To evaluate effect of subpopliteogluteal manipulation on chronic radiculopathy
Design
After evaluating the inclusion criteria. patients with the authorised consent forms, are randomised into two 24 members groups.Simple randomization is applied. First group receive manipulation in 4 sessions and asked to do home exercises meanwhile.The second group is asked to do home exercises alone.
Settings and conduct
After orthopedic visit of patients, and receiving their consent, the designed forms are filled and manipulation is implemented by Dr Mohamad Sanei, in orthopedics clinic of Emam hospital of Jiroft Medical Sciences University. Soft tissue manipulation is done on the gluteal and sub popliteal are in about 15 minutes and variable data is recorded.
Participants/Inclusion and exclusion criteria
Chronic Radiculopathy (more than 3 months), with or without back pain
age between 20 to 55
no significant surgery indication
no spinal surgery history
no NSAIDs, Analgesic or interfering drug consumption
Intervention groups
2 groups:
1st: Manipulation + Home Exercises
2nd: only home exercises
Main outcome variables
Pain severity; Disability severity; Body flexibility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161225031563N1
Registration date:2018-09-03, 1397/06/12
Registration timing:registered_while_recruiting
Last update:2018-09-03, 1397/06/12
Update count:0
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26760756
Email address
sanei.stu@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Fateh subpopliteogluteal manipulation on chronic radiculopathy
Public title
Effect of subpopliteogluteal manipulation on chronic radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic radiculopathy, with or without back pain
age between 20 to 55
Exclusion criteria:
Surgery Indication
Spinal surgery history
NSAID, Analgesic consumption, or other drugs consumption which Doctor find them interfering with the survey.
signs of non mechanical low back pain.
Age
From 20 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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 Shahid Beheshti University of Medical Sciences
Street address
Department of Traditional Medicine,Shahid Beheshti University of Medical Sciences,Shams Alley, Vali Asr ave, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Approval date
2017-12-22, 1396/10/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.853
Health conditions studied
1
Description of health condition studied
Chronic Radiculopathy
ICD-10 code
M54.1
ICD-10 code description
Radiculopathy
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, before and after each session, 1 month after complete intervention
Method of measurement
VAS
2
Description
Disability
Timepoint
Before intervention, After 4th session, 1 month after complete intervention
Method of measurement
Rolland Morris Questionnaire
Secondary outcomes
1
Description
Flexibility
Timepoint
Before and after each intervention session, 1 month after complete intervention
Method of measurement
Finger to Floor test
Intervention groups
1
Description
First Intervention group: Subpopliteogluteal Manipulation with home exercises
Category
Treatment - Other
2
Description
Second Intervention group: Home exercises
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic clinic of Jiroft Emam Khomeini Hospital
Full name of responsible person
Roshanak Mokaberinejad
Street address
Shafa St, Emam Khomeini Ave, Jiroft, Kerman, Iran
City
Jiroft
Province
Kerman
Postal code
7861644481
Phone
+98 34 4331 8501
Email
jiroft.hospital@gmail.com
Web page address
http://www.jmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roshanak Mokaberinejad
Street address
Shams alley, Vali Asr ave, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
rmokaberi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roshanak Mokaberinejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shams alley, Vali Asr ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
rmokaber@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roshanak Mokaberinejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shams alley, Vali Asr ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
rmokaberi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Sanei
Position
MD, PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shams alley, Vali Assr ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
sanei.stu@gmail.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