Effectiveness of early rehabilitation following lumbar spine fusion surgery: A randomized controlled trial

Phase 3

• Conditions: Patient underwent 1-2 levels of MIS-TLIF, OLIF and endoscopic lumbar fusion surgery due to diagnosis of degenerative spine; Minimal Invasive Transforaminal lumbar Interbody fusion, Oblique lumbar interbody fusion, endoscopic lumbar fusion surgery

• Registration Number: TCTR20230410008
• Lead Sponsor: Pending

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-10
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1.Patient underwent 1-2 levels of MIS-TLIF, OLIF and endoscopic lumbar fusion surgery due to diagnosis of degenerative spine 2.Motor power of hip muscle and thigh at postoperative status at least grade 3

Exclusion Criteria

1.Previous spinal surgery 2.Underwent lumbar fusion surgery due to trauma/infection/tumor or pseudoarthrosis 3.History of inflammatory (spondyloarthropathy) or neurological disease affecting movement 4.Severe psychotic disease 5.Post operative complications (e.g., weaker than baseline(more than 2 week after surgery), instrumental failure, surgical wound infection, sepsis)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability Preoperative, Postoperative at 0,2,8 and 14 weeks Oswestry Disability Index

Secondary Outcome Measures

Name	Time	Method
Pain Preoperative, Postoperative at 0,2,8 and 14 weeks Visual analogue scale,Gait speed Preoperative, Postoperative at 0,2,8 and 14 weeks Gait analysis,Balance 6 weeks COP analysis,Range of motion of lower back Preoperative, Postoperative at 0,2,8 and 14 weeks Goniometer,Fear of avoidance Preoperative, Postoperative at 0,2,8 and 14 weeks FABQ,Quality of life Preoperative, Postoperative at 0,2,8 and 14 weeks EQ5D5