1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of conventional physiotherapy and conventional physiotherapy with lumbar multifidus dry needling on pain, disability and pressure pain threshold in patients with chronic non specific low back pain

Protocol summary

Study aim
Study the effect of conventional physiotherapy and the effect of multifidus muscle dry needling with conventional physiotherapy on pain, disability and pressure pain threshold in patients with chronic non-specific low back pain
Design
A randomized clinical trial with controlled, paralleled groups, double blind with a sample size of 40 people
Settings and conduct
After the call, people with chronic non-specific low back pain are randomly divided into intervention and control groups. Statistical analysts and patients are unaware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion : Back pain between the 12th rib and the buttock area , Age between 18 and 50 years, active trigger point in the lumbar multifidus muscle, At least three months of low back pain, BMI<40 kg/m2 exclusion : Rheumatic and systemic diseases,Contraindications of dry needling, fibromyalgia syndrome and neurological problems, Pregnancy, mental disorders, previous lumbar surgery, Uncontrolled endocrine disorders
Intervention groups
Control group: 20 people will be placed in this group and will receive 8 conventional physiotherapy sessions including: TENS, US and Hot pack in addition to conventional exercises. Intervention group: 20 people, similar to the control group, will receive conventional physiotherapy plus three sessions of dry needling of the multifidus muscle.
Main outcome variables
Pain, ِDisability , pressure pain threshold

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210221050441N1
Registration date: 2022-08-30, 1401/06/08
Registration timing: registered_while_recruiting

Last update: 2022-08-30, 1401/06/08
Update count: 0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Mehdi Marani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3344 0304
Email address
mahdimarani@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of conventional physiotherapy and conventional physiotherapy with lumbar multifidus dry needling on pain, disability and pressure pain threshold in patients with chronic non specific low back pain
Public title
Comparison of the effect of conventional physiotherapy and conventional physiotherapy with lumbar multifidus dry needling on pain, disability and pressure pain threshold in patients with chronic non specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Back pain between the 12th rib and the buttock area Age between 18 and 50 years active trigger point in the lumbar multifidus muscle At least three months of low back pain BMI<40 kg/m2
Exclusion criteria:
Rheumatic and systemic diseases Contraindications of dry needling such as: trauma, taking anticoagulants, infections, immune and heart diseases fibromyalgia syndrome and neurological problems Pregnancy, mental disorders, previous lumbar surgery Uncontrolled endocrine disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
It is done by randomization secretary and permuted-block method with blocks of volume 4 . In this method, there are ten blocks of 4 in the form of a list, each block has 4 numbers that are randomly designed by the statistical analyzer. In each block, 2 smaller numbers are allocated to the conventional physiotherapy group and 2 larger numbers are assigned to the conventional physiotherapy group with dry needling. When referring to these groups, the samples are randomly placed from the first to the last list and two people in the intervention group and two people in the control group in each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the statistician, he analyzes the results without knowing the groups. To blinding patients, patient placed in the prone position and shows the patient the real needle, but when the needle is inserted, a false needle (through the tooth) is struck on the skin and after that the patient does not see the false needle.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical science
Street address
Isfahan University of Medical Sciences , Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-08-06, 1401/05/15
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.057

Health conditions studied

1

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

Primary outcomes

1

Description
Pain
Timepoint
Before, after and one month after treatment
Method of measurement
Visual Analogue Scale

2

Description
Pressure pain Threshold
Timepoint
Before, after and one month after treatment
Method of measurement
Algometer

3

Description
Disability
Timepoint
Before, after and one month after treatment
Method of measurement
oswestry disability index

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 20 people are included in this group and 8 conventional physiotherapy sessions include: 20 minutes TENS, 4 minutes US and 15 minutes Hot pack, in addition conventional exercises including knee to chest , raising the trunk in prone position,heel slide in supine position , bridging and bicycle training. Each exercise will be repeated 10 times and each repetition will be done for 10 seconds.
Category
Rehabilitation

2

Description
Intervention group: 20 people are included in this group and 8 conventional physiotherapy sessions in addition dry needling of the multifidus muscle includes: 20 minutes of TENS, 4 minutes of US and 15 minutes of Hot pack, in addition conventional exercises including knee to chest , raising the trunk in prone position,heel slide in supine position , bridging and bicycle training, as well as three sessions of dry needling in the second, fourth, sixth session and inserting and removing the needle into the muscle for 10 seconds. Each exercise will be repeated 10 times and each repetition will be done for 10 seconds.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sedigheh tahereh Rehabilitation center
Full name of responsible person
Hosseinali ahmadi
Street address
khorram st
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3337 7880
Email
heshmatipour@rehab.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Deputy of research and technology ,Isfahan University of Medical Sciences , Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Heshmatipour
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences , Isfahan University of Medical Sciences , Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5024
Email
heshmatipour@rehab.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Heshmatipour
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences , Isfahan University of Medical Sciences , Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5024
Email
heshmatipour@rehab.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Heshmatipour
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences , Isfahan University of Medical Sciences , Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5024
Email
heshmatipour@rehab.mui.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The personal information of the persons and the results of the treatment and their relationship cannot be shared with each other, only the analyzed information without mentioning the names of the persons is accessible to other researchers.
When the data will become available and for how long
Since the publication of the results
To whom data/document is available
Researchers and other physiotherapists
Under which criteria data/document could be used
In order to access for the design of other studies by researchers and to increase the quality of treatment by colleagues and other physiotherapists
From where data/document is obtainable
Author
What processes are involved for a request to access data/document
If the request is registered in the email, it will be answered as soon as possible
Comments
Loading...