IRCT | Comparison of the effect of performing therapeutic selected exercises using virtual reality and routine method on pain, function and quality of life in patients with non-specific chronic low back pain.

Protocol summary

Study aim: Comparison of the effect of selective therapeutic exercise using virtual and normal reality methods on pain, performance and quality of life in patients with non-specific chronic low back pain.
Design: a randomized, single blinded, clinical trial with a parallel group design of 44 patients , enrolled between July 2023 and November 2023.
Settings and conduct: People with non-specific chronic back pain referred to the physiotherapy department of Rofidah Rehabilitation Hospital in 1402 At first, the goals, method of conducting the study and other required information are provided to the participant. Then the patients will be randomly divided into two control and intervention groups. After the completion of the treatment sessions, the evaluation of the end of the treatment period is done, and two weeks after the end of the treatment period, the evaluation will be repeated .Participants will be treated every other day for 10 sessions.
Participants/Inclusion and exclusion criteria: People with non-specific chronic mechanical back pain with the diagnosis of the attending physician and file. People who are between 20-50 years old. Having a history of back pain for at least 12 weeks. Have an average pain of 4-7 on the visual analog scale of pain in the previous seven days ؛ Patients with congenital abnormalities. Fracture of the spine or lower and upper limbs. Any systemic disease or neurological disease Previous back surgery pregnant women
Intervention groups: In the intervention group, physical therapy is performed routinely for the participants. In the next step, the participants take part in virtual reality therapeutic exercise training.
Main outcome variables: kinesiophobia, muscle strength, range of motion, quality of life, disability ,pain ,balance

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20230411057885N1

Registration date: 2023-05-15, 1402/02/25

Registration timing: prospective

Last update: 2023-05-15, 1402/02/25

Update count: 0
Registration date: 2023-05-15, 1402/02/25

Registrant information: Name

fatimah khalifeh

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 933 454 5341

Email address

fatimah.khalifeh@hotmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-07-02, 1402/04/11
Expected recruitment end date: 2023-12-23, 1402/10/02
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the effect of performing therapeutic selected exercises using virtual reality and routine method on pain, function and quality of life in patients with non-specific chronic low back pain.

Public title: The effect of virtual reality therapeutic exercise in the treatment of chronic low back pain.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

People with non-specific chronic mechanical back pain with the diagnosis of the attending physician and file. People who are between 20-50 years old. They are not involved in any other treatment program during the study. Have stopped taking painkillers 24 hours before the evaluation. Having a history of back pain for at least 12 weeks. Have an average pain of 4-7 on the visual analog scale of pain in the previous seven days.

Exclusion criteria:

Patients with congenital abnormalities. History of trauma Fracture of the spine or lower and upper limbs Any systemic disease or neurological disease Individuals who have taken corticosteroids, benzodiazepines, antidepressants, or anticonvulsants three weeks prior to the evaluation. pregnant women previous back surgeries Vestibular and vision disorders Obese people according to body mass index Aggravation of symptoms so that it is not possible to perform.
Age: From 20 years old to 50 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor

Sample size

Target sample size: 44

Randomization (investigator's opinion)

Randomized

Randomization description

Placement of samples in intervention and control groups is done in a simple random stratified manner. Considering that it is necessary for the groups to be homogeneous in terms of sex, the classes include 2 classes resulting from the sex (two groups). A person is placed in one of the classes based on gender. The desired sample is then randomly placed in one of the two groups, and the next sample placed in the same class is placed in the opposite group.

Blinding (investigator's opinion)

Single blinded

Blinding description

The evaluator of patients participating in the first session and the final 10th session is blinded to the information, purpose and results of the thesis.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethical committee of rehabilitation and social welfare sciences university

Street address

velenjak , daneshju boulevard, kodakyar ave

City

Tehran

Province

Tehran

Postal code

1985713871
Approval date: 2023-03-19, 1401/12/28
Ethics committee reference number: IR.USWR.REC.1401.256

Health conditions studied

1

Description of health condition studied: patients suffering chronic non specific low back pain
ICD-10 code: M54.9
ICD-10 code description: Dorsalgia, unspecified

Primary outcomes

1

Description: pain score that is calculated between 0 and 10.
Timepoint: Measuring the pain score before the intervention and at the end of the treatment sessions and two weeks later.
Method of measurement: using the virtual analogue scale

Secondary outcomes

1

Description: kinesiophobia
Timepoint: before the intervention and at the end of the treatment sessions and two weeks later.
Method of measurement: tampa scale of kinesiophobia

Intervention groups

1

Description: Intervention group: It should be noted that all patients are placed in the lying position on the stomach during all stages of using the modalities and a pillow is placed under the abdomen and leg. The spine should be in a neutral position. Using a small towel under the patient's forehead will be used to prevent neck rotation. Applying ten sessions of physiotherapy using modalities that include three modalities. which includes three modalities: 1) Continuous ultrasound with a frequency of 3 MHz for 8 minutes. The application of pulsed ultrasound was standardized in the lower back area between the first and fifth lumbar vertebra and in the area of interest, the distance between the spinous and transverse appendages on the right and left sides, the target muscles including the spinalis, the erector spinae muscles and in the multifidus area, which is below the two The mentioned muscle is located. One minute was considered for each point, after the electric current of TENS continuously in the lower back area in the pain area for 15 minutes using two channels and four electrodes (10 x 10 cm) placed around the pain area with Frequency setting of 20 Hz and pulse width of 10 pulses per second (pps) along with 15 minutes of our infrared heat is used at a distance of 30 cm on the lower back area. The next step, which is the exercise step, first teaches the patient how to perform each exercise. Each exercise mentioned is repeated ten times. The red reference is placed in the middle of the patient's foot, and the ball is displayed at a certain distance from the red marker when it is shown on either side of the patient. The patient is placed individually (alone) with the therapist in a room dedicated to virtual reality and face to face with a distance of 200-250 cm from the device. The progress of the exercises will be done depending on the patient's ability during the sessions.
Category: Rehabilitation

2

Description: Control group: It should be noted that all patients are placed in the lying position on the stomach during all stages of using the modalities and a pillow is placed under the abdomen and leg. The spine should be in a neutral position. Using a small towel under the patient's forehead will be used to prevent neck rotation. Applying ten sessions of physiotherapy using modalities that include three modalities. which includes three modalities: 1) Continuous ultrasound with a frequency of 3 MHz for 8 minutes. The application of pulsed ultrasound was standardized in the lower back area between the first and fifth lumbar vertebra and in the area of interest, the distance between the spinous and transverse appendages on the right and left sides, the target muscles including the spinalis, the erector spinae muscles and in the multifidus area, which is below the two The mentioned muscle is located. One minute was considered for each point, after the electric current of TENS continuously in the lower back area in the pain area for 15 minutes using two channels and four electrodes (10 x 10 cm) placed around the pain area with Frequency setting of 20 Hz and pulse width of 10 pulses per second (pps) along with 15 minutes of our infrared heat is used at a distance of 30 cm on the lower back area.The next step, which is the exercise step, first teaches the patient how to perform each exercise. Each exercise mentioned is repeated five times in the first session, and increased to 10 repetitions in the second session, 15 repetitions in the third session, and 20 repetitions in the fourth session. The remaining sessions are continued with 20 repetitions. The exercises of the control and intervention groups have been selected in such a way that they can be implemented in a similar and corresponding way in each group, with the difference that in the intervention group, the exercises are performed using a virtual reality system.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Rofeideh Rehabilitation Hospital

Full name of responsible person

Fatimah Nader Khalifeh

Street address

Gheytariye , neamati street ,

City

Tehran

Province

Tehran

Postal code

1985713871

Phone

+98 933 454 5341

Email

fatimah.khalifeh@hotmail.com

1

Sponsor: Name of organization / entity

University of social welfare and rehabilitation sciences

Full name of responsible person

Hamid Reza Khanke

Street address

Evin Daneshju Blvd kodakyar ave

City

Tehran

Province

Tehran

Postal code

1985713871

Phone

+98 912 376 8849

Email

hamid.khanke@ki.se
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: University of social welfare and rehabilitation 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

University of social welfare and rehabilitation sciences

Full name of responsible person

Fatimah Khalifeh

Position

PhD student

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

Aghdasiye street , sadr nejad street , sahel end , boustan compound , block 1 plak 6

City

Tehran

Province

Tehran

Postal code

1985713871

Phone

+98 933 454 5341

Fax

Email

fatimah.khalifeh@hotmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

University of social welfare and rehabilitation sciences

Full name of responsible person

Noureddin Karimi

Position

professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Evin , daneshju blvd, kodakyar ave, university of rehabilitation and social welfare sciences

City

Tehran

Province

Tehran

Postal code

1985713871

Phone

0989122573865

Fax

Email

karimi@uswr.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

University of social welfare and rehabilitation sciences

Full name of responsible person

Fatimah Khalifeh

Position

PhD student

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

Aghdasiye street , sadr nejad street , sahel end , boustan compound , block 1 plak 6

City

Tehran

Province

Tehran

Postal code

1985713871

Phone

+98 933 454 5341

Fax

Email

fatimah.khalifeh@hotmail.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: Yes - There is a plan to make this available
Title and more details about the data/document: demographic information and outcomes
When the data will become available and for how long: 6 months after article acceptance
To whom data/document is available: other researchers
Under which criteria data/document could be used: more advanced researches like meta analysis
From where data/document is obtainable: fatimah nader khalifeh 09334545341 fatimah.khalifeh@hotmail.com
What processes are involved for a request to access data/document: university of rehabilitation and social welfare sciences
Comments

Comparison of the effect of performing therapeutic selected exercises using virtual reality and routine method on pain, function and quality of life in patients with non-specific chronic low back pain.