Does The Application of Interferential Current Therapy with Vacuum Electrodes Provide Additional Effect in Patients with Nonspecific Chronic Low Back Pain? A Randomized Controlled Study
To evaluate effectiveness of interferential current therapy (IFT) on pain, disability and quality of life in patients with chronic low back pain and to compare the advantages of application IFT with vacuum and carbon silicon pad electrodes to each other.
Design
This is a single blinded randomized controlled trial. Randomization was made by sealed numbered envelopes. The same physician blinded to randomization evaluated all the patients before treatment, and on the first and twelfth week after the end of the treatments. Patients were not blinded.
Settings and conduct
There were three groups in this study.
Patients were evaluated three times: before treatment, one week and twelve weeks after treatment with the same investigator whom was blinded for the group allocation. Assessor was blinded (by sealed envelopes method), patients were not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
to be more than 18 years old;
seeking treatment for chronic low back pain.
Exclusion criteria:
cognitive dysfunction;
neurological deficits;
an extruded and/or sequestrated lumbar disc herniation;
spinal fusion;
pregnancy;
malignancy;
spinal compression fracture;
spondylolisthesis;
severe peripheral neuropathy;
an aortic aneurysm;
vertebral infection;
rheumatological disease;
vertebral column surgery.
Intervention groups
One hundred patients with LBP were randomized in three groups. Group-1 received interferantial current therapy with vacuum electrodes, Group-2 received interferantial current therapy with carbon silicon pad electrodes. Group-3; received no interferantial current therapy. All of the groups have performed core stabilizating exercises.
Main outcome variables
Pain was assessed using Visual Analog Scale, disability with Oswestry Disability Index and quality of life with Short Form-36.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180108038268N3
Registration date:2018-04-13, 1397/01/24
Registration timing:retrospective
Last update:2018-04-13, 1397/01/24
Update count:0
Registration date
2018-04-13, 1397/01/24
Registrant information
Name
Fatmanur Aybala Koçak
Name of organization / entity
Ahi Evran University Faculty of Medicine
Country
Turkey
Phone
+90 386 213 45 15
Email address
aybala.kocak@ahievran.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-02-01, 1393/11/12
Expected recruitment end date
2017-02-01, 1395/11/13
Actual recruitment start date
2015-03-01, 1393/12/10
Actual recruitment end date
2017-03-01, 1395/12/11
Trial completion date
empty
Scientific title
Does The Application of Interferential Current Therapy with Vacuum Electrodes Provide Additional Effect in Patients with Nonspecific Chronic Low Back Pain? A Randomized Controlled Study
Public title
Does The Application of Interferential Current Therapy with Vacuum Electrodes Provide Additional Effect in Patients with Nonspecific Chronic Low Back Pain? A Randomized Controlled Study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
To be more than 18 years old
Seeking treatment for chronic low back pain
Exclusion criteria:
cognitive dysfunction
neurological deficits
an extruded and/or sequestrated lumbar disc herniation
spinal fusion
pregnancy
malignancy
spinal compression fracture
spondylolisthesis
severe peripheral neuropathy
an aortic aneurysm
vertebral infection
rheumatological disease
vertebral column surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Casual randomization using sealed numbered envelopes without strata or blocks was performed by an administrative assistant. The same physician blinded to randomization evaluated all the patients before treatment, and on the first and twelfth week after the end of the treatments. After evaluation by the physiatrist the patients were randomized into three groups:
Group 1: The patients in this group were applied interferential current with vacuum electrodes (n = 34) and exercise therapy.
Group 2: The patients in this group were applied interferential current with carbon-silicone pad electrodes (5x5 cm) and exercise therapy.
Group 3 (control group): The patients in this group have performed only exercise therapy.
Blinding (investigator's opinion)
Single blinded
Blinding description
Casual randomization using sealed numbered envelopes without strata or blocks was performed by an administrative assistant. The same physician blinded to randomization evaluated all the patients before treatment, and on the first and twelfth week after the end of the treatments. Patients were not blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Turgut Özal Üniversitesi Tıp Fakültesi Etik Kurulu
Street address
Alparslan Türkeş Cad. Cad. No:57 Emek
City
Ankara
Postal code
06510
Approval date
2015-01-12, 1393/10/22
Ethics committee reference number
0000-5894-2356
Health conditions studied
1
Description of health condition studied
Low back pain (Pain between 12th rib and gluteal fold)- nonspesific origin
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
pain intensity
Timepoint
pretreatment, one week and twelve weeks after the treatment
Method of measurement
The VAS pain assessment scale was used for subjective assessment of the pain.
2
Description
Disability
Timepoint
pretreatment, one week and twelve weeks after the treatment
Method of measurement
The Oswestry questionnaire (The Oswestry Low Back Pain Disability Questionnaire, Oswestry Disability Index ) was used to evaluate the functional ability of patients.
3
Description
Quality of life
Timepoint
pretreatment and twelve weeks after the treatment
Method of measurement
Short Form 36 (SF-36) was used to assess quality of life of the patients.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The patients in this group were applied interferential current with vacuum electrodes (n = 34). Four vacuum electrodes were placed so that the painful area remained in the middle. The sponges were wetted with tap water and placed in the electrode cups. To apply the electrodes to the patient, the cups were slightly squeezed, brought into contact with the skin and held there for a few minutes until suction occurred. Before application of IFT, hot pack was applied for 20 minutes to the low back. The patients in this group also received exercise therapy
Category
Treatment - Devices
2
Description
Intervention group 2: The patients in this group were applied interferential current with carbon-silicone pad electrodes (5x5 cm) (n = 34). Treatment of subjects with bilateral LBP involved paraspinal application of the cathode and anode electrodes at the lateral limits of the painful area parallel to the vertebral column. The sponges for the pad electrodes were wetted with tap water and placed them to the area to be treated using straps in the electrode cups. Before application of IFT, hot pack was applied for 20 minutes to the low back. The patients in this group also received exercise therapy.
Category
Treatment - Devices
3
Description
Control group: The patients in this group have performed only exercise therapy and hot pack was applied for 20 minutes to the low back (n = 32). Patients were requested to do core strengthening and spine stabilization exercises. The stabilization training included: activation techniques for the neutral spine position, training the activation transversus abdominis, external and internal obliques, training the activation diaphragmatic breathing, myofascial release techniques for the erector spinae muscle, exercising the coordination of superficial and deep trunk muscles, and postural and dynamic training. The exercises were performed 5 times a week. The duration of a training session was 45 min (each exercise once a day with 20 repetitions).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahi Evran University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Full name of responsible person
Fatmanur Aybala Koçak
Street address
Bağbaşı Mahallesi, Şehit Sahir Kurutluoğlu Cd. No:100
City
Kırşehir
Postal code
40100
Phone
+90 386 213 45 15
Email
faybalarem@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahi Evran University Faculty of Medicine
Full name of responsible person
Fatmanur Aybala Koçak
Street address
Bağbaşı Mah. Şehir Sahir Kurutluoğlu Cad. No:100
City
Kırşehir
Postal code
40200
Phone
+90 386 213 45 15
Email
faybalarem@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahi Evran University Faculty of Medicine
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
Ahi Evran University Faculty of Medicine
Full name of responsible person
Fatmanur Aybala Koçak
Position
Asistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Bağbaşı Mah. Şehit Sahir Kurutluoğlu Cad. No: 100
City
Kırşehir
Province
Merkez
Postal code
40100
Phone
+90 386 213 45 15
Fax
Email
aybala.kocak@ahievran.edu.tr
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahi Evran University Faculty of Medicine
Full name of responsible person
Fatmanur Aybala Koçak
Position
Asistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Bağbaşı Mah. Şehit Sahir Kurutluoğlu Cad. No: 100
City
Kırşehir
Province
Merkez
Postal code
40100
Phone
+90 386 213 45 15
Fax
Email
aybala.kocak@ahievran.edu.tr
Person responsible for updating data
Contact
Name of organization / entity
Ahi Evran University Faculty of Medicine
Full name of responsible person
Fatmanur Aybala Koçak
Position
Asistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
physical medicine and rehabilitation
Street address
Bağbaşı Mah. Şehit Sahir Kurutluoğlu Cad. No: 100
City
Kırşehir
Province
Merkez
Postal code
40100
Phone
+90 386 213 45 15
Fax
Email
aybala.kocak@ahievran.edu.tr
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Does The Application of Interferential Current Therapy with Vacuum Electrodes Provide Additional Effect in Patients with Nonspecific Chronic Low Back Pain? A Randomized Controlled Study
This is a scientific study which was being conducted to evaluate effectiveness of interferential current therapy on pain, disability and quality of life in patients with chronic low back pain and to compare the advantages of application IFT with vacuum and carbon silicon pad electrodes to each other.
When the data will become available and for how long
The data will become available after publishing process.
To whom data/document is available
To the patints, to the PMR specialists, to the physioteharpist
Under which criteria data/document could be used
Data is available after getting permission from the authors.
From where data/document is obtainable
Via e-mail.
What processes are involved for a request to access data/document
For a request, one can write an e-mail to the address : faybalarem@gmail.com