Efficiency of Surgical Treatment for Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

Surgical Treatment Versus Nonoperative Treatment in Lumbar Spinal Stenosis: a Multicenter Open-label Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03365401
• Other study ID #: LSS011
• Status: Not yet recruiting
• Phase: N/A
• First received: December 2, 2017
• Last updated: December 2, 2017
• Start date: February 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: chen guo
• Phone: 8618055644700
• Email: fantasy_g[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Decompression surgery has proved to be effective for Lumbar Spinal Stenosis (LSS) with persistent pain. But the efficiency of the surgery for degenerated LSS remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to surgical group or a nonoperative group. Because of the procedure , neither patients nor investigators were blinded. The primary outcome is the change of symptom measure by the Oswestry disability index 6, 12, and 24 months after procedure.

Description:

This study will use a randomised controlled trial to access the efficiency of the surgery for degenerated LSS. Patients aged 50 years or older, had LSS will be invited to take part. Patients will be randomised divided into 2 arms. The participants in the intervention arm will have decompression surgery ; those randomised to the control arm will receive current standard conservative treatment methods.

Patients were clinically assessed at baseline (the day of surgery or treatment), and at 6,12 and 24 months afterwards. The primary outcome will be the pain release , categorised according to Oswestry disability index.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical symptoms: back pain radiation to lower limbs or buttocks; fatigue or loss of sensation in the lower limbs aggravated by walking.

• Persistent pain without progressive neurologic dysfunction

• Duration of symptoms and signs for more than 6 months

• Severity of the disease justifying either surgical or nonoperative treatment

Exclusion Criteria:

• severe LSS with intractable pain and progressive neurologic dysfunction, suggesting forthcoming surgical treatment

• spinal stenosis not caused by degeneration

• lumbar herniated disc diagnosed during the last 12 months

• neurologic disease causing impaired function of the lower limbs

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• decompression surgery
undertake decompression surgery
• nonsurgical treatment
complete on bed with prevention of complication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of symptoms	Oswestry disability index (ODI)	6, 12, and 24 months
Secondary	change of pain relief	World Health Organization pain classification	6, 12, and 24 months