Abstract:
The purpose of present study was compared the effect of DN on the pain and function of subjects with discogenic radiating LBP with standard conservative approach.
This study was a double blinded (subjects and examiner) randomized control trial. Fifty eight patients with discopathic radicular low back pain were screened for eligibility criteria then were randomized into control(n=29) or the experimental group(n=29).Inclusion criteria was radiating pain at one or both legs.Exclusion criteria were coagulation disorder ,tumor, infection , fracture or instability in lumbar region. Primary outcome measure was pain intensity. Secondary outcome measure was functional disability. Radiating pain intensity and disability were assessed at baseline, at the end of treatment and two months follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071121479N2
Registration date:2015-08-31, 1394/06/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-31, 1394/06/09
Registrant information
Name
Abdolkarim Karimi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2024
Email address
a_karimi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
The study is the results of a thesis for M.Sc. degree in physical therapy registered in Isfahan University of Medical Sciences (Grant 393082).
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2015-04-18, 1394/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Dry Needling on the Radiating Pain in Subjects with Discopathic Low Back Pain
Public title
Evaluating the Effect of Dry Needling on the Radiating Pain in Subjects with Discopathic Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria :( age between 20 and 50 years old ؛ radiating pain at one or both legs ؛ abnormal electromyographyfinding)
exclusion: ( they had coagulation disorder or they were under anticoagulant therapy for any reason (due to high risk of hemorrhage following needling) ; if they suffered from psychologic disorders (due to unreliable pain report during the study) ; Subjects with needle phobia ; tumor and infection in lumbar region ; acute or chronic radiating LBP due to fracture or instability ; contraindications of dry needling )
Age
From 74 years old to 44 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezer Jarib, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
393082
Health conditions studied
1
Description of health condition studied
discopathy low back pain
ICD-10 code
M51.1
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy
Primary outcomes
1
Description
radiating pain
Timepoint
at baseline (in the first intervention session), in the last intervention session and two months after the last intervention session (follow up)
Method of measurement
visual analog scale
Secondary outcomes
1
Description
functional disability
Timepoint
at baseline (in the first intervention session), in the last intervention session and two months after the last intervention session (follow up)
Method of measurement
Oswestry functional disability questionnaire
Intervention groups
1
Description
Participants in experimental group received standard physiotherapy for 10 sessions every other day and dry needling for 5 sessions. Standard physiotherapy included thermal modality, TENS (Acupuncture like: Frequency = 1-4Hz, Duration= 250 ms , Time= 20 minute ) , ultrasound ( Frequency = 1MHz , pulsed , intensity = 1 w/cm2 , Time = 1minute / 1 cm2)and exercise therapy( Mckenzie program and stabilizing exercise). Each standard physiotherapy session took about 45 minutes. Dry needling sessions were at the end of second, forth, six, eighth and tenth sessions DN needed an addition 15 minutes to be performed
Category
Other
2
Description
Subjects in control group received standard physiotherapy for 10 sessions every other day. Standard physiotherapy included thermal modality, TENS (Acupuncture like: Frequency = 1-4Hz, Duration= 250 ms , Time= 20 minute ) , ultrasound ( Frequency = 1MHz , pulsed , intensity = 1 w/cm2 , Time = 1minute / 1 cm2)and exercise therapy( Mckenzie program and stabilizing exercise). Each session took about 45 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayat Alah Kashani Hospital
Full name of responsible person
Mojtaba Heshmati pour
Street address
Ayat Alah Kashani , Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Zahra Sadat Rezaeian
Street address
Hezar Jarib , Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Abdolkarim Karimi
Position
Assistant Professor of Physical Therapy
Other areas of specialty/work
Street address
Hezar Jarib , Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
a_karimi@rehab.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abdolkarim Karimi
Position
Assistant Professor of Physical Therapy
Other areas of specialty/work
Street address
Hezar Jarib , Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
00
Fax
Email
a_karimi@rehab.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abdolkarim Karimi
Position
Assistant Professor of Physical Therapy
Other areas of specialty/work
Street address
Hezar Jarib , Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
00
Fax
Email
a_karimi@rehab.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)