Low Back PainNCT05524129
An Exercise Program in Patients With Chronic Low Back Pain
A study testing rehabilitation exercise and electrotherapy in people with Low Back Pain, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Exercise intervention aims to improve the function of the deep back muscles and spine stabilizers, which appear to be an essential factor in preventing low back pain recurrences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- rehabilitation exercise and electrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2022to 3 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The cause of the problems most likely lies in the back area (e.g., dysfunction of trunk stabilization, faulty posture, inappropriate movement habits, beginning mild degenerative changes of the spine)
- age over 18 years (upper limit not determined)
- chronic lower back pain (pain duration of at least 12 weeks) - especially non-specific pain (pain localized in the lumbar spine or pain with propagation above the knee at the most), chronic radicular pain of vertebral etiology (not requiring rehabilitation aimed at paresis) can also be present.
- All patients enrolled in the study must have had an imaging examination of the lumbar spine.
Who cannot join
- overall poor physical condition, it should be noted that the patient must undergo entrance and exit examinations with a physiotherapist as part of the study, which requires a certain level of physical fitness
- involvement of the lumbar spine by another pathology (fracture, inflammation, tumor)
- the presence of comorbidity affecting the overall mobility of the patient (e.g., the presence of paresis after a stroke, severe heart failure leading to immobilization)
- significant impairment of cognitive functions (restricting cooperation in the study and filling out questionnaires)
- the patient is not motivated to exercise regularly to strengthen the paraspinal muscles
- back pain arose acutely (e.g., acute disc herniation, injury, acute blockage
Show all 14Show fewer
- lower limb problems cause back pain (arthrosis, dysplasia, longer lower limb, one-sided flat feet) and problems with internal organs (inflammation of the bladder, kidneys, genitals)
- arthrosis of the hip, knee, and shoulder joints higher than grade II
- cachexia, obesity grade II to III,
- Comment:
- the presence of milder chronic radiculopathy does not matter for entry into the study (muscle strength of lower limbs in individual segments should be at least IV grade)
- condition after lumbar spine surgery for degenerative changes in the anamnesis (more than 6 months) does not affect inclusion if the patient's condition allows exercise
- the exercise program can be adjusted individually according to the patient's condition
- it is necessary to have a signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Adherence, Effect and Satisfaction With an Exercise Program in Patients With Chronic Low Back Pain - A Randomized Study
Exercise intervention aims to improve the function of the deep back muscles and spine stabilizers, which appear to be an essential factor in preventing low back pain recurrences. In order to achieve the best possible effect of exercise, the patient should exercise for a long time even after finishing the exercise program, and it is also essential that exercises improve the function of the deep back muscles and become a regular part of the patient's life. In cooperation with the Neurological Clinic and physiotherapists from the Rehabilitation Department of the Brno University Hospital, the investigators put together a rehabilitation program to improve the function of the deep back muscles and spine stabilizers (group I). This program contains commonly used exercises; the patient can perform the exercises himself at home after the training, and no special aids are needed. The rehabilitation program is based on daily independent exercise, while the patient keeps a record of his activity in an exercise diary, which should contribute to motivation for regular exercise. At the same time, the physiotherapist will contact the patients by phone at regular weekly intervals, thereby maintaining their motivation. A total of 3 exercises were created, in which the patient will be taught gradually, according to his abilities and exercise tolerance. Regular checks with a physiotherapist are established to evaluate the correctness of the exercises, frequency, and effect and to increase the difficulty of the exercises. At the end of the exercise program, the patient will be instructed that it is desirable to continue the regular exercise. That exercise should become a part of everyday life to prevent the recurrence of vertebral disorders.
As part of our previous study entitled "Changes in the lumbar paraspinal muscles in patients with lower back pain," preliminary results showed a positive effect on the clinical condition of the patients, good tolerance of the exercises on the part of the patients, and satisfaction with completing the rehabilitation program.
Read the detailed description
Patients with chronic lower back pain, eligible for study inclusion at the outpatient clinic of the Rehabilitation Department of the Brno University Hospital, will be randomized by an authorized physiotherapist into one of two groups. Interventional group, where a hybrid form of rehabilitation will be delivered. According to brochures, home-based exercises and regular outpatient visits will be delivered by a physiotherapist. Moreover, regular phone contact at weekly intervals will be provided for maintaining patient motivation. Control group, where patients will undergo regular rehabilitation-only in the outpatient center with the usually indicated frequency visits twice a week for 4 weeks).
In the experimental intervention, the exercise program is based on patient education, home-based individual training, and regular check-ups by a physiotherapist. The patients will also explain the importance of regular training and receive a booklet with photographed and described exercises. The patients will record their exercise frequency in a previously prepared diary - record sheet, which should also increase the patient's motivation to exercise. The first check-up with the physiotherapist will be 2 weeks from the start of the exercise to check the correct execution and regularity. The next check-up with the physiotherapist will be after 4 weeks, when the physiotherapist will recheck the current exercises. After the physiotherapist finds that the patient can perform individual exercises without problems, the difficulty of exercise will be increased (the patient receives another booklet with new, more challenging exercises). The same control and increase in the exercise's difficulty will occur after another 6 weeks. The total duration of the exercise program is 18 weeks.
In the control group, patients will be offered regular rehabilitation, including electrotherapy, and visits will be 2 times a week. The total duration of the rehabilitation program will be 4 weeks.
At the beginning and the end of the rehabilitation program, the disability of all patients will be evaluated using the Rolland-Morris questionnaire, the intensity of back pain, the quality of life using the short-form questionnaire, and the endurance of the trunk extensors (Biering-Sørensen test). At the end of the rehabilitation program, the patient will also evaluate his overall satisfaction with the completed rehabilitation program. The patient will be invited for a check-up 6 months after the end of the rehabilitation program to assess the same parameters that were assessed at the end of the program and to find out whether the patient continues to exercise regularly on his own.
Patients of both groups will undergo the exact measurements, which will then be statistically compared between the two groups.
The investigators plan to include 60 patients in the project.
- Conditions
- Low Back Pain
- Being tested
- rehabilitation exercise, electrotherapy
- Keywords
- Low Back Pain, Physiotherapy, Telerehabilitation
- 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.
rehabilitation exerciseOther
Conventional rehabilitation exercise.
electrotherapyOther
A middle frequency electro-therapy
| Study group | Role | What they receive |
|---|---|---|
| Interventional (Group I) | Experimental | It will be a hybrid form of rehabilitation, i.e. home exercises according to brochures in combination with regular visits to the ambulance for check-ups according to a precisely set schedule, the authorized physiotherapist will also contact the patients by phone at regular weekly intervals, thereby maintaining their motivation. Receives: Other: rehabilitation exercise |
| Control (Group II) | Active comparator | These patients will undergo regular rehabilitation only in the outpatient center with the normally indicated frequency visits twice a week for 4 weeks. Receives: Other: rehabilitation exercise; Other: electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Functioning and disability score at 18 weeks and 6 months
Patient functioning and disability will be measured by the Roland-Morris Disability Questionnaire. Values ranges from 0-24, lower scores mean a better outcome.
Measured: Baseline, 18 weeks, 6 months
Change from baseline Health-related quality of life score at 18 weeks and 6 months
Short Form Survey (SF-36) - 36-item. Maximum value is 100 points, minimum value is 36 point. Higher score mean a better outcome.
Measured: Baseline, 18 weeks, 6 months
Change from baseline Endurance of the trunk extensors value at 18 weeks and 6 months
With the Biering-Sorensen Test, the patient's trunk extensors' endurance will be evaluated. Patients will be positioned in the prone position with the pelvis, hips, and knees in complete contact with the treatment bed. The patient's pelvis will be supported with a belt and fixed by the physiotherapist. The patients were asked to extend their upper body straight forward from the edge of the table and stay in this position. The time able to hold position properly will be recorded in seconds.
Measured: Baseline, 18 weeks, 6 months
Secondary outcomes (2)
Satisfaction - self-completed questionnaire
Patients will be provided with a 5-item self-completed questionnaire developed by our research team that will measure their satisfaction with the intervention they received and the study in general. The items will be presented in the form of statements to which patients will be asked to respond using a 1-5 Likert scale ("strongly agree", "agree", "not sure", "disagree", and strongly disagree").
Measured: 18 week
Exercise adherence
Adherence to the exercise will be recorded in the data-sheets.The overall completion rate of prescribed exercise lessons in percentage.
Measured: 18 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Sep 2022
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladislav Batalik, Brno University Hospital
- Investigators
- Blanka Adamova, MD., PhD, Study chair, Department of Neurology, University Hospital Brno, Czech RepublicPeter Krkoška, MD, Study director, Department of Neurology, University Hospital Brno, Czech RepublicFilip Dosbaba, PT., PhD, Study director, Department of Rehabilitation, University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524129
- Sponsor's protocol ID
- Vertebro-RHB_RHO/NK2022
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dosbaba F, Senkyr V, Vlazna D, Minarikova J, Nevelikova M, Sladeckova M, Krkoska P, Adamova B, Su JJ, Batalik L. Comparison of hybrid guided home-based and outpatient rehabilitation in patients with chronic low back pain: A randomized controlled trial. J Bodyw Mov Ther. 2025 Dec;45:110-118. doi: 10.1016/j.jbmt.2025.08.009. Epub 2025 Aug 20.
PubMed 41316561
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence, Effect and Satisfaction With an Exercise Program in Patients With Chronic Low Back Pain - A Randomized Study
- ClinicalTrials.gov ID
- NCT05524129
- Acronym / sponsor ID
- Vertebro-RHB_RHO/NK2022
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Physiotherapy, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 1 Sep 2022 (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.
Exercise intervention aims to improve the function of the deep back muscles and spine stabilizers, which appear to be an essential factor in preventing low back pain recurrences. In order to achieve the best possible effect of exercise, the patient should exercise for a long time even after finishing the exercise program, and it is also essential that exercises improve the function of the deep back muscles and become a regular part of the patient's life. In cooperation with the Neurological Clinic and physiotherapists from the Rehabilitation Department of the Brno University Hospital, the investigators put together a rehabilitation program to improve the function of the deep back muscles and spine stabilizers (group I). This program contains commonly used exercises; the patient can perform the exercises himself at home after the training, and no special aids are needed. The rehabilitation program is based on daily independent exercise, while the patient keeps a record of his activity in an exercise diary, which should contribute to motivation for regular exercise. At the same time, the physiotherapist will contact the patients by phone at regular weekly intervals, thereby maintaining their motivation. A total of 3 exercises were created, in which the patient will be taught gradually, according to his abilities and exercise tolerance. Regular checks with a physiotherapist are established to evaluate the correctness of the exercises, frequency, and effect and to increase the difficulty of the exercises. At the end of the exercise program, the patient will be instructed that it is desirable to continue the regular exercise. That exercise should become a part of everyday life to prevent the recurrence of vertebral disorders.
As part of our previous study entitled "Changes in the lumbar paraspinal muscles in patients with lower back pain," preliminary results showed a positive effect on the clinical condition of the patients, good tolerance of the exercises on the part of the patients, and satisfaction with completing the rehabilitation program.
Detailed description
Patients with chronic lower back pain, eligible for study inclusion at the outpatient clinic of the Rehabilitation Department of the Brno University Hospital, will be randomized by an authorized physiotherapist into one of two groups. Interventional group, where a hybrid form of rehabilitation will be delivered. According to brochures, home-based exercises and regular outpatient visits will be delivered by a physiotherapist. Moreover, regular phone contact at weekly intervals will be provided for maintaining patient motivation. Control group, where patients will undergo regular rehabilitation-only in the outpatient center with the usually indicated frequency visits twice a week for 4 weeks).
In the experimental intervention, the exercise program is based on patient education, home-based individual training, and regular check-ups by a physiotherapist. The patients will also explain the importance of regular training and receive a booklet with photographed and described exercises. The patients will record their exercise frequency in a previously prepared diary - record sheet, which should also increase the patient's motivation to exercise. The first check-up with the physiotherapist will be 2 weeks from the start of the exercise to check the correct execution and regularity. The next check-up with the physiotherapist will be after 4 weeks, when the physiotherapist will recheck the current exercises. After the physiotherapist finds that the patient can perform individual exercises without problems, the difficulty of exercise will be increased (the patient receives another booklet with new, more challenging exercises). The same control and increase in the exercise's difficulty will occur after another 6 weeks. The total duration of the exercise program is 18 weeks.
In the control group, patients will be offered regular rehabilitation, including electrotherapy, and visits will be 2 times a week. The total duration of the rehabilitation program will be 4 weeks.
At the beginning and the end of the rehabilitation program, the disability of all patients will be evaluated using the Rolland-Morris questionnaire, the intensity of back pain, the quality of life using the short-form questionnaire, and the endurance of the trunk extensors (Biering-Sørensen test). At the end of the rehabilitation program, the patient will also evaluate his overall satisfaction with the completed rehabilitation program. The patient will be invited for a check-up 6 months after the end of the rehabilitation program to assess the same parameters that were assessed at the end of the program and to find out whether the patient continues to exercise regularly on his own.
Patients of both groups will undergo the exact measurements, which will then be statistically compared between the two groups.
The investigators plan to include 60 patients in the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional (Group I) | Experimental | Other: rehabilitation exerciseIt will be a hybrid form of rehabilitation, i.e. home exercises according to brochures in combination with regular visits to the ambulance for check-ups according to a precisely set schedule, the authorized physiotherapist will also contact the patients by phone at regular weekly intervals, thereby maintaining their motivation. |
| Control (Group II) | Active comparator | Other: rehabilitation exercise, Other: electrotherapyThese patients will undergo regular rehabilitation only in the outpatient center with the normally indicated frequency visits twice a week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The cause of the problems most likely lies in the back area (e.g., dysfunction of trunk stabilization, faulty posture, inappropriate movement habits, beginning mild degenerative changes of the spine)
- age over 18 years (upper limit not determined)
- chronic lower back pain (pain duration of at least 12 weeks) - especially non-specific pain (pain localized in the lumbar spine or pain with propagation above the knee at the most), chronic radicular pain of vertebral etiology (not requiring rehabilitation aimed at paresis) can also be present.
- All patients enrolled in the study must have had an imaging examination of the lumbar spine.
Key exclusion criteria (14 listed)
- overall poor physical condition, it should be noted that the patient must undergo entrance and exit examinations with a physiotherapist as part of the study, which requires a certain level of physical fitness
- involvement of the lumbar spine by another pathology (fracture, inflammation, tumor)
- the presence of comorbidity affecting the overall mobility of the patient (e.g., the presence of paresis after a stroke, severe heart failure leading to immobilization)
- significant impairment of cognitive functions (restricting cooperation in the study and filling out questionnaires)
- the patient is not motivated to exercise regularly to strengthen the paraspinal muscles
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 |
|---|---|---|
| rehabilitation exerciseConventional rehabilitation exercise. | Other | Control (Group II), Interventional (Group I) |
| electrotherapyA middle frequency electro-therapy | Other | Control (Group II) |
Primary outcome
Change from baseline Functioning and disability score at 18 weeks and 6 months
Time frame: Baseline, 18 weeks, 6 months
Patient functioning and disability will be measured by the Roland-Morris Disability Questionnaire. Values ranges from 0-24, lower scores mean a better outcome.
Change from baseline Health-related quality of life score at 18 weeks and 6 months
Time frame: Baseline, 18 weeks, 6 months
Short Form Survey (SF-36) - 36-item. Maximum value is 100 points, minimum value is 36 point. Higher score mean a better outcome.
Change from baseline Endurance of the trunk extensors value at 18 weeks and 6 months
Time frame: Baseline, 18 weeks, 6 months
With the Biering-Sorensen Test, the patient's trunk extensors' endurance will be evaluated. Patients will be positioned in the prone position with the pelvis, hips, and knees in complete contact with the treatment bed. The patient's pelvis will be supported with a belt and fixed by the physiotherapist. The patients were asked to extend their upper body straight forward from the edge of the table and stay in this position. The time able to hold position properly will be recorded in seconds.
2 secondary outcomes
Satisfaction - self-completed questionnaire
Time frame: 18 week
Exercise adherence
Time frame: 18 week
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 19 Sep 2024.
- Derived from this study: PubMed 41316561Dosbaba F, Senkyr V, Vlazna D, Minarikova J, Nevelikova M, Sladeckova M, Krkoska P, Adamova B, Su JJ, Batalik L. Comparison of hybrid guided home-based and outpatient rehabilitation in patients with chronic low back pain: A randomized controlled trial. J Bodyw Mov Ther. 2025 Dec;45:110-118. doi: 10.1016/j.jbmt.2025.08.009. Epub 2025 Aug 20.
- Individual participant dataSharing planned: No
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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.
Blanka Adamova, MD., PhD study chair
Department of Neurology, University Hospital Brno, Czech Republic
Peter Krkoška, MD study director
Department of Neurology, University Hospital Brno, Czech Republic
Filip Dosbaba, PT., PhD study director
Department of Rehabilitation, University Hospital Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation exercise and electrotherapy in people with Low Back Pain, run by Brno University Hospital at 1 site in Czechia.
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 4 inclusion and 14 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 19 Sep 2024. 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 Czechia. 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?
Change from baseline Functioning and disability score at 18 weeks and 6 months (time frame: Baseline, 18 weeks, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05524129, which also lists 1 linked publication.
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 19 Sep 2024.