Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy
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.
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.
연구 개요
상태
정황
상세 설명
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
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Massachusetts
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Boston, Massachusetts, 미국, 02114
- 모병
- Massachusetts General Hospital
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연락하다:
- Rishabh D Phukan
- 전화번호: 617-724-1509
- 이메일: rphukan@partners.org
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수석 연구원:
- Krikham B. Wood, M.D.
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Boston, Massachusetts, 미국, 02115
- 모병
- Brigham & Women's Hospital
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연락하다:
- Dana A Leonard, B.A.
- 전화번호: N/A/ 617-525-8761
- 이메일: dleonard7@partners.org
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수석 연구원:
- Christopher M Bono, M.D.
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부수사관:
- Mitchel B. Harris, M.D.
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Boston, Massachusetts, 미국, 02115
- 모병
- Beth Israel Deaconess Medical Center
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연락하다:
- Andrew White, M.D.
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수석 연구원:
- Kevin McGuire, M.D.
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부수사관:
- Andrew White, M.D.
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Two-Week Post-Operative Restriction
Restrict bending, lifting, and twisting for two-weeks following discectomy.
|
Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy.
|
|
활성 비교기: Six-Week Post-Operative Restriction
Restrict bending, lifting, and twisting for six-weeks following discectomy.
|
Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Reherniation Rates
기간: 2 years
|
To compare the reherniation rates between the restricted and unrestricted groups.
|
2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Activity/Health Outcomes
기간: 2 years
|
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.
|
2 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Christopher M Bono, M.D., Brigham & Women's Hospital / Harvard Medical School
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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