NCT02731196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 15, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

April 1, 2016

Last Update Submit

August 22, 2019

Conditions

Injury of Nerve Root of Lumbar and Sacral Spine

Keywords

exerciselumbar microdiscectomy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Lumbar mobility of flexion and extension

    3 months

  • Slump test mobility

    3 months

  • Straight leg raise

    3 months

  • 50 ft Walk test

    3 months

  • Step count per day

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Early exercise intervention group

EXPERIMENTAL

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

Late exercise intervention group

ACTIVE COMPARATOR

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

Interventions

Exercise InterventionBEHAVIORAL

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

Early exercise intervention groupLate exercise intervention group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Fahad Alkherayf, MD MSc FRCSC

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 7, 2016

Study Start

April 15, 2016

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

August 26, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)