NCT01363830

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

4.3 years

First QC Date

May 31, 2011

Last Update Submit

October 18, 2013

Conditions

Lumbar Disc Herniation

Keywords

Disclumbarherniation

Outcome Measures

Primary Outcomes (1)

  • Reherniation Rates

    To compare the reherniation rates between the restricted and unrestricted groups.

    2 years

Secondary Outcomes (1)

  • Activity/Health Outcomes

    2 years

Study Arms (2)

Two-Week Post-Operative Restriction

EXPERIMENTAL

Restrict bending, lifting, and twisting for two-weeks following discectomy.

Behavioral: Two-Week Post-Operative Restriction

Six-Week Post-Operative Restriction

ACTIVE COMPARATOR

Restrict bending, lifting, and twisting for six-weeks following discectomy.

Behavioral: Six-Week Post-Operative Restriction

Interventions

Two-Week Post-Operative RestrictionBEHAVIORAL

Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy.

Two-Week Post-Operative Restriction
Six-Week Post-Operative RestrictionBEHAVIORAL

Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.

Six-Week Post-Operative Restriction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • English speaking
  • single level lumbar disc herniation
  • surgical candidate
  • no previous lumbar surgery
  • primary radicular pain

You may not qualify if:

  • Less than 18 years of age
  • Non-English speaking
  • Multi-level lumbar disc herniation
  • Disc reherniation
  • Previous lumbar surgery
  • Primary low back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc DisplacementHernia

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher M Bono, M.D.

    Brigham & Women's Hospital / Harvard Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana A Leonard

CONTACT

617-525-8761dleonard7@partners.org

Christopher M Bono, M.D.

CONTACT

617-732-7238cmbono@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Christopher M. Bono, MD

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

August 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

US(3)