- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04144452
Therapeutic Exercises and Educational Sessions After Microdiscectomy for Disc Herniation
Effects of Therapeutic Exercises and Educational Sessions After Microdiscectomy Through Minimally Invasive Surgery for Disc Herniation
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan
- Ghurki Trust and Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Patient Education Session
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.
|
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.
|
Experimental: Therapeutic exercises plus educational sessions
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Post Surgery (Oswestry Disability Questionnaire)
Time Frame: 3 months
|
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. |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Post Surgery (Short Form 36)
Time Frame: 3 months
|
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
|
3 months
|
Change from Baseline Post Surgery (Quality of life Scale)
Time Frame: 3 months
|
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
|
3 months
|
Collaborators and Investigators
Investigators
- Study Chair: Professor Amer Aziz, Ghurki Trust and Teaching Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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