- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00929773
Low Level Laser Therapy to Reduce Chronic Pain
2014년 4월 2일 업데이트: Erchonia Corporation
Study of the Effect of Low Level Laser Light Therapy on the Reduction of Chronic Pain of the Neck and Shoulders
The purpose of this study was to determine whether low level laser light directed at the neck and shoulders could be effective in the temporary reduction of chronic pain in the neck and shoulder region.
연구 개요
상세 설명
Chronic neck and shoulder pain arising from osteoarthritis, chronic muscle spasms or thoracic or cervical spine sprain strain can be seriously debilitating.
Currently available treatment options such as pain relief medication, ice pack, massage, physical therapy and chiropractic are typically of limited effectiveness.
More permanent options such as surgery are invasive with long recovery periods and side-effects and complications of their own.
Low level laser light therapy, with its proven anti-inflammatory ability, offers a simple non-invasive option for the reduction of chronic neck and shoulder pain.
연구 유형
중재적
등록 (실제)
100
단계
- 해당 없음
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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Muscular-skeletal pain in the neck/shoulder region
- Acute and chronic pain in the neck/shoulder region
- Restricted range of motion in the neck/shoulder region
- Fibrosis or scar tissue in the neck/shoulder region
- Inflammation in the neck/shoulder region
- Altered function in the neck/shoulder region
- Muscle strains in the neck/shoulder region
- Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale
- 18-65 years of age
Exclusion Criteria:
- Severely herniated disks
- Pregnancy
- Taken pain medication within the past 12 hours
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Erchonia PL2000 Laser
Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).
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Low level laser light therapy device that emits 1 mW of red (635 nm wavelength) light.
It is a hand-held device that uses rechargeable batteries or a separate power adapter.
다른 이름들:
|
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위약 비교기: Placebo laser
inactive light
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Inactive laser light.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment.
기간: baseline and one hour
|
Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS).
The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end.
Participants mark a point along the line that best represents the pain they are experiencing at that moment.
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baseline and one hour
|
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Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)
기간: baseline and one hour
|
Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS).
The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end.
Participants mark a point along the line that best represents the pain they are experiencing at that moment.
The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration.
A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better.
|
baseline and one hour
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
기간: baseline and one hour
|
Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side.
The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees.
The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment.
If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment.
If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment
|
baseline and one hour
|
|
Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.
기간: one hour
|
Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder.
The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees.
The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment.
If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment.
If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment
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one hour
|
|
Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.
기간: baseline and one hour
|
Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side.
The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees.
The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment.
If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment.
If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment.
|
baseline and one hour
|
|
Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.
기간: baseline and one hour
|
Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder.
The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees.
The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment.
If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment.
If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment.
|
baseline and one hour
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Richard Amy, DC
- 수석 연구원: George Gonzalez, DC
- 수석 연구원: John Pinto, DC
- 수석 연구원: Allen Wentworth, DC
- 수석 연구원: Robert Stashko, DC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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
2000년 7월 1일
기본 완료 (실제)
2000년 9월 1일
연구 완료 (실제)
2000년 9월 1일
연구 등록 날짜
최초 제출
2009년 6월 25일
QC 기준을 충족하는 최초 제출
2009년 6월 26일
처음 게시됨 (추정)
2009년 6월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 5월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 4월 2일
마지막으로 확인됨
2014년 4월 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. .
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