Protocol summary
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Study aim
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The primary aim of this study is to investigate the possible effect of TENS on postural control in patients with chronic low back pain.
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Design
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The participants are assigned randomly to the intervention or the control groups with a block randomization method using excel software. Twenty eight participants (14 patients in each group) are enrolled in this randomized controlled trial study.
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Settings and conduct
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This study is done at the research center of the Shiraz University of Medical Sciences and they are referred to a physiotherapy clinic in the hospitals of the University. The participants then are assigned randomly to the intervention or the control groups.
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Participants/Inclusion and exclusion criteria
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In this study, twenty eight low back pain patients participate are included between 25 to 45 years old with at least 6 months low back pain in the low back area and pain intensity of more than 3 on a Visual Analog Scale (VAS). The participants with a history of sciatica or other radicular involvement, and spinal surgery are also excluded. All participants are recruited from referrals of local physiotherapy clinics in Shiraz. Then, patients by using block randomization allocate in intervention and control group.
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Intervention groups
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We perform low frequency 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 2 HZ frequency through surface electrodes placed at between spinus process L1 and L5bilaterally for 20 minutes at tolerance level. In control group, protocol are done like to intervention group but they receive placebo electrical stimulation. postural control assess befoe, immediately and 24 hours after of the TENS application.We expect that TENS improve postural control in low back pain patients.
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Main outcome variables
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Pain, Static and dynamic balance
General information
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Reason for update
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Since our study is prospective and the starting date of the sample entry was mistakenly entered on April 21, 2013, instead of February 8, 2014, we made the desired corrections.
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Acronym
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Balance and chronic low back pain
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IRCT registration information
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IRCT registration number:
IRCT201305292391N11
Registration date:
2014-01-31, 1392/11/11
Registration timing:
prospective
Last update:
2020-05-08, 1399/02/19
Update count:
1
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Registration date
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2014-01-31, 1392/11/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Shiraz University of Medical Sciences - Shiraz Faculty of Rehabilitation
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Expected recruitment start date
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2014-02-08, 1392/11/19
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Expected recruitment end date
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2014-06-11, 1393/03/21
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Actual recruitment start date
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2014-03-05, 1392/12/14
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Actual recruitment end date
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2014-07-15, 1393/04/24
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Trial completion date
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2014-07-15, 1393/04/24
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Scientific title
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Evaluation of the effect of low Frequency TENS on postural stability in patients with mechanical chronic low back pain
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Public title
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Effect of electrical stimulation on mechanical low back pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The participants are included between 25 and 45 years old with at least 6 months low back pain in the area between the gluteal fold and the 12th rib, pain intensity of more than 3 on a Visual Analog Scale (VAS), and Oswestry questionnaire score of 0 to 40% (mild to moderate disability).
Exclusion criteria:
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Age
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From 25 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
28
Actual sample size reached:
28
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2013-09-23, 1392/07/01
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Ethics committee reference number
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CT- 92- 6511
Health conditions studied
1
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Description of health condition studied
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Mechanical chronic low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Balance
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Timepoint
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Imediately , after 30 min
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Method of measurement
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Force plate
Intervention groups
1
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Description
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Low frequency TENS( low frequency TENSwith the pulse duration of 250 µs and 2 HZ frequency through surface electrodes placed at between spinus process L1 and L5 bilaterally for 20 minutes at tolerance level). Intervention group is 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 20 minutes at tolerance level. Control group receives placebo electrical stimulation.Treatment is carried out for 8 sessions in 2 weeks.
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Category
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N/A
2
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Description
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Low frequency TENS with the pulse duration of 250 µs and 2 HZ frequency through surface electrodes placed at between spinus process L1 and L5bilaterally for 20 minutes at tolerance level. Control group is 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 20 minutes .This group receives placebo electrical stimulation.Treatment is carried out for 8 sessions in 2 weeks.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Some of the data, such as information about the consequences, can be shared.
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When the data will become available and for how long
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Starting the access period: 6 months after publish the results.
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To whom data/document is available
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Researchers working in academic and academic institutions.
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Under which criteria data/document could be used
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Only statistical analyzes can be used to find treatment for improvement of patients.
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From where data/document is obtainable
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Applicants can be guided by email authors.
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What processes are involved for a request to access data/document
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First, they will email the authors of the study and we will be answered within a week.
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Comments
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