Recruiting

Post-Operative Restrictions

Sponsor:

Brigham and Women's Hospital

Code:

NCT01363830

Conditions

Lumbar Disc Herniation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Two-Week Post-Operative Restriction

Six-Week Post-Operative Restriction

Study Details

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.

Conditions

Lumbar Disc Herniation

Study ID

NCT01363830

Start date

Aug, 2009

Status verified date

Oct, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Two-Week Post-Operative Restriction

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

active comparator: Six-Week Post-Operative Restriction

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

Interventions

Two-Week Post-Operative Restriction

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

Six-Week Post-Operative Restriction

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

Primary outcome measure

  • Reherniation Rates [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Dana A Leonard

617-525-8761dleonard7@partners.org

Christopher M Bono, M.D.

617-732-7238cmbono@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Rishabh D Phukan

617-724-1509rphukan@partners.org

Principal Investigator:

Krikham B. Wood, M.D.

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Kevin McGuire, M.D.

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Dana A Leonard, B.A.

617-525-8761dleonard7@partners.org

Principal Investigator:

Christopher M Bono, M.D.

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 22, 2013

Last verified

Oct, 2013

Keywords

  • Disc
  • lumbar
  • herniation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2013-10-22.