group, single blinded
Settings and conduct
Patients with coccydynia referred to physical medicine and rehabilitation clinics of Firoozgar hospital randomly assigned into two groups using allocation sequence numbered sealed envelops. physician assessing the outcome measures and data analyser will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: coccydynia more than 2 months, Visual Analog Scale (VAS) equal or greater than 4 in standing, sitting, and supine positions
Exclusion criteria: history of coccyx dislocation, history of fecal and urine incontinency, local infection in coccyx area, history of coccygeal manipulation or injection within last 6 months, poor controlled diabetes mellitus, malignancy, anticoagulant use, low back pain, myelomeningocele, spina bifida, rheumatologic diseases
Intervention groups
Intervention group: radial shock wave
Control group: local corticosteroid injection
Main outcome variables
Pain intensity in standing, sitting and supine positions; Quality of life ; Effect of pain on daily activities and leisure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151020024621N8
Registration date:2019-11-16, 1398/08/25
Registration timing:prospective
Last update:2019-11-16, 1398/08/25
Update count:0
Registration date
2019-11-16, 1398/08/25
Registrant information
Name
Tannaz Ahadi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 8207
Email address
ahadi.t@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Radial Extracorporeal Shockwave and Corticosteroid Injection In The Treatment of Patients With Coccydynia
Public title
Effect of Shockwave and Corticosteroid in Coccydynia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Coccydynia more than 2 months
Visual Analog Scale (VAS) equal or greater than 4
Exclusion criteria:
History of coccyx dislocation
History of fecal and urine incontinency
Local infection in coccyx area
History of coccygeal manipulation or injection within last 6 months
Poor controlled diabetes mellitus
Malignancy
Anticoagulant use
Low back pain
Myelomeningocele
Spina bifida
Rheumatologic diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Participants who will meet the inclusion criteria will assign into two groups using randomly generated treatment allocations produced by an analyst who is not engaged with the enrollment. َSealed opaque envelopes is a method of allocation concealment.Random allocations will be recorded on the card and cards will be placed in the envelops. During the enrollment of each participant, one envelop will be opened and allocation of that participant will be disclosed.
Blinding (investigator's opinion)
Single blinded
Blinding description
physician who is in charge of outcome assessment and data analyser are blinded. blinding of participants could not be done dute the nature of interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences , Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.FMD.REC.1397.088
Health conditions studied
1
Description of health condition studied
coccydynia
ICD-10 code
M53.3
ICD-10 code description
Sacrococcygeal disorders, not elsewhere classified
Primary outcomes
1
Description
Pain intensity in standing, sitting and supine positions
Timepoint
Before and 1 week, 1 month, 2 months, 6 months after treatment
Method of measurement
visual analog scale (VAS)
2
Description
Quality of life
Timepoint
Before and one month after the treatment
Method of measurement
SF-36 questionnaire
3
Description
Effect of pain on daily activity and leisure time
Timepoint
Before and one month after treatment
Method of measurement
Dallas pain questionnaire
Secondary outcomes
1
Description
side effects
Timepoint
one week and one month after treatment
Method of measurement
physical examination
Intervention groups
1
Description
Interُvention group: Radial Shock wave in coccyx area consecutive 3 sessions weekly with 2000 pulse, 5 Hz frequency, Energy bar 3-4
Category
Treatment - Devices
2
Description
Control group: corticosteroid injection : 1 cc triamcinolon acetonide in maximum tender area in sacrococcygeal joint or tip of coccyx
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Sima Hosseinverdi
Street address
Firoozgar Hospital ,Valadi alley, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
simahosseinverdi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abas Motevalian
Street address
Iran University of Medical sciences, Hemmet highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4704
Email
amotevalian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Sima Hosseinverdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Valadi alley, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
simahosseinverdi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tannaz Ahadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar hospital, Valadi alley, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
tannaz.ahadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sima Hosseinverdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar hospital, Valadi alley, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
simahosseinverdi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD