Short Clinical Outcome of Microscope As… | Clinical Trial

Key information

Conditions

To Evaluate the Effectiveness if Microscope in Discectomy Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microscope assisted discectomy

Procedure

Microdiscectomy

Primary outcomes

Visual analogue score for back and leg pain

Time frame: 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

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 )
Oswestry disability index

Time frame: 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

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)

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Sep 30, 2019
Registry last updated: Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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