Clinical trial NCT02731196: Comparison of Exercise Intervention Effects Following Lumbar Microdiscectomy
Official title: Comparison of Early Exercise Intervention Versus Late Exercise Intervention on Pain and Neurodynamic Mobility Following Unilateral Lumbar Microdiscectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Nerve Root of Lumbar and Sacral Spine
Keywords: exercise
lumbar microdiscectomy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Ottawa
First posted: 2016-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Low Back Disability Questionnaire
timeFrame: 3 months
measure: Numeric Pain Rating Scale
timeFrame: 3 months
measure: Fear Avoidance Beliefs Questionnaire
timeFrame: 3 months
measure: Patient Specific Functional Scale
timeFrame: 3 months
Secondary outcomes:
measure: Lumbar mobility of flexion and extension
timeFrame: 3 months
measure: Slump test mobility
timeFrame: 3 months
measure: Straight leg raise
timeFrame: 3 months
measure: 50 ft Walk test
timeFrame: 3 months
measure: Step count per day
timeFrame: 4 weeks
measure: Return to work
timeFrame: 3 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Fahad Alkherayf, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References: