Comparison of the analgesic effects of topical application Althaea officinalis ointment and Piroxicam gel in patients with chronic low back pain
Design
This study is a clinical trial with parallel groups, double blind, randomized, phase 3 on 110 patients
Settings and conduct
Among the people referring to the medical centers of Fasa University of Medical Sciences, people who suffer from chronic non-specific low back pain based on clinical evaluation and doctor's approval are included in the study after obtaining informed consent. 110 patients with chronic low back pain are purposefully selected and randomly divided into 2 groups of 55 people.One group receives Althaea officinalis ointment and the other group receives Piroxicam gel.The drugs are given to patients in coded containers and without names.This is a double-blind clinical trial (outcome assessor-patients)
Participants/Inclusion and exclusion criteria
Patient informed consent; doctor's approval; back pain for more than three months; pain intensity higher than 3 on the Visual Analogue Scale; score higher than 4 in the Roland-Morris Disability Questionnaire
Intervention groups
Intervention group 1: 2.5 gr of Athaea officinalis ointment used topically twice a day for each person and Acetaminophen 500 mg tablets once a day for 14 days
Intervention group 2: 2 gr of 0.5% Piroxicam gel, which is used twice a day for each person and Acetaminophen 500 mg tablets once a day for 14 days
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050387N1
Registration date:2021-03-27, 1400/01/07
Registration timing:prospective
Last update:2021-03-27, 1400/01/07
Update count:0
Registration date
2021-03-27, 1400/01/07
Registrant information
Name
Maryam Kianitabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 0994
Email address
m.kianitabar@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effects of Topical application Althaea officinalis ointment and Piroxicam gel in patients with chronic low back pain
Public title
Evaluation of the effect of Althaea officinalis ointment in chronic low back pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient informed consent
Doctor's approval
Back pain for more than three months
Pain intensity higher than 3 on the Visual Analogue Scale
Score higher than 4 in the Roland-Morris Disability Questionnaire
Exclusion criteria:
Having surgery, fractures, dislocations and sprains in the spine
Diseases such as osteoporosis, osteoarthritis, cancer, rheumatism, disc herniation, sciatica, inflammatory diseases, malignant tumors
Nervous system diseases and spinal cord injuries
Skeletal malformation
Severe structural disorder of the lower limbs and spine
Pregnancy
Injectable analgesics and corticosteroids
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
A 2 groups will be studied and each of the letters A and B will be assigned to an intervention group, 6 possible modes for placing the letters A and B in
will be considered in blocks of 4. 28 blocks of 4 will be considered. For concealment, the type of intervention is written in a random allocation sequence, placed in opaque sealed envelopes and are encoded on the envelopes in order.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients randomly divided into 2 groups of 55 people.One group receives Althaea officinalis ointment and the other group receives Piroxicam gel.The drugs are given to patients in coded containers and without names.This is a double-blind clinical trial (outcome assessor-patients)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Avicenna square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2021-03-02, 1399/12/12
Ethics committee reference number
IR.FUMS.REC.1399.176
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain intensity
Timepoint
Beginning of the intervention - end of the intervention and 2 weeks after the end of the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Functional Disability
Timepoint
Before intervention - end of the intervention
Method of measurement
Roland-Morris Disability Questionnaire
2
Description
Blood pressure
Timepoint
Before intervention - end of the intervention
Method of measurement
Aneroid Sphygmomanometer
3
Description
Oxygen saturation
Timepoint
Before intervention - end of the intervention
Method of measurement
Finger Pulse Oximeter
4
Description
Pulse rate
Timepoint
Before intervention - end of the intervention
Method of measurement
Finger Pulse Oximeter
5
Description
Respiratory rate
Timepoint
Before intervention - end of the intervention
Method of measurement
Stopwatch
Intervention groups
1
Description
Intervention group: 2.5 gr of 20% Althaea officinalis ointment produced in the laboratory of medicinal plants of Fasa University of Medical Sciences used topically twice a day for each person and Acetaminophen 500 mg tablets (manufactured by Zagros darou) once a day for 14 days.
Category
Treatment - Drugs
2
Description
Intervention group: 2 gr of 0.5% Piroxicam gel(manufactured by Razk laboratories), which is used twice a day for each person topically, and Acetaminophen 500 mg tablets(manufactured by Zagros darou) once a day for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers of Fasa University of Medical Sciences
Full name of responsible person
Maryam Kianitabar
Street address
Medical centers of Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
m.kianitabar@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Avicenna square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Fax
+98 71 5335 7091
Email
research@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Dr. Leila Nikrouz
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Avicenna square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
L.nikrouz@fums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Leila Nikrouz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Avicenna square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
L.nikrouz@fums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Maryam Kianitabar
Position
Master student of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Avicenna square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Fax
Email
m.kianitabar@fums.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