Comparison of Exercise Intervention Effects Following Lumbar Microdiscectomy

Injury of Nerve Root of Lumbar and Sacral Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731196
• Other study ID #: 20150717-01H
• Status: Completed
• Phase: N/A
• Start date: April 15, 2016
• Est. completion date: March 31, 2019

Study information

• Verified date: August 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Injury of Nerve Root of Lumbar and Sacral Spine

Intervention

Behavioral:
• Exercise Intervention
Early versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy

Locations

Country	Name	City	State
Canada	The Ottawa Hospital - Civic Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Low Back Disability Questionnaire	Pain and function related to low back pain	3 months
Primary	Numeric Pain Rating Scale	Pain related to low back pain	3 months
Primary	Fear Avoidance Beliefs Questionnaire	Psychological barriers related to low back pain	3 months
Primary	Patient Specific Functional Scale	Function related to low back pain	3 months
Secondary	Lumbar mobility of flexion and extension	Range of lumbar motion related to low back pain	3 months
Secondary	Slump test mobility	Mobility restrictions in the slump test related to low back pain	3 months
Secondary	Straight leg raise	Mobility restrictions in the straight leg raise related to low back pain	3 months
Secondary	50 ft Walk test	Time to complete 50 ft walk test	3 months
Secondary	Step count per day	Step count per day related to Low back pain	4 weeks
Secondary	Return to work	Timing for return to work related to low back pain	3 months

External Links

•   The Ottawa Hospital website