- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06014632
Efficacy of Motor Control Exercise Program After Lumbar Spinal Decompression Surgery
December 7, 2025 updated by: Fatih Ozden, Muğla Sıtkı Koçman University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Muğla, Turkey (Türkiye)
- Muğla
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
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.
|
The study group will be given motor control exercises in addition to the program given to the control group.
|
|
Active Comparator: Control Group
The control group will receive stretching, strengthening, core stabilization and educational content as usual care.
|
The control group will receive stretching, strengthening, core stabilization and educational content as usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Change from Baseline TUG at 12 weeks
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|
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.
|
Change from Baseline ÖMSQ-12 at 12 weeks
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|
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.
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Change from Baseline FABQ at 12 weeks
|
|
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.
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Change from Baseline ODI at 12 weeks
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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.
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Change from Baseline proprioception measurement at 12 weeks
|
|
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.
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Change from Baseline 5TSST at 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fatih Özden, PhD, Muğla Sıtkı Koçman University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2023
Primary Completion (Actual)
September 1, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
August 17, 2023
First Submitted That Met QC Criteria
August 23, 2023
First Posted (Actual)
August 28, 2023
Study Record Updates
Last Update Posted (Estimated)
December 15, 2025
Last Update Submitted That Met QC Criteria
December 7, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRŞ RKÇ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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