Injury of Nerve Root of Lumbar and Sacral SpineNCT02731196
Comparison of Exercise Intervention Effects Following Lumbar Microdiscectomy
A study testing Exercise Intervention in people with Injury of Nerve Root of Lumbar and Sacral Spine, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Injury of Nerve Root of Lumbar and Sacral Spine
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2016to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Compression of the spinal cord
- Uncontrolled cardiovascular or respiratory disease
- Peripheral vascular disease with sensory loss in the foot
- Discitis
- Pregnancy
- Previous spinal surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise Intervention
- Keywords
- exercise, lumbar microdiscectomy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Early versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Low Back Disability Questionnaire
Pain and function related to low back pain
Measured: 3 months
Numeric Pain Rating Scale
Pain related to low back pain
Measured: 3 months
Fear Avoidance Beliefs Questionnaire
Psychological barriers related to low back pain
Measured: 3 months
Patient Specific Functional Scale
Function related to low back pain
Measured: 3 months
Secondary outcomes (6)
Lumbar mobility of flexion and extension
Range of lumbar motion related to low back pain
Measured: 3 months
Slump test mobility
Mobility restrictions in the slump test related to low back pain
Measured: 3 months
Straight leg raise
Mobility restrictions in the straight leg raise related to low back pain
Measured: 3 months
50 ft Walk test
Time to complete 50 ft walk test
Measured: 3 months
Step count per day
Step count per day related to Low back pain
Measured: 4 weeks
Return to work
Timing for return to work related to low back pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start15 Apr 2016
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Nerve Root of Lumbar and Sacral SpineStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Principal investigator, Fahad AlKherayf, Ottawa Hospital Research Institute
- Investigators
- Fahad Alkherayf, MD MSc FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731196
- Sponsor's protocol ID
- 20150717-01H
- Status last verified
- Aug 2019
- First submitted
- 1 Apr 2016
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Exercise Intervention Versus Late Exercise Intervention on Pain and Neurodynamic Mobility Following Unilateral Lumbar Microdiscectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02731196
- Acronym / sponsor ID
- 20150717-01H
- Keywords
- exercise, lumbar microdiscectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early exercise intervention group | Experimental | Behavioral: Exercise InterventionEducation, 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. |
| Late exercise intervention group | Active comparator | Behavioral: Exercise InterventionEducation, 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionEarly versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy | Behavioural | Early exercise intervention group, Late exercise intervention group |
Primary outcome
Oswestry Low Back Disability Questionnaire
Time frame: 3 months
Pain and function related to low back pain
Numeric Pain Rating Scale
Time frame: 3 months
Pain related to low back pain
Fear Avoidance Beliefs Questionnaire
Time frame: 3 months
Psychological barriers related to low back pain
Patient Specific Functional Scale
Time frame: 3 months
Function related to low back pain
6 secondary outcomes
Lumbar mobility of flexion and extension
Time frame: 3 months
Slump test mobility
Time frame: 3 months
Straight leg raise
Time frame: 3 months
50 ft Walk test
Time frame: 3 months
Step count per day
Time frame: 4 weeks
Return to work
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- The Ottawa Hospital websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahad Alkherayf, MD MSc FRCSC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Injury of Nerve Root of Lumbar and Sacral Spine, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Low Back Disability Questionnaire (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.