Protocol summary

Study aim
Determining the effect of topical application of black broad tail scorpion oil on pain in patients with chronic sciatica
Design
A parallel-group, double-blind, randomized clinical trial
Settings and conduct
The place of study is Tehran Traditional Medicine Research Center (Ahmadiyeh Health Center located on Khodaparast Street). The present study is a double-blind randomized clinical trial study. The study is conducted on 84 patients with chronic sciatica for 4 weeks. The study is double-blind (lack of knowledge of the patient and the researcher). How to use topical ointment: 3 times a day (morning, noon, night) each time in the size of 2 knuckles in the lower back area (from L1 down), buttock area to the middle of the back of the thigh on the side that hurts, for 4 weeks along with The massage will be rubbed. Also, due to compliance with ethical principles and not depriving patients of common treatments, study participants (both groups) can take diclofenac 25 mg tablets up to 2 times a day if they feel the need and severe pain.
Participants/Inclusion and exclusion criteria
-Entry criteria: 1-Patient with sciatica pain that lasts for at least 12 weeks 2-Age over 18 years 3-Pain equal to 4 or more based on VAS criteria 4-Not a candidate for surgery 5-Lack of any surgical history Exclusion criteria: 1-Pregnancy or breastfeeding 2-Creating severe side effects 3-Severe sensitivity to any of the drugs used in the study 4-Not agreeing to continue participating in the study 5-Intensification of the patient's pain and lack of control
Intervention groups
The first group received medicated ointment containing scorpion oil and the second group received placebo ointment containing liquid paraffin.
Main outcome variables
Severity of leg and back pain with the Visual Analogue Scale

General information

Reason for update
Acronym
-
IRCT registration information
IRCT registration number: IRCT20240916063059N1
Registration date: 2024-10-17, 1403/07/26
Registration timing: prospective

Last update: 2024-10-17, 1403/07/26
Update count: 0
Registration date
2024-10-17, 1403/07/26
Registrant information
Name
Yaیزدانzdan Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3256 7175
Email address
yazdanamini1213@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-05, 1403/08/15
Expected recruitment end date
2025-03-04, 1403/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of topical use of Black fat-tailed scorpion oil (Androctonus crassicauda ) on the pain of patient with chronic sciatica: A double-blind randomized clinical trial
Public title
Investigating the topical effectiveness of Black fat-tail scorpion oil on pain in patients with chronic sciatica
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patient with chronic sciatica pain for at least 12 weeks 2- Age above 18 years 3- Pain equivalent to 4 or more based on VAS criteria 4- Willingness of patients to cooperate in the study 5- People without communication problems. 6- Pain that is not due to malignancies, inflammatory joint diseases, etc. 7- Don't have congenital abnormalities of the spine and bone fractures. 8- Not a candidate for surgery. 9- Absence of any history of surgery in the back area 10- Not having a history of alcohol and narcotic drugs 11- BMI between 18.4 and 35
Exclusion criteria:
1- Pregnancy or breastfeeding 2- causing severe side effects 3- Severe sensitivity to any of the drugs used in the study 4- Lack of consent to continue participating in the study 5- Patients with a history of lumbar disc surgery 6- Concurrent acute illness or accident during the study 7- People suffering from favism 8- Intensification of the patient's pain and its lack of control 9- Use of non-pharmacological soothing treatments 10- Use of painkillers outside the study program during the study 11- Symptoms of cauda equina syndrome 12- Occurrence of serious clinical symptoms during treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method is used to divide people into two groups. The first group uses oleogel containing scorpion oil and placebo (oleogel without scorpion oil) is used on the second group. Simple Random Sampling (Simple Random Sampling) is one of the statistical sampling methods in which people in the community have an equal chance of being selected. In this method, each element of the desired statistical population has an equal chance to be selected. In this method, the needed people or objects are randomly selected from the list of the statistical population that is numbered and prepared for this purpose. According to the law of probability, the selected people should have the same characteristics as the society from which they were selected. The advantage of the authentication block method is the balance of the number of participants in two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicines and placebo are in similar tubes with the same shape, color and smell. The specific codes are written by the pharmacist on the label of the medicine container and the placebo so that the patients and the researcher do not know the meaning of the codes.
Placebo
Used
Assignment
Parallel
Other design features
Due to compliance with ethical principles and not depriving patients of common treatments, study participants (both groups) can take diclofenac 25 mg tablets up to 2 times a day, one at a time, if they feel the need and have severe pain. As much as medicinal ointment is more effective than placebo on the pain intensity of patients, the amount of oral pain reliever (diclofenac) should be lower in the first group than in the second group (placebo ointment recipient). Accordingly, the participants are asked to write down the number of diclofenac consumed per day and finally inform the presenter.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Alborz University of Medical Sciences
Street address
Deputy Research Building., Shahid Safarian Alley., 45-meter Golshahr St., Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2024-09-18, 1403/06/28
Ethics committee reference number
IR.ABZUMS.REC.1403.150

Health conditions studied

1

Description of health condition studied
Chronic Sciatica
ICD-10 code
M00-M99
ICD-10 code description
Disease of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
Severity of leg and back pain
Timepoint
at the beginning of the study (before the start of the intervention) and 7, 14, 21 and 28 days after the start of the study
Method of measurement
Visual Analogue Scale for leg and back pain intensity

Secondary outcomes

1

Description
The number of diclofenac tablets taken daily
Timepoint
Length of study
Method of measurement
number

2

Description
The degree of disability of patients
Timepoint
before the start of the study and 4 weeks after the start of the study (end of the study)
Method of measurement
Questionnaire Oswestry Disability Index

3

Description
Skin Adverse effect
Timepoint
Days 3, 7, 14, 21 and 28 after the start of the study
Method of measurement
Skin side effects form based on CTCAE version 5 (Common Terminology Criteria for Adverse effects)

Intervention groups

1

Description
Intervention group: Recipient of topical ointment containing scorpion oil: 3 times a day (morning, noon, night) each time in the size of 2 knuckles in the lumbar area (from L1 down), buttock area to the middle of the back of the thigh on the side that hurts, for 4 The week will be rubbed along with the massage. If they feel the need and have severe pain, they can take diclofenac 25 mg tablets up to 2 times a day, one at a time.
Category
Treatment - Drugs

2

Description
Control group: recipient of topical ointment containing liquid paraffin: 3 times a day (morning, noon, night) each time the size of 2 knuckles in the lumbar region (from L1 down), buttock region to the middle of the back of the thigh on the side that has pain. It will be applied for 4 weeks along with massage. If they feel the need and have severe pain, they can take diclofenac 25 mg tablets up to 2 times a day, one at a time.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Traditional Medicine Research Center (Salam Takdeh Ahmadiyya located on Khodaparast St.)
Full name of responsible person
Alireza abbasian
Street address
No. 42, Next to the Tabriz Alley, North Sarparast Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4535
Fax
Email
spm@tums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Doctor Mohammad Mahdi Ahmadian
Street address
Department of Pharmacognosy, Faculty of Pharmacy, Alborz University of Medical Sciences, Valiasr Boulevard, Shora Blvd., Azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Fax
Email
info@abzums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Yazdan Amini
Position
Non-faculty student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Alborz University of Medical Sciences.,Valiasr Blvd.,Shura Blvd.,Azimieh.,Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Fax
Email
yazdanamini1213@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Yazdan Amini
Position
Non-faculty student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Alborz University of Medical Sciences., Valie-asr Blvd., Shura Blvd., Azimieh., Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
yazdanamini1213@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Yazdan Amini
Position
Non-faculty student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy., Alborz University of Medical Sciences., Vali-e asr Blvd., Shura Blvd., Azimieh., Karaj
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3419 7000
Email
yazdanamini1213@gmail.com

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
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