Lumbar Spine DiseaseNCT06014632
Efficacy of Motor Control Exercise Program After Lumbar Spinal Decompression Surgery
A study testing Rehabilitation in people with Lumbar Spine Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted with volunteer patients who have undergone lumbar decompression surgery and who are followed up by the Neurosurgery outpatient clinic of Fethiye State Hospital. The cases will be divided into 2 groups by randomization software. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Spine Disease
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2023to 1 Dec 2025
- 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
- To have undergone lumbar decompression surgery without fusion and 3 months have passed, to participate in all necessary follow-up evaluations and treatment sessions
- To be between the ages of 18-65, to be able to understand simple commands and to have signed the consent form
Who cannot join
- Presence of a previous spinal fusion surgery, presence of malignancy
- Having undergone spine surgery before
- Have any other orthopedic or neurological problem that may affect treatment and assessments
- Situations that may interfere with communication
- Lack of cooperation during the study and refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Supervised Motor Control Exercise Program on Pain, Disability, Kinesiophobia, Proprioception and Function After Lumbar Spinal Decompression Surgery
The study will be conducted with volunteer patients who have undergone lumbar decompression surgery and who are followed up by the Neurosurgery outpatient clinic of Fethiye State Hospital. The cases will be divided into 2 groups by randomization software. The control group will receive stretching, strengthening, core stabilization and educational content as usual care 3 months post-operatively. The study group will be given motion control exercises in addition to the program given to the control group 3 months post-operatively. These applications will be applied to the patients face-to-face in the clinical environment 2 days a week for 12 weeks. The first evaluation will be performed 3 months post-operatively before the treatment and the second evaluation will be performed 3 months after the treatment.
- Conditions
- Lumbar Spine Disease
- Being tested
- Rehabilitation, Control
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
The study group will be given motor control exercises in addition to the program given to the control group.
ControlOther
The control group will receive stretching, strengthening, core stabilization and educational content as usual care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The study group will be given motor control exercises in addition to the program given to the control group. It will include exercise therapy aimed at improving the motor control of the lumbar spine. These applications will be applied to the patients face-to-face in a clinical setting 2 days a week for 12 weeks. In addition, both groups will be told that they can contact the researcher upon request. Receives: Other: Rehabilitation |
| Control Group | Active comparator | The control group will receive stretching, strengthening, core stabilization and educational content as usual care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-item Örebro Musculoskeletal Screening Questionnaire (ÖMSQ-12)
ÖMSQ-12 is a 12-item self-report questionnaire. Each item is scored on an 11-point Likert scale (0-10) based on the response to the question asked. Items 8, 11 and 12 are reverse scored items. The maximum score that can be obtained from the questionnaire is 120. A high score means a high risk of absenteeism, high cost, chronicity or delayed recovery, and severity of the problem due to the individual's problematic musculoskeletal condition.
Measured: Change from Baseline ÖMSQ-12 at 12 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
The FABQ consists of 16 items and is divided into 2 subscales. The items are scored on a 7-point Likert scale (from strongly disagree to strongly agree). The score of each subscale is used independently. Higher scores represent more fear avoidance beliefs.
Measured: Change from Baseline FABQ at 12 weeks
Oswestry Disability Index (ODI)
The Oswestry Disability Index consists of 10 questions measuring functional status. Each question is evaluated between 0 and 5 points and the total maximum score is 50. Higher score indicates more disability.
Measured: Change from Baseline ODI at 12 weeks
Lumbar region proprioception measurement
Subjects are asked to stand in a neutral position, with knees straight and weight equal to both feet. To measure lumbar repositioning errors in flexion, the first inclinometer is placed on the lateral chest (T12 level) and the second inclinometer on the hemipelvis (S1 level). The primary inclinometer (T12) and the secondary inclinometer (sacral midpoint) are used in the frontal plane to record the lateral bending angle error. Velcro straps are used to secure the digital inclinometer. The inclinometer is calibrated by the examiner to a starting position (0 degrees). Subjects memorize this neutral position for a few seconds, perform active full flexion and then return to the neutral position. Displacement accuracy is measured in degrees.
Measured: Change from Baseline proprioception measurement at 12 weeks
Five Times Sit to Stand Test (5TSST)
A chair without armrests, with a 28.5 cm deep seat and backrest and adjustable height is used for the tests. Subjects start in a seated position, with their arms in the desired position and their backs against the chair backrest. The following verbal instructions are given: "Please stand up and sit down 5 times as quickly as possible. Straighten your knees when standing up and lean your back against the backrest when sitting down." Timing with the digital stopwatch is started manually with the instruction "Start" and stopped when the subject's back touches the backrest after the fifth standing up.
Measured: Change from Baseline 5TSST at 12 weeks
Timed Up and Go Test (TUG)
Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
Measured: Change from Baseline TUG at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start12 Jun 2023
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DiseaseStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Fatih Özden, PhD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014632
- Sponsor's protocol ID
- NRŞ RKÇ
- Status last verified
- Dec 2025
- First submitted
- 17 Aug 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supervised Motor Control Exercise Program on Pain, Disability, Kinesiophobia, Proprioception and Function After Lumbar Spinal Decompression Surgery
- ClinicalTrials.gov ID
- NCT06014632
- Acronym / sponsor ID
- NRŞ RKÇ
- Conditions
- Lumbar Spine Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 28 Aug 2023 (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 study will be conducted with volunteer patients who have undergone lumbar decompression surgery and who are followed up by the Neurosurgery outpatient clinic of Fethiye State Hospital. The cases will be divided into 2 groups by randomization software. The control group will receive stretching, strengthening, core stabilization and educational content as usual care 3 months post-operatively. The study group will be given motion control exercises in addition to the program given to the control group 3 months post-operatively. These applications will be applied to the patients face-to-face in the clinical environment 2 days a week for 12 weeks. The first evaluation will be performed 3 months post-operatively before the treatment and the second evaluation will be performed 3 months after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: RehabilitationThe study group will be given motor control exercises in addition to the program given to the control group. It will include exercise therapy aimed at improving the motor control of the lumbar spine. These applications will be applied to the patients face-to-face in a clinical setting 2 days a week for 12 weeks. In addition, both groups will be told that they can contact the researcher upon request. |
| Control Group | Active comparator | Other: ControlThe control group will receive stretching, strengthening, core stabilization and educational content as usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To have undergone lumbar decompression surgery without fusion and 3 months have passed, to participate in all necessary follow-up evaluations and treatment sessions
- To be between the ages of 18-65, to be able to understand simple commands and to have signed the consent form
Key exclusion criteria (5 listed)
- Presence of a previous spinal fusion surgery, presence of malignancy
- Having undergone spine surgery before
- Have any other orthopedic or neurological problem that may affect treatment and assessments
- Situations that may interfere with communication
- Lack of cooperation during the study and refusal to participate in the study
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 |
|---|---|---|
| RehabilitationThe study group will be given motor control exercises in addition to the program given to the control group. | Other | Intervention Group |
| ControlThe control group will receive stretching, strengthening, core stabilization and educational content as usual care. | Other | Control Group |
Primary outcome
12-item Örebro Musculoskeletal Screening Questionnaire (ÖMSQ-12)
Time frame: Change from Baseline ÖMSQ-12 at 12 weeks
ÖMSQ-12 is a 12-item self-report questionnaire. Each item is scored on an 11-point Likert scale (0-10) based on the response to the question asked. Items 8, 11 and 12 are reverse scored items. The maximum score that can be obtained from the questionnaire is 120. A high score means a high risk of absenteeism, high cost, chronicity or delayed recovery, and severity of the problem due to the individual's problematic musculoskeletal condition.
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Change from Baseline FABQ at 12 weeks
The FABQ consists of 16 items and is divided into 2 subscales. The items are scored on a 7-point Likert scale (from strongly disagree to strongly agree). The score of each subscale is used independently. Higher scores represent more fear avoidance beliefs.
Oswestry Disability Index (ODI)
Time frame: Change from Baseline ODI at 12 weeks
The Oswestry Disability Index consists of 10 questions measuring functional status. Each question is evaluated between 0 and 5 points and the total maximum score is 50. Higher score indicates more disability.
Lumbar region proprioception measurement
Time frame: Change from Baseline proprioception measurement at 12 weeks
Subjects are asked to stand in a neutral position, with knees straight and weight equal to both feet. To measure lumbar repositioning errors in flexion, the first inclinometer is placed on the lateral chest (T12 level) and the second inclinometer on the hemipelvis (S1 level). The primary inclinometer (T12) and the secondary inclinometer (sacral midpoint) are used in the frontal plane to record the lateral bending angle error. Velcro straps are used to secure the digital inclinometer. The inclinometer is calibrated by the examiner to a starting position (0 degrees). Subjects memorize this neutral position for a few seconds, perform active full flexion and then return to the neutral position. Displacement accuracy is measured in degrees.
Five Times Sit to Stand Test (5TSST)
Time frame: Change from Baseline 5TSST at 12 weeks
A chair without armrests, with a 28.5 cm deep seat and backrest and adjustable height is used for the tests. Subjects start in a seated position, with their arms in the desired position and their backs against the chair backrest. The following verbal instructions are given: "Please stand up and sit down 5 times as quickly as possible. Straighten your knees when standing up and lean your back against the backrest when sitting down." Timing with the digital stopwatch is started manually with the instruction "Start" and stopped when the subject's back touches the backrest after the fifth standing up.
Timed Up and Go Test (TUG)
Time frame: Change from Baseline TUG at 12 weeks
Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
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 15 Dec 2025.
- 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.
Fatih Özden, PhD principal investigator
Muğla Sıtkı Koçman 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 Rehabilitation in people with Lumbar Spine Disease, run by Muğla Sıtkı Koçman 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 2 inclusion and 5 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 15 Dec 2025. 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?
12-item Örebro Musculoskeletal Screening Questionnaire (ÖMSQ-12) (time frame: Change from Baseline ÖMSQ-12 at 12 weeks). 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 15 Dec 2025.