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Therapeutic Exercises and Educational Sessions After Microdiscectomy for Disc Herniation

NCT ID: NCT04144452

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2019-05-01

Brief Summary

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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

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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)

Conditions

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Minimally Invasive Surgical Procedures Disk, Herniated

Keywords

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Back Pain Exercise Therapy Functionality Microdiscectomy Patient Education Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Patient Education Session

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Therapeutic Exercise plus educational session

Intervention Type OTHER

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.

Interventions

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Patient Education Session

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

Therapeutic Exercise plus educational session

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ghurki Trust and Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Professor Amer Aziz

Role: STUDY_CHAIR

Ghurki Trust and Teaching Hospital

Locations

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Ghurki Trust and Teaching Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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18

Identifier Type: -

Identifier Source: org_study_id