Protocol summary

Study aim
The evaluation of adding tecar therapy effect on routine physiotherapy treatments compared to placebo tecar and routine physiotherapy treatments on pain, disability and electrical activity of erector spine muscles in patients with non-specific chronic low back pain
Design
Clinical trial with a control group, with parallel groups, three blinded, randomized, on 32 patients. The rand function of Excel software was used for randomization.
Settings and conduct
In this study, 32 patients with non-specific chronic back pain are divided into two groups of 16, treatment and control. In the treatment group, 20 minutes of Tecar therapy, 35 minutes of routine physiotherapy (20 minutes of TENS and 15 minutes of IR and exercise therapy) and the control group (placeboTecar and routine physiotherapy) are performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with back pain who do not have documentation of discopathy or disc herniation Patients with symptoms of chronic back pain who are between 20 and 60 years old Diagnosis of chronic back pain for at least 12 weeks Visual pain index 4-7 Exclusion criteria: Contraindication of tecar therapy: neoplasm, regional infection, patients with cardiac pacemaker and pregnancy. Active vertebral fracture previous spine surgery Rheumatoid diseases such as rheumatoid arthritis infectious diseases Systemic diseases that affect pain perception, such as diabetes and... Local injection such as (local anesthesia, corticosteroid...) Taking medicines and doing physiotherapy in the last 4 weeks
Intervention groups
The intervention group includes Tecar therapy, routine physiotherapy (IR, TENS and exercise therapy). The control group is the same as the intervention group, but Tecar will be done as placebo.
Main outcome variables
VAS scale Oswestry disability scale electrical activity of the paraspinal muscles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221101056358N1
Registration date: 2022-11-21, 1401/08/30
Registration timing: prospective

Last update: 2022-11-21, 1401/08/30
Update count: 0
Registration date
2022-11-21, 1401/08/30
Registrant information
Name
Morteza Heydarinasir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3311 7923
Email address
m.heydarinasir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of adding tecar therapy effect on routine physiotherapy treatments compared to placebo tecar and routine physiotherapy treatments on pain, disability and electrical activity of erector spine muscles in patients with non-specific chronic low back pain
Public title
The Evaluation of adding tecar therapy effect on routine physiotherapy treatments compared to placebo tecar and routine physiotherapy treatments on pain, disability and electrical activity of erector spine muscles in patients with non-specific chronic low back pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptoms of chronic back pain who are between 20 and 60 years old Diagnosis of chronic back pain for at least 12 weeks Visual pain index 4-7 Patients with back pain who have no documentation of discopathy or disc herniation
Exclusion criteria:
Contraindication of tecar therapy: neoplasm, regional infection, patients with cardiac pacemaker and pregnancy. Active vertebral fracture previous spine surgery Rheumatoid diseases such as rheumatoid arthritis infectious diseases Systemic diseases that affect pain perception, such as diabetes and... Local injection such as (local anesthesia, corticosteroid...) Taking medicines and doing physiotherapy in the last 4 weeks
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this research is done in the form of simple sampling. Allocation of samples (into two groups) is done randomly using the Stratified Permuted Block Randomization method with 5 blocks of 4 and 8 assigned to two groups 1 BBBAABAA 2 ABAB 3 AABBAABB 4 AABBBABA 5 AABB. Considering A as the routine physiotherapy treatment group and B as the exercise group, the methodologist randomly selects a number between 1 and 5 after each patient enters. The result of the lottery result of the corresponding block number is determined. In the next step, by referring to the above table, the type of intervention (whether it is A or B) is determined. For example, let's assume that the number 3 appears at some point in the lottery, by referring to block three, we can see that before AAB choices were made and now it is the turn to perform intervention B, then, the expert is asked for this patient exercise and Takar should be done together. In the image that the block number appeared in the lottery that all the previous options were completed, the lottery is completed again until the number of duplicate samples is completed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The main researcher will not divide the samples into two groups, and this work will be done by the research assistant who is a physiotherapy expert, and the information obtained from the data will be provided to the statistical evaluator in a coded and non-recognizable form. And the evaluator will not know about the grouping of people. Also, the intervention is done by another person, and the evaluation before and after the treatment is done by the main researcher, so this study is a thriple-blind one.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
East Sahib Al Zaman Street, corner of Pakan Alley, P7
City
asadabad
Province
Hamadan
Postal code
6541833586
Approval date
2022-10-31, 1401/08/09
Ethics committee reference number
IR.SEMUMS.REC.1401.190

Health conditions studied

1

Description of health condition studied
non-specific chronic low back pain
ICD-10 code
M95-M99
ICD-10 code description
Other disorders of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
pain
Timepoint
Before the intervention and two weeks after the intervention and 1 month after the end of the last session of the intervention.
Method of measurement
visual analogue scale- -

2

Description
Functional disability
Timepoint
Before the intervention and two weeks after the intervention and 1 month after the end of the last session of the intervention.
Method of measurement
Oswestry disability scale

3

Description
Electrical activity of erector spine muscles
Timepoint
Before the intervention and two weeks after the intervention and 1 month after the end of the last session of the intervention.
Method of measurement
Electromyographic device

Secondary outcomes

empty

Intervention groups

1

Description
The patients in the treatment group are treated for 5 sessions a week and a total of 10 sessions. 10 minutes of capacitive Tecar and 10 minutes of resistance Tecar are used. The frequency of the capacitive phase of the treatment is 600 KHZ and the frequency of the resistive phase of the treatment is 450 KHZ. Intensity in both types of treatment is 10-12 w or 0.42 j/cm2 for an area of ​​228.2 cm. The routine physiotherapy treatment is 10 sessions of TENS along with therapeutic exercises similar to the sessions of the treatment group and in each treatment session for 35 minutes (20 minutes Low-frequency TENS, with a frequency of 5 Hz and a pulse duration of 300 microseconds and the use of IR for 15 minutes on the lower back area), therapeutic exercise including lumbar pelvic stabilization exercises and paraspinal stretching
Category
Rehabilitation

2

Description
Control group: Routine physiotherapy treatment, 10 sessions of TENS along with therapeutic exercises similar to the sessions of the treatment group and in each treatment session for 35 minutes (20 minutes of low frequency TENS, with a frequency of 5 Hz and pulse duration of 300 microseconds and use of IR for 15 minutes on the lower back area), therapeutic exercises include lumbar pelvic stabilization exercises and paraspinal stretching. Also, Tecar placebo is used.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic, Faculty of Rehabilitation, Hamadan University of Medical Sciences
Full name of responsible person
Morteza Heydari Nasir
Street address
East Sahib Al Zaman St. corner of Pakan Alley
City
Asadabad
Province
Hamadan
Postal code
6541833586
Phone
+98 81 3311 7923
Fax
+98 81 3311 7923
Email
m.heydarinasir@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mir Mohammad Khani
Street address
East Sahib Al Zaman St. corner of Pakan Alley
City
Asadabad
Province
Hamadan
Postal code
6541833586
Phone
+98 81 3311 7923
Fax
+98 81 3311 7923
Email
m.heydarinasir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
1
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
Semnan University of Medical Sciences
Full name of responsible person
Morteza Heydari Nasir
Position
Master science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
East Sahib Al Zaman St. corner of Pakan Alley
City
Asadabad
Province
Hamadan
Postal code
6541833586
Phone
+98 81 3311 7923
Fax
+98 81 3311 7923
Email
m.heydarinasir@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Morteza Heydari Nasir
Position
Master science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
East Sahib Al Zaman St. corner of Pakan Alley
City
Asadabad
Province
Hamadan
Postal code
6541833586
Phone
+98 81 3311 7923
Email
m.heydarinasir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Morteza Heydari Nasir
Position
Master science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
East Sahib Al Zaman St. corner of Pakan Alley
City
Asadabad
Province
Hamadan
Postal code
6541833586
Phone
+98 81 3311 7923
Email
m.heydarinasir@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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