Effects of one session interferential therapy on electroencephalography of patients with chronic nonspecific low back pain: A Randomized Controlled Trial
Effects of one session interferential therapy on electroencephalography of patients with chronic nonspecific low back pain
Design
Clinical trial with control and placebo groups and intervention, with parallel groups, double-blind, randomized with Random software allocation, number of patients 20 and healthy individuals 20
Settings and conduct
This study will be performed in the Tabriz University of Medical Sciences. All participants will have an EEG recorded before and after the intervention and pain intensity of low back pain patients will be recorded before and after the intervention. Blinding will be done by keeping participants and data analyzers unaware of groupings
Participants/Inclusion and exclusion criteria
Inclusion criteria for low back pain patients are having a minimum pain intensity of 4 on the VAS scale for more than 3 months in the lower back with or without radiating to the lower extremities. Healthy people should also not report any chronic pain. Exclusion criteria for patients are disorders such as fractures, tumors, discopathy that indicate the specificity of low back pain, having concomitant treatment, treatment with corticosteroids in the past 2 weeks and physiotherapy in the past 8 weeks. Other exclusion criteria for patients and healthy individuals include: Cancer patients and people with pacemakers, People with electrotherapy contraindications, People with sleep disorders, or taking drugs that affect the nervous system, or History People with neurological and psychological disorders, who have metal implants in their spine, pregnant women
Intervention groups
Intervention: interferential current with effective intensity- low back pain patients
Placebo: interferential current with ineffective intensity- low back pain patients
Control: interferential current with effective intensity- healthy people
Main outcome variables
Intensity of pain, power of brain waves
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210316050727N1
Registration date:2021-07-06, 1400/04/15
Registration timing:registered_while_recruiting
Last update:2021-07-06, 1400/04/15
Update count:0
Registration date
2021-07-06, 1400/04/15
Registrant information
Name
Abas Soltani someh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 5359
Email address
ab.soltani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of one session interferential therapy on electroencephalography of patients with chronic nonspecific low back pain: A Randomized Controlled Trial
Public title
Effects of interferential therapy on electroencephalography of patients with chronic nonspecific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Low back pain with or without pain radiating to the lower extremities above the knee for more than three months
Pain perception over 40 mm in the Visual Analogue Scale
Exclusion criteria:
Existence of any serious disorders in the spine such as fractures, tumors, inflammatory diseases
Nerve root disorders confirmed by neurological testing
Having simultaneous treatment
Cancer patients and heart patients with pacemakers
Any contraindicationto the use of electrotherapy
Having received physiotherapy treatment in the eight weeks before data collection
Having metal implants in the spine
Pregnancy
Taking drugs that affect the nervous system
History of neuropsychological diseases
Corticosteroid treatment in the last 2 weeks
sleep disorder
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Random software allocation
For the allocation concealment, the type of intervention received is written on a piece of paper and placed inside the opaque envelopes and the back of the envelope will be numbered. The envelopes will be opened according to the entry of the participants and the type of group for each patient will be specified accordingly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants: Individuals are unaware of the groupings and the group to which they belong and there is no exchange of information between participants.
Data Analyzer: The collected information is provided to the analyzer without mentioning the groupings and patient information.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Rehabilitation faculty, Daneshgah avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR. TBZMED.REC.1399.1036
Health conditions studied
1
Description of health condition studied
chronic nonspecific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Theta wave power( Absolute power of the frequency range 4-7 Hz)
Timepoint
Before and after the intervention
Method of measurement
EEG recorder
2
Description
Alpha wave power( Absolute power of the frequency range 8-12 Hz)
Timepoint
Before and after the intervention
Method of measurement
EEG recorder
3
Description
Beta wave power( Absolute power of the frequency range 13-30 Hz)
Timepoint
Before and after the intervention
Method of measurement
Absolute power of the frequency range 13-30 Hz
4
Description
Gamma wave power( Absolute power of frequency range above 30 Hz)
Timepoint
Before and after the intervention
Method of measurement
EEG recorder
5
Description
Intensity of pain( VAS scale score)
Timepoint
Before and after the intervention
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In the intervention group, participants will receive one session interferential current for 30 minutes with a carrying frequency of 4 kHz and a bit frequency of 100 Hz with intensity at the level of sensory stimulation in the lumbar region. The intensity of the current increases until the patient has a strong tingling sensation and at the same time comfort, and the intensity of the current will increase every 5 minutes.
Category
Treatment - Other
2
Description
Intervention group 2: placebo group, In the placebo group, patients will receive one session interferential current for 30 minutes with a carrying frequency of 4 kHz and a bit frequency of 100 Hz with ineffective intensity so that the current intensity does not reach the target point and every 5 minutes without increasing the current intensity, the patient's comfort will be questioned.
Category
Placebo
3
Description
Control group: Healthy people participating in the study will receive one session interferential current for 30 minutes with a carrying frequency of 4 kHz and a bit frequency of 100 Hz with intensity at the level of sensory stimulation in the lumbar region. The intensity of the current increases until the patient has a strong tingling sensation and at the same time comfort, and the intensity of the current will increase every 5 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic, Rehabilitation Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Abas soltani someh
Street address
Faculty of rehabilitation, Golgasht Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3326 3293
Email
ab.soltani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad samiei
Street address
Vice-Chancellor for Research and Technology, Daneshgah avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Abas Soltani someh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Daneshgah avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3337 5359
Fax
+98 41 3337 5359
Email
ab.soltani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abas Soltani someh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Daneshgah avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3337 5359
Fax
+98 41 3337 5359
Email
ab.soltani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abas Soltani someh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Daneshgah avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3337 5359
Fax
+98 41 3337 5359
Email
ab.soltani@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study protocol, statistical analysis plan,and informed consent form will be available to share with other investigators if they request by email.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Only available for people working in academic institutions in Iran
Under which criteria data/document could be used
In case of journal or reviewers request for data set
From where data/document is obtainable
Via email and giving documents to prove their identity for administrator Dr Abas Soltani ab.soltani@yahoo.com
What processes are involved for a request to access data/document
Sending email and documents to prove their identity