Lumbar Disc HerniationNCT01363830
Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy
A study testing Two-Week Post-Operative Restriction and Six-Week Post-Operative Restriction in people with Lumbar Disc Herniation, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
Post-operative restrictions following lumbar discectomy is a controversial topic. While the most widely accepted protocol restricts bending, lifting, and twisting for four to six weeks following discectomy, a number of studies support an early return to full activity without restriction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Two-Week Post-Operative Restriction and Six-Week Post-Operative Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2009to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- English speaking
- single level lumbar disc herniation
- surgical candidate
- no previous lumbar surgery
- primary radicular pain
Who cannot join
- Less than 18 years of age
- Non-English speaking
- Multi-level lumbar disc herniation
- Disc reherniation
- Previous lumbar surgery
- Primary low back pain
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rishabh D Phukan, 617-724-1509, rphukan@partners.org
Krikham B. Wood, M.D.
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Andrew White, M.D.
Kevin McGuire, M.D.
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Dana A Leonard, B.A., 617-525-8761 ext. N/A/, dleonard7@partners.org
Christopher M Bono, M.D.
About this study
Official title: Short (2-weeks) Versus Long (6-weeks) Post-Operative Restrictions Following Lumbar Discectomy: A Prospective Randomized Control Study
Post-operative restrictions following lumbar discectomy is a controversial topic. While the most widely accepted protocol restricts bending, lifting, and twisting for four to six weeks following discectomy, a number of studies support an early return to full activity without restriction. Since the goal of discectomy is to promptly provide pain relief and a return to a fully active lifestyle, perhaps post-operative restrictions are more hindering than beneficial.
Hypothesis: Post-operative restrictions following lumbar discectomy do not influence reherniation rate.
Read more
Specific Aim 1: To compare the reherniation rates between the 6-weeks of restriction and the 2-weeks of restriction groups.
Specific Aim 2: To determine the return to full activity and return to work dates of both the 6-weeks of restriction and 2-weeks of restriction groups.
Specific Aim 3: To assess the health outcomes of both the 6-weeks of restriction and 2-weeks of restriction groups.
Read the detailed description
Upon enrollment, subjects will be randomized to the "6-weeks of restriction" or "2-weeks of restriction" group. Subjects will also be asked to provide/complete:
- demographical information
- VAS back and leg score
- Modified Oswestry questionnaire
All of the surgeries will be performed using a so-called limited discectomy in which the herniated disc fragment is removed without an aggressive disc space curettage. Prior to surgery, the subjects' discs will be classified by the Primary Investigator and Site Responsible Investigator on a T-2 weighted MRI according to the Carragee Disc Herniation Classification system.
The discs will be reassessed intraoperatively by the surgeon to confirm the assigned classification. In addition, a radiologist will review a random sampling set of discs on T-2 weighted MRI to eliminate bias and validate the classifications.
Subjects will be followed for a 2 year time period with study visits at 2 weeks, 6 weeks, 3 months, 1 year, and 2 years. At every follow-up visit, the following will be completed and/or documented:
- A reherniation (any clinical symptoms of a reherniation will be verified and documented by MRI)
- Return to full activity and/or work (date)
- VAS back and leg score
- Modified Oswestry questionnaire
- Conditions
- Lumbar Disc Herniation
- Being tested
- Two-Week Post-Operative Restriction, Six-Week Post-Operative Restriction
- Keywords
- Disc, lumbar, herniation
- Medical subject headings
- Intervertebral Disc Displacement, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-Week Post-Operative RestrictionBehavioural
Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy.
Six-Week Post-Operative RestrictionBehavioural
Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.
| Study group | Role | What they receive |
|---|---|---|
| Two-Week Post-Operative Restriction | Experimental | Restrict bending, lifting, and twisting for two-weeks following discectomy. Receives: Behavioral: Two-Week Post-Operative Restriction |
| Six-Week Post-Operative Restriction | Active comparator | Restrict bending, lifting, and twisting for six-weeks following discectomy. Receives: Behavioral: Six-Week Post-Operative Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reherniation Rates
To compare the reherniation rates between the restricted and unrestricted groups.
Measured: 2 years
Secondary outcomes (1)
Activity/Health Outcomes
To determine the return to full activity and return to work dates of both the restricted and unrestricted groups. Also, to assess the health outcomes of both the restricted and unrestricted groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Bono, Brigham and Women's Hospital
- Investigators
- Christopher M Bono, M.D., Principal investigator, Brigham & Women's Hospital / Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363830
- Sponsor's protocol ID
- 2009P001125
- Status last verified
- Oct 2013
- First submitted
- 31 May 2011
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short (2-weeks) Versus Long (6-weeks) Post-Operative Restrictions Following Lumbar Discectomy: A Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT01363830
- Acronym / sponsor ID
- 2009P001125
- Conditions
- Lumbar Disc Herniation
- Keywords
- Disc, lumbar, herniation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Study start
- Aug 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 2 Jun 2011 (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.
Post-operative restrictions following lumbar discectomy is a controversial topic. While the most widely accepted protocol restricts bending, lifting, and twisting for four to six weeks following discectomy, a number of studies support an early return to full activity without restriction. Since the goal of discectomy is to promptly provide pain relief and a return to a fully active lifestyle, perhaps post-operative restrictions are more hindering than beneficial.
Hypothesis: Post-operative restrictions following lumbar discectomy do not influence reherniation rate.
Specific Aim 1: To compare the reherniation rates between the 6-weeks of restriction and the 2-weeks of restriction groups.
Specific Aim 2: To determine the return to full activity and return to work dates of both the 6-weeks of restriction and 2-weeks of restriction groups.
Specific Aim 3: To assess the health outcomes of both the 6-weeks of restriction and 2-weeks of restriction groups.
Detailed description
Upon enrollment, subjects will be randomized to the "6-weeks of restriction" or "2-weeks of restriction" group. Subjects will also be asked to provide/complete:
- demographical information
- VAS back and leg score
- Modified Oswestry questionnaire
All of the surgeries will be performed using a so-called limited discectomy in which the herniated disc fragment is removed without an aggressive disc space curettage. Prior to surgery, the subjects' discs will be classified by the Primary Investigator and Site Responsible Investigator on a T-2 weighted MRI according to the Carragee Disc Herniation Classification system.
The discs will be reassessed intraoperatively by the surgeon to confirm the assigned classification. In addition, a radiologist will review a random sampling set of discs on T-2 weighted MRI to eliminate bias and validate the classifications.
Subjects will be followed for a 2 year time period with study visits at 2 weeks, 6 weeks, 3 months, 1 year, and 2 years. At every follow-up visit, the following will be completed and/or documented:
- A reherniation (any clinical symptoms of a reherniation will be verified and documented by MRI)
- Return to full activity and/or work (date)
- VAS back and leg score
- Modified Oswestry questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-Week Post-Operative Restriction | Experimental | Behavioral: Two-Week Post-Operative RestrictionRestrict bending, lifting, and twisting for two-weeks following discectomy. |
| Six-Week Post-Operative Restriction | Active comparator | Behavioral: Six-Week Post-Operative RestrictionRestrict bending, lifting, and twisting for six-weeks following discectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- English speaking
- single level lumbar disc herniation
- surgical candidate
- no previous lumbar surgery
Key exclusion criteria (6 listed)
- Less than 18 years of age
- Non-English speaking
- Multi-level lumbar disc herniation
- Disc reherniation
- Previous lumbar surgery
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 |
|---|---|---|
| Two-Week Post-Operative RestrictionSurgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy. | Behavioural | Two-Week Post-Operative Restriction |
| Six-Week Post-Operative RestrictionSurgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy. | Behavioural | Six-Week Post-Operative Restriction |
Primary outcome
Reherniation Rates
Time frame: 2 years
To compare the reherniation rates between the restricted and unrestricted groups.
1 secondary outcome
Activity/Health Outcomes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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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.
Christopher M Bono, M.D. principal investigator
Brigham & Women's Hospital / Harvard Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-Week Post-Operative Restriction and Six-Week Post-Operative Restriction in people with Lumbar Disc Herniation, run by Brigham and Women's Hospital at 3 sites in United States.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana A Leonard (617-525-8761, dleonard7@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reherniation Rates (time frame: 2 years). 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 22 Oct 2013.