Comparison of Exercise Intervention Effects Following Lumbar Microdiscectomy

NCT ID: NCT02731196

Last Updated: 2019-08-26

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-15

Study Completion Date

2019-03-31

Brief Summary

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Low back pain is common, costly and affecting up to 80% of the population with the lumbar discectomy being a frequent spinal procedure for disc herniations. Pain \& mobility impairments persist in patients following microdiscectomy with long term issues of back pain. The question remains as to why some patients recover quickly and without lasting difficulties while other patients persist with prolonged disability following the same surgery. The purpose of this study is to determine how to guide the patient towards full function and evaluate the timing to initiate strengthening, neurodynamics and a walking exercise program.

Detailed Description

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The direction of treatment for low back pain both surgically and conservatively seeks to improve function in both daily and sporting activities for all patients. The patients continuing to suffer from a significant level of pain, disability and reduced function following single level microdiscectomy may benefit from a multi-factorial approach. A reduction in neurodynamic mobility related to dural adhesions is considered to be a contributing factor in this persistent peripheral neuropathic pain. The clinical efficacy of this study will address an exercise protocol post surgery in order to provide an optimal approach in the prevention of scar tissue that may be contributing to persistent pain post microdiscectomy. Mobility and motor control impairments are considered the consequence to the onset of pain. Education, neurodynamics and stabilization exercises are instrumental in the recovery post microdiscectomy with a reduction in pain and disability and the goal towards full functioning. The introduction of a neurodynamic protocol as an early exercise intervention may serve to reduce pain inhibition resulting with improved mobility and motor control. The recording of step count per day following a lumbar microdiscectomy will serve to document daily and physical activity levels following surgery. The purpose of this study is to determine whether or not there is a significant difference in pain levels and lumbar mobility between an early exercise intervention group versus a late exercise intervention group post microdiscectomy.

Conditions

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Injury of Nerve Root of Lumbar and Sacral Spine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early exercise intervention group

Education, stabilization and neurodynamic level one exercises will be provided to the intervention group within one to two weeks following a unilateral lumbar microdiscectomy L3-4, L4-5, L5-S1. Within 4-6 weeks, this group will be provided with education, stabilization and neurodynamic level two exercises and a pedometer to monitor step count between week 4 and week 10 following the surgery.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Early versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy

Late exercise intervention group

Education, stabilization and neurodynamic level one and two exercises will be provided to the active comparator group within 4-6 weeks following a unilateral lumbar microdiscectomy L3-4, L4-5, L5-S1. Within 4-6 weeks, this group will also be given instructions and a pedometer to monitor step count between week 4 and week 10 following the surgery.

Group Type ACTIVE_COMPARATOR

Exercise Intervention

Intervention Type BEHAVIORAL

Early versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy

Interventions

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Exercise Intervention

Early versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Uncomplicated unilateral post-op microdiscectomy L3-4, L4-5, L5-S1
* Radicular symptoms within one year of surgical intervention
* Ability to understand English or French for instructional purposes
* Able to participate in physical activity

Exclusion Criteria

* Under the age of 18 years or over the age of 65 years
* Diagnosis of inflammatory conditions such as rheumatoid arthritis, ankylosing spondylitis
* Neoplasm
* Metabolic bone disease
* Cauda equine syndrome
* Neurological disorders ie Multiple Sclerosis, Parkinsons
* Compression of the spinal cord
* Uncontrolled cardiovascular or respiratory disease
* Peripheral vascular disease with sensory loss in the foot
* Discitis
* Pregnancy
* Previous spinal surgeries
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ottawa

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Fahad AlKherayf

Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fahad Alkherayf, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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The Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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http://www.ottawahospital.on.ca

The Ottawa Hospital website

Other Identifiers

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20150717-01H

Identifier Type: -

Identifier Source: org_study_id

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