The aim of this study is to determine the effect of both, warm and cold therapy on pain in patients with low back pain treatment. This study is a clinical trial. 87 men and women who are 20-50 years old with acute low back pain (pain that is less than one month) referred to the Ayatollah orthopedic clinic in the Kashan University of Medical Sciences with the convenience sampling method. Patients are divided randomly into three groups (warm, cold therapy, and control group). All three groups treated with Naproxen 500 mg tablets twice a day for one week. Group A: They treat with a warm water bag for 20 minutes twice daily in a week. Group B: They treat with ice for 20 minutes twice daily in a week. Group C: They treat just with Naproxen. All patients are examined in days 0, 3, 8, 15 and standardized measure of pain will be collected based on the McGill pain questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303106480N5
Registration date:2013-04-18, 1392/01/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-18, 1392/01/29
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research Affairs, Shahrekord University of Medical Sciences.
Expected recruitment start date
2013-03-15, 1391/12/25
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of heat and cold therapy on acute back pain in patients referred to Orthopaedic Clinic of Kashani hospital in Shahrekord
Public title
The effectiveness of warm therapy and cold therapy on acute back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients (men and women) who are between 20 and 50 years old suffering from acute low back pain (LBP); back pain in patients is less than one month ) referred to the orthopedic clinic; willingness to participate in the study.
Exclusion criteria: history of those diseases, including: cardiovascular, kidney, lung, endocrinology and metabolism diseases and etc; patients who had a history of trauma; patients who consumed other medications to relieve pain other than Naproxen; patients who were treated with physiotherapy and patients with unwillingness to continue treatment.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
87
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Kashani Blvd, Secretery of Shahrekord University of Medical Sciences, Deputy of Research Affairs
City
Shahrekord
Postal code
Approval date
2012-01-10, 1390/10/20
Ethics committee reference number
90-10-32
Health conditions studied
1
Description of health condition studied
Acute back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 15th, 8th, 30th day after intervention
Method of measurement
McGill standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Under treatment with oral naproxen 500 mg twice daily and warm water bag daily for 20 minutes twice in a week
Category
Treatment - Other
2
Description
Under treatment with 500 mg Naproxen twice daily and under treatment with ice for 20 minutes in a day, twice in a week
Category
Treatment - Other
3
Description
Treated with oral naproxen 500 mg twice a day for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Ayatallah Kashani Hospital
Full name of responsible person
Dr Morteza Dehghan
Street address
Kashani Blvd
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research Affairs, Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmoud Mobasheri
Street address
Kashani Blvd
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Affairs, Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University OF Medical Sciences
Full name of responsible person
Dr Morteza Dehghan
Position
Assistant Professor in Orthopedics Department
Other areas of specialty/work
Street address
Kashani Hospital,Orthopedics Department
City
Shahrekord
Postal code
Phone
+98 38 1226 4835
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord university of Medical Sciences
Full name of responsible person
Dr Morteza Dehghan
Position
Orthopedic Surgery
Other areas of specialty/work
Street address
Ayatallah Kashani Hospital
City
Shahrekord
Postal code
Phone
+98 38 1226 4835
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)