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Clinical Study on the Impact of Kai Xin San on the Outcomes of Lumbar Surgery in the Elderly by Alleviating Anxiety

Clinical Study on the Impact of Kai Xin San on the Outcomes of Lumbar Surgery in the Elderly by Alleviating Anxiety

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001382
Enrollment
Unknown
Registered
2025-07-11
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis

Interventions

Control Group:Routine postoperative treatment for lumbar spine surgery +Kai Xin San placebo
Treatment Group:Routine postoperative treatment for lumbar spine surgery +Kai Xin San

Sponsors

Sichuan Province Orthopedic Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) patients aged 60 - 80; 2) with typical intermittent claudication; 3) physical examination: positive lumbar extension test; 4) CT and MRI scans indicative of lumbar spinal canal stenosis at L4/5, L3/4, or L5/S1; 5) candidates for posterior TLIF surgery.

Exclusion criteria

Exclusion criteria: 1) Patients with lumbar instability, spondylolisthesis, tumors, or infection; 2) Patients presenting with cauda equina syndrome, such as abnormal bowel/bladder function or saddle anesthesia; 3) Patients with a history of trauma leading to low back and lower limb pain/numbness; 4) Patients with severe cardiopulmonary diseases or hepatic/renal dysfunction, who cannot tolerate surgery or anesthesia; 5) Patients diagnosed with anxiety or depressive disorders.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;5-hydroxytryptamine;Oswestry disability index;Brain-Derived Neurotrophic Factor;Hospital Anxiety and Depression Scale;

Secondary

MeasureTime frame
Blood pressure;CRP;Heart rate;surgical duration;Length of hospital stay,;IL-1ß;blood loss;ESR;

Countries

China

Contacts

Public ContactWang Ye-Hui

Sichuan Province Orthopedic Hospital

wyh_scsgkyy@163.com13568996832

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026