Protocol summary

Study aim
Determination of the effect of Nettle spray on the pain of patients with low back pain referring to Orthopedic Clinic.
Design
In this study, 40 people who are referred to orthopedic clinics who are studying are selected, and randomly assigned to the intervention and control group.
Settings and conduct
The present study is a randomized clinical trial. The aim of this study was to determine the effect of nettle spray on chronic back pain in patients referred to Vaseji Hospital in Sabzevar city in 1396. In this study, 40 patients from the study population aged 40-80 years Two groups of recipients of nettle spray and routine treatment will be divided. In the intervention group, nettle spray will be used topically twice a day and twice daily, and the pain intensity will be investigated at the beginning and the end of the intervention.
Participants/Inclusion and exclusion criteria
1-Inclination to participate in research 2- Being Aware of Answering Questions 3- Having at least 40 years of age 4-Confirmation of Chronic Low Back Pain with Interview 5-having pain for more than three months
Intervention groups
A nettle spray will be given to each group of interventions. Which should be used topically twice a day for one week.
Main outcome variables
Pain, age, gender, employment status, nettle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171217037930N1
Registration date: 2018-03-20, 1396/12/29
Registration timing: retrospective

Last update: 2018-03-20, 1396/12/29
Update count: 0
Registration date
2018-03-20, 1396/12/29
Registrant information
Name
Azadeh Khani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3228 1031
Email address
khania94@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-03-18, 1396/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Nettle Spray on the Pain of Patients with Chronic Low Back Pain Referring to Sabzevar Orthopedic Clinic
Public title
Nettle Effect in Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with at least 40 years of age who have chronic back pain (more than 3 months) Inclination to participate in research Being alert for answering questions
Exclusion criteria:
Drug addiction There is a complication behind which urine spray can not be used use other therapies,such as physiotherapy,warm water bags
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of the intervention and control groups.
Blinding (investigator's opinion)
Not 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 Sabzevar University of Medical Sciences
Street address
Univercity campus, The City of Tawhid Blvd, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2017-12-06, 1396/09/15
Ethics committee reference number
IR.medsab.RCE.1396.76

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
People who have chronic pain (pain more than three months)
Timepoint
Measurement of pain at the beginning of the study and one week after the onset of nettle spray
Method of measurement
Pain Relief Tool (visual analogue pain)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group of net urine spray made inside the country, for one week and twice a day, it is used topically.
Category
Treatment - Drugs

2

Description
Control group: In this group, the treatment prescribed by the doctor will be used, the severity of pain will be examined at the beginning of the design and after one week.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Azadeh khani
Street address
Bilvar City Tawhid, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4465 1300
Email
Vasei.h@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ghorat Fereshteh
Street address
Tohid shahr, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8319
Email
VCResearch@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Koushan Mohsen
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tohid shahr, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8319
Email
Mkoushan42@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Koushan Mohsen
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tohid shahr, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8319
Fax
Email
Mkoushan42@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Azadeh khani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 8 , West Shahid Alamy2 , Melli
City
Bojnord
Province
North Khorasan
Postal code
9417175194
Phone
+98 58 3228 1031
Email
khaniA94@medsab.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
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