The primary aim of this study is to investigate the possible effect of TENS on static postural control in patients with chronic low back pain. Twenty eight (4 men, 24 women) chronic chronic low back pain patients participate in this study. Then, patients by using block randomization allocate in intervention and control group. The inclusion criteria are localized back pain, lasting more than 6 months and least 3 of the 10 visual analog scale (VAS). The exclusion criteria are the history of sciatica or other radicular involvement and history of spinal surgery. All participants are recruited from referrals of local physiotherapy clinics in Shiraz. We performe low back TENS for both groups. Intervention group are positioned proned on a treatment bench; then, Low frequency electrical stimulation with the duration of 250 µs and 7 HZ frequency through surface electrodes placed at between spinus process L1 and L5bilaterally for 15 minutes at tolerance level. In control group, protocol are done like to intervention group but they receive sham electrical stimulation. postural control assess befoe, immediately and after of the TENS application.we expect that TENS improve postural control in low back pain patients.
General information
Acronym
Balance and chronic low back pain
IRCT registration information
IRCT registration number:IRCT201305292391N11
Registration date:2014-01-31, 1392/11/11
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-01-31, 1392/11/11
Registrant information
Name
Zahra Rojhani Shirazi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1552
Email address
rojhaniz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences - Shiraz Faculty of Rehabilitation
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of low Frequency TENS on postural stability in patients with mechanical chronic low back pain
Public title
Effect of electrical stimulation on mechanical low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion/exclusion criteria : The inclusion criteria for study participation in the non specific chronic low back pain: aged 25_45 years; localized back pain; lasting more than 6 months ; radiating no further than the buttock;no previous history of sciatica ; other radicular involvement;normal neurological examination;at least 3 of the 10- cm visual analog scale(VAS); low back pain with oswestry questionnaire 0-40% . The exclusion criteria: a history of neurological signs such as sensory deficits ; motor paralysis ; vestibular system impairment ;a history of dizziness ; medication with known effects on balance; a History of spinal surgery ; a history of rheumatic diseases ;diabetes ; mental disorders ;Pregnancy ;a history of lower extremity injuries ; neuromuscular diseases .
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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, Shiraz University of Medical Sciences
Street address
Ethics Committee, Shiraz University of Medical Sciences, Zand blv.
City
Shiraz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
CT- 92- 6511
Health conditions studied
1
Description of health condition studied
Mechanical chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Balance
Timepoint
Imediately , after 30 min
Method of measurement
Force plate
Secondary outcomes
empty
Intervention groups
1
Description
Low frequency electrical stimulation) low frequency TENS with the duration of 250 µs and 7 HZ frequency through surface electrodes placed at between spinus process L1 and L5bilaterally for 15 minutes at tolerance level). Intervention group are positioned proned on a treatment bench; then, electrical stimulation applies via an surface electrical stimulations places at between spinus process L1 and L5 in each sides for 15 minutes at tolerance level. controlled Group receive sham electrical stimulation.
Category
N/A
2
Description
Low frequency TENS with the duration of 250 µs and 7 HZ frequency through surface electrodes placed at between spinus process L1 and L5bilaterally for 15 minutes at tolerance level. Controlled group are positioned proned on a treatment bench; then, electrical stimulation applies via an surface electrical stimulations places at between spinus process L1 and L5 in each sides for 15 minutes .This group receives sham electrical stimulation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of physiotherapy
Full name of responsible person
Zahra Rojhani Shirazi
Street address
Shiraz Faculty of Rehabilitation Sciences, Chamran blvd
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rojhani Shirazi
Position
PHD
Other areas of specialty/work
Street address
Shiraz Faculty of Rehabilitation Sciences
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
+98 71 1627 2495
Email
Rojhaniz@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rojhani Shirazi
Position
PHD
Other areas of specialty/work
Street address
Shiraz Faculty of Rehabilitation Sciences , Chamran blvd.
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
+98 71 1627 2495
Email
Rojhaniz@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rojhani Shirazi
Position
PHD
Other areas of specialty/work
Street address
Shiraz Faculty of Rehabilitation Sciences, Chamran blvd.
City
Shiraz
Postal code
Phone
+98 71 1235 7282
Fax
+98 71 1627 2495
Email
Rojhaniz@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)