To evaluate the effect of biofeedback on pain and quality of life of patients with chronic coccydynia
Design
Clinical trial with control group, with parallel groups, randomized, no blinding, on 64 patients. The rand function of Excel software was used for randomization
Settings and conduct
patients with chronic coccydynia referred to the physical medicine and rehabilitation clinic of Imam Reza Hospital in Tehran in 1403
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years with a VAS score equal to or greater than 4 in any of the sitting, standing or lying positions for at least 2 months, with no history of coccyx injection or manipulation in the past two months, no systemic diseases (poorly controlled diabetes, rheumatoid arthritis, etc.), no history of malignancy, dislocation of the coccyx, no acute fissure, and no simultaneous biofeedback treatment to treat other pelvic floor disorders
Intervention groups
Patients with chronic pelvic pain under Kegel exercises and 8 sessions of pelvic floor biofeedback
Main outcome variables
Visual analog scale and 12-question quality of life questionnaire (SF-12 )and Dallas pain questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250203064633N1
Registration date:2025-02-15, 1403/11/27
Registration timing:retrospective
Last update:2025-02-15, 1403/11/27
Update count:0
Registration date
2025-02-15, 1403/11/27
Registrant information
Name
Hamidreza Matin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8609 6350
Email address
h.matin@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
2024-07-05, 1403/04/15
Actual recruitment end date
2024-12-21, 1403/10/01
Trial completion date
2024-12-21, 1403/10/01
Scientific title
Investigating the effect of pelvic floor biofeedback on pain and quality of life of patients with chronic coccydynia
Public title
Investigating the effect of pelvic floor biofeedback on pain and quality of life of patients with chronic coccydynia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic coccyx pain with a VAS score equal to or greater than 4 in any of the sitting, standing or lying positions for at least 2 months, with no history of injection or manipulation of the coccyx in the past two months.
Exclusion criteria:
Absence of systemic diseases (poorly controlled diabetes, rheumatoid arthritis, etc.)
No history of malignancy
Absence of coccyx dislocation
Absence of acute anal fissure
Absence of simultaneous biofeedback treatment to treat other pelvic floor disorders
There were patients who no longer wanted to continue the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Actual sample size reached:
57
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی ارتش ایران kamiteh akhlagh daneshgah alum pezeshki ertash iran Ethics
Street address
West Fatemi St., not reaching Shahid Chamran Highway, Etemadzadeh St
City
تهران
Province
Tehran
Postal code
1411718546
Approval date
2024-06-11, 1403/03/22
Ethics committee reference number
IR.AJAUMS.REC.1403.058
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
Visual Analogue Scale
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the 4th and 12th week
Method of measurement
Visual Analogue Scale
2
Description
Short form health survey 12
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the 12th week
Method of measurement
Short form health survey 12
3
Description
Dallas pain questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the 12th week
Method of measurement
Dallas pain questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with coccydynia treated with Kegel exercises and 8 sessions of pelvic floor biofeedback
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital (AS) - 501 Army
Full name of responsible person
Hamidreza Matin
Street address
Tehran - Fatemi West St. - Shahid Etemadzadeh St. - Imam Reza (AS) Hospital - 501 Artesh
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
H.matin@ajaums.ac.ir
Web page address
https://imamreza.ajaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hamidreza Matin
Street address
Tehran - Fatemi West St. - Shahid Etemadzadeh St. - Imam Reza (AS) Hospital - 501 Artesh1
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
H.matin@ajaums.ac.ir
Web page address
https://www.ajaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Hamidreza Matin
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Tehran - Fatemi West St. - Shahid Etemadzadeh St. - Imam Reza (AS) Hospital - 501 Artesh
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
H.matin@ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hamidreza Matin
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Tehran - Fatemi West St. - Shahid Etemadzadeh St. - Imam Reza (AS) Hospital - 501 Artesh
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
H.matin@ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hamidreza Matin
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Tehran - Fatemi West St. - Shahid Etemadzadeh St. - Imam Reza (AS) Hospital - 501 Artesh
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
H.matin@ajaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available