The effect of resistive capacitive electric transfer method and flexibility exercises on pain, range of motin, disability and quality of life in patients with chronic nonspecific low back pain
Comparative effect of comparative heat transfer by capacitive-resistance method and flexibility exercises on pain, disability and range of patients with chronic nonspecific back pain
Capacitive-resistive heat transfer is one of the treatment methods using heat. Heat increases blood flow to the muscle and increases the expansion of soft tissue and helps to improve symptoms.
Design
Both groups first use a stationary bike for 5 minutes to prepare and warm up. Then both groups do stability exercises. Capacitive-resistance heat transfer (CRET therapy) is one of the treatment methods using heat.
The CRET group is first treated with a capacitive method for 5 minutes, then with a resistance method for 10 minutes, and again with a capacitive electrode for 5 minutes. Give.
The first group is treated with placebo and flexibility exercises. The second group is treated with flexibility training and placebo therapy with no energy therapy.
Settings and conduct
Clinical trial with control group, with parallel group, one-way blind, randomized, on about 50 patients. Random Number software was used for randomization.
Participants/Inclusion and exclusion criteria
Patient with non-specific chronic low back pain between the ages of 18 and 50 who have had pain for at least the past 3 months are included in the study.
People who are not in this age group, have pain for less than 3 months, and have conditions such as deformity of the lower limbs and spine or pacemaker are not included in the study.
Intervention groups
• Patient aged 18 to 50 years
• Pain in the lower back for at least 3 months if the exact cause is not known
• Patient with moderate pain intensity (VAS between 3 and 6)
• The person has the ability to do exercises
Main outcome variables
Evaluation of pain and disability in people with non-specific chronic low back pain
Range of motion and quality of life are also measured as a secondary variable.
General information
Reason for update
Acronym
TECAR(of resistive capacitive electric transfer method)
IRCT registration information
IRCT registration number:IRCT20220227054142N1
Registration date:2022-04-18, 1401/01/29
Registration timing:registered_while_recruiting
Last update:2022-04-18, 1401/01/29
Update count:0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Mehdi Jarghouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 313 5153
Email address
ptmehdi.j1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resistive capacitive electric transfer method and flexibility exercises on pain, range of motin, disability and quality of life in patients with chronic nonspecific low back pain
Public title
Evaluation of the effect of TECAR and exercise therapy in patients with chronic nonspecific back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in the lower back for at least 3 months if the exact cause is not known
• The person has the ability to do exercises
• The person is willing to do exercises and therapy sessions
Exclusion criteria:
No acute back pain (at least 3 months after pain)
Infection in the lumbar region
Fracture or tumor
History of lumbar surgery
Pace Maker or any electrical device in the body
Severe deformity in the lower limbs or spine such as scoliosis
Specific diseases of the spine such as severe osteoporosis or ankylosing spondylitis
Neurological problems such as stroke or other problems that deprive a person of the ability to perform exercises and tests
Lack of understanding and inability of the questionnaire
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are initially divided into two groups 1 and 2 with the help of Random Number program
The number one in the application indicates the addiction therapy group and the exercise therapy placebo, and the number 2 in the software indicates the addiction therapy and exercise therapy group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient does not know how to group and study
The data analyzer does not know how to group and study
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of iran University of Medical Sciences
Pain: The effect of resistive capacitive electric transfer method and flexibility exercises in patients with chronic nonspecific low back pain
Timepoint
Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days)
Method of measurement
Visual-analog scale
2
Description
Disability: Any limitation or inability to perform an activity in the normal range that is possible for a normal and healthy person to perform
Timepoint
Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days)
Method of measurement
Oswestry Disability Index (ODI)
Secondary outcomes
1
Description
Quality of life :: Quality of life is the perception of each person of their health status and the degree of satisfaction with this situation.
Timepoint
Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days)
Method of measurement
Persian version of the 12-item SF-12 questionnaire
2
Description
Range of motion: The amount of movement in a joint that depends on the bone structure and physiological characteristics of the connective tissue around the joint.
Timepoint
Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days)
Method of measurement
در بررسی خم شدن طرفی فرد به دیوار تکیه داده و بدون این که شانه هایش از دیوار فاصله بگیرد به طرف خم می شود و فصله ی نوک انگشتان تا زمین اندازه گرفته می شود.
3
Description
Range of motion Bending forward: The amount of movement in a joint that depends on the bone structure and physiological characteristics of the connective tissue around the joint.
Timepoint
Before the start of the study - at the end of 10 treatment sessions - one month (30 days) days after the end of treatment - three months after the end of treatment (90 days)
Method of measurement
Modified Schober Index
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
2
Description
Control group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
دانشکده توانبخشی دانشگاه علوم پزشکی ایران
Full name of responsible person
مهدی جرقوئی
Street address
Mirdamad, Shah Nazari St., Maddakaran Alley
City
Tehran
Province
Tehran
Postal code
13487 - 15459
Phone
+98 21 2222 2059
Email
ptmehdi.j1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
دکتر حسین کیوانی
Street address
بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City
تهران
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Mehdi Jarghouei
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
University Street, Shahed Alley 3
City
khansar
Province
Isfehan
Postal code
8791816764
Phone
+98 31 5777 0545
Email
ptmehdi.j1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Jarghouei
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
University Street, Shahed Alley 3
City
khansar
Province
Isfehan
Postal code
8791816764
Phone
+98 31 5777 0545
Email
ptmehdi.j1995@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Jarghouei
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
University Street, Shahed Alley 3
City
khansar
Province
Isfehan
Postal code
8791816764
Phone
+98 31 5777 0545
Email
ptmehdi.j1995@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All primary and secondary variable data will be published
When the data will become available and for how long
About 6 months after printing the results.
To whom data/document is available
This information will be available to people working in academic institutions as well as graduate physiotherapists.
Under which criteria data/document could be used
The use of results and data for academic institutions and for the purpose of conducting research is available only by mentioning the source.
From where data/document is obtainable
Via email and contact Mehdi Jarghouei at ptmehdi.j1995@gmail.com
What processes are involved for a request to access data/document
After submitting the response request, finally up to 2 weeks later