Symptomatic Lumbar Disc HerniationNCT05544331
Rehabilitation in Lumbar Disc Herniation
A study testing Exercise group (written form) and Exercise group (video based) in people with Symptomatic Lumbar Disc Herniation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of written and video based home exercise program in patients with symptomatic lumbar disc herniation on pain level, function and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Symptomatic Lumbar Disc Herniation
- What is being tested?
- Exercise group (written form) and Exercise group (video based)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2022to 30 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between of 18-65 years
- Having been diagnosed with a lumbar disc herniation
- No need for surgery due to lumbar disc herniation
- Having pain in the lower back or leg for at least 12 weeks
- Not using corticosteroids
- To be oriented and cooperative
- To be volunteer to participate in the study
Who cannot join
- Having undergone lumbar spine surgery
- Having undergone lower extremity, upper extremity, spine surgery in the last 1 year
- Presence of lumbar stenosis
- Analgesic addiction, or any addiction
- Presence of tumor
- Presence of metastases
Show all 12Show fewer
- Presence of rheumatological diseases
- The presence of scoliosis, congenital deformity
- Presence of leg length discrepancy
- Being pregnant
- To have uncontrolled hypertension
- To have exercise-dependent angina
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University
Istanbul, 34000
Tugce Ozen, MSc, 5052275829, tugceozen1709@gmail.com
About this study
Official title: Comparison of Written and Video Home Exercise Program in the Patients With Chronic Symptomatic Lumbar Disc Herniation
The aim of this study is to compare the effects of written and video based home exercise program in patients with symptomatic lumbar disc herniation on pain level, function and quality of life.
Read the detailed description
45 symptomatic lumbar disc herniation patients, who are in chronic period and aged between 18-65 years, will be included. The participants will be randomised into three groups. 15 patients will be included in the written home exercise group,15 patients will be in video based home exercise group and 15 patients in the control group. In the written exercise group and video based exercise group, exercise programs will be 8 weeks. In the control group, the exercise protocol will not be performed during 8 weeks.
The outcomes will include the quality of life, pain level, functional capacity, kinesiophobia. In the exercise groups, the evaluations will be made in the first interview (before exercise program), at the end of 8 weeks of exercise (when the exercise program is completed) and in 12th weeks (4 weeks after the exercise program completion). Evaluations in the control group will be carried out at the first interview, at the 8th week, 12th weeks.
- Conditions
- Symptomatic Lumbar Disc Herniation
- Being tested
- Exercise group (written form), Exercise group (video based)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise group (written form)Behavioural
The exercise program will be structUred with core stabilization exercises. Patients will be given the written form of exercises and will be applied as home exercises. Exercise progression will be provided by position changes.
Exercise group (video based)Behavioural
The exercise program will be structUred with core stabilization exercises. Patients will be given the exercise videos, which provide visual and auditory feedback, and will be applied as home exercises. Exercise progression will be provided by position changes.
| Study group | Role | What they receive |
|---|---|---|
| Written exercise group | Experimental | The exercise program will consist of core stabilization exercises, which target various trunk muscles to optimize segmental control, spinal stability, spinal stiffness, orientation and the interoperability of these features. The exercise program will be in writing form, which is a common home exercise program type. Receives: Behavioral: Exercise group (written form) |
| Video based exercise group | Experimental | The exercise program will consist of core stabilization exercises, which provide segmental control optimization, spinal stabilization, spinal stiffness, orientation and the interoperability of these features. The exercise program will be given patients as video records, which provide visual and auditory feedbacks. Receives: Behavioral: Exercise group (video based) |
| Control group | No intervention | The patients, who are referred and will wait for the exercise program in their routine daily life. Measurements will be performed at the same time frame in experimental group. After the 12 weeks of follow up period, they will join the exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Oswestry Disability Index (ODI) will be used to evaluate patients perceptions of low back related disability. ODI consists of 10 questions, scored between 0 and 5.
Measured: Change from baseline at week 8, and 12.week.
Pain perception
Numeric Rated Scale (NRS) will be used to evaluate pain perception. Patients will be asked rated their pain between 0 and 10.
Measured: Change from baseline at week 8, and12.week.
Kinesiophobia
Tampa Kinesiophobia Scale will be used. It consists of 17 questions about fear of movement and reinjury. Each question scored between 1 and 4.
Measured: Change from baseline at week 8, and12.week.
Emotional status
Hospital Anxiety and Depression Scale (HADS) will be used for evaluate the patients' anxiety and depression status. HADS consists of 14 questions, which scored between 1 and 3.
Measured: Change from baseline at week 8, and12.week.
Health related quality of life
SF-36 Health Related Quality of Life (SF-36) questionnaire will be used. SF-36 consists of 36 questions and evaluate different aspects of quality of life.
Measured: Change from baseline at week 8, and12.week.
Range of motion of lumbar spine
The range of lumbar flexion and extension will be measured by the inclinometer. While the person is standing on both feet, first the inclinometer will be placed on the reference points on the spine. For lumbar flexion value The person will be asked to bend forward as much as he can without bending his legs. For extension value, the person will be asked to bend backwards as much as possible without bending his legs, and at the last point, the inclinometer will be read and the value will be recorded.
Lumbar lordosis will be measured by the inclinometer. While the patients stands with his feet shoulder-width apart and knees straight, the measurement will be taken by the inclinometer placed on the reference points.
Measured: Change from baseline at week 8, and12.week.
Flexibility
Fingertip-to-Floor Test will be applied. The person will be asked to lean forward without bending their knees while standing on a high platform, and the distance between the fingertip and the platform will be measured. Values will be recorded as centimeter.
Side bending test will be used to measure the flexibility of spine in right and left lateral flexion. The patient will be asked to bend his back to the right and left sides, without separating his back from the wall. The results will be recorded as centimeter.
Measured: Change from baseline at week 8, and12.week.
Static endurance
Lateral Bridge Test will be used to evaluate the static endurance of the lateral core muscles. The subjects will be asked to turn on their right side, raise their body on their forearms and toes and keep them in this position, and the time until the position deteriorates will be recorded as second.
Sorensen Test will be used to evaluate the static endurance of trunk extensors. The subjects were positioned in the prone position, with the pelvis, hips and knees on the bed. The subjects will be asked to extend their upper body straight forward from the edge of the table and the time until the deterioration of the straight position is recorded.
Trunk Flexors Endurance Test will be used to evaluate static endurance of the trunk flexors. The subjects were positioned with the trunk in 60 degree flexion, knees and hips in 90 degree flexion position.When the 60 degree trunk flexion is impaired, the test will be terminated and the time will be recorded.
Measured: Change from baseline at week 8, and12.week.
Dynamic endurance
Sit-ups' Test will be used to evaluate the endurance of the abdominal muscles. The patients will be asked to flex the trunk while the knees are in the flexed position and the feet are stabilized. Each test of the patients is 30 seconds. The number of times they can do it will be recorded.
Modified 'Push-ups' Test will be used to evaluate the upper body strength endurance. Subjects will be asked to lift the head, shoulders and trunk from the ground in the prone position with the arms and elbows flexed and the elbows fully extended. During the test, the knees will be positioned in flexion (25). Each test of the patients is 30 seconds. The number of times they can do it will be recorded.
Measured: Change from baseline at week 8, and12.week.
Exercise adherence
The patients will be asked to note the number of the days they exercise in each week.
Measured: Change from baseline at week 8, and12.week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start10 Oct 2022 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Lumbar Disc HerniationStudies 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
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Ozen, Marmara University
- Investigators
- Tugce Ozen, MSc, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544331
- Sponsor's protocol ID
- 09.2021.351
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Written and Video Home Exercise Program in the Patients With Chronic Symptomatic Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT05544331
- Acronym / sponsor ID
- 09.2021.351
- Conditions
- Symptomatic Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 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.
The aim of this study is to compare the effects of written and video based home exercise program in patients with symptomatic lumbar disc herniation on pain level, function and quality of life.
Detailed description
45 symptomatic lumbar disc herniation patients, who are in chronic period and aged between 18-65 years, will be included. The participants will be randomised into three groups. 15 patients will be included in the written home exercise group,15 patients will be in video based home exercise group and 15 patients in the control group. In the written exercise group and video based exercise group, exercise programs will be 8 weeks. In the control group, the exercise protocol will not be performed during 8 weeks.
The outcomes will include the quality of life, pain level, functional capacity, kinesiophobia. In the exercise groups, the evaluations will be made in the first interview (before exercise program), at the end of 8 weeks of exercise (when the exercise program is completed) and in 12th weeks (4 weeks after the exercise program completion). Evaluations in the control group will be carried out at the first interview, at the 8th week, 12th weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Written exercise group | Experimental | Behavioral: Exercise group (written form)The exercise program will consist of core stabilization exercises, which target various trunk muscles to optimize segmental control, spinal stability, spinal stiffness, orientation and the interoperability of these features. The exercise program will be in writing form, which is a common home exercise program type. |
| Video based exercise group | Experimental | Behavioral: Exercise group (video based)The exercise program will consist of core stabilization exercises, which provide segmental control optimization, spinal stabilization, spinal stiffness, orientation and the interoperability of these features. The exercise program will be given patients as video records, which provide visual and auditory feedbacks. |
| Control group | No intervention | –The patients, who are referred and will wait for the exercise program in their routine daily life. Measurements will be performed at the same time frame in experimental group. After the 12 weeks of follow up period, they will join the exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between of 18-65 years
- Having been diagnosed with a lumbar disc herniation
- No need for surgery due to lumbar disc herniation
- Having pain in the lower back or leg for at least 12 weeks
- Not using corticosteroids
Key exclusion criteria (12 listed)
- Having undergone lumbar spine surgery
- Having undergone lower extremity, upper extremity, spine surgery in the last 1 year
- Presence of lumbar stenosis
- Analgesic addiction, or any addiction
- Presence of tumor
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 |
|---|---|---|
| Exercise group (written form)The exercise program will be structUred with core stabilization exercises. Patients will be given the written form of exercises and will be applied as home exercises. Exercise progression will be provided by position changes. | Behavioural | Written exercise group |
| Exercise group (video based)The exercise program will be structUred with core stabilization exercises. Patients will be given the exercise videos, which provide visual and auditory feedback, and will be applied as home exercises. Exercise progression will be provided by position changes. | Behavioural | Video based exercise group |
Primary outcome
Disability
Time frame: Change from baseline at week 8, and 12.week.
Oswestry Disability Index (ODI) will be used to evaluate patients perceptions of low back related disability. ODI consists of 10 questions, scored between 0 and 5.
Pain perception
Time frame: Change from baseline at week 8, and12.week.
Numeric Rated Scale (NRS) will be used to evaluate pain perception. Patients will be asked rated their pain between 0 and 10.
Kinesiophobia
Time frame: Change from baseline at week 8, and12.week.
Tampa Kinesiophobia Scale will be used. It consists of 17 questions about fear of movement and reinjury. Each question scored between 1 and 4.
Emotional status
Time frame: Change from baseline at week 8, and12.week.
Hospital Anxiety and Depression Scale (HADS) will be used for evaluate the patients' anxiety and depression status. HADS consists of 14 questions, which scored between 1 and 3.
Health related quality of life
Time frame: Change from baseline at week 8, and12.week.
SF-36 Health Related Quality of Life (SF-36) questionnaire will be used. SF-36 consists of 36 questions and evaluate different aspects of quality of life.
Range of motion of lumbar spine
Time frame: Change from baseline at week 8, and12.week.
The range of lumbar flexion and extension will be measured by the inclinometer. While the person is standing on both feet, first the inclinometer will be placed on the reference points on the spine. For lumbar flexion value The person will be asked to bend forward as much as he can without bending his legs. For extension value, the person will be asked to bend backwards as much as possible without bending his legs, and at the last point, the inclinometer will be read and the value will be recorded. Lumbar lordosis will be measured by the inclinometer. While the patients stands with his feet shoulder-width apart and knees straight, the measurement will be taken by the inclinometer placed on the reference points.
Flexibility
Time frame: Change from baseline at week 8, and12.week.
Fingertip-to-Floor Test will be applied. The person will be asked to lean forward without bending their knees while standing on a high platform, and the distance between the fingertip and the platform will be measured. Values will be recorded as centimeter. Side bending test will be used to measure the flexibility of spine in right and left lateral flexion. The patient will be asked to bend his back to the right and left sides, without separating his back from the wall. The results will be recorded as centimeter.
Static endurance
Time frame: Change from baseline at week 8, and12.week.
Lateral Bridge Test will be used to evaluate the static endurance of the lateral core muscles. The subjects will be asked to turn on their right side, raise their body on their forearms and toes and keep them in this position, and the time until the position deteriorates will be recorded as second. Sorensen Test will be used to evaluate the static endurance of trunk extensors. The subjects were positioned in the prone position, with the pelvis, hips and knees on the bed. The subjects will be asked to extend their upper body straight forward from the edge of the table and the time until the deterioration of the straight position is recorded. Trunk Flexors Endurance Test will be used to evaluate static endurance of the trunk flexors. The subjects were positioned with the trunk in 60 degree flexion, knees and hips in 90 degree flexion position.When the 60 degree trunk flexion is impaired, the test will be terminated and the time will be recorded.
Dynamic endurance
Time frame: Change from baseline at week 8, and12.week.
Sit-ups' Test will be used to evaluate the endurance of the abdominal muscles. The patients will be asked to flex the trunk while the knees are in the flexed position and the feet are stabilized. Each test of the patients is 30 seconds. The number of times they can do it will be recorded. Modified 'Push-ups' Test will be used to evaluate the upper body strength endurance. Subjects will be asked to lift the head, shoulders and trunk from the ground in the prone position with the arms and elbows flexed and the elbows fully extended. During the test, the knees will be positioned in flexion (25). Each test of the patients is 30 seconds. The number of times they can do it will be recorded.
Exercise adherence
Time frame: Change from baseline at week 8, and12.week.
The patients will be asked to note the number of the days they exercise in each week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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.
Tugce Ozen, MSc principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group (written form) and Exercise group (video based) in people with Symptomatic Lumbar Disc Herniation, run by Marmara 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tugce Ozen, MSc (+905052275829, tugceozen1709@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: Change from baseline at week 8, and 12.week.). The study lists 10 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 16 Sep 2022; AzTrials last refreshed its copy on 1 Nov 2026.