Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments
Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments: a Randomised Controlled Trial
Acute low back pain is a common reason for emergency department visits (4.39% [95% CI: 3.67-5.18]). Drug treatment options are limited and largely ineffective. Paracetamol and opioids are no better than placebo for acute low back pain. Only NSAIDs and muscle relaxants have a slightly beneficial effect on pain, but muscle relaxants have an unfavorable benefit-risk ratio.
Given this situation, it is necessary to explore new non-pharmacological treatment options to relieve the pain of these patients. Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological therapy that involves applying an electrical current through the skin. Using one or two pairs of electrodes attached to the skin, TENS delivers painless, low-intensity electrical pulses to a painful area or along the path of a nerve.
TENS works by selectively activating large-diameter, non-nociceptive afferent fibers to induce segmental analgesia. In addition, TENS increases the concentration of endorphins in the bloodstream and cerebrospinal fluid.
The use of TENS has been studied primarily in chronic low back pain. A 2007 Cochrane systematic review concluded that TENS appears to reduce pain and improve range of motion in subjects with chronic low back pain.
The use of TENS in the emergency department has been little studied. To our knowledge, there are no high-quality studies comparing TENS versus placebo for acute low back pain in patients presenting to an emergency department. This study aims to investigate the analgesic efficacy of TENS compared to placebo in the treatment of acute low back pain in the emergency department.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Charles Grégoire, MD
- 전화번호: 0032497534996
- 이메일: charles.gregoire@saintluc.uclouvain.be
연구 장소
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Brussels, 벨기에, 1200
- 모병
- Cliniques Universitaires Saint-Luc
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연락하다:
- Charles Grégoire, MD
- 전화번호: 0032497534996
- 이메일: charles.gregoire@saintluc.uclouvain.be
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연락하다:
- Lara Absil, PhD
- 전화번호: 003227648645
- 이메일: lara.absil@saintluc.uclouvain.be
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- = or > 18 years old
- pain (EN > 3) related to acute lower back pain in the emergency department.
Exclusion Criteria:
- Refusal to participate in the study, refusal to sign the informed consent form
- Consent cannot be obtained (cognitive impairment, language barrier, etc.)
- Patients with lower back pain lasting more than 6 weeks
- Taking immediate-release pain medication within the last 6 hours
- Taking extended-release pain medication within the last 12 hours
- Taking a muscle relaxant within the last 24 hours
- Pregnant women
- Patients requiring immediate medical attention (life-threatening situation)
- Patient already treated with TENS
- Patient with a body temperature > 38°C
- Patient with a known spinal infection
- Lower back pain related to trauma
- Patient with a known systemic rheumatological or spinal disease
- Patient with a known systemic inflammatory disease
- Patient with a known chronic pain condition such as fibromyalgia
- Patient with pain radiating into the lower limb along the path of one of the following nerves (L3-L4-L5-S1)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 수십
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Transcutaneous electrical nerve stimulation (TENS) for group 1.
The device is placed and is activated on the patient's back
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위약 비교기: FAKE TENS
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The device is placed on the patient's back even in the placebo group (FAKE TENS) but it is not active
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Comparison of the proportion of patients experiencing a >30% reduction in their initial pain after 30 minutes of treatment.
기간: From enrollment to the end of treatment at 30 minutes
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Pain is quantified using the EN numerical pain scale ranging from 0 (no pain present) to 10 (maximum pain). This is a self-assessment scale for the patient. The patient's pain level (according to EN numerical pain scale) is assessed at enrollment (Time 0) before the medical device is placed. A pain assessment using this scale is requested after 15 and 30 minutes. |
From enrollment to the end of treatment at 30 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Compare the number of patients experiencing a reduction of >50% in their initial pain.
기간: From enrollment to the end of treatment at 30 minutes.
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Pain is quantified using the EN numerical pain scale ranging from 0 (no pain present) to 10 (maximum pain). This is a self-assessment scale for the patient. The patient's pain level (according to EN numerical pain scale) is assessed at enrollment (Time 0) before the medical device is placed. A pain assessment using this scale is requested after 15 and 30 minutes. |
From enrollment to the end of treatment at 30 minutes.
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Compare the number of patients requiring rescue treatment.
기간: From enrollment to the end of treatment at 30 minutes.
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From enrollment to the end of treatment at 30 minutes.
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Compare the occurrence of side effects between the groups.
기간: From enrollment to the end of treatment at 30 minutes.
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From enrollment to the end of treatment at 30 minutes.
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Compare patient satisfaction levels and comfort at 30 minutes.
기간: From enrollment to the end of treatment at 30 minutes.
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From enrollment to the end of treatment at 30 minutes.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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. .
허리 통증에 대한 임상 시험
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Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
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Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)완전한
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Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
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Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
transcutaneous electrical nerve stimulation (TENS)에 대한 임상 시험
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University of Malaga아직 모집하지 않음스트레스 | 불명증 | 수면 장애