Proctalgia fugax is an anorectal dysfunction characterized by severe, transient , repeated pain with irregular intervals in the anorectal region. Regarding the safety and being noninvasive administration of nitroglycerin among other medical treatments, the aim of this study was to evaluate the effectiveness of nitroglycerin on this disease. A total of 40 patients admitted to the GI clinic of Sanandaj randomly selected and using block method divided in 2 groups of 20 (each block was consisted of 4 people and totally 10 blocks). The intervention group received Nitroglycerin ointment 0.2% and control group received placebo. Drug and placebo were provided by the pharmacist and looks quite similar. Patients were given medication by a trained nurse. The patients as well as researchers were not aware of the type of ointment. Patients were told to use the ointment as much as a cherry core 3 times a day (every 8 hours) on pain site and intra anal for 2 weeks. Patients were assessed at the second week, three months and six months after starting treatment using post treatment questionnaire by treating physician. We defined a remarkable improvement if the number of episodes decreased to a half or the level of pain (according to the VPS) dropped by more than 50%.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122212789N12
Registration date:2016-02-08, 1394/11/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-08, 1394/11/19
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Kurdistan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of topical nitroglycerin 0.2% with placebo on pain severity reduction in patients with proctalgia fugax
Public title
The effect of topical nitroglycerin 0.2% on anal pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria including:
1. Consent to participate in the study
2. Patients with recurrent episodes of severe pain localized in the lower rectum and anus area, and the episodes of pain lasting a few seconds up to 20 minutes and there was no pain between episodes.
Exclusion criteria including:
1. Any proved pathology during clinical history, physical examination and rectosigmoidoscopy in anorectal including (Hemorrhoids, ischemia, anal abscess, anal fissure, rectocele, malignancy, inflammation, anal prolapsed).
2. History of trauma, urinary tract infection, surgery and hysterectomy in recent 6 months
3. Associated symptoms (fever, change in stool consistency, anemia, anal secretions, abdominal pain, weight loss and rectal bleeding).
4. History of heart and neurological disease and aortic stenosis
5. History of hypotension
6. Chronic proctalgia
7. Unwillingness to continue participating in the study
8. Single rectal ulcer
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Postal code
Approval date
2015-05-05, 1394/02/15
Ethics committee reference number
MUK.REC.1394.47
Health conditions studied
1
Description of health condition studied
Proctalgia fugax
ICD-10 code
K59.4
ICD-10 code description
Anal spasm
Primary outcomes
1
Description
Pain severity
Timepoint
The second week, three months and six months after treatment
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
the repetition of pain
Timepoint
The second week, three months and six months after treatment
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention Group:
To use nitroglycerin 0.2% ointment as much as a cherry core 3 times a day (every 8 hours) on pain site and intra anal for 2 weeks.
Category
Treatment - Drugs
2
Description
Control Group:
To use the eucerin (placebo) as much as a cherry core 3 times a day (every 8 hours) on pain site and intra anal for 2 weeks.