(1) Objectives: The aim of the present study is investigation of the effects of low intensity pulsed magnetic field on radicular pain, active range of motion of lumbar spine and disability in patient with lumbar radicular pain.
(2) Design: This is a randomized clinical trial on 24 radicular pain patients which will be divided to two groups (physiotherapy with and without magnet radiation) randomly. The patient will not aware about she/his group. (3) Setting and conduct:
a) The patients will divided to two groups randomly: group 1 with a routine physiotherapy protocol for 10 sessions (3 sessions each week) included transcutaneous electrical stimulation (TENS), hot pack for 20 minutes and routine exercises for lumbar region. The same physiotherapy protocol will execute for group 2 but 30 minutes of low intensity pulsed magnet radiation with pulse frequency of 50 pulse per second and intensity of 80 G (Gauss) will add to the protocol. Pain will be measured in each session based on visual analog scale (VAS) but active range of motion of lumbar spine and disability index will be measured in 1ST, 5th and 10th sessions. Active range of lumbar spine flexion and extension will be measured based on modified-modified Schober test and active lateral bending range of motion will be measured based on the measurement the distant of middle finger from the ground. Ostwestry questionnaire will be used for disability index. The variables will be compared before and after physiotherapy for each group and also between groups.
(4) Participants: Lumbar radicular pain patients.
Inclusion criteria: Age between 20-50; evidence of lumbar radiculopathy based on presence of sharp and shooting permanent or intermittent radicular pain in buttock or thigh or leg of one side associated with one of the following features: pain evoked by straight leg raising (SLR) test under 60 degree or positive prone knee bending test or MRI with evidences of lumbar radiculopathy.
Exclusion criteria: Patients with pacemaker; pregnancy or breast-feeding; pain attributable to inflammation or infection; spondylolisthesis grade 2 and more; numbness and pain because of diabetic polyneuropathy or peripheral vascular disease; history of surgery in spinal column; piriformis syndrome; steroid injection; having other rehabilitation treatment during the present research; If the patient dose not complete the physiotherapy program and missing the sessions for more than two. The patient will stop his/she program any time he/she wants.
(5) Intervention: Two routine physiotherapy protocols with and without low intensity pulsed magnetic field for 10 sessions.
(6) Variables: The main variables are pain, active lumbar range of motion and disability index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102818754N2
Registration date:2015-01-27, 1393/11/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-27, 1393/11/07
Registrant information
Name
Javad Sarrafzadeh
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
00982122228051-00982122227124
Email address
sarrafzadeh.j@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low intensity pulsed magnetic field radiation on pain, lumbar range of motion and lumbar disability in patients with neuropathic pain.
Public title
The effect of magnetic field radiation on pain, range of motion and disability in patients with neuropathic pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20-50; evidence of lumbar radiculopathy based on presence of sharp and shooting permanent or intermittent radicular pain in buttock or thigh or leg of one side associated with one of the following features: pain evoked by straight leg raising (SLR) test under 60 degree or positive prone knee bending test MRI with evidences of lumbar radiculopathy.
Exclusion criteria: Patients with pacemaker; pregnancy or breast-feeding; pain attributable to inflammation or infection; spondylolisthesis grade 2 and more; numbness and pain because of diabetic polyneuropathy or peripheral vascular disease; history of surgery in spinal column; piriformis syndrome; steroid injection; having other rehabilitation treatment during the present research; If the patient dose not complete the physiotherapy program and missing the sessions for more than two. The patient will stop his/she program any time he/she wants.
Age
From 20 years old to 49 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Iran University of Medical Sciences
Street address
5th floor, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Approval date
2014-06-24, 1393/04/03
Ethics committee reference number
93/د/105/1453
Health conditions studied
1
Description of health condition studied
Lumbar radiculopathy
ICD-10 code
M51.1
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy
Primary outcomes
1
Description
Pain
Timepoint
Each session
Method of measurement
Visual analog scale (VAS)
2
Description
Lumbar region active range of motions include flexion, extention and lateral bending.
Timepoint
First, fifth and tenth sessions.
Method of measurement
A measuring tape and modified-modified Schober test
3
Description
Low back disability
Timepoint
First, fifth and tenth sessions.
Method of measurement
Oswestry low back disability questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Transcutaneous electrical nerve stimulation or TENS for both groups.
Category
Rehabilitation
2
Description
Lumbar therapeutic exercises for both groups.
Category
Rehabilitation
3
Description
Low intensity pulsed magnetic field radiation for group 2.
Category
Rehabilitation
4
Description
Superficial heating by hot pack for both groups.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Medicine Federation of the Islamic Republic of Iran
Full name of responsible person
Javad Sarrafzadeh
Street address
Sport Medicine Federation , Varzandeh St, Mofateh Ave,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Seyed Ali Javad Moosavi, Vice chancellor for research
Street address
5th Floor, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Vice chancellor for research
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
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran st., Shahnazari st, Mirdamad St
City
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences.
Full name of responsible person
Javad Sarrafzadeh
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran st., Shahnazari st, Mirdamad St
City
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Fax
+98 82122220946
Email
sarrafzadeh.j@iuma.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dept. of Physical therapy, School of Rehabilitation, Iran University of Medical Sciences.
Full name of responsible person
Javad Sarrafzadeh
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran st., Shahnazari st, Mirdamad St
City
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)