The effect of adding paraspinal lumbar muscle dry Needling technique to the general postural reeducation approach of patients with non-specific chronic low back pain
Comparative evaluation of the effects of paraspinal muscles dry needling against the GPR (General Postural Retraining) approach in patients with non-specific chronic low back pain
Design
This study is a clinical trial including control and intervention groups with parallel, double-blind groups on 40 patients, who will be randomly divided into two groups.
Settings and conduct
This study will be performed in a private clinic in Tehran, Iran. In intervention group, 10 GPR sessions will be performed every other day in combination to 5 dry needling sessions. In the control group, 10 GPR sessions will be performed every other day.
Participants/Inclusion and exclusion criteria
Inclusion:
People with low back pain who are in the age range of 25 to 50 years
Pain more than 3 base on Visual Analogue Scale (VAS)
Disability score of at least 25
Non-specific low back pain for three months or more
Results of the below test should be positive:
Anterior and posterior pelvic tilt
Prone hip extension test
Side lying hip abduction test
Thomas test
Ober test
Intervention groups
In this study, both groups receive the GPR technique and in the intervention group, the dry needling technique will be added.
Main outcome variables
Pain, function, flexibility.
General information
Reason for update
Acronym
GPR
IRCT registration information
IRCT registration number:IRCT20211123053161N1
Registration date:2022-01-03, 1400/10/13
Registration timing:registered_while_recruiting
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
Registrant information
Name
Naeimeh Alimardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4460 8378
Email address
naeimeh.alimardani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-20, 1400/08/29
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding paraspinal lumbar muscle dry Needling technique to the general postural reeducation approach of patients with non-specific chronic low back pain
Public title
adding paraspinal lumbar muscle dry Needling technique to the general postural reeducation approach of patients with non-specific chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of pain based on visual analog scale more than 3 and 4
Disability score of at least 25
Low Back Pain for more than three months without specific cause
Positive tests of muscle Imbalance
Exclusion criteria:
Neurological, Rheumatic, or oncological problems
They received physiotherapy less than 6 months ago
Did not take the corticosteroids or oral medications
Those who had needling phobia
Osteoporosis
Systemic disease such as arthritis
The history of pelvic and lumbar surgery during the last six months
Pregnancy
No muscle imbalance
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of individuals to the two groups will be by random allocation. Block randomization will be used. The therapist divides people into subgroups called blocks. 8 to four blocks are selected. Individuals in each block are randomly divided into two groups: control (A) and treatment (B). We have 40 per in block each group 20 per in intervention group and 20 per in control group to do this, excel computer software is used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding of this study will be double-blind. In other words, people enter the study randomly and in the grouping, neither the people themselves know which group they are in nor the person who does the evaluation.
Placebo
Not used
Assignment
Parallel
Other design features
The way of grouping in this study is that both control and intervention groups receive a basic treatment (general postural retraining), but in the intervention group, in addition to the basic treatment, dry needle treatment will be performed for them.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Social Welfare and Rehabilitation Sciences
Street address
Daneshjoo Blvd., Koodkiar Alley, University of Social Welfare and Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
14731-19373
Approval date
2021-11-20, 1400/08/29
Ethics committee reference number
IR.USWR.REC.1400.208
Health conditions studied
1
Description of health condition studied
Non-Specific chronic low back pain
ICD-10 code
M95.9
ICD-10 code description
Acquired deformity of musculoskeletal system, unspecified
Primary outcomes
1
Description
1-Pain
Timepoint
Before, after and 2 weeks follow up
Method of measurement
Visual analog scale
2
Description
2- Function
Timepoint
Before, after and 2 weeks follow up
Method of measurement
Ostwersy disability index
3
Description
Flexibility level
Timepoint
Before, after and 2 weeks follow up
Method of measurement
Finger to floor test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment in this group includes 10 sessions GPR with one day interval (three times in a week) plus 5 sessions of dry needling.
Category
Treatment - Devices
2
Description
Control group: In this group, only ten GPR sessions are given every other day.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Private physiotherapy clinic
Full name of responsible person
Naeimeh Alimardani
Street address
South Janatabad St., Chahar Bagh Square, Green Building, First Floor, Unit 12
City
Tehran
Province
Tehran
Postal code
1474754435
Phone
+98 21 4441 1510
Email
naeimeh.alimardani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Hamid reza khoram khorshid
Street address
Daneshjoo Blvd., Koodkiar Alley, University of Social Welfare and Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
webmaster@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Naeimeh Alimardani
Position
Master student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Daneshjoo Blvd., Koodkiar Alley, University of Social Welfare and Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
14731-19373
Phone
+98 21 4460 8378
Email
naeimeh.alimardani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Naeimeh Alimardani
Position
Master student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Daneshjoo Blvd., Koodkiar Alley, University of Social Welfare and Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
14731-19373
Phone
+98 21 4460 8378
Email
naeimeh.alimardani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Naeimeh Alimardani
Position
Master student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Daneshjoo Blvd., Koodkiar Alley, University of Social Welfare and Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
14731-19373
Phone
+98 21 4460 8378
Email
naeimeh.alimardani@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
Some of the data, such as information about the consequences, can be shared.
When the data will become available and for how long
Starting the access period: 6 months after publition the results.
To whom data/document is available
Researchers working in academic and academic institutions.
Under which criteria data/document could be used
Only statistical analyzes can be used to find treatment for improvement of patients.
From where data/document is obtainable
Applicants can be guided by email authors.
What processes are involved for a request to access data/document
First, they will email the authors of the study and we Will be answered within a week.