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The Comparison of the Effectiveness of Electroacupancture and Routine physiotherapy on Pain, Functional disability and Ultrasonographic changes of Gluteus Maximus in Non specific Chronic Low back Pain Patients with Gluteus Maximus Trigger Points

Protocol summary

Study aim
The effect of electroacupancture on pain, functional disability and ultasonographic changes of gluteus maximus muscle in patient with non specific chronic low back pain with gluteus maximus trigger point.
Design
The clinical trial with control group, parallel group with 40 patients, randomized
Settings and conduct
40 volunteers with non specific low back pain will be randomly assigned to two intervention group including routine treatment of physiotherapy and routine treatment with electroacupuncture
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients with non specific chronic low back pain at least three months from the onset of their pain and Gluteus Maximus muscle trigger points, Number of trigger points 2_4, Scale of visual analog scale of pain 1_4, Score of functional disability questionnaire 1_15 Exclusion criteria included fear of needle, hypersensitivity to needle, fibromyalgia, lumbar disk herniation, spinal cord stenosis, low back arthritis, pregnancy, taking anticoagulants and hip surgery
Intervention groups
In the intervention group, the electroacupancture treatment will be performed for two sessions per week and each session is done for 20 minutes and treatment is done in 4 sessions. In the control group, subjects 10 sessions will be treated routine physiotherapy 3 times per week and the duration of treatment will be 45 minutes per session.
Main outcome variables
The size of gluteus maximus muscle, pain, functional disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150602022539N9
Registration date: 2019-03-28, 1398/01/08
Registration timing: prospective

Last update: 2019-03-28, 1398/01/08
Update count: 0
Registration date
2019-03-28, 1398/01/08
Registrant information
Name
Ziaeddin Safavi Farokhi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
zsafavi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effectiveness of Electroacupancture and Routine physiotherapy on Pain, Functional disability and Ultrasonographic changes of Gluteus Maximus in Non specific Chronic Low back Pain Patients with Gluteus Maximus Trigger Points
Public title
The Effect of Electroacupuncture in Non specific Low Back Pain Patients with Gluteus Maximus Trigger Points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non specific chronic low back pain at least three months from the onset of their pain Gluteus Maximus trigger points 2_4 trigger points Visual analogues scale of pain 1_4 Score of functional disability questionnaire 1_15
Exclusion criteria:
Diabetes Fear from needle Needle sensitivity Pregnancy Systemic, infectious and inflammatory disease of vertebral column Aََcute and sub acute low back pain Disc herniation Tumor Osteomyelitis Ankylosing spondylitis Vertebral fracture Scoliosis Taking anticoagulants Depression Fibromyalgia Spinal cord stenosis Hip joint surgery Osteoporosis
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Permuted block randomization Randomization unit: Person Stratified randomization: Not done Randomization instrument: ٌRandom allocation software (Excel) Random sequence generation: Used random blocks, each block containing 4 people and allocated a number from 1 to 6 to each block Allocation concealment: Because of physiotherapy interventions for patients, allocation concealment is not possible
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The clinical trial with control group, parallel group with 40 patients, randomized

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Kilometer 5 Damghan road, Semnan
City
Semnan
Province
Semnan
Postal code
5319899951
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.SEMUMS.REC.1397.256

Health conditions studied

1

Description of health condition studied
Non specific chronic low back pain with trigger point in gluteus Maximus muscle
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
The size of gluteus Maximus muscle
Timepoint
First session of treatment, The last session of treatment and Two weeks after the last meeting
Method of measurement
Ultrasonographic apparatus

2

Description
Pain
Timepoint
First session of treatment, The last session of treatment and Two weeks after the last meeting
Method of measurement
Visual Analog Scale

3

Description
Functional disability
Timepoint
First session of treatment, The last session of treatment and Two weeks after the last meeting
Method of measurement
Oswestry disability index questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, the electroacupancture treatment was performed for two sessions per week and each session is done for 20 minutes and treatment is done in 4 sessions. The treatment method in all sessions is one way and it will be under the supervision of a therapist.
Category
Rehabilitation

2

Description
Control group: In the control group, the interventions will be done 10 sessions routine physiotherapy 3 times per week and the duration of treatment will be 45 minutes per session.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Street address
Mashahir Square, in front of Helal Ahmar, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3332 2332
Email
ziasafavi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Street address
Mashahir Square, in front of Helal Ahmar, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Email
ziasafavi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, 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
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3013138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3013138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3013138111
Phone
+98 23 3365 4180
Email
ziasafavi@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
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