Ultrasonographic evaluation thickness of Multifidus muscles before and immediately after dry needling in non- specific low back pain patients in comparison sham group
after completing the consent form and demographic characteristics in the neuromuscular Rehabilitation Research Center, participants were included. the thickness of the multifidus is measured by ultra sonography in rest and contraction at first, then needle therapy is performed in prone in the 1.5 cm spinous process is inclined to the muscles at a 20 ° angle with internal and lower orientation. In this study, participants are blinded to type of intervention (real-sham needle therapy) And the main investigator are blind to the type of intervention of each participants
Participants/Inclusion and exclusion criteria
inclusion criteria:
age between 18 and 45;
have back pain for three months ago or more;
Pain in the region between the margin of the costa up to the top of the lower fold of the gluteal;
pain intensity below 3 based on visual pain scale;
exclusion criteria:
any symptoms of serious spinal cord involvement;
symptoms of Spinal Cord Syndrome;
Symptoms of Spinal Cord Stenosis;
symptoms of Nerve root involvement;
spinal manipulation , stabilization exercises in Multifidus lumbar during the last 4 weeks;
any signs and symptoms of a pathology (cancer, infection, etc.);
history of any problems with coagulation or taking anti-clot drugs;
pregnancy;
fear of needle
Intervention groups
dry needle group؛ insertion of needle in lumbar multifidus, one session for 5 seconds at each trigger point
sham group؛ without insertion of needle(Contact needles on the skin)
Main outcome variables
Thickness of multifidus in rest;
thickness of multifidus in submaximal contraction mode;
Percentage changes in thickness of multifidus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190311043012N1
Registration date:2019-06-18, 1398/03/28
Registration timing:registered_while_recruiting
Last update:2019-06-18, 1398/03/28
Update count:0
Registration date
2019-06-18, 1398/03/28
Registrant information
Name
pooran madani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3332 8502
Email address
pooran.madani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-22, 1398/02/02
Expected recruitment end date
2019-07-24, 1398/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ultrasonographic evaluation thickness of Multifidus muscles before and immediately after dry needling in non- specific low back pain patients in comparison sham group
Public title
assessment the thickness of multifidus muscles activity before and after one session dry needling in patient with low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 45 years
Having back pain for a period of three months ago or more
Pain in the region between the margin of the costa up to the top of the lower fold of the gluteal region
Pain intensity below 3 based on visual pain scale
Exclusion criteria:
Any symptoms of serious spinal cord involvement
Symptoms of cauda equina Syndrome
Symptoms of spinal canal stenosis
Symptoms of Nerve root involvement
Spinal manipulation
Fear of the needle
stabilization exercise in the lumbar multifidus muscles during the last 4 weeks
any signs and symptoms of a pathology (cancer, infection, etc.)
history of any coagulation problems or taking anti-clot drugs
pregnancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are blind to the type of intervention, that way in sham group, the needle is moved only on the skin and the needle does not actually enter the multifidus.the main investigator is blind to the type of intervention of each participant, so that main investigator uses the assistant to intervene
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Tabatabaee clinic, Mashahir square, Blvd ghods
City
semnan
Province
Semnan
Postal code
35196-98375
Approval date
2019-02-19, 1397/11/30
Ethics committee reference number
IR.SEMUMS.REC.1397. 272
Health conditions studied
1
Description of health condition studied
Non-specific chronic low back pain
ICD-10 code
M95-M99
ICD-10 code description
Other disorders of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Lumbar Multifidus muscle rest thickness
Timepoint
Measuring the thickness of the multifidus Before,immediately after and 10 days after the end of intervention
Method of measurement
ultrasonography setting
2
Description
Thickness of submaximal contraction mode of the lumbar Multifidus muscle
Timepoint
Measuring the thickness of the multifidus Before,immediately after and 10 days after the end of intervention
Method of measurement
ultrasonography setting
3
Description
Muscle thickness changes of lumbar Multifidus
Timepoint
Measurement of thickness changes of the multifidus Before,immediately after and 10 days after end the intervention
Method of measurement
ultrasonography setting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group: non-specific low back pain volunteers, with real dry needle therapy. In this one session technique, needles with sizes 0.30 ~ 50 mm or 0.30 ~ 60 mm are used according to the size of the muscle participant. In this technique, the patient is lying down and inserted the sterile needle into the muscle of the multifidus at the L4-L5 or L5-S1 levels. needle is placed approximately 1.5 cm next to spinous proces vertically at the desired surface. After punching the surface of the skin, the needle toward the multifidus and lumbar vertebral lamina.oriented downward and inward (approximately 20 °).
Category
Treatment - Devices
2
Description
Control group: nonspecific low back pain volunteers without insertion of needle(sham).In this technique, like intervention group, the patient is prone and the needle contacts the skin without insert to the muscle.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic Taba Babaei
Full name of responsible person
pooran madani
Street address
Tabatabaee clinic,Mashahir square,Blvd ghods
City
Semnan
Province
Semnan
Postal code
35196-98375
Phone
+98 23 3332 8502
Fax
+98 23 3365 4180
Email
pooran.madani@yahoo.com
Web page address
https://nmrrc.semums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr rozita hedayati
Street address
Faculty of Rehabilitation, University of Medical Sciences,Training Complex, 5 km of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
983519899951+
Phone
+98 23 3344 8996
Fax
+98 23 3344 8999
Email
Hedayati@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Pooran Madani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Tabatabaee clinic, Mashahir square,Blvd Ghods
City
Semnan
Province
Semnan
Postal code
35196-98375
Phone
+98 23 3332 8502
Fax
+98 23 3365 4180
Email
Pooran.madani@yahoo.com
Web page address
https://nmrrc.semums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rosita Hedayati
Position
Presidency of the Faculty of Rehabilitation
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
University of Medical Sciences,Complex of university,5 Km of Damghan Road,Semnan
City
Semnan
Province
Semnan
Postal code
983519899951
Phone
+98 23 3365 4180
Fax
+98 23 3365 4180
Email
Rosehed@yahoo.com
Web page address
https://rehab.semums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rosita Hedayati
Position
Assistant Professor of Faculty of Rehabilitation
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
University of Medical Sciences,Complex of university,5 Damghan Road,
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3365 4180
Fax
+98 23 3365 4180
Email
Rosehed@yahoo.com
Web page address
https://rehab.semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD