To determine the effects of ECSWT on pain in patients with chronic coccydynia, in a single blind interventional clinical study, including patients with chronic coccydynia without acute fracture,
patients will be randomly divide into intervention and control groups. All the patients in the intervention group will receive ECSWT with radial probe delivering 3,000 shock waves of 2 Bar per session with 21 Hz frequency directed to the coccyx in 4 sessions by 1 week intervals. The control group will be treated with one episode of steroid injection (Triamcinolone 40mg) instead. The pain severity will be recorded according to VAS scale before beginning of therapy and 1 and 6 months after ending the therapy. All data will studied with a person who has no information about the case or control groups. Each group contains 10 patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071921673N2
Registration date:2015-07-27, 1394/05/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-27, 1394/05/05
Registrant information
Name
Mahboobeh Mashayekhi Asl
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3443 9361
Email address
h.ghasemi@eng.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-05-01, 1393/02/11
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Extracorporeal Shock Wave Therapy on Pain in Patients with Chronic Refractory Coccydynia
Public title
Effects of Extracorporeal Shock Wave Therapy on Pain in Patients with Chronic Refractory Coccydynia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least 18y old; At least 24-month history of pain in coccygeal area being triggered by changing position without radiation; Had received conservative therapies for at least 1 year without recovery;
Exclusion criteria: Acute coccygeal fractures; Tumors; Osteomyelitis; Pilonidal abscess; Genitourinary incontinency; Neurologic deficit; Opium addiction;
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Daneshgah st.
City
Isfahan
Postal code
Approval date
2015-07-11, 1394/04/20
Ethics committee reference number
IR.MUI.REC.1394.1.048
Health conditions studied
1
Description of health condition studied
Coccygodynia
ICD-10 code
M53.3
ICD-10 code description
Sacrococcygeal disorders, not elsewhere classified
Primary outcomes
1
Description
Pain severity
Timepoint
Before Intervention, 4w after last intervention, 6m after last intervention
Method of measurement
VAS score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: ECSWT with radial probe delivering 3,000 shock waves per session of 2 Bar with 21 Hz frequency directed to the coccyx, 4 session of ECSWT with 1 week intervals.
Category
Treatment - Devices
2
Description
Control: Triamcinolone 40mg, Ampule, Injection, only once.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashany Hospital
Full name of responsible person
Mahboobeh Mashayekhi Asl
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Univercity of Medical Sciences
Full name of responsible person
Shila Haghighat M.D.
Street address
Physical medicine and rehabilation Group, Medical Department, Isfahan University of Medical Sciences, Daneshgah St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Univercity of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahboobeh Mashayekhi Asl
Position
Resident, Phisycal Medicine and Rehabilitation
Other areas of specialty/work
Street address
Phisycal Mmedicine and Rrehabilitation Group, Al-Zahra Hospital,
City
Isfahan
Postal code
Phone
+98 31 3443 9361
Fax
Email
mashayekhi.asl@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Univercity of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Physiatrists
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Group, Medical Department, Isfahan University of Medical Sciences, Daneshgah st.
City
Isfahan
Postal code
Phone
+98 31 3623 4508
Fax
Email
haghighatshila@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahboobeh Mashayekhi Asl M.D.
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation, Medical Department, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3443 9361
Fax
Email
mashayekhi.asl@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)