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The effectiveness of acupressure on pain and quality of life in women with chronic low back pain who work in hospitals affiliated to Isfahan University of Medical Sciences in 2016

Protocol summary

Summary
This study is a single-blind randomized clinical trial that evaluated 60 nurses with chronic low back pain, working in selected hospitals of Medical Sciences. Inclusion criteria included nurses desire to take part and placed randomly in three groups, aged 25-55 years, take at least 4 scour according to VAS criteria before the intervention, experience nonspecific low back pain continuously for more than three months based on the detection neurosurgeon, absence of severe pain need immediate treatment or surgery, any open wound, being during menstruation and pregnancy, physical pain, such as rheumatic arthritis, autoimmune diseases, addiction and depression. Exclusion criteria included lack of desire to continue, absence of samples from one sessions, use of other methods of complementary medicine, develop other diseases of the lumbar and Serious physical and mental damage.Simple Sampling conduct and samples are randomly divided into two groups of 30 experimental and sham acupressure. Intervention is during for 9 sessions in 3 weeks. The first 2 minutes of each session will be considered to slow stroke massage on hands, legs and waist. And then the each point GB30, BL32, BL60, K1, GV20, and H7 will be pressed for 2 minutes. Demographic and quality of life questionnaire SF36 and VAS scale, during the fourth stage before intervention, immediately after intervention, 2 weeks and 4 weeks after finish of the intervention will be completed by the samples. Data analysis using descriptive statistics and statistical tests in SPSS.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020617387N5
Registration date: 2016-05-28, 1395/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Fatemeh Nazari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7589
Email address
nazari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy Of Research Of Esfahan University Of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acupressure on pain and quality of life in women with chronic low back pain who work in hospitals affiliated to Isfahan University of Medical Sciences in 2016
Public title
The effectiveness of acupressure on pain and quality of life in women with chronic low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included nurses desire to take part and placed randomly in three groups, aged 25-55 years, take at least 4 scour according to VAS criteria before the intervention, experience nonspecific low back pain continuously for more than three months based on the detection neurosurgeon, absence of severe pain need immediate treatment or surgery, any open wound, being during menstruation and pregnancy, physical pain, such as rheumatic arthritis, autoimmune diseases, addiction and depression. Exclusion criteria included lack of desire to continue, absence of samples from one sessions, use of other methods of complementary medicine, develop other diseases of the lumbar and Serious physical and mental damage
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy Of Research Of Esfahan University Of Medical Sciences
Street address
Esfahan University Of Medical Sciences, Hezarjrib street, Esfahan -
City
Esfahan
Postal code
Approval date
2016-01-20, 1394/10/30
Ethics committee reference number
ir.mui.rec.1394.3.738

Health conditions studied

1

Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back strain

Primary outcomes

1

Description
pain
Timepoint
Before the intervention, immediately after intervention, 2 weeks and 4 weeks after intervention
Method of measurement
VAS Scale

2

Description
Quality Of Life
Timepoint
Before the intervention, immediately after intervention, 2 weeks and 4 weeks after intervention
Method of measurement
SF36

Secondary outcomes

1

Description
Fatigue
Timepoint
Before the intervention, immediately after intervention, 2 weeks and 4 weeks after intervention
Method of measurement
FSS questionnaire

2

Description
Quality of sleep
Timepoint
Before the intervention, immediately after intervention, 2 weeks and 4 weeks after intervention
Method of measurement
Pittsburgh questionnaire

Intervention groups

1

Description
Acupressure intervention will be done on the main points GB30, BL32, BL60, K1, GV20, H7 for 2 minutes on each of the points, by the researcher, 9 sessions for 3 weeks and 3 times per week in experimental group. It should be noted that intervention will begin after the completion of menstrual bleeding. as well as to the homogeneity of the samples in the subjects noted that by the end of this technique they do not use the technique at home. In the experimental group, each session lasts 14 minutes, 2 minutes is for initial surface back Stroke to loosen and open channels of Meridian acupressure points and 12 minutes for pressing each of the 6 point (2 minutes for each point).
Category
Treatment - Other

2

Description
Intervention in the sham group carried out by the researcher for 2 minutes on each of the points, 3 times a week for three weeks, with the difference that points of pressure one to one and a half centimeters away from the main points where the pressure is less than acupressure is effective
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Somaye Ghafari
Street address
Esfahan University of Medical Sciences, Hezarjrib Street, Esfahan
City
Esfahan

2

Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Somaye Ghafari
Street address
Esfahan University of Medical Sciences, Hezarjrib Street, Esfahan
City
Esfahan

3

Recruitment center
Name of recruitment center
Montazeri hospital
Full name of responsible person
Somaye Ghafari
Street address
Esfahan University of Medical Sciences, Hezarjrib Street, Esfahan
City
Najaf Abad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy Of Research Of Esfahan University Of Medical Sciences
Full name of responsible person
Ashraf Kazemi
Street address
Esfahan University of Medical Sciences, Hezarjrib street, Esfahan
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Of Research Of Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam movahedi
Position
BS nursing
Other areas of specialty/work
Street address
No. 10, Amin alley, Abshar street, Najaf Abad
City
Najaf Abad
Postal code
8514858577
Phone
+98 31 3792 7544
Fax
Email
maryammovahedi2015@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University Of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Position
PhD
Other areas of specialty/work
Street address
No. 108, Bisim street, Bozorgmehr street, Esfahan
City
Esfahan
Postal code
8174673461
Phone
+98 31 3792 7500
Fax
Email
ghafari_somayeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Position
PhD Of Nursing
Other areas of specialty/work
Street address
No. 108, Bisim street, Bozorgmehr street, Esfahan
City
Esfahan
Postal code
8174673461
Phone
+98 31 3792 7500
Fax
Email
ghafari_somayeh@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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