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determine the effect of acupressure on severe low back pain and depression in patients with chronic low back pain

Protocol summary

Study aim
Determining the effect of acupressure on severe low back pain and depression in patients with chronic low back pain
Design
Patients were divided into two groups of intervention and sham treatment by random one-way blind and parallel block with sealing wax bag. In each group, 46 people were placed.
Settings and conduct
individuals with inclusion criteria will be included in the study, then will be randomly divided into two groups of intervention and sham treatment, and acupressure training will be given to both groups and the intervention will be performed for one month and analysis Statistics will be done by Spss software, The research samples will include patients with chronic low back pain referred to the neurology clinic of Razi Hospital.
Participants/Inclusion and exclusion criteria
Conscious consent to participate in the study, having low back pain for more than 12 weeks, their cause of low back pain should not be spinal problems, no wounds, infections or fractures at the point of acupressure or treatment points, age 18 years And above, the patient is not pregnant, does not use other traditional or complementary medicine treatments, does not use acupressure for the past 12 months, does not have malignancy or autoimmune diseases Criteria for non-inclusion: dissatisfaction to participate in the study
Intervention groups
Acupressure is performed on Feng Chi, Shu fu and Yin Tong points using the pulp of the thumb. Pressure (at a rate of 3 to 4 kg) for 5 minutes at any point and once a day for 2 weeks. In the control panel, acupressure is performed on the Gi ache and Huang shu and Cheng Jiang points using the thumb pulp. These points are located below the mastoid bone, below the clavicle, in the front line of the body, and between the eyebrows. Pressure for 5 minutes at any point and once a day for 4 weeks.
Main outcome variables
low back pain, depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200812048386N1
Registration date: 2021-12-26, 1400/10/05
Registration timing: registered_while_recruiting

Last update: 2021-12-26, 1400/10/05
Update count: 0
Registration date
2021-12-26, 1400/10/05
Registrant information
Name
Ali Ghanbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3272 9731
Email address
alighanbari971373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-26, 1400/10/05
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
determine the effect of acupressure on severe low back pain and depression in patients with chronic low back pain
Public title
determine the effect of acupressure on severe low back pain and depression in patients with chronic low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent to participate in the study 3. Their back pain should not be caused by spinal problems (such as fractures and disc herniations) Having low back pain for more than 12 weeks No wounds, infections or fractures at the acupuncture point or treatment points Age 18 years and older The patient is not pregnant Do not use other traditional or complementary medicine treatments (such as physiotherapy, massage therapy and acupuncture) at the same time Not using acupressure during the last 12 months No malignancy or autoimmune diseases
Exclusion criteria:
Includes dissatisfaction to continue participating in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups of intervention and sham treatment using an individual block method using a seal envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were kept blind from being in the intervention or treatment group
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Central Organization of Birjand University of Medical Sciences, Ghaffari St, Birjand, South Khorasan.
City
birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2021-03-02, 1399/12/12
Ethics committee reference number
Ir.bums.REC.1398.384

Health conditions studied

1

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

2

Description of health condition studied
depression
ICD-10 code
F06.32
ICD-10 code description
Mood disorder due to known physiological condition with major depressive-like episode

Primary outcomes

1

Description
Percentage of people with chronic low back pain
Timepoint
Measurement of low back pain score before the intervention and after one month after the start of acupressure
Method of measurement
VAS Questionnaire

Secondary outcomes

1

Description
Depression score
Timepoint
Measure before the intervention and then measure immediately after the intervention
Method of measurement
Beck Depression Inventory

Intervention groups

1

Description
Intervention group: Intervention group: Acupressure in Feng Chi Yin Tong and Shufu points for 5 minutes at each point and once a day for a month by the patient herself who will be taught by the researcher.
Category
Treatment - Other

2

Description
Control group: Control group: Acupressure in Chen Jiang Ji ach and Huang shu for 5 minutes at each point and once a day for a month by the patient herself who will be trained by the researcher
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Ali Ghanbari
Street address
Central Organization of Birjand University of Medical Sciences, Ghaffari St, Birjand, South Khorasan.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
alighanbari971373@gmail.com

2

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Ali Ghanbari
Street address
Razi Hospital, Ghaffari St, Birjand, South Khorasan.
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3238 1128
Fax
+98 56 3238 1128
Email
razihospital@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mohammad Riahi
Street address
Central Organization of Birjand University of Medical Sciences, Ghaffari St, Birjand, South Khorasan,
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
public_r@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ali Ghanbari
Position
Post Graduate Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Omid St. 5, Omid, Ferdows, South Khorasan.
City
Birjand
Province
South Khorasan
Postal code
9771756586
Phone
+98 56 3273 6091
Email
alighanbari971373@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ali Ghanbari
Position
Post Graduate Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Omid St. 5, Omid, Ferdows, South Khorasan.
City
Birjand
Province
South Khorasan
Postal code
9771756586
Phone
+98 56 3273 6091
Email
alighanbari971373@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ali Ghanbari
Position
Post Graduate Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Omid St. 5, Omid , Ferdows, South Khorasan.
City
Birjand
Province
South Khorasan
Postal code
9771756586
Phone
+98 56 3273 6091
Email
alighanbari971373@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no conditions
From where data/document is obtainable
Alighanbari971373@gmail .com...alighanbari...Birjand University of Medical Sciences
What processes are involved for a request to access data/document
Request information via email to the researcher and receive the information
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