a clinical trial on the effect of biofeedback therapy in treatment of coccygodynia in patients referring to physical medicine and rehabilitation clinic of Firoozgar hospital
(1)Objectives: the aim of this trial is to investigate the effect of biofeedback therapy in the treatment of patients with coccygodynia.
(2) Design: it is a randomized control trial, single blinded, without placebo control, unicentral and in second or third phase of clinical trial.
(3) Setting and conduct the population under research are patients with coccygodynia referring to physical medicine and rehabilitation clinic via an advertisement. the sample size is 30 people. in all patients, coccydynia is confirmed with superficial and intrarectal palpation. patients will be randomized to 2 groups of 15.
(4) Participants including major eligibility criteria: inclusion criteria are age 18 to 65 years and Visual Analogue Scale equal to or more than 4 in any position of sitting, standing or supine lying and exclusion criteria are coccygeal injection or manipulation in last 2 months, history of poor control diabetes or rheumatologic diseases, coccyx dislocation and Simultaneous biofeedback therapy due to any other reason.
(5) Intervention: the intervention is local injection of methylprednisolone in the point of maximum tenderness and also teaching of pelvic floor exercises for 4 weeks and lifestyle modification in one group and the same work in the other group in combination with pelvic floor biofeedback.
(6) main outcome measures (variables): the patients are followed and assessed of their pain 4 and 8 weeks after the intervention with Visual Analogue Scale. also, patient's quality of life will be tested with a valid questionnaire before and after the intervention. sample collection and intervention will be done in 6 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011824621N4
Registration date:2016-02-17, 1394/11/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-17, 1394/11/28
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
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
a clinical trial on the effect of biofeedback therapy in treatment of coccygodynia in patients referring to physical medicine and rehabilitation clinic of Firoozgar hospital
Public title
the effect of biofeedback therapy in the treatment of coccygodynia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 18 to 65 years; VAS scale equal to or more than 4 in any position of sitting, standing or supine lying
exclusion criteria: coccygeal injection or manipulation in last 2 months; history of poor control diabetes or rheumatologic diseases; any low back pain radiating to sacrococcygeal region or interfering with appropriate position during biofeedback therapy; history of any malignancy, coccyx dislocation; acute fissure; Simultaneous biofeedback therapy due to any other reason
Age
From 18 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics Committee of Iran Universiy of Medical Science
Street address
Hemmat highway, Tehran
City
Tehran
Postal code
Approval date
2016-01-19, 1394/10/29
Ethics committee reference number
IR.IUMS.REC.1394.26154
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
coccygeal pain
Timepoint
before intervention, 4 and 8 weeks after intervention
Method of measurement
Visual Analogue Scale
2
Description
patient's quality of life
Timepoint
before intervention, 4 and 8 weeks after intervention
Method of measurement
the standard SF36 questionare
Secondary outcomes
empty
Intervention groups
1
Description
in the intervention group local injection of 1cc Lidocaine and 1cc of 40 mg Methylprednisolone in the point of maximum tenderness plus teaching of pelvic floor exercises for 4 weeks and lifestyle modification plus pelvic floor biofeedback. biofeedback is a kind of physiotherapy which is done 2 sessions per week, each time for 15 minutes and in total number of 8 sessions for 1 month by a physiotherapist. Pelvic floor exercises are done 3 times a day, each time for 5 minutes by the patient.
Category
Treatment - Other
2
Description
in the control group local injection of 1cc Lidocaine and 1cc of 40 mg Methylprednisolone in the point of maximum tenderness plus teaching of pelvic floor exercises for 4 weeks and lifestyle modification. Pelvic floor exercises are done 3 times a day, each time for 5 minutes by the patient.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar educational hospital
Full name of responsible person
Maryam Hosseini, resident of physical medicine and rehabilitation
Street address
Firoozgar hospital, physical medicine and rehabilitation clinic, Behafarin street, Valiasr square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Pejman Madani
Street address
Hemmat Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University 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
Iran University of Medical Science
Full name of responsible person
Maryam Hosseini
Position
resident of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Hemmat highway, Tehran
City
Tehran
Postal code
Phone
+98 21 86701
Fax
Email
SchoolOfMedicine@iums.ac.ir
Web page address
www.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Tannaz Ahadi
Position
assisstant professor of physical medicine and rehabilitation