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Efficacy of Motor Control Exercise Program After Lumbar Spinal Decompression Surgery

Primary Purpose

Lumbar Spine Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rehabilitation
Control
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spine Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fethiye State HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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 control group will receive stretching, strengthening, core stabilization and educational content as usual care.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
August 23, 2023
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT06014632
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
May 13, 2024 (Anticipated)
Study Completion Date
August 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive stretching, strengthening, core stabilization and educational content as usual care.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
The study group will be given motor control exercises in addition to the program given to the control group.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control group will receive stretching, strengthening, core stabilization and educational content as usual care.
Primary Outcome Measure Information:
Title
12-item Örebro Musculoskeletal Screening Questionnaire (ÖMSQ-12)
Description
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.
Time Frame
Change from Baseline ÖMSQ-12 at 12 weeks
Title
Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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.
Time Frame
Change from Baseline FABQ at 12 weeks
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
Change from Baseline ODI at 12 weeks
Title
Lumbar region proprioception measurement
Description
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.
Time Frame
Change from Baseline proprioception measurement at 12 weeks
Title
Five Times Sit to Stand Test (5TSST)
Description
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.
Time Frame
Change from Baseline 5TSST at 12 weeks
Title
Timed Up and Go Test (TUG)
Description
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.
Time Frame
Change from Baseline TUG at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Özden, PhD
Phone
543 433 4593
Ext
+90
Email
fatihozden@mu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail Uysal, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
Organizational Affiliation
Süleyman Demirel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ferdi Başkurt, PhD
Organizational Affiliation
Süleyman Demirel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehmet Şimşek, MD
Organizational Affiliation
Fethiye State Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Baki Umut Tuğay, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fethiye State Hospital
City
Muğla
State/Province
Fethiye
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Phone
543 433 4593
Ext
+90
Email
fatihozden90@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Motor Control Exercise Program After Lumbar Spinal Decompression Surgery

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