- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02343315
Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?
Effectiveness of TENS and Supervised Motor Control Exercises Compared To Unsupervised Exercises in Subjects With Chronic Low Back Pain: A Randomized Clinical Trial
연구 개요
상세 설명
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Nonspecific Low back pain for more than 3 months with pain primarily localized between T12 and gluteal folds, if patients report that their pain is provoked and relieved with postures, movement and activities.
- Age between 18 to 65 years
- Male or female
- All educational backgrounds (educated or uneducated)
- Pain intensity more than 2/10 on NPRS and
- Disability of more than 20/100 on NODI
Exclusion Criteria:
- Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
Signs consistent with nerve root compression, this includes any one of the following:
- Reproduction of low back or leg pain with straight leg raise at less than 45 degrees
- Muscle weakness involving a major muscle group of the lower extremity
- Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
- Diminished or absent sensation to pinprick in any lower extremity dermatome
- Prior surgery to the lumbar spine or buttock
- Current pregnancy
- Past medical history of osteoporosis or spinal compression fracture
Participants who do not provide informed consent for the study
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: TENS
Participants will receive Active-TENS along with SMCE and UHEP.
Six treatment sessions will be given over two weeks.
Total duration of the treatment session may last from 40 - 60 minutes.
|
Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes.
다른 이름들:
Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles. Initially participants will be taught how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities.
다른 이름들:
All the participants will receive the following treatments:
다른 이름들:
|
실험적: SMCE
Participants will receive SMCE and UHEP.
Six sessions of supervised Motor control exercises will be provided over the period of two weeks.
|
Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles. Initially participants will be taught how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities.
다른 이름들:
All the participants will receive the following treatments:
다른 이름들:
|
활성 비교기: UHEP
Unsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session.
|
All the participants will receive the following treatments:
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Disability (Nepali version of Oswestry Disability Index (NODI)
기간: 2 weeks
|
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal.
The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
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2 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pain intensity (Numerical Pain Rating Scale (NPRS)
기간: 2 weeks
|
Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours.
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2 weeks
|
Pain intensity (Numerical Pain Rating Scale (NPRS)
기간: 6 months
|
Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours.
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6 months
|
Disability (Nepali version of Oswestry Disability Index (NODI)
기간: 6 months
|
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal.
The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
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6 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Changes in pain and disability (Global Rating of Change (GROC)
기간: 2 weeks
|
Global Rating of Change (GROC) - The fifteen-point global rating scale will be used.
The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better).
Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
The global rating will be administered at the follow-up examinations only.
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2 weeks
|
Changes in pain and disability (Global Rating of Change (GROC)
기간: 6 months
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Using Global rating of change (GROC)
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6 months
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Need for medication (using frequency and dosage and types of analgesics used)
기간: 6 months
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using frequency and dosage and types of analgesics used
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6 months
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Need for follow up (number of treatment sessions in past six months will be recorded)
기간: 6 months
|
number of treatment sessions in past six months will be recorded
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6 months
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Adverse events
기간: 6 months
|
numbers of adverse events are noted down using a questionnaire
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6 months
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Fear avoidance (Fear avoidance belief questionnaire (FABQ)
기간: 6 months
|
Fear avoidance belief questionnaire (FABQ) - The FABQ is a 16-item scale that assesses the influence of fear avoidance behaviors on physical and work activities.
Each item is scored from 0-6 with possible scores ranging between 0-42 and higher scores representing increased fear-avoidance beliefs.
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6 months
|
Pain Catastrophizing (Pain catastrophizing Scale (PCS)
기간: 6 months
|
Pain catastrophizing Scale (PCS) - Nepali translation of PCS is a 13-item scale that assesses the pain catastrophizing.
Pain catastrophizing is an exaggerated, negative focus on pain and is related to psychological distress, pain severity, and other negative outcomes in pain population.
Participants responded to each item using a Likert-type scale from 0 ('not at all') to 4 ('all the time').
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Saurab Sharma, MPT, Kathmandu University School of Medical Sciences, Nepal
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
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