This study was double-blind a clinical trial. The study population consisted of 50 female and male nurses suffering from chronic low back pain working in hospitals affiliated with Isfahan University of Medical Sciences. This research has been conducted to investigate the effect of reflexology on chronic low back pain intensity .Nurses were included if they had, chronic non-specific back pain diagnosed by a neurosurgery specialist for more than 3months, healthy feet without injury or damage. The subjects were excluded if they, were pregnant or lactating, or had a vascular disease , thrombo phlebitis or diseases such as urinary tract infection or kidney stones (with pain in the lower back). The participants were randomized and divided into two groups of reflexology and non-specific massage. A questionnaire three section by researcher was made and completed through interviews. The 40 minute sessions of interventions were performed three times a week for two weeks. Pain intensity was measured by Numerical Analogue Scale for pain before and immediately after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108217391N1
Registration date:2016-06-05, 1395/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-05, 1395/03/16
Registrant information
Name
Maryam Eghbali Babadi
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7539
Email address
eghbali@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2010-04-05, 1389/01/16
Expected recruitment end date
2010-07-20, 1389/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of reflexology on chronic low back pain intensity in nurses
Public title
The effect of Reflexology on chronic low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Nurses were included if they had low back pain; chronic non-specific back pain diagnosed by a neurosurgery specialist for more than 3months; healthy feet without injury or damage; and willingness to participate in the study.On the other hand, subjects were excluded if they had participated in another clinical research during the past 3 months;had an experience or knowledge of reflexology; were pregnant or lactating; used other methods of complementary therapy during the study;or had a vascular disease ; thrombophlebitis or diseases such as urinary tract infection or kidney stones (with pain in the lower back).
exclusion criteria: They were also excluded if any physical damage; making the subjects unable to continue their participation; was made or if they used new medical treatments (new drugs effective on pain; physical therapy or other methods).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Total of 50 nurses with chronic back pain
were selected by simple random sampling method. They
were then randomly numbered. Afterwards, individuals
with odd and even numbers were assigned to the
reflexologyand nonspecific massage
groups, respectively
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
009881746-73461
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUI.REC.1389.3.008
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
Low back pain
Timepoint
Before and Immediately after the intervention
Method of measurement
Numerical Analogue Scale of Pain
Secondary outcomes
1
Description
NO
Timepoint
Before intervention and Immediately after intervention
Method of measurement
McGill Mlzak questionnaire
Intervention groups
1
Description
Intervention group:In this group, reflexology performed 3 times a week for two continuous weeks and each session was 40 minutes. In this group, a simple massage from the lower legs to the ankles, soles and finally toes. Then specific reflexology was performed on all reflex points on the feet.
Category
Prevention
2
Description
Control group:In this group, simple and nonspecific massage performed 3 times a week for two continuous weeks and each session was 40 minutes. However, simple massaging was not followed by deep stimulation of reflexology points in this group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospitals
Full name of responsible person
Street address
City
ISFAHAN
2
Recruitment center
Name of recruitment center
Kashani Hospitals
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
peyman adibi
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
________
Grant code / Reference number
______
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
reza safari
Position
MSc Student
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences،School Of Nursing And Midwifery
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3792 2940
Fax
Email
reza.safari1356@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Maryam Eghbali Babadi
Position
PhD Candidate And academic member
Other areas of specialty/work
Street address
School Of Nursing and Midwifery, Isfahan University Of Medical Sciences
City
Isfahan
Postal code
009881746-73461
Phone
+98 31 3792 2940
Fax
Email
eghbali@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
fatemeh nazari
Position
Academic member- PhD Candidate
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3792 7589
Fax
Email
nazari@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)