Improvement of back pain in brucellosis patients with low back pain with using core stability training
Design
A randomized controlled clinical trial with parallel groups including exercise therapy group and control group without specific exercises
Settings and conduct
Patients with brucellosis in the ward and infectious disease ward of Valiasr Hospital in Zanjan
After randomization, they will be divided into experimental and control groups.
In the exercise group, patients will be trained to exercise pelvic girdle and abdominal strength exercises.
In the control group only the relevant indicators in the study qualifications will be evaluated reliably and will do no exercise.
Participants/Inclusion and exclusion criteria
Patients with brucellosis with acute low back pain informed consent and lack of known chronic diseases
Intervention groups
Patients will be randomly divided into two groups:
Intervention or Exercise Group: Abdominal and Lumbar Endurance Muscle Tests will be removed at the beginning of the study.
And then, during admission to the respective training sessions, they will perform three times daily for 10 minutes each time. The initial tests will be repeated two weeks later.
The second group will consist of patients who will only receive abdominal and lumbar endurance tests at the beginning of the study and will not receive treatment again after the initial two weeks of follow-up.
Main outcome variables
Severity of back pain in patients with brucellosis
Endurance of lumbar and abdominal muscles in patients with brucellosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190225042842N1
Registration date:2019-09-30, 1398/07/08
Registration timing:retrospective
Last update:2019-09-30, 1398/07/08
Update count:0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
leila rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8823 0523
Email address
leila.rezaei.sport@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-07-06, 1398/04/15
Trial completion date
2019-07-27, 1398/05/05
Scientific title
Effectiveness of core stability Training of Lumbar Muscles in brucellosis Patients with Acute Low Back Pain
Public title
Effectiveness of core stability Training of Lumbar Muscles in patients with Acute Low Back Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Written and informed consent to the study process
Diagnosis of brucellosis based on history and laboratory examination
Ages 15 to 75 years
Acute low back pain (LBP less than three weeks old)
Exclusion criteria:
History of surgery in the spinal cord
Cancer
History of fractures and discopaty in the spine
Infectious disease or renal, pulmonary, cardiac and hepatic diseases
Severe psychiatric illness
Alcohol consumption of psychotropic drugs
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, a sample size of approximately 24 people, 12 balls for intervention group A and 12 balls for intervention group B were placed in a lottery container and then the balls were randomly removed from the container without replacement and the resulting sequence was recorded.
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
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi blvd.zanjan
City
zanjan
Province
Zanjan
Postal code
13191-45156
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.ZUMS.REC.1398.093
Health conditions studied
1
Description of health condition studied
Low back pain in patients with brucellosis
ICD-10 code
A23.0
ICD-10 code description
Brucellosis due to Brucella melitensis
Primary outcomes
1
Description
The amount of pain
Timepoint
Measurement of pain at baseline and after 2 weeks of treatment
Method of measurement
Pain Questionnaire(Visual Analogue Score)
2
Description
lumbar muscles endurance
Timepoint
Measurement of lumbar muscle endurance at baseline and 2 weeks after treatment initiation
Method of measurement
The number of lumbar muscle contractions based on the Sorensen test
3
Description
َََُAbdominal muscles endurance
Timepoint
Abdominal muscle endurance measurement at baseline and 2 weeks after initiation of treatment
Method of measurement
Sit up test(crunch test)
Secondary outcomes
empty
Intervention groups
1
Description
Stabilization Exercise Group Exercise Program: In this group, the sample will perform training sessions in 42 sessions under the supervision of a sports medicine specialist and physical education expert, in 3 sessions per day for 2 weeks in each session for approximately 10 minutes. At the beginning of each treatment session, a warm-up (about 5 minutes) will consist of light stretching exercises and each exercise will be repeated in 3 sets. The overload and incremental increase of each exercise will be monitored and determined with respect to the correct execution and pressure of the exercise in the previous session. The goal is to maximize the repetitions of each exercise per set. The major emphasis will be on the multifidus and transverse abdominal muscles. All movements should be performed ten times in painless range. Ten minutes in the morning, ten minutes in the afternoon and ten minutes in the evening. Intervention group: Patients with low back pain will undergo core stability training called core stability training. 2 to 3 times and 10 times each. Repeat the first move: the person pulls the legs up and down in a cramped position while the legs are rotating. The second move: back and forth The knee lifts the knee and lower limb to the bridging position, pausing to tolerate the bridge position and then slowly lowering and then repeating the move Third Movement: In supine position, with elbows resting on the ground, lift the servo upward for six seconds and then rest for three seconds. Repeat this motion. Fourth move: Sleeping behind each foot with the help of hands. The abdomen closes and stretches for six seconds, then lifts the opposite leg. Fifth move: The person is placed in a four-legged position, with the elbow flexing upward and downward, and the elbow flexion at least shrinks and the elbow returns to normal. Sixth Movement: While lying on his back while knee flexing, his abdomen is contracted into the abdomen, adhering repeatedly to the ground, maintaining the contraction for six seconds, and the movements are repeated.
Category
Rehabilitation
2
Description
Control group: Patients with acute low back pain who do not receive exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Infectious diseases ward Valiasr hospital zanjan city
Full name of responsible person
Leila Rezaei
Street address
Valiasr Medical Center;Valiasr Square,Sheikh Fazlollah Noori Highway,Zanjan
City
Zanjan
Province
Zanjan
Postal code
45157-77978
Phone
+98 24 3377 0801
Email
valiasr@zums.ac.ir
Web page address
http://zums.ac.ir/page/808
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali niazi
Street address
Central University Organization.Shohada Hesarak Boulevard.University Square.End of Shahid Sattari Highway (North).Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4735 3702
Email
ali.niazi@gmail.com
Web page address
https://rvp.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Leila rezaei
Position
ُStudent
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 5, Pamcal Alley,etaati strteet,marzdaran town
City
Tehran
Province
Tehran
Postal code
1464764319
Phone
+98 21 8823 0532
Email
leila.rezaei.sport@gmail
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Leila rezaei
Position
پرستار
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 5, Pamcal Alley,etaati street,marzdaran town
City
Tehran
Province
Tehran
Postal code
1464764319
Phone
+98 21 8823 0532
Email
Leila.rezaei.sport@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Leila rezaei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 5, Pamcal Alley,etaati street,marzdaran town
City
Tehran
Province
Tehran
Postal code
1464764319
Phone
+98 21 8823 0532
Email
Leila.rezaei.sport@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Patients' information includes family name and confidential registration and access to researcher and related researcher
But the information extracted and the results of the study will be published in the form of a master's thesis and the resulting papers
When the data will become available and for how long
Access will usually be available to clients and undergraduates at the University Central Library after completion of the defense and dissertation procedures.
Estimated time is the end of 2019 and the article extracted from it is likely to be available in related journals in 2020
To whom data/document is available
Undergraduate Students of Tehran Azad University Central Branch
Under which criteria data/document could be used
For use in academic and hospital research
From where data/document is obtainable
Islamic Azad University Central Library Web site
What processes are involved for a request to access data/document
After registration at Azad University Central Library, applicants can access the full text or abstract of the dissertation and related article if they are a student of Azad University