Low Level Laser Therapy to Reduce Chronic Pain
2014年4月2日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
100
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Erchonia PL2000 Laser
Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).
|
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.
他の名前：
|
|
プラセボコンパレーター：Placebo laser
inactive light
|
Inactive laser light.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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.
|
baseline and one hour
|
|
Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
時間枠：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.
時間枠：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
|
one hour
|
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Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.
時間枠：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.
時間枠：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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Richard Amy, DC
- 主任研究者：George Gonzalez, DC
- 主任研究者：John Pinto, DC
- 主任研究者：Allen Wentworth, DC
- 主任研究者：Robert Stashko, DC
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2000年7月1日
一次修了 (実際)
2000年9月1日
研究の完了 (実際)
2000年9月1日
試験登録日
最初に提出
2009年6月25日
QC基準を満たした最初の提出物
2009年6月26日
最初の投稿 (見積もり)
2009年6月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年5月2日
QC基準を満たした最後の更新が送信されました
2014年4月2日
最終確認日
2014年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。