The effect of neuromuscular training on severity of pain, functional disability and balance of military personnel with chronic low back pain.
Design
A randomized, -controlled clinical trialParallels on 30 military with chronic low back pain.
Settings and conduct
The statistical population of this study consisted of 20- to 40-year-old military men referring to Baqiyatallah University of Medical Sciences Hospital with chronic low back pain. Among these, 30 patients with chronic low back pain who were informed in writing to participate in the study were selected as the study subjects and divided into experimental and control groups. The control group does not perform any exercise. And the experimental group, under the supervision of a correction specialist, performs the researcher's chosen neuromuscular exercises.
Participants/Inclusion and exclusion criteria
Entry requirements
1- Having back pain for more than three months
2- No surgery
Exclusion criteria:
Having surgery
Having fractures
Intervention groups
Experimental protocol was performed in experimental group for 8 weeks and three times a week on pain intensity. Balance and motor function of patients.
Main outcome variables
1. Balance
2. Severity of pain
3. Level of functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190427043384N1
Registration date:2020-04-09, 1399/01/21
Registration timing:registered_while_recruiting
Last update:2020-04-09, 1399/01/21
Update count:0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Ehsan Alvani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 2402
Email address
ehsanalvani90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-12, 1398/02/22
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neuromuscular training on severity of pain, functional disability and balance of military personnel with chronic low back pain.
Public title
The effect of neuromuscular exercises on low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: At least three months low back pain.
Not having any surgery.
No disc herniation.
No fracture.
Not having discopathy.
Exclusion criteria:
Having any surgery.
Having a disc herniation.
Having fractures.
Having discopathy.
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization
Randomization unit: individual
Random tool: sealed envelope
How to make randomization: Randomization is done using sealed envelopes. Inside the envelopes, the names of the groups are written, and the subjects are randomly grouped by removing each envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University Of Medical Sciences
Street address
Vanak Square - Mulla Sadra Street - Sheikh Bahai Street South - Shahid Nosrati Alley.
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2019-06-08, 1398/03/18
Ethics committee reference number
IR.BMSU.REC.1398.142
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 M54.5
Primary outcomes
1
Description
Balance
Timepoint
Before Exercise Protocol - After Exercise Protocol
Method of measurement
Balance with equilibrium tests (static equilibrium: stork test) (dynamic equilibrium: star test).
2
Description
Severity of pain
Timepoint
Before Exercise Protocol - After Exercise Protocol.
Method of measurement
Severity of pain: Using the VAS Analog Scale
3
Description
Functional disability
Timepoint
Before Exercise Protocol - After Exercise Protocol.
Method of measurement
Functional disability: Using Oster questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They perform a neuromuscular exercise protocol for 8 weeks, doing three sessions of about 30 to 60 minutes of exercise three times a week.
Category
Rehabilitation
2
Description
Control group: Control groupThey will not participate in any private treatment plan and only receive routine care
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University Of Medical Sciences Hospital.
Full name of responsible person
Dr. Alireza Shams Aldini.
Street address
Vanak Square, Mulla Sadra Street, South Sheikh Bahai Street.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
alirezaot@bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ehsan Alvani
Street address
Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 87 5552 5051
Email
Ehsanalvani90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?