Protocol summary

Summary
This study is an investigation of the influence of foot reflexology on pain intensity and disability in patients with low back pain. In this quasi-experimental design, we recruited 150 men with chronic low back pain returnee to Baghiatallah hospital in Tehran, who were able to communicate in Persian, were literacy and had history of low back pain for about 3 months and excluded from study if had not consent for study and used tobacco and alcohol. Participants were selected by purposive sampling and then were divided into three groups using random allocation method: intervention group (foot reflexology was applied in real points once a week for three weeks), control (without any intervention) and placebo (sham foot reflexology was applied low pressure in all points once a week for three weeks). Data were collected by Roland- Morris Disability Questionnaire, Visual Analog Scale and Mc-Gill Questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904304431N1
Registration date: 2013-02-28, 1391/12/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-28, 1391/12/10
Registrant information
Name
Mahdi Rezvani Amin
Name of organization / entity
Baghiatallah University
Country
Iran (Islamic Republic of)
Phone
+98 54 1241 9085
Email address
rezvaniamin@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baghiatallah University of Medical Sciences
Expected recruitment start date
2010-03-11, 1388/12/20
Expected recruitment end date
2010-07-13, 1389/04/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot Reflexology on Disability and Pain Intensity in Chronic Low Back Pain
Public title
The Effect of Foot Reflexology on Low Back Pain
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Able to communicate in Persian; having literacy; health of the legs and history of low back pain more than three months. Exclusion criteria: Patient was not consent to continue participation in the study; death; use of drug, alcohol and tobacco addiction.
Age
From 19 years old to 85 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baghiatallah University of Medical Sciences
Street address
Baghiatallah Hospital, Mollasadra avenue, Vanak Square
City
Tehran
Postal code
Approval date
2010-04-08, 1389/01/19
Ethics committee reference number
354

Health conditions studied

1

Description of health condition studied
Chronic low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Pain intensity
Timepoint
Before of intervention, three weeks and six weeks after intervention
Method of measurement
Short Form Mc-Gill Pain Questionnaire

Secondary outcomes

1

Description
Disability
Timepoint
Before of intervention, three weeks and six weeks after intervention
Method of measurement
Roland Morris Questioner

Intervention groups

1

Description
In intervention group, foot reflexology was applied in real points related to low back pain in once a week for three weeks
Category
Other

2

Description
In placebo group, foot reflexology was applied in all point of sole with pressure lower than intervention group
Category
Placebo

3

Description
In control group, do not apply any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghiatallah Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baghiatallah University of Medical Sciences, Nursing College
Full name of responsible person
Dr. Ebadi
Street address
Araj Square, Aghdasie
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baghiatallah University of Medical Sciences, Nursing College
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
Baghiatallah University of Medical Sciences
Full name of responsible person
Masoud Sirati Nir
Position
Master of science in nursing, Teacher
Other areas of specialty/work
Street address
Aghdasie, Araj Square, Baghiatallah Nursing College
City
Tehran
Postal code
Phone
+98 21 2221 8639
Fax
Email
sirati.info@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baghiatallah University of Medical Sciences
Full name of responsible person
Mahdi Rezvani Amin
Position
Master of science in nursing
Other areas of specialty/work
Street address
No 4, Hashemi st, Jamaran Avenuse, Niavaran Highway
City
Tehran
Postal code
Phone
+98 937 818 8100
Fax
Email
rezvaniamin@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baghiatallah University of Medical Sciences
Full name of responsible person
Mahdi Rezvani Amin
Position
Master of science
Other areas of specialty/work
Street address
No 4, Hashemi st, Jamaran Avenuse, Niavaran Highway
City
Tehran
Postal code
Phone
+98 937 818 8100
Fax
Email
rezvani.1386@yahoo.com
Web page address

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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