Evaluation of efficacy of Manipulation in patients with subacute and chronic radicular low back pain in 501 hospital in 1396.
Design
Clinical trial with a control group with parallel groups and randomized.
Settings and conduct
This study will conducted as a clinical trial in Imam Reza Hospital and patients with low back pain. This will be in phase 3 and conducted in 44 patients divided by block method into two groups, 22 patients in intervention group and receive manipulation, and 22 patients in control and receiving routine treatment. Based on this, at first, after end of treatment and 3 months after starting treatment, low back pain is assessed by VAS method.
Participants/Inclusion and exclusion criteria
Patients with unilateral radicular low back pain in more than 4 weeks and refer to 501 Physical Medicine Hospital's with satisfaction to participate in the study are included in study, also patients with underlying illness and impossibility of manipulation are excluded from the study.
Intervention groups
In control group, therapeutic are performed with acetaminophen 325 mg and gabapentin 100 mg every 12 hours and physiotherapy of ten sessions of HP, TENSE, US, Core EXC and exercise, and in intervention group with manipulation with mine approach, including 3 sessions at intervals of one week were done.
Main outcome variables
Low Back Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190109042315N1
Registration date:2019-04-23, 1398/02/03
Registration timing:registered_while_recruiting
Last update:2019-04-23, 1398/02/03
Update count:0
Registration date
2019-04-23, 1398/02/03
Registrant information
Name
Seyede Zahra Hosseini Ghasabmahale
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3476
Email address
sh.najafi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of Manipulation in patients with subacute and chronic radicular low back pain in 501 hospital in 1396.
Public title
Evaluation of efficacy of Manipulation in patients with subacute and chronic radicular low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single-sided radiculer low back pain
Back pain over 4 weeks
Referring to the Medical Physics Clinic of 501 hospital
Satisfaction to participate in the study
Exclusion criteria:
Severe osteoporosis
Unstable fracture
Multiple myeloma
Osteomyelitis
Primary tumors of the bone
Paget
Any progressive neurological defect
Spinal cord tumors
Cauda Equina Syndrome
Joint hypermobility
Rheumatoid arthritis and non-mechanical low back pain
Inflammatory phase of ankylosing spondylitis
Psoriatic arthritis
Reiter's disease
Anticoagulant therapy
Congenital hemorrhagia
History of disc surgery
Spondylosis and spondylolisthesis
Congenital malformation
Acute radiculopathy
Taking an analgesic drug other than acetaminophen and gabapentin
No pain free direction for maneuvering
Bilateral radiculopathy
Hernia intense (extrusion)
Pregnancy
Age
From 25 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B will be as case group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical University for the Islamic Republic of Iran's Army
Street address
Tehran, West Fatemi St., Etemadzadeh Avenue, Medical University for the Islamic Republic of Iran's Army
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-06-02, 1397/03/12
Ethics committee reference number
IR.AJAUMS.REC.1397.008
Health conditions studied
1
Description of health condition studied
Radicular low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
low back pain
Timepoint
At first, immediately after the end of treatment and 3 months after the end of treatment
Method of measurement
Using the Visual Analogue Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Therapeutic treatments are performed with acetaminophen 325 mg and gabapentin 100 mg every 12 hours and physiotherapy of ten sessions of HP, TENSE, US, Core EXC and exercise with manipulation with mines approach, including 3 sessions at intervals of one week.
Category
Rehabilitation
2
Description
Control group: Therapeutic treatments are performed with acetaminophen 325 mg and gabapentin 100 mg every 12 hours and physiotherapy of ten sessions of HP, TENSE, US, Core EXC and exercise.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Sharif Najafi
Street address
Tehran, West Fatemi St., Shahid Etemadzadeh, Imam Reza - 501 Army Hospital
City
Tehran
Province
Tehran
Postal code
88028724
Phone
+98 21 8609 6350
Email
nfo@ajaums.ac.i
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mostafa Shahrezaee
Street address
Tehran, West Fatemi St., Etemadzadeh Avenue, Medical University for the Islamic Republic of Iran's Army
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
moshahrezayee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Seyyedeh Zahra Hosseini
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Tehran, West Fatemi St., Etemadzadeh Avenue, Medical University for the Islamic Republic of Iran's Army
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
hosseini.zs@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sharif Najafi
Position
Assistant Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Tehran, West Fatemi St., Etemadzadeh Avenue, Medical University for the Islamic Republic of Iran's Army
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
hosseini.zs@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyyedeh Zahra Hosseini
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Tehran, West Fatemi St., Etemadzadeh Avenue, Medical University for the Islamic Republic of Iran's Army
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
hosseini.zs@yahoo.com
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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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