Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy

Lumbar Disc Herniation Clinical Trial

Official title:

Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538027
• Other study ID #: HMU/Sherwan11
• Status: Completed
• Phase: N/A
• Start date: January 3, 2016
• Est. completion date: February 20, 2020

Study information

• Verified date: September 2020
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

97 patients in 3 randomized groups were treated by Microdiscectomy for lumbar disc herniation; Group A was operated at 6 weeks of symptoms, Group B at 3 months and group C at 6 months. These patients were followed for 3 years for the clinical and functional outcomes.

Description:

150 patients were enrolled in this study and only 97 patients were finally analyzed for primary outcomes measures of Oswestry disability index and Roland-Morris Questionnaire and secondary outcome measures of Visual analogue scale for back pain and leg pain as well as length of hospital stay and time to return for daily activities. Assessments done at different periods of 2 weeks, 3 months, 6 months, 1year, 2 years and 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 20, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 47 Years

Eligibility

Inclusion Criteria:

• Age more than 18 years

• Disc herniation of L3-4, L4-5 or L5-S1

• MRI showed disc protrusion or extrusion with nerve root compression corresponding to clinical features.

Exclusion Criteria:

• Spondylolysis or spondylolisthesis.

• Spinal deformity like scoliosis.

• Previous spinal surgery or infection.

• Cauda equina syndrome.

• Lumbar segmental instability on dynamic radiograph: translation more than 3 mm or change in angulation more than 10 degrees

• Smoking

• Diabetes Mellitus

• Disc herniation other than levels L3-L4, L4-L5 and L5-S1

• More than single level disc hernaition.

• Body mass index 30 or more than 30

• Contained disc herniation by MRI

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Procedure:
• Lumbar Microdiscectomy at 6 weeks of symptoms
Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms
• Lumbar Microdiscectomy at 3 months of symptoms
Microscope assisted lumbar discectomy done at 3 months of starting symptoms
• Lumbar Microdiscectomy at 6 months of symptoms
Microscope assisted lumbar discectomy done at 6 months of starting symptoms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry disability index	Primary outcome measure for functional disability, the higher score is better function	Oswestry disability index was measured the functional disability at 2 weeks
Primary	Roland-Morris Questionnaire	Primary outcome measure for functional disability, the higher score is worse function	Roland-Morris Questionnaire was measured the functional disability at 2 weeks
Secondary	Visual analogue scale	Secondary outcome measure for back pain and leg pain, the higher score is more pain and bad results	Visual analogue scale was measured at 2 weeks
Secondary	Length of hospital stay	Secondary outcome measure of how many days patient remains in the hospital after operation	Measuring the days of postoperative hospital stay immediately after the surgery
Secondary	Return to daily activities	Secondary outcome measure of time patient needed to return to daily activities	Measuring the time needed t return to daily activities immediately after the surgery