NCT06014645|Completed
Effectiveness of Home Programs After Lumbar Spinal Decompression Surgery
The Effect of Different Home Programs on Pain and Mobility Gain After Lumbar Spinal Decompression Surgery
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The Effect of Different Home Programs on Pain and Mobility Gain After Lumbar Spinal Decompression Surgery
Sponsor study identifier
interventional
22
1 country
1
Study Start
June 14, 2023
Actual (reported)Primary Completion
April 10, 2024
Actual (reported)Study Completion
April 15, 2024
Actual (reported)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 exercise training and will be encouraged to move. The study group will receive a core stabilization program in addition to education via telerehabilitation. The first evaluation will be performed 2 months post-operatively and the second evaluation will be performed 2 months after treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 15, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2023
Actual (reported)August 17, 2023
Actual (reported)August 28, 2023
Actual (reported)April 10, 2024
Actual (reported)April 15, 2024
Actual (reported)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).
Change from Baseline VAS at 8 weeks
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.
Change from Baseline TSK at 8 weeks
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.
Change from Baseline PCS at 8 weeks
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).
Change from Baseline RMDQ at 8 weeks
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.
Change from Baseline flexibilty tests at 8 weeks
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.
Change from Baseline endurance tests at 8 weeks
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.
Change from Baseline FRT at 8 weeks
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.
Change from Baseline SCT at 8 weeks
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.
The control group will receive post-operative exercise training and will be encouraged to move as described by Moseley et al., 2004.
The study group will be given a core stabilization program in addition to education.
The control group will receive post-operative cognitive training and will be encouraged to move.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bursa Çekirge State Hospital
Bursa, Osmangazi, Turkey (Türkiye)
Fatih Özden, PhD
Muğla Sıtkı Koçman University
Mustafa Yalçın, MSc
Bursa Çekirge State Hospital
Baki Umut Tuğay, PhD
Muğla Sıtkı Koçman University
22 participants (actual enrollment reported by the registry).
First Submitted
August 17, 2023
First Posted
August 28, 2023
Study Start
June 14, 2023
Actual (reported)3D Model - Classification of Thoracic and Lumbar Spinal Fractures.
Contact the study team to confirm eligibility.
Primary Completion
April 10, 2024
Actual (reported)Study Completion
April 15, 2024
Actual (reported)Last Updated
May 7, 2024
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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