Clinical trial NCT06014632: Efficacy of Motor Control Exercise Program After Lumbar Spinal Decompression Surgery
Official title: The Effect of Supervised Motor Control Exercise Program on Pain, Disability, Kinesiophobia, Proprioception and Function After Lumbar Spinal Decompression Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Spine Disease
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: 12-item Örebro Musculoskeletal Screening Questionnaire (ÖMSQ-12)
timeFrame: Change from Baseline ÖMSQ-12 at 12 weeks
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Change from Baseline FABQ at 12 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: Change from Baseline ODI at 12 weeks
measure: Lumbar region proprioception measurement
timeFrame: Change from Baseline proprioception measurement at 12 weeks
measure: Five Times Sit to Stand Test (5TSST)
timeFrame: Change from Baseline 5TSST at 12 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: Change from Baseline TUG at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Fethiye State Hospital
state: Fethiye
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: İsmail Uysal, PhD
role: STUDY_DIRECTOR
affiliation: Muğla Sıtkı Koçman University
name: Fatih Özden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Süleyman Demirel University
name: İsmet Tümtürk, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Süleyman Demirel University
name: Ferdi Başkurt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fethiye State Hospital
name: Mehmet Şimşek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman University
name: Baki Umut Tuğay, PhD
role: PRINCIPAL_INVESTIGATOR
References: