Protocol summary

Summary
The aim of this study was to determine the effect of heat treatment on reducing pain from a slipped disc between lumbar vertebrae in patients referred to physiotherapy, Tamine Ejtemaei hospital in Sanandaj. Thirty patients with back pain caused by disc herniation were randomly assigned into equal groups to receive moist heat (hot bag) or dry heat (infrared) for one month, three sessions a week, each time for 15 minutes. Intensity and duration of pain before and after the intervention group were measured and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902163885N1
Registration date: 2010-04-04, 1389/01/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-04-04, 1389/01/15
Registrant information
Name
Mokhtar Yaghobi
Name of organization / entity
Kurdistan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 87 1662 7636
Email address
mokhtar-yaghobi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Management of Kurdistan University of Medical Sciences
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2010-07-21, 1389/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of heat treatment on pain caused by disc herniation
Public title
Effect of heat treatment on pain caused by disc herniation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: at least 6 months experience of low back pain, pain due to disc herniation, lumbar canal stenosis, no other disease, ability to read and write, Exclusion criteria: non-compliance, changing current treatment, other spinal diseases, not willing to continue
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
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
Research Affairs Management and Information Science, Kurdistan University of Medical Sciences
Street address
Research Affairs Management and Information Science, Kurdistan University of Medical Sciences, pasdaran St., Sanandaj
City
Sannadj
Postal code
6617713446
Approval date
2010-03-18, 1388/12/27
Ethics committee reference number
11961پ14پ

Health conditions studied

1

Description of health condition studied
lumbar disk herniation
ICD-10 code
M51.1
ICD-10 code description
lumbar and other intervertebral disc disorder

Primary outcomes

1

Description
Incidence of pain
Timepoint
Before intervention and immediately after intervention
Method of measurement
numeric pain VAS and data record sheet

2

Description
Duration of pain
Timepoint
Before and after intervention
Method of measurement
In minutes

Secondary outcomes

1

Description
Incidence of behavioral signs of pain
Timepoint
Before and immediately after intervention
Method of measurement
observation

Intervention groups

1

Description
moist heat (hot bag) within one month, three sessions a week, 20 minutes each time
Category
Prevention

2

Description
Dry heat (infrared) for a month, three sessions a week, each time for 15 minutes
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy ward, Tamie Ejtemaei hospital, Sanandaj
Full name of responsible person
Mokhtar Yaghobi
Street address
Department of Operating Room, School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Mokhtar Yaghobi
Street address
Department of Operating Room, School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Mokhtar Yaghobi
Position
Master of Science in Nursing Education - Lecturer School of Nursing and Midwifery
Other areas of specialty/work
Street address
Department of Operating Room, School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj
City
Sanandaj
Postal code
6617713446
Phone
+98 87 1662 7636
Fax
+98 87 1666 0092
Email
mokhtar-yaghobi@muk.ac.irmy11202002@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Mokhtar Yaghobi
Position
Master of Science in Nursing Education
Other areas of specialty/work
Street address
Department of Operating Room, School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj
City
Sanandaj
Postal code
6617713446
Phone
+98 87 1662 7636
Fax
+98 87 1666 0092
Email
mokhtar-yaghobi@muk.ac.irmy11202002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Mokhtar Yaghobi
Position
Master of Science in Nursing Education
Other areas of specialty/work
Street address
Department of Operating Room, School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj
City
Sanandaj
Postal code
6617713446
Phone
+98 87 1662 7636
Fax
+98 87 1666 0092
Email
mokhtar-yaghobi@muk.ac.irmy11202002@yahoo.com
Web page address
www.muk.ac.ir/research

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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