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The comparison of delivering low back exercises by an smartphone application and traditional methods in non-specific chronic low back pain

Protocol summary

Study aim
The comparison of delivering low back exercises by an smartphone application and traditional methods in non-specific chronic low back pain
Design
Clinical trial with control group, with parallel groups, not blind, randomized, on 40 patients, envelope is used for randomization
Settings and conduct
study will be performed in the physiotherapy centers of Tabriz Rehabilitation faculty. Patients will receive ten sessions of physiotherapy with home exercises.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Low back pain patients aged 18-60 years who have had low back pain for more than 3 months, no specific cause for low back pain Has been identified and physiotherapy has been prescribed. Pain intensity is mild to moderate (VAS 2 to 6). The Oswestry questionnaire score should be higher than 10 before starting treatment. Have at least one smartphone in the patient's family. The person has the ability to read and understand the Persian language. ٍExclusion criteria: cases such as infection and spinal tumors, osteoporosis and vertebral fractures History of spinal surgery in the last 6 months Injury to the knee and ankle that restricts movement People whose symptoms are reproduced at the beginning of the slump test during neck flexion People with spinal deformities
Intervention groups
In this study, patients with chronic low back pain are divided into two groups: doing exercises with a mobile phone application and an exercise booklet. Both groups will receive the same exercises, except that in the smartphone app group, people will be able to use therapist support, send daily reports and watch exercise videos, and in the exercise booklet group, people can read photos and descriptions of exercises.
Main outcome variables
Pain intensity, disability, lumbar neuromuscular control, neurodynamic, Adherence to exercise, compliance with treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210316050727N2
Registration date: 2021-08-30, 1400/06/08
Registration timing: prospective

Last update: 2021-08-30, 1400/06/08
Update count: 0
Registration date
2021-08-30, 1400/06/08
Registrant information
Name
Abas Soltani someh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 5359
Email address
ab.soltani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of delivering low back exercises by an smartphone application and traditional methods in non-specific chronic low back pain
Public title
The comparison of delivering low back exercises by an smartphone application and traditional methods in non-specific chronic low back pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Low back pain patients aged 18-60 years who have had low back pain for more than 3 months, no specific cause for low back pain has been identified and physiotherapy has been prescribed. Mild to moderate pain intensity (VAS 2 to 6 ) The Oswestry questionnaire score is above 10 before starting treatment. Have at least one smartphone in the patient's family. The person has the ability to read and understand the Persian language.
Exclusion criteria:
cases such as infection and spinal tumors, osteoporosis and vertebral fractures History of spinal surgery in the last 6 months injury to the knee and ankle that restricts movement People whose symptoms are reproduced at the beginning of the slump test during neck flexion People with spinal deformities and ankylosing spondylitis
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Random software allocation For the allocation concealment, the type of intervention received is written on a piece of paper and placed inside the opaque envelopes and the back of the envelope will be numbered. The envelopes will be opened according to the entry of the participants and the type of group for each patient will be specified accordingly.
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 of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Department of Physiotherapy, School of Rehabilitation Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5355116553
Approval date
2021-05-03, 1400/02/13
Ethics committee reference number
IR.TBZMED.REC.1400.126

Health conditions studied

1

Description of health condition studied
Chronic non-specific low back pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain Intensity
Timepoint
At the beginning of the study (before the intervention) and after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment
Method of measurement
Visual analog scale

2

Description
Functional disability
Timepoint
At the beginning of the study (before the intervention) and after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment
Method of measurement
Oswestry questionnaire

Secondary outcomes

1

Description
Low back neuromuscular control
Timepoint
At the beginning of the study (before the intervention) and after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment
Method of measurement
Double leg lowering test

2

Description
Neurodynamic
Timepoint
At the beginning of the study (before the intervention) and after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment
Method of measurement
Straight leg raise test

3

Description
Patient satisfaction with treatment
Timepoint
after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment
Method of measurement
Special satisfaction questionnaire for this study

4

Description
Adherence to home exercise program
Timepoint
after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment
Method of measurement
Exercise Adherence Questionnaire

Intervention groups

1

Description
Intervention group:The duration of interventions is 4 weeks with one month of follow-up. Patients are visited three times a week in the physiotherapy centers of the School of Rehabilitation and the interventions will be performed under the supervision of the project researchers. The duration of each exercise therapy session can vary depending on the stage of the treatment protocol and the number of exercises. Due to the difficulty of stabilizing exercises and the emphasis on doing the exercises correctly, patients in both groups are given a period of time to learn basic and basic exercises with the help of compression biofeedback, and then a 4-week treatment protocol with one month of follow-up. begins. In both groups, people first do some general stretching exercises to warm up before the main exercises; In the case of neurodynamic exercises, 4 exercises are considered that will be used only for patients with chronic low back pain who have pain referred to the lower extremities. Each neurodynamic exercise is performed one set of 20 per day. In the case of stabilization exercises, each exercise is held for 5 to 10 seconds and repeated 10 times a day (a set of ten). Each session adds one exercise to the patient's exercises so that in the first 4 weeks the patient receives all the relevant exercises and in the next 4 weeks repeats all the exercises; During this period, the number and timing of the exercises are improved. At the end of this section, the exercise schedule is set, but this schedule may change slightly depending on the patient's ability and skills. The patient is asked to do the exercises on a daily basis at home. Using the application in the treatment group is to examine the importance of using technology in the field of physiotherapy. In this regard, in order to prevent forgetfulness and doing wrong exercises in the application group, these exercises are provided to people through the application, which includes an instructional video of doing the exercises, teaching tips about back care, contacting the therapist, and sending a reminder message. Doing exercises and the message of doing or not doing exercises by the person is sent to the therapist through the application.
Category
Rehabilitation

2

Description
Control group: The duration of interventions is 4 weeks with one month of follow-up. Patients are visited three times a week in the physiotherapy centers of the School of Rehabilitation and the interventions will be performed under the supervision of the project researchers. The duration of each exercise therapy session can vary depending on the stage of the treatment protocol and the number of exercises. Due to the difficulty of stabilizing exercises and the emphasis on doing the exercises correctly, patients in both groups are given a period of time to learn basic and basic exercises with the help of compression biofeedback, and then a 4-week treatment protocol with one month of follow-up. begins. In both groups, people first do some general stretching exercises to warm up before the main exercises; In the case of neurodynamic exercises, 4 exercises are considered that will be used only for patients with chronic low back pain who have pain referred to the lower extremities. Each neurodynamic exercise is performed one set of 20 per day. In the case of stabilization exercises, each exercise is held for 5 to 10 seconds and repeated 10 times a day (a set of ten). Each session adds one exercise to the patient's exercises so that in the first 4 weeks the patient receives all the relevant exercises and in the next 4 weeks repeats all the exercises; During this period, the number and timing of the exercises are improved. At the end of this section, the exercise schedule is set, but this schedule may change slightly depending on the patient's ability and skills. The patient is asked to do the exercises on a daily basis at home. In the control group, the exercises and tips for taking care of the back are provided through a tutorial booklet with explanations and it is recommended to him to set phone alarm in order to not forget doing home exercises.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic of Tabriz Rehabilitation faculty
Full name of responsible person
Abbas Soltani Somee
Street address
Tabriz,Tavanir,physiotherapy clinic of rehabilitation sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5355116553
Phone
+98 41 3337 5359
Email
Ab.soltani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Tabriz University of Medical Sciences, Research Vice-Chancellor, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5355116553
Phone
+98 41 3329 9654
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Abbas Soltani Somee
Position
Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz, Tavanir, physiotherapy clinic of rehabilitation sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5355116553
Phone
+98 41 3337 5359
Email
Ab.soltani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abbas Soltani Somee
Position
Tabriz
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz, Tavanir, physiotherapy clinic of rehabilitation sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5355116553
Phone
+98 41 3337 5359
Email
Ab.soltani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abbas Soltani Somee
Position
Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz, Tavanir, physiotherapy clinic of rehabilitation sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5355116553
Phone
+98 41 3337 5359
Email
Ab.soltani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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