Efficacy of Motor Control Exercise Program After Lumbar Spinal Decompression Surgery

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06014632
Collaborator
(none)
30
1
2
14.4
2.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation
  • Other: Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Supervised Motor Control Exercise Program on Pain, Disability, Kinesiophobia, Proprioception and Function After Lumbar Spinal Decompression Surgery
Actual Study Start Date :
Jun 12, 2023
Anticipated Primary Completion Date :
May 13, 2024
Anticipated Study Completion Date :
Aug 23, 2024

Arms and Interventions

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.

Other: Rehabilitation
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.

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

Outcome Measures

Primary Outcome Measures

  1. 12-item Örebro Musculoskeletal Screening Questionnaire (ÖMSQ-12) [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.

  2. Fear-Avoidance Beliefs Questionnaire (FABQ) [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.

  3. Oswestry Disability Index (ODI) [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.

  4. Lumbar region proprioception measurement [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.

  5. Five Times Sit to Stand Test (5TSST) [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.

  6. Timed Up and Go Test (TUG) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fethiye State Hospital Muğla Fethiye Turkey

Sponsors and Collaborators

  • Muğla Sıtkı Koçman University

Investigators

  • Study Director: İsmail Uysal, PhD, Muğla Sıtkı Koçman University
  • Principal Investigator: Fatih Özden, PhD, Muğla Sıtkı Koçman University
  • Principal Investigator: İsmet Tümtürk, MSc, Süleyman Demirel University
  • Principal Investigator: Ferdi Başkurt, PhD, Süleyman Demirel University
  • Principal Investigator: Mehmet Şimşek, MD, Fethiye State Hospital
  • Principal Investigator: Baki Umut Tuğay, PhD, Muğla Sıtkı Koçman University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatih Ozden, Assistant Professor, Muğla Sıtkı Koçman University
ClinicalTrials.gov Identifier:
NCT06014632
Other Study ID Numbers:
  • Fethiye NRŞ RKÇ
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2023