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Remote Exercise Programs in Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Face to Face Exercise
Telerehabilitation
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring spinal stabilization exercise, tele-rehabilitation, low back pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having low back pain for more than 3 months,
  • Pain intensity of 3 or more according to VAS,
  • literate,
  • A smartphone user,
  • Own a smartphone
  • Individuals who are able to understand the exercises (total score >21 on the Montreal Cognitive Assessment Scale (MOCA)) will be included in the study.

Exclusion Criteria:

  • Those who have been diagnosed with cervical or lumbar region pathologies,
  • Cervical rapiculopathy, thoracic outlet syndrome,
  • Having a malignant condition,
  • Having systemic diseases such as neurological, psychological, cardiovascular, rheumatological and loss of function due to these diseases,
  • History of previous surgery on the spine and upper extremity,
  • Acute infection,
  • Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation

Face to Face Exercises

Arm Description

Remotely (with video) progressive spinal stabilization exercises.

Face to face (in clinic) progressive spinal stabilization exercises.

Outcomes

Primary Outcome Measures

Evaluation of Trunk Range of Motion
Trunk range of motion measurement is a frequently used method in the evaluation of individuals with low back pain. Trunk range of motion measurements will be carried out before and after the exercise program using Valedo® system (Hocoma, Switzerland). Valedo® system is a professional system used in the evaluation and treatment of low back pain and valid and reliable system that is routinely used in the evaluation of trunk range of motion. Within the scope of our study, trunk flexion, extension, lateral flexion and rotation movements will be evaluated. All angles will be measured in degrees.
Evaluation of Gait Parameters - Time Characteristics 1
Gait analyses is used to evaluate the time-distance gait parameters in chronic conditions such as low back pain. Gait analyses measurements will be carried out before and after the exercise program using OPTOGait (OPTOGait, Microgate, İtalya, 2010). The OPTOGait system consists of two bars, each 1 meter, and one a sender and the other a receiver unit. It is a portable platform that can be placed on the treadmill. Its validity and reliability have been established. During the assessment, individuals will walk in comfortable clothes and sneakers. Individuals' walking at the pace they choose will be recorded for 1 minute. Within the scope of our study, step time, gait cycle, and cadance will be evaluated and results will be recorded in seconds.
Evaluation of Gait Parameters - Time Characteristics 2
Gait analyses is used to evaluate the time-distance gait parameters in chronic conditions such as low back pain. Gait analyses measurements will be carried out before and after the exercise program using OPTOGait (OPTOGait, Microgate, İtalya, 2010). The OPTOGait system consists of two bars, each 1 meter, and one a sender and the other a receiver unit. It is a portable platform that can be placed on the treadmill. Its validity and reliability have been established. During the assessment, individuals will walk in comfortable clothes and sneakers. Individuals' walking at the pace they choose will be recorded for 1 minute. Within the scope of our study, stance phase, swing phase, single support, double support, load response and pre-swing will be evaluated and results will be recorded as percentages.
Evaluation of Gait Parameters - Distance Characteristics
Gait analyses is used to evaluate the time-distance gait parameters in chronic conditions such as low back pain. Gait analyses measurements will be carried out before and after the exercise program using OPTOGait (OPTOGait, Microgate, İtalya, 2010). The OPTOGait system consists of two bars, each 1 meter, and one a sender and the other a receiver unit. It is a portable platform that can be placed on the treadmill. Its validity and reliability have been established. During the assessment, individuals will walk in comfortable clothes and sneakers. Individuals' walking at the pace they choose will be recorded for 1 minute. Within the scope of our study, step length and stride length will be evaluated and results will be recorded in centimeter.
Evaluation of Functional Capacity Level
Functional capacity level will be evaluated with The Back Performance Scale. This scale is a test that evaluates the effectiveness of each activity that includes 5 different activities (socks test, gathering test, righting test, fingertip-floor test, carrying test). The Back Performance Scale test is scored between 0-15 points. A high score means poor functional capacity.
Evaluation of Pain Intensity
Pain intensity will be evaluated with Visual Analog Scale (VAS). The VAS consists of a 10cm line. The pain experienced by the patient is marked as "0: I have no pain", "10: I have a lot of pain". Scoring is based on measuring the level marked by the participant on the line with a ruler.

Secondary Outcome Measures

Evaluation of Quality of Life
Quality of life will be evaluated with Nottingham Health Profile. This scale consists of 38 questions. The scale with validity and reliability has 6 subgroups: physical activity, pain, sleep, social isolation, emotional reaction and energy level. Each subgroup is scored within the range of 0-100, and a high score means poor quality of life.
Evaluation of Exercise Adaptation
Exercise adaptation will be evaluated with the Exercise Adherence Rating Scale (EARS). The scale consists of 3 parts. The first 2 parts of the scale consist of 6 questions and the third part consists of 10 questions. An increase in score indicates an increased adaptation to exercise. A higher score indicates greater adaptation to exercise.
Evaluation of Pain Catastrophization
Pain catastrophization will be evaluated with the Pain Catastrophizing Scale. Sullivan et al. was created to evaluate the catastrophic thoughts and feelings of individuals regarding the pain they feel. Consisting of 13 questions, the scale consists of rumination (thoughts spinning in the mind), magnification of pain and helplessness sub-dimensions. The total score is evaluated out of 52. A high score means a high pain catastrophe.
Evaluation of Disability
Disability will be evaluated with the Oswestry Disability İndex (ODI). It was developed by Fairbank et al to evaluate the level of functional loss in individuals with low back pain. The scale consists of 10 questions about pain intensity, self-care, lifting-carrying, walking, sitting, standing, sleep, degree of change in pain, travel and social life. Each question is scored between 0-5 points. The total score is evaluated out of 100. A high score means a high level of disability.
Evaluation of Media and Social Media Usage Situations with Technological Tools
The scale was created by Rosen et al. to evaluate the use of technological tools such as computers, smart phones, and media and social media. The scale consists of two subscales and 15 factors. The factors of the usage subscale are smartphone usage, general social network usage, searching the internet, using e-mail, sharing media, using text messages (SMS), playing video games, making phone calls, watching TV, online friendship and social media friendship. The factors of the attitude subscale are positive attitude towards technology, anxiety of being without technology or technology addiction, negative attitude towards technology and transition preferences between tasks. The validity and reliability study shows that the subscales of the scale can be used together or separately. A high score means a high level of media and technology use.

Full Information

First Posted
July 14, 2021
Last Updated
July 3, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05082649
Brief Title
Remote Exercise Programs in Chronic Low Back Pain
Official Title
Investigation of Short and Long Term Results of Remote and Face-to-Face Exercise Education Programme for Chronic Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
September 3, 2023 (Anticipated)
Study Completion Date
December 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Low back pain is a common problem that affects many people at some point in their lives. These people constitute a big part of the disease burden due to their recurrent complaints. About 45% of individuals with chronic low back pain seek medical attention. This situation makes chronic low back pain the second reason for individuals to apply to the hospital. Exercise therapy is the first option that comes to mind in the management of low back pain. It is seen that exercise therapy both reduces the intensity of pain and reduces the recurrence rate of complaints. When the literature is examined, it is observed that among the exercise models, stabilization exercises can provide more benefits than general exercises in reducing pain and improving disability. The COVID-19 pandemic causes disruptions in face-to-face rehabilitation services. The development of telemedicine and telerehabilitation services, whose popularity is increasing with the advancing technology, gained momentum with these disruptions. With telerehabilitation, long-term treatments tailored to the needs of the patients can be offered, the cost is low, and the patients can exercise at home, on their own, at their own pace, whenever they want. These reasons make telerehabilitation stand out especially during the pandemic period. The aim of the study planned in this context is to investigate short and long-term results of remote and face-to-face exercise training on function and disease symptoms for individuals with chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
spinal stabilization exercise, tele-rehabilitation, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Remotely (with video) progressive spinal stabilization exercises.
Arm Title
Face to Face Exercises
Arm Type
Active Comparator
Arm Description
Face to face (in clinic) progressive spinal stabilization exercises.
Intervention Type
Other
Intervention Name(s)
Face to Face Exercise
Intervention Description
Face to face (in clinic) progressive spinal stabilization exercises.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
Remotely (with video) progressive spinal stabilization exercises.
Primary Outcome Measure Information:
Title
Evaluation of Trunk Range of Motion
Description
Trunk range of motion measurement is a frequently used method in the evaluation of individuals with low back pain. Trunk range of motion measurements will be carried out before and after the exercise program using Valedo® system (Hocoma, Switzerland). Valedo® system is a professional system used in the evaluation and treatment of low back pain and valid and reliable system that is routinely used in the evaluation of trunk range of motion. Within the scope of our study, trunk flexion, extension, lateral flexion and rotation movements will be evaluated. All angles will be measured in degrees.
Time Frame
15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline trunk range of motion at 8 weeks and 6th months
Title
Evaluation of Gait Parameters - Time Characteristics 1
Description
Gait analyses is used to evaluate the time-distance gait parameters in chronic conditions such as low back pain. Gait analyses measurements will be carried out before and after the exercise program using OPTOGait (OPTOGait, Microgate, İtalya, 2010). The OPTOGait system consists of two bars, each 1 meter, and one a sender and the other a receiver unit. It is a portable platform that can be placed on the treadmill. Its validity and reliability have been established. During the assessment, individuals will walk in comfortable clothes and sneakers. Individuals' walking at the pace they choose will be recorded for 1 minute. Within the scope of our study, step time, gait cycle, and cadance will be evaluated and results will be recorded in seconds.
Time Frame
15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline time-distance gait parameters at 8 weeks and 6th months
Title
Evaluation of Gait Parameters - Time Characteristics 2
Description
Gait analyses is used to evaluate the time-distance gait parameters in chronic conditions such as low back pain. Gait analyses measurements will be carried out before and after the exercise program using OPTOGait (OPTOGait, Microgate, İtalya, 2010). The OPTOGait system consists of two bars, each 1 meter, and one a sender and the other a receiver unit. It is a portable platform that can be placed on the treadmill. Its validity and reliability have been established. During the assessment, individuals will walk in comfortable clothes and sneakers. Individuals' walking at the pace they choose will be recorded for 1 minute. Within the scope of our study, stance phase, swing phase, single support, double support, load response and pre-swing will be evaluated and results will be recorded as percentages.
Time Frame
15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline time-distance gait parameters at 8 weeks and 6th months
Title
Evaluation of Gait Parameters - Distance Characteristics
Description
Gait analyses is used to evaluate the time-distance gait parameters in chronic conditions such as low back pain. Gait analyses measurements will be carried out before and after the exercise program using OPTOGait (OPTOGait, Microgate, İtalya, 2010). The OPTOGait system consists of two bars, each 1 meter, and one a sender and the other a receiver unit. It is a portable platform that can be placed on the treadmill. Its validity and reliability have been established. During the assessment, individuals will walk in comfortable clothes and sneakers. Individuals' walking at the pace they choose will be recorded for 1 minute. Within the scope of our study, step length and stride length will be evaluated and results will be recorded in centimeter.
Time Frame
15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline time-distance gait parameters at 8 weeks and 6th months
Title
Evaluation of Functional Capacity Level
Description
Functional capacity level will be evaluated with The Back Performance Scale. This scale is a test that evaluates the effectiveness of each activity that includes 5 different activities (socks test, gathering test, righting test, fingertip-floor test, carrying test). The Back Performance Scale test is scored between 0-15 points. A high score means poor functional capacity.
Time Frame
10 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline functional capacity level at 8 weeks and 6th months
Title
Evaluation of Pain Intensity
Description
Pain intensity will be evaluated with Visual Analog Scale (VAS). The VAS consists of a 10cm line. The pain experienced by the patient is marked as "0: I have no pain", "10: I have a lot of pain". Scoring is based on measuring the level marked by the participant on the line with a ruler.
Time Frame
5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline pain intensity level at 8 weeks and 6th months
Secondary Outcome Measure Information:
Title
Evaluation of Quality of Life
Description
Quality of life will be evaluated with Nottingham Health Profile. This scale consists of 38 questions. The scale with validity and reliability has 6 subgroups: physical activity, pain, sleep, social isolation, emotional reaction and energy level. Each subgroup is scored within the range of 0-100, and a high score means poor quality of life.
Time Frame
5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline quality of life at 8 weeks and 6th months
Title
Evaluation of Exercise Adaptation
Description
Exercise adaptation will be evaluated with the Exercise Adherence Rating Scale (EARS). The scale consists of 3 parts. The first 2 parts of the scale consist of 6 questions and the third part consists of 10 questions. An increase in score indicates an increased adaptation to exercise. A higher score indicates greater adaptation to exercise.
Time Frame
5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline exercise adaptation at 8 weeks and 6th months
Title
Evaluation of Pain Catastrophization
Description
Pain catastrophization will be evaluated with the Pain Catastrophizing Scale. Sullivan et al. was created to evaluate the catastrophic thoughts and feelings of individuals regarding the pain they feel. Consisting of 13 questions, the scale consists of rumination (thoughts spinning in the mind), magnification of pain and helplessness sub-dimensions. The total score is evaluated out of 52. A high score means a high pain catastrophe.
Time Frame
5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline pain catastrophizing scale score at 8 weeks and 6th months
Title
Evaluation of Disability
Description
Disability will be evaluated with the Oswestry Disability İndex (ODI). It was developed by Fairbank et al to evaluate the level of functional loss in individuals with low back pain. The scale consists of 10 questions about pain intensity, self-care, lifting-carrying, walking, sitting, standing, sleep, degree of change in pain, travel and social life. Each question is scored between 0-5 points. The total score is evaluated out of 100. A high score means a high level of disability.
Time Frame
5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline ODI score at 8 weeks and 6th months
Title
Evaluation of Media and Social Media Usage Situations with Technological Tools
Description
The scale was created by Rosen et al. to evaluate the use of technological tools such as computers, smart phones, and media and social media. The scale consists of two subscales and 15 factors. The factors of the usage subscale are smartphone usage, general social network usage, searching the internet, using e-mail, sharing media, using text messages (SMS), playing video games, making phone calls, watching TV, online friendship and social media friendship. The factors of the attitude subscale are positive attitude towards technology, anxiety of being without technology or technology addiction, negative attitude towards technology and transition preferences between tasks. The validity and reliability study shows that the subscales of the scale can be used together or separately. A high score means a high level of media and technology use.
Time Frame
15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline score at 8 weeks and 6th months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having low back pain for more than 3 months, Pain intensity of 3 or more according to VAS, literate, A smartphone user, Own a smartphone Individuals who are able to understand the exercises (total score >21 on the Montreal Cognitive Assessment Scale (MOCA)) will be included in the study. Exclusion Criteria: Those who have been diagnosed with cervical or lumbar region pathologies, Cervical rapiculopathy, thoracic outlet syndrome, Having a malignant condition, Having systemic diseases such as neurological, psychological, cardiovascular, rheumatological and loss of function due to these diseases, History of previous surgery on the spine and upper extremity, Acute infection, Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

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Remote Exercise Programs in Chronic Low Back Pain

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