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Effectiveness of Home Programs 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: Having undergone lumbar decompression surgery without fusion and 2 months of history Participate in all necessary follow-up assessments Being between 18-65 years old Understand simple commands Signing 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 prevent communication Lack of cooperation during the study

Sites / Locations

  • Bursa Çekirge 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 a core stabilization program in addition to the training. This program will include reeducation isometric contraction exercises for transversus obdominus, oblique abdominals, multifidus lumborum muscles and strengthening stretching exercises for other extremities. These interventions will be sent to the patients via telerehabitation method and the patients will always have access to the programs and training. In addition, both groups will be told that they can contact the researcher upon request.

The control group will receive post-operative cognitive training and will be encouraged to move as described by Moseley et al., 2004.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
Tampa Scale for Kinesiophobia (TSK)
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Pain Catastrophising Scale (PCS)
Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Roland Morris Disability Questionnaire (RMDQ)
The RMDQ is a self-administered questionnaire consisting of 24 items reflecting various activities of daily living. Each item is scored 1 if it is declared applicable to the participant and 0 otherwise, so that the total score can range from 0 (no disability) to 24 (severe disability).
Lumbar region flexibility in flexion extension lateral flexion directions
The subject stands on a block and then performs lumlal flexion with knees straight. The distance above the block with the finger is recorded with a negative sign and the distance below the block is recorded with a positive sign. The subject stands in front of a wall. The pelvis and trunk should be in contact with the wall. The subject is asked to perform lumbar extension. The distance between the sternal notch and the wall is measured and noted. The subject stands in front of a wall with hands next to the trunk. The subject is asked to perform lumbar lateral flexion. The distance from the first position to the last position is measured using the middle finger as a base and noted.
Lumbar region endurance flexor and extensor
The participant is placed prone on a treatment bed with the upper edge of the iliac crests flush with the edge of the bed. The lower body is secured to the bed with two straps. At the beginning of the test, participants cross their arms over their chest and remain in a neutral position for as long as possible. The time the position can be maintained is measured using a stopwatch. Participants are held in a supine position with both hips and knees flexed 90 degrees and the trunk flexed 60 degrees on a wedge. Stabilization is achieved with support from the back of the foot. After the wedge is moved back 10 cm, the participants maintain their body position for as long as possible. The time from the moment the wedge is moved back to the moment the participant re-establishes contact with the wedge is measured.
Functional Reach Test (FRT)
The subject stands sideways next to a wall and flexes the shoulder 90 degrees. The 3rd metacarpal level is marked on the wall. The subject reaches as far as he/she can without taking a step. The 3rd metacarpal line is marked again. The difference between the marks is measured and noted.
Stair Climbing Test (SCT)
The time (in seconds) taken to ascend and descend one flight of stairs is noted. A 9-step ladder with a 20 cm step height and a handrail is used. You are instructed to ascend and descend the stairs as quickly but safely as possible. The use of a handrail and walking aid is allowed if necessary. Timing starts with the start signal and ends when the participant has lowered both feet to ground level. The participant can stop and rest if necessary, but the timing continues.

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
NCT06014645
Brief Title
Effectiveness of Home Programs After Lumbar Spinal Decompression Surgery
Official Title
The Effect of Different Home Programs on Pain and Mobility Gain After Lumbar Spinal Decompression Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
July 15, 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 are followed up by Bursa Çekirge State Hospital Cekirge State Hospital Neurosurgery outpatient clinic and who have undergone lumbar decompression surgery and who meet the study criteria. The cases will be divided into 2 groups by randomization software. The control group will receive post-operative cognitive training and will be encouraged to move. The study group will receive a core stabilization program in addition to education. The first evaluation will be performed 2 months post-operatively and the second evaluation will be performed 2 months after 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
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The study group will be given a core stabilization program in addition to the training. This program will include reeducation isometric contraction exercises for transversus obdominus, oblique abdominals, multifidus lumborum muscles and strengthening stretching exercises for other extremities. These interventions will be sent to the patients via telerehabitation method and the patients will always have access to the programs and training. 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 post-operative cognitive training and will be encouraged to move as described by Moseley et al., 2004.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
The study group will be given a core stabilization program in addition to education.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control group will receive post-operative cognitive training and will be encouraged to move.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
Time Frame
Change from Baseline VAS at 8 weeks
Title
Tampa Scale for Kinesiophobia (TSK)
Description
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Time Frame
Change from Baseline TSK at 8 weeks
Title
Pain Catastrophising Scale (PCS)
Description
Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Time Frame
Change from Baseline PCS at 8 weeks
Title
Roland Morris Disability Questionnaire (RMDQ)
Description
The RMDQ is a self-administered questionnaire consisting of 24 items reflecting various activities of daily living. Each item is scored 1 if it is declared applicable to the participant and 0 otherwise, so that the total score can range from 0 (no disability) to 24 (severe disability).
Time Frame
Change from Baseline RMDQ at 8 weeks
Title
Lumbar region flexibility in flexion extension lateral flexion directions
Description
The subject stands on a block and then performs lumlal flexion with knees straight. The distance above the block with the finger is recorded with a negative sign and the distance below the block is recorded with a positive sign. The subject stands in front of a wall. The pelvis and trunk should be in contact with the wall. The subject is asked to perform lumbar extension. The distance between the sternal notch and the wall is measured and noted. The subject stands in front of a wall with hands next to the trunk. The subject is asked to perform lumbar lateral flexion. The distance from the first position to the last position is measured using the middle finger as a base and noted.
Time Frame
Change from Baseline flexibilty tests at 8 weeks
Title
Lumbar region endurance flexor and extensor
Description
The participant is placed prone on a treatment bed with the upper edge of the iliac crests flush with the edge of the bed. The lower body is secured to the bed with two straps. At the beginning of the test, participants cross their arms over their chest and remain in a neutral position for as long as possible. The time the position can be maintained is measured using a stopwatch. Participants are held in a supine position with both hips and knees flexed 90 degrees and the trunk flexed 60 degrees on a wedge. Stabilization is achieved with support from the back of the foot. After the wedge is moved back 10 cm, the participants maintain their body position for as long as possible. The time from the moment the wedge is moved back to the moment the participant re-establishes contact with the wedge is measured.
Time Frame
Change from Baseline endurance tests at 8 weeks
Title
Functional Reach Test (FRT)
Description
The subject stands sideways next to a wall and flexes the shoulder 90 degrees. The 3rd metacarpal level is marked on the wall. The subject reaches as far as he/she can without taking a step. The 3rd metacarpal line is marked again. The difference between the marks is measured and noted.
Time Frame
Change from Baseline FRT at 8 weeks
Title
Stair Climbing Test (SCT)
Description
The time (in seconds) taken to ascend and descend one flight of stairs is noted. A 9-step ladder with a 20 cm step height and a handrail is used. You are instructed to ascend and descend the stairs as quickly but safely as possible. The use of a handrail and walking aid is allowed if necessary. Timing starts with the start signal and ends when the participant has lowered both feet to ground level. The participant can stop and rest if necessary, but the timing continues.
Time Frame
Change from Baseline SCT at 8 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: Having undergone lumbar decompression surgery without fusion and 2 months of history Participate in all necessary follow-up assessments Being between 18-65 years old Understand simple commands Signing 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 prevent communication Lack of cooperation during 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
Fatih Özden, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Director
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
Mustafa Yalçın, MSc
Organizational Affiliation
Bursa Çekirge 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
Bursa Çekirge State Hospital
City
Bursa
State/Province
Osmangazi
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Phone
543 433 4593
Email
fatihozden90@gmail.com

12. IPD Sharing Statement

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Effectiveness of Home Programs After Lumbar Spinal Decompression Surgery

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