Low Back PainNCT05082649
Remote Exercise Programs in Chronic Low Back Pain
A study testing Face to Face Exercise and Telerehabilitation in people with Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Face to Face Exercise and Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Short and Long Term Results of Remote and Face-to-Face Exercise Education Programme for Chronic Low Back Pain Patients
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.
- Conditions
- Low Back Pain
- Being tested
- Face to Face Exercise, Telerehabilitation
- Keywords
- spinal stabilization exercise, tele-rehabilitation, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face to Face ExerciseOther
Face to face (in clinic) progressive spinal stabilization exercises.
TelerehabilitationOther
Remotely (with video) progressive spinal stabilization exercises.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Remotely (with video) progressive spinal stabilization exercises. Receives: Other: Telerehabilitation |
| Face to Face Exercises | Active comparator | Face to face (in clinic) progressive spinal stabilization exercises. Receives: Other: Face to Face Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 outcomes (5)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Nov 2021
- Primary completion5 Jan 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybüke Fanuscu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082649
- Sponsor's protocol ID
- KA-21024
- Status last verified
- Oct 2023
- First submitted
- 14 Jul 2021
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Short and Long Term Results of Remote and Face-to-Face Exercise Education Programme for Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT05082649
- Acronym / sponsor ID
- KA-21024
- Conditions
- Low Back Pain
- Keywords
- spinal stabilization exercise, tele-rehabilitation, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: TelerehabilitationRemotely (with video) progressive spinal stabilization exercises. |
| Face to Face Exercises | Active comparator | Other: Face to Face ExerciseFace to face (in clinic) progressive spinal stabilization exercises. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face to Face ExerciseFace to face (in clinic) progressive spinal stabilization exercises. | Other | Face to Face Exercises |
| TelerehabilitationRemotely (with video) progressive spinal stabilization exercises. | Other | Telerehabilitation |
Primary outcome
Evaluation of Trunk Range of Motion
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
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
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
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
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
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
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
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
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
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
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
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.
5 secondary outcomes
Evaluation of 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
Evaluation of Exercise Adaptation
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
Evaluation of Pain Catastrophization
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
Evaluation 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
Evaluation of Media and Social Media Usage Situations with Technological Tools
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
Related trials for Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face to Face Exercise and Telerehabilitation in people with Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Trunk Range of Motion (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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.