Clinical trial NCT04087694: Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis
Official title: Comparative Study Between Microdecompression and Open Decompression With Posterior Stabilization for Symptomatic Lumbar Spine Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Microdecompression
laminectomy
pain
stenosis
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 41
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compare the results of 2 methods in surgical treatment of Lumbar spine stenosis.These are microdecompresssion and open decompression with posterior stabilization. 100 patients are involved in this study who divided in 2 groups.Each group was treated with one method and follow up done which showed both method are effective with better results in those patients treated with microdecomppression.

Detailed description: This randomized controlled study was conducted between January 2016 and October 2018. One hundred patients were involved in this study. All these patients were suffered from radicular leg pain with MRI features of multilevel lumbar spinal stenosis and were treated by conservative treatment of medical treatment and physiotherapy without benefit for (6) months. Those patients were divided into two groups; Group A, (50) Microdecompression, and Group B, (50) patients who were treated by open wide laminectomy and posterior stabilization. Both groups of patients were followed up with ODI (Oswestry disability index) and VAS (Visual analogue score) for the back and leg pain for one year.

Results: The results showed that both groups got significant improvement regarding Oswestry disability index. Regarding back pain, there was a significant improvement in both groups with better results in-group A due minimal tissues injury as the advantage of minimal invasive technique. In both groups, there were marked improvement of radicular leg pain postoperatively.

Conclusions: Both Microdecompression and wide open laminectomy with posterior stabilization were effective in treatment of multilevel lumbar spinal stenosis with superior results of Microdecompression regarding less back pain postoperatively with less blood loss and soft tissue dissection.

Eligibility criteria: Inclusion Criteria:

* patients were suffered from back pain of different degrees with spinal claudication

Exclusion Criteria:

* Smoking
* Diabetic patients,
* Previous spinal surgery,
* any neuromuscular disorder like poliomyelitis, and
* vertebral instability proved by Dynamic plain radiographs

Primary outcomes:
measure: Oswestry disability index
timeFrame: It was measured at 12 months after operation
measure: Visual analoge score
timeFrame: It was measured at 12 months after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hawler medical university / college of medicine
name: Sherwan Hamawandi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamawandi SA, Sulaiman II, Al-Humairi AK. Microdecompression versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis: A Randomized Controlled Trial. Pain Res Manag. 2019 Nov 7;2019:7214129. doi: 10.1155/2019/7214129. eCollection 2019.