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Therapeutic Exercises and Educational Sessions After Microdiscectomy for Disc Herniation

Primary Purpose

Minimally Invasive Surgical Procedures, Disk, Herniated

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Patient Education Session
Therapeutic Exercise plus educational session
Sponsored by
Ghurki Trust and Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Minimally Invasive Surgical Procedures focused on measuring Back Pain, Exercise Therapy, Functionality, Microdiscectomy, Patient Education, Quality of Life

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghurki Trust and Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patient Education Session

Therapeutic exercises plus educational sessions

Arm Description

Educational session will be given twice a day for three months. Individualized instructional booklet about back care for each patient will be designed, reviewed and finalized by operating surgeons according to the needs of patients.

Trunk and lower musculature strength and endurance training will be performed twice a week for three months. Therapeutic exercises incorporating mat exercises will be performed. Progression will be made according to patient status.

Outcomes

Primary Outcome Measures

Change from Baseline Post Surgery (Oswestry Disability Questionnaire)
The Oswestry Disability Index is considered as a vital tool that investigators and disability assessors use to measure an individual's permanent functional disability. The test is defined as the 'gold standard' of low back functional outcome tools. ODI consist of 10 items and each item is scored on Likert scale from 0 to 5. The total score is then added and multiplied by 2. Thus the score is from 0 to 100. Greater score represents more severe disability.

Secondary Outcome Measures

Change from Baseline Post Surgery (Short Form 36)
Short Form -36 will be used to evaluate baseline quality of life for each patient prior to and post intervention period. It has been utilized in patients with low back pain and post lumbar surgeries. A higher score on questionnaire indicates better functioning
Change from Baseline Post Surgery (Quality of life Scale)
The Quality of Life Scale consists of only one item, and is utilized to obtain a general quality of life assessment.Scores can range from 16 to 112. Higher scores shows higher quality of life

Full Information

First Posted
October 28, 2019
Last Updated
October 29, 2019
Sponsor
Ghurki Trust and Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04144452
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ghurki Trust and Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimally Invasive Surgical Procedures, Disk, Herniated
Keywords
Back Pain, Exercise Therapy, Functionality, Microdiscectomy, Patient Education, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Education Session
Arm Type
Active Comparator
Arm Description
Educational session will be given twice a day for three months. Individualized instructional booklet about back care for each patient will be designed, reviewed and finalized by operating surgeons according to the needs of patients.
Arm Title
Therapeutic exercises plus educational sessions
Arm Type
Experimental
Arm Description
Trunk and lower musculature strength and endurance training will be performed twice a week for three months. Therapeutic exercises incorporating mat exercises will be performed. Progression will be made according to patient status.
Intervention Type
Other
Intervention Name(s)
Patient Education Session
Intervention Description
The intervention of Patient Education will be designed individually according to the patient's need who have undergone lumbar microdiscectomy procedure through MIS. The basic purpose of the educational session will be to inform the participants about their pre operative and current back condition and discuss methods to care for their back. The session will be given for one hour and face to face interaction will be ensured twice a week. Initially the post operative education plan and instructions will be formulated, reviewed and finalized by the operating surgeon.
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise plus educational session
Intervention Description
Therapeutic exercises include strength and endurance training and mat exercises. Strengthening exercises of the trunk extensors will be initiated first and then endurance exercises will be targeted. Mat exercises will be performed to strengthen the back and lower musculature. Treatment will be given twice a week for almost three months. Individualized educational sessions will be performed in the same way as conducted in the other group. Progression of the exercises and the rest periods will be incorporated according to the status of patient.
Primary Outcome Measure Information:
Title
Change from Baseline Post Surgery (Oswestry Disability Questionnaire)
Description
The Oswestry Disability Index is considered as a vital tool that investigators and disability assessors use to measure an individual's permanent functional disability. The test is defined as the 'gold standard' of low back functional outcome tools. ODI consist of 10 items and each item is scored on Likert scale from 0 to 5. The total score is then added and multiplied by 2. Thus the score is from 0 to 100. Greater score represents more severe disability.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from Baseline Post Surgery (Short Form 36)
Description
Short Form -36 will be used to evaluate baseline quality of life for each patient prior to and post intervention period. It has been utilized in patients with low back pain and post lumbar surgeries. A higher score on questionnaire indicates better functioning
Time Frame
3 months
Title
Change from Baseline Post Surgery (Quality of life Scale)
Description
The Quality of Life Scale consists of only one item, and is utilized to obtain a general quality of life assessment.Scores can range from 16 to 112. Higher scores shows higher quality of life
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Amer Aziz
Organizational Affiliation
Ghurki Trust and Teaching Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ghurki Trust and Teaching Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapeutic Exercises and Educational Sessions After Microdiscectomy for Disc Herniation

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