Short Clinical Outcome of Microscope Assisted Discectomy: Results of 90 Cases in Iraq

To Evaluate the Effectiveness if Microscope in Discectomy Clinical Trial

Official title:

Short Clinical Outcome of Microscope Assisted Discectomy: Results of 90 Cases in Iraq

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109781
• Other study ID #: HMU/Sherwan2
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: September 2019
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A total of (90) patients involved in this study a randomized sampling use. The adult patient between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, NSAIDs, and physiotherapy). They are operated by Microscopic assisted discectomy and were followed by ODI and VAS for back pain and leg pain for 4 months after surgery

Description:

A total of (90) patients involved in this study a randomized sampling use. The adult patient between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, NSAIDs, and physiotherapy). The diagnosis carried out using history, physical examination, MRI done for the patient to confirm the diagnosis and the level of disc herniation and know the direction and extend of disc herniation.Population excluded from study were the age group above or less the ones whom involved in the study, any other type of disc herniation apart from L3-L4, L4-L5, L5-S1, multilevel pathology, patients with spondylolisthesis, spondylolysis, patients with scoliosis and kyphosis, patients with cauda equina syndrome, patients with previous back surgery, and with no local infection.All the patients discharged on the same day of operation or a day after, mobilized soon as they were ready. Patient were reviewed in intervals of (2) weeks (2) months and (4) months after surgery using VAS for low back pain and leg pain and Oswestry disability index.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 50 Years

Eligibility

Inclusion Criteria:

• lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, NSAIDs, and physiotherapy).

Exclusion Criteria:

• Population excluded from study were the age group above or less the ones whom involved in the study, any other type of disc herniation apart from L3-L4, L4-L5, L5-S1, multilevel pathology, patients with spondylolisthesis, spondylolysis, patients with scoliosis and kyphosis, patients with cauda equina syndrome, patients with previous back surgery, and with no local infection.

Related Conditions & MeSH terms

• To Evaluate the Effectiveness if Microscope in Discectomy

Intervention

Procedure:
• Microscope assisted discectomy
Microdiscectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue score for back and leg pain	Visual analogue score for back pan and leg pain is measurement of patient feeling of pain which can be from 0 (no pain) to 10 ( severe pain )	Visual analogue score was assessed in all patients preoperatively and then assessed postoperatively at 2 weeks , 2 months and 4 months which showed that there is changes after operation which indicates improvement by Microdiscectomy
Primary	Oswestry disability index	Oswestry disability index is low back pain questionnaire as followingFor each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement)	Oswestry disability index was assessed preoperatively and postoperatively at 2 weeks , 2 months and 4 months and showed there is improvement in this index after surgery which indicates improvement with microdiscecetomy