Our aim is to investigate the effect of applying one session of Diadynamic current on prompt relief of pain in low back region of patients suffering from non specific low back pain.
This is a clinical randomized double blind trial.
It is double blind because patients will not be aware of the allocation as well as the therapist who take measurements.
Patients are recruited from Firouzgar Hospital.
Subjects with low back pain of no specific origin or history of spine fracture and not having any systemic diseases will be referred to physiotherapy clinic of the hospital and will be consecutively randomized into Diadynamic or TENS (tanscutaneous electrical nerve stimulation) groups using sealed envelopes. In this, participating therapist is given randomly generated treatment allocations within sealed opaque envelopes. Once a patient consents to enter the trial, an envelope is opened and the patient is then offered the allocated treatment regimen.
Primary outcome measures (VAS and PPT (pressure pain threshold) of the main location of pain) will be measured before applying the currents, just after the current is off the patient, 20 minutes after and 48 hours later.
Patients are asked not to use anti pain medicine 24 hours before treatment session and until the last measurement (48 hours later).
TENS and Diadynamic currents will be applied using Multistimulator ,model 733 X, NOVIN company, Iran, using two electrodes.
Diadynamic group will receive 5 minutes LP followed by 5 minutes CP and the TENS group will receive 15 minutes conventional TENS (120 Hz).
Thirty patients, 15 in each group is estimated as the proper sample size.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021921139N1
Registration date:2015-05-25, 1394/03/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-25, 1394/03/04
Registrant information
Name
Safoora Ebadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 175 7107
Email address
ebadi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research ,Iran University of Medical Sciences, Faculty of Medicine
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Diadynamic current on prompt relief of pain in nonspecific low back pain in comparison with TENS
Public title
The effect of Diadynamoc current on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients having nonspecific low back pain
2. No systemic disease
3. No specific diagnosis could be made for low back pain(like tumor, osteoporosis,discopathy ,…..)
4. No history of fracture or surgery in low back
5. Not pregnant
6. Not having obvious mental and psychological problems
Exclusion criteria:
1.Having used anti pain medicine during last 24 hours
2.Not coming for follow up
3.Not being able to tolerate ES for the desired amount of time
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences ,Shahid Hemmat Highway .Tehran,1449614535,IRAN
City
Tehran
Postal code
Approval date
2015-02-24, 1393/12/05
Ethics committee reference number
93-04-30-25303-109299
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back strain Lumbago NOS Excl.: lumbago: due to intervertebral disc displacement (M51.2) with sciatica (M54.4)
Primary outcomes
1
Description
pressure pain threshold
Timepoint
before -just after-after 20 mints of second measurement-after 48 hours
Method of measurement
algometer-kgf
2
Description
pain
Timepoint
before applying current-just after ES-after 20 mins-after 48 hours
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Diadynamic current
5 mins LP
5 mins CP
Diadynamic current is a monophasic alternating current with a frequency of 50 hertz.
LP and CP are current modulations of Diadynamic produced by the device.
Category
Rehabilitation
2
Description
TENS
15 mins conventional TENS
transcutenous electrical stimulation is a byphasic interrupted direct current with frequencies between 10 to 150 Hz.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Dr. Safoora Ebadi
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Javad Ali Musavi
Street address
Iran University of Medical Sciences ,Shahid Hemmat Highway .Tehran,1449614535,IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Iran University of Medical Sciences, Faculty of Medicine
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir; e_safoora@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical sciences, Faculty of Medicine
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant professor, PhD Pt
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)