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NCT Number: NCT02731196

Comparison of Exercise Intervention Effects Following Lumbar Microdiscectomy

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.

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Key information

Conditions

Injury of Nerve Root of Lumbar and Sacral Spine Behavior Motor Activity

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

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

Primary outcomes

  1. Oswestry Low Back Disability Questionnaire

    Time frame: 3 months

    Pain and function related to low back pain

  2. Numeric Pain Rating Scale

    Time frame: 3 months

    Pain related to low back pain

  3. Fear Avoidance Beliefs Questionnaire

    Time frame: 3 months

    Psychological barriers related to low back pain

  4. Patient Specific Functional Scale

    Time frame: 3 months

    Function related to low back pain

Secondary outcomes

  1. Lumbar mobility of flexion and extension

    Time frame: 3 months

    Range of lumbar motion related to low back pain

  2. Slump test mobility

    Time frame: 3 months

    Mobility restrictions in the slump test related to low back pain

  3. Straight leg raise

    Time frame: 3 months

    Mobility restrictions in the straight leg raise related to low back pain

  4. 50 ft Walk test

    Time frame: 3 months

    Time to complete 50 ft walk test

  5. Step count per day

    Time frame: 4 weeks

    Step count per day related to Low back pain

  6. Return to work

    Time frame: 3 months

    Timing for return to work related to low back pain

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • University of Ottawa

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 7, 2016
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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