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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spine Disease
• Intervention / Treatment: Other: Rehabilitation; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Osmangazi
    • Bursa, Osmangazi, Turkey
      • Bursa Çekirge State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Other: Rehabilitation; The study group will be given a core stabilization program in addition to education.
Active Comparator: Control Group; The control group will receive post-operative exercise training and will be encouraged to move as described by Moseley et al., 2004.	Other: Control; The control group will receive post-operative cognitive training and will be encouraged to move.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University
• Investigators: Study Director: Fatih Özden, PhD, Muğla Sıtkı Kocman University; Principal Investigator: Mustafa Yalçın, MSc, Bursa Çekirge State Hospital; Principal Investigator: Baki Umut Tuğay, PhD, Muğla Sıtkı Kocman University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Actual): April 10, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: Bursa NRŞ RKÇ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No