This study is a randomized, double-blind, non-placebo controlled and single-center clinical trial. The aim of this study is to compare the efficacy of local Dextrose 20% injection as a prolotherapy solution and corticosteroid injection as a standard treatment for treating the coccygodynia. This study include 32 patients who have coccygodynia for over 2 months and their visual analogue scale pain score (VAS) is greater than or equal to four. Patients with coccyx dislocation, history of coccyx injection in 6 month ago and pain duration less than 2 months are not enrolled. Using block randomization, patients are categorized to one of two groups: 1. Local injection of dextrose 20% as an intervention group, 2. Local injection of corticosteroid (methylprednisolone) as a control group. Patients don't know about their group. All patients after giving ethical consent undergoing transrectal coccyx manipulation. In all patients after skin prep, anesthesia with 2 milliliter lidocaine 2% will be done. 8 cc of dextrose 20% in the first group and 1 milliliter methylprednisolone 40 milligrams in the second group inject topically and transdermally in the maximum tenderness area of coccyx. Both groups of patients are evaluated by resident of Physical medicine and rehabilitation who are not aware of the type of injection. This evaluation is performed before injection, a week later (by phone) and 1 month after the injection (by visit) via VAS (sitting, standing and supine). Finally, statistical comparison of results will perform.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080418687N1
Registration date:2014-09-03, 1393/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-03, 1393/06/12
Registrant information
Name
Lobat Majidi
Name of organization / entity
Department of physical medicine and rehabilitation, Iran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1679
Email address
lobat.majidi@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2014-08-30, 1393/06/08
Expected recruitment end date
2014-10-30, 1393/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between local injection of dextrose 20% and corticosteroid in coccygodynia treatment: Clinical Randomized Trial
Public title
Clinical trial of comparison between dextrose and corticosteroid injection on coccygodynia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: From 18 up to 75 years old patients; Pain duration more than 2 month, VAS(visual analog scale) is greater than or equal to 4 (In each of sitting, standing and supine position); No injection of the coccyx in 6 months ago; Coccyx dynamic radiography and patient history don't show coccyx dislocation.
Exclusion criteria: Age less than 18 and more than 75 years old; History of coccyx injection in 6 month ago; Pain duration less than 2 months; Poorly controlled diabetes mellitus; History of rheumatic diseases; Concomitant low back pain; History of malignancy; Coccyx dislocation; Radiographic coccyx spicule; Bowel and bladder incontinence; Coagulopathy; Myelomeningocele and spina bifida; Skin abnormality in injection site; Concurrent pelvic floor physiotherapy.
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Each participant is randomly assigned to a group via block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
6th floor, Central Organization of university, Keshavarz Boulevard, Tehran
City
Tehran
Postal code
Approval date
2013-10-30, 1392/08/08
Ethics committee reference number
130/1645/د/92
Health conditions studied
1
Description of health condition studied
Coccygodynia
ICD-10 code
M53.3
ICD-10 code description
Sacrococcygeal disorders, not elsewhere classified, Coccygodynia
Primary outcomes
1
Description
VAS(visual analogue scales) in standing, sitting and supine position
Timepoint
before intervention, 1 week after intervention, 1 month after intervention
Method of measurement
How much pain patient can feel, what is the score of your pain? From 0 (no pain) up to 10 (the worst pain experienced in his/her life)? Patient shows its pain on 10 centimeters special Ruler.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, Trans rectal manipulation of the coccyx will be done. Then for anesthesia, 2 milliliter of lidocaine 2% inject on coccyx. After local anesthesia, 8 milliliter of dextrose 20 % inject in maximum tender point of the coccyx for prolotherapy at single dose.
Category
Treatment - Drugs
2
Description
Control group: First, Trans rectal manipulation of the coccyx will be done. Then for anesthesia, 2 milliliter of lidocaine 2% inject on coccyx. After local anesthesia, 1 milliliter of methylprednisolone 40 milligram inject in maximum tender point of coccyx at single dose, as a standard treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of physical medicine and rehabilitation, Firoozgar Hospital
Full name of responsible person
Lobat Majidi, Resident of physical medicine and rehabilitationi