Therapeutic Exercises and Educational Sessions After Microdiscectomy for Disc Herniation

NCT04144452 | Completed

• 1 other identifier: 18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Minimally Invasive Surgical Procedures; Disk, Herniated

Keywords

Back Pain; Exercise Therapy; Functionality; Microdiscectomy; Patient Education; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Change from Baseline Post Surgery (Short Form 36)

  3 months

• Change from Baseline Post Surgery (Quality of life Scale)

  3 months

Study Arms (2)

Patient Education Session

ACTIVE COMPARATOR

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.

Other: Patient Education Session

Therapeutic exercises plus educational sessions

EXPERIMENTAL

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.

Other: Therapeutic Exercise plus educational session

Interventions

Patient Education Session 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.

Patient Education Session

Therapeutic Exercise plus educational session 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.

Therapeutic exercises plus educational sessions

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ghurki Trust and Teaching Hospital: lead

Study Sites (1)

Ghurki Trust and Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Back Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Professor Amer Aziz

  Ghurki Trust and Teaching Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: December 20, 2018
• Primary Completion: April 15, 2019
• Study Completion: May 1, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)