- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01611792
Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain
2017년 10월 16일 업데이트: Sharon M. Henry, University of Vermont
Low back pain affects 80% of Americans at some time during their lives.
Although recovery usually occurs within 6 months, there is a 50% recurrence within one year's time.
It has long been thought that poor control of trunk muscle may lead to abnormal forces across the spine, which then damage local spinal structures, thus, leading to low back pain.
However, the investigators know little about the function of specific trunk muscles in healthy subjects during various activities of daily life.
Furthermore, the precise muscle dysfunction associated with low back pain has not been well characterized at all.
In addition, the investigators know little about which exercise protocol is most beneficial for particular subgroups of people with low back pain.
Thus, the purposes of this study are to learn more about: 1) how trunk muscles are affected by low back pain; 2) which exercises might be most beneficial for people with certain kinds of low back pain; and 3) how these exercises influence trunk muscle function.
By having a better understanding of which trunk muscles are affected by low back pain, rehabilitation specialists can design exercise programs and therapeutic interventions that are more specific and more effective.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
58
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Vermont
-
Burlington, Vermont, 미국, 05405
- Human Motion Analysis Laboratory
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
21년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- a history of chronic LBP with or without recurrences for a minimum of 12 months
- between 21 - 55 years of age
- able to stand and walk without assistance
- have an Oswestry Disability Score of 19% or higher
Exclusion Criteria:
- any major structural spinal deformity including scoliosis, kyphosis, or stenosis
- spinal fracture or dislocation
- osteoporosis
- ankylosing spondylitis
- rheumatoid arthritis
- disc herniation with corroborating clinical signs and symptoms
- serious spinal complications such as tumor or infection
- previous spinal surgery
- frank neurological loss, i.e., weakness and sensory loss
- pain or paresthesia below the knee
- etiology of LBP other than the lumbar spine, e.g., hip joint
- history of neurological disease which required hospitalization
- active treatment for cancer
- history of unresolved cancer
- pregnancy or less than 6 months post-partum or less than 6 months post weaning
- magnified symptom-behavior
- worker's compensation or disability case
- in litigation for the LBP problem
- have a BMI ≥ 30
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Stabilization
|
The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles.
Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally.
Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance.
Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task.
Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
다른 이름들:
|
|
활성 비교기: Strengthening and Conditioning
|
This protocol contained trunk strengthening and endurance exercises.
It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements.
Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements).
During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses.
There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)
기간: Baseline and 11 weeks
|
Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement
|
Baseline and 11 weeks
|
|
Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)
기간: Baseline and 6 Months
|
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
|
Baseline and 6 Months
|
|
Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)
기간: 11 Weeks and 6 Months
|
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
|
11 Weeks and 6 Months
|
|
Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)
기간: Baseline and 11 weeks
|
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
|
Baseline and 11 weeks
|
|
Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)
기간: Baseline and 6 months
|
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
|
Baseline and 6 months
|
|
Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)
기간: 11 weeks and 6 months
|
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
|
11 weeks and 6 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sharon M Henry, PT, PhD, University of Vermont
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Jacobs JV, Henry SM, Jones SL, Hitt JR, Bunn JY. A history of low back pain associates with altered electromyographic activation patterns in response to perturbations of standing balance. J Neurophysiol. 2011 Nov;106(5):2506-14. doi: 10.1152/jn.00296.2011. Epub 2011 Jul 27.
- Jones SL, Henry SM, Raasch CC, Hitt JR, Bunn JY. Individuals with non-specific low back pain use a trunk stiffening strategy to maintain upright posture. J Electromyogr Kinesiol. 2012 Feb;22(1):13-20. doi: 10.1016/j.jelekin.2011.10.006. Epub 2011 Nov 18.
- Stokes IA, Gardner-Morse MG, Henry SM. Abdominal muscle activation increases lumbar spinal stability: analysis of contributions of different muscle groups. Clin Biomech (Bristol, Avon). 2011 Oct;26(8):797-803. doi: 10.1016/j.clinbiomech.2011.04.006. Epub 2011 May 14.
- Stokes IA, Gardner-Morse MG, Henry SM. Intra-abdominal pressure and abdominal wall muscular function: Spinal unloading mechanism. Clin Biomech (Bristol, Avon). 2010 Nov;25(9):859-66. doi: 10.1016/j.clinbiomech.2010.06.018. Epub 2010 Jul 23.
- Jones SL, Henry SM, Raasch CC, Hitt JR, Bunn JY. Responses to multi-directional surface translations involve redistribution of proximal versus distal strategies to maintain upright posture. Exp Brain Res. 2008 May;187(3):407-17. doi: 10.1007/s00221-008-1312-1. Epub 2008 Feb 26.
- Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558.
- Henry SM, Teyhen DS. Ultrasound imaging as a feedback tool in the rehabilitation of trunk muscle dysfunction for people with low back pain. J Orthop Sports Phys Ther. 2007 Oct;37(10):627-34. doi: 10.2519/jospt.2007.2555.
- Anderson-Worth SG, Henry SM, Bunn JY. Use of real time ultrasound feedback enhances learning the abdominal hollowing exercise in patients with low back pain. New Zealand J Physiotherapy. 35(1):4-11, 2007.
- Henry SM, Hitt JR, Jones SL, Bunn JY. Decreased limits of stability in response to postural perturbations in subjects with low back pain. Clin Biomech (Bristol, Avon). 2006 Nov;21(9):881-92. doi: 10.1016/j.clinbiomech.2006.04.016. Epub 2006 Jun 27.
- Henry SM, Westervelt KC. The use of real-time ultrasound feedback in teaching abdominal hollowing exercises to healthy subjects. J Orthop Sports Phys Ther. 2005 Jun;35(6):338-45. doi: 10.2519/jospt.2005.35.6.338.
- Lomond KV, Henry SM, Hitt JR, DeSarno MJ, Bunn JY. Altered postural responses persist following physical therapy of general versus specific trunk exercises in people with low back pain. Man Ther. 2014 Oct;19(5):425-32. doi: 10.1016/j.math.2014.04.007. Epub 2014 Apr 24.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2003년 3월 1일
기본 완료 (실제)
2008년 6월 1일
연구 완료 (실제)
2008년 6월 1일
연구 등록 날짜
최초 제출
2012년 6월 1일
QC 기준을 충족하는 최초 제출
2012년 6월 4일
처음 게시됨 (추정)
2012년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 10월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 10월 16일
마지막으로 확인됨
2017년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
하부 요통에 대한 임상 시험
-
FibroGenAstraZeneca; Astellas Pharma Inc종료됨빈혈증 | 기본 MDS(Very Low, Low 또는 Intermediate IPSS-R with미국, 호주, 벨기에, 독일, 이스라엘, 이탈리아, 대한민국, 러시아 연방, 스페인, 영국, 프랑스, 칠면조, 캐나다, 덴마크, 인도, 폴란드
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Cancer Institute and Hospital, Chinese Academy...모병내장 위기로 인해 복잡한 HER2-LOW 절제 불가능한/전이성 유방암중국
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Shanghai Henlius Biotech모병HER2-LOW 호르몬 수용체 양성 유방암중국
-
Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)완전한
-
Yeon Hee ParkHelsinn Healthcare SA초대로 등록T-DXD로 치료 한 HER2 양성 진행 유방암 환자 | T-DXD로 치료 한 HER2-LOW 진행된 유방암 환자대한민국
-
Eisai Inc.완전한LEC(Low Emetogenic Chemotherapy)를 받기 위해 확인된 악성 질환이 있는 환자 또는 LEC의 마지막 주기 동안 최소한 메스꺼움 및 구토를 경험한 환자미국
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
Stabilization exercise protocol에 대한 임상 시험
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for... 그리고 다른 협력자들완전한
-
Cukurova University완전한
-
The Hong Kong Polytechnic University완전한
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)완전한