Comparison of Exercise Intervention Effects Following Lumbar Microdiscectomy

Comparison of Early Exercise Intervention Versus Late Exercise Intervention on Pain and Neurodynamic Mobility Following Unilateral Lumbar Microdiscectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Injury of Nerve Root of Lumbar and Sacral Spine
• Intervention / Treatment: Behavioral: Exercise Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital - Civic Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Exercise Intervention; Early versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy
Active Comparator: 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.	Behavioral: Exercise Intervention; Early versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Low Back Disability Questionnaire	Pain and function related to low back pain	3 months
Numeric Pain Rating Scale	Pain related to low back pain	3 months
Fear Avoidance Beliefs Questionnaire	Psychological barriers related to low back pain	3 months
Patient Specific Functional Scale	Function related to low back pain	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar mobility of flexion and extension	Range of lumbar motion related to low back pain	3 months
Slump test mobility	Mobility restrictions in the slump test related to low back pain	3 months
Straight leg raise	Mobility restrictions in the straight leg raise related to low back pain	3 months
50 ft Walk test	Time to complete 50 ft walk test	3 months
Step count per day	Step count per day related to Low back pain	4 weeks
Return to work	Timing for return to work related to low back pain	3 months

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: University of Ottawa
• Investigators: Principal Investigator: Fahad Alkherayf, MD MSc FRCSC, Ottawa Hospital Research Institute

Publications and helpful links

Helpful Links

• The Ottawa Hospital website

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2016
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: exercise; lumbar microdiscectomy
• Other Study ID Numbers: 20150717-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No