Clinical trial NCT04144452: Therapeutic Exercises and Educational Sessions After Microdiscectomy for Disc Herniation
Official title: Effects of Therapeutic Exercises and Educational Sessions After Microdiscectomy Through Minimally Invasive Surgery for Disc Herniation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minimally Invasive Surgical Procedures
Disk, Herniated
Keywords: Back Pain
Exercise Therapy
Functionality
Microdiscectomy
Patient Education
Quality of Life
Lead sponsor: Ghurki Trust and Teaching Hospital
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The basic purpose of current research is to evaluate the comparative effectiveness of therapeutic exercises and educational sessions after microdiscectomy through Minimally Invasive Surgery for disc herniation. A Randomized trial will be conducted on 60 patients from Ghurki hospital , divided into two groups. Simple random sampling will be utilized as sampling strategy. Assessment of physical activities of daily living and quality of life will be performed before and after 8 weeks of post intervention surgery through Oswestry Disability Index, Physical activity survey , SF 36 and Subjective Quality of Life scale respectively . A follow up assessment will be performed after 6 months. Analysis will be done through SPSS 21.

Detailed description: The increasing number of spinal injuries and pathologies directs the need of technological advancement in spinal surgeries and its approaches in Pakistan. Among various expansion in surgical procedures; minimally invasive surgery of spine has gaining more advantage for spinal decompression, spinal fusion and instrumentation over lumbar, thoracic and cervical spine areas considering multilevel pathology.(1) Minimally invasive spine surgery (MISS), has attracted increasing attention within the last decade. The common thread between all minimally invasive spine surgeries is use of smaller incisions and less deterioration of surrounding soft tissue, typically results in less pain after surgery and a faster recovery with reduced length of stay at hospital. The patient reported functional outcome after this procedure was found to be better in comparison with the open approach procedures.(2) Therapeutic exercise post-operatively was programmed to maximize recovery and to minimize potential future problems including disability and improving quality of life. Three different approaches for post-operative management has been practiced including: 1. Recovery phase: 4 to 16 weeks of limited activity following the surgery, 2. eliminating post-operative activity restriction leads to enhanced short-term outcomes for patients after limited open discectomy, 3. Incorporating therapeutic exercise intervention program.(3) The purpose of therapeutic exercise post-operatively was to maximize recovery and to minimize potential future problems including disability and improving quality of life. (4)The therapeutic intervention program comprises of two components: patient education and exercise therapy based on protocols by clinical expertise considering the philosophy of surgeon. Patient education comprises of a one hour counseling session. Therapeutic exercise program encompasses trunk strengthening exercises (both isometrics and dynamics) along with core stabilization exercises and endurance training. (5)

Eligibility criteria: Inclusion Criteria:

* Aged between 20 to 50 years
* Diagnosed cases of L4-L5 through Gold standard MRI
* Who have undergone minimally invasive microdiscectomy due to herniated disc
* Both male and female
* Patients who will be without adverse events or complications 4 weeks post surgery

Exclusion Criteria:

* Low back pain due to causes other than herniated disc
* Leg pain due to causes other than herniated disc
* Who have undergone standard/open microdiscectomy
* Previous history of spinal surgery
* Patients unwilling to participate

Primary outcomes:
measure: Change from Baseline Post Surgery (Oswestry Disability Questionnaire)
timeFrame: 3 months
Secondary outcomes:
measure: Change from Baseline Post Surgery (Short Form 36)
timeFrame: 3 months
measure: Change from Baseline Post Surgery (Quality of life Scale)
timeFrame: 3 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ghurki Trust and Teaching Hospital
state: Punjab
Study officials:
affiliation: Ghurki Trust and Teaching Hospital
name: Professor Amer Aziz
role: STUDY_CHAIR
References: