Comparison of corticosteroid injection & extra corporeal shock wave therapy efficacy on pain intensity, condition of lumbar functional , quality of life and threshold compressive pain in distal trigger point of quadratus lumborum muscle.
Design
This study is a randomized single-blind clinical trial in 54 participants with distal trigger point of quadratus lumborum muscle. Participants will be randomly assigned into tow groups to take extra corporeal shock wave and corticosteroid injection.
Settings and conduct
The target population are all patients with low back pain that has distal trigger point of quadratus lumborum muscle referred to the specialized clinics of Tabriz University of Medical Sciences. Sampling will be done by convenience randomized method. To conceal the allocation, the same envelope will be used in the opaque package to be numbered sequentially.
Participants/Inclusion and exclusion criteria
Inclusion criteria: existence lumbar pain more than 2 months; local tenderness and to have trigger point in quadratus lumborum muscle area; normal neurological examination; VAS score above 4.
Exclusion criteria: any injection or physiotherapy in 3 months ago; dynamic spondylolisthesis in radiography.
Intervention groups
Participants will be randomly divided into tow groups (A and B). In group A patients will receive extra corporeal shock wave with 1500 shock whit low flux density 0.1 mj/mm2/min on trigger point in 5 sessions during 3 weeks and in group B injection triamcinolone (40mg ) and lidocaiene 2% (2cc) (with syringe 5cc). Both groups will receive stretching exercises.
Main outcome variables
Pain intensity; condition of lumbar functional; quality of life and threshold compressive pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100827004641N14
Registration date:2019-01-19, 1397/10/29
Registration timing:registered_while_recruiting
Last update:2019-01-19, 1397/10/29
Update count:0
Registration date
2019-01-19, 1397/10/29
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of corticosteroid injection & extra corporeal shock wave therapy efficacy in distal trigger point of quadratus lumborum muscle.
Public title
Comparison of corticosteroid injection & extra corporeal shock wave therapy efficacy on low back pain arising from quadratus lumborum muscle.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence lumbar pain more than 2 months
Local tenderness and to have trigger point in quadratus lumborum muscle area
Normal neurological examination
VAS score above 4
Would like to participate in study
No received of any drug simultaneously
Exclusion criteria:
Any injection or physiotherapy in 3 months ago
Sacroiliac joint problem in examination
Bertolleti”s syndrome
Bleeding disorders
Systemic infection and local infection in injection area
Biography of allergic reaction to corticosteroid
Pregnancy
Dynamic spondylolisthesis in graphy
Diabetes
BMI 30 and above
Patient discontent to treatment method.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
54
Actual sample size reached:
54
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation of study participants to study groups, computer software Random Allocation Software ( RAS ) will be used through 4 and 8 glass block and allocation ratio of 1:1.
Blinding (investigator's opinion)
Single blinded
Blinding description
For concealment of the allocation, the same envelopes will be used in the opaque package to be numbered sequentially. Envelopes will be numbered from 1 to 100. The first envelope will be given to the first person who will be included in the study and will continue to complete the sampling.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
IR. TBZMED. REC. 1397.342
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Quality of life
Timepoint
Evaluating the quality of life at the beginning of the study ( before the intervention ) and 2 and 4 weeks after the intervention.
Method of measurement
The Quality of Life Question SF-36
2
Description
Lumbar Fuctional
Timepoint
Evaluating the lumbar functional at the beginning of the study ( before the intervention ) and 2 and 4 weeks after the intervention.
Method of measurement
The Lumbar Functional Question Oswestry
3
Description
Threshold Compressive Pain
Timepoint
Evaluating the Threshold Compressive Pain at the beginning of the study (before the intervention ) and 2 and 4 weeks after the intervention.
Method of measurement
Digital Algometer
4
Description
Pain Intencity
Timepoint
Evaluating the Pain Intensity at the beginning of the study (before the intervention ) and 2 and 4 weeks after the intervention
Method of measurement
Ruler of VAS
Secondary outcomes
empty
Intervention groups
1
Description
patients will be received standard extracorporeal shock wave with 1500 shock wh low flux density 0.1 mj/mm2/min in 5 sessions during 3 weeks
Category
Treatment - Devices
2
Description
Triamcinolone (40mg ) manufactured by Sinadaro’s pharmaceutiical company and lidocaiene 2% (2cc) manufactured by caspin tamin’s pharmaceutiical company (with sorang 5cc) will now be injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Negar Fasaie
Street address
Shohada hospital, Golshahr Ave., Elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
6987559867
Phone
+98 41 3389 3336
Email
shohadahospital@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jooyban
Street address
Research vice chancellor, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
3698576985
Phone
+98 41 3333 7510
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Bina Eftekharsadat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
3698525698
Phone
+98 413361928
Email
binasadat@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bina Eftekharsadat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Golgasht, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
6589423698
Phone
+98 41 3336 1928
Email
binasadat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Negar Fasaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza Hospital, Golgasht,Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
6589423698
Phone
+98 41 3336 1928
Email
dr_nf68@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available