急性非特異的首痛に対する温熱療法
急性非特異的頸部痛ランダム化対照試験における表面温熱療法適用の短期効果の比較
Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Medical and non-medical treatments such as physiotherapy are applied in its treatment. Patients with nonspecific neck pain (NBA) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. Although it is frequently used in clinical practice, there is no evidence that superficial thermotherapy (hot or cold) methods effectively relieve neck pain. Therefore, this study aims to compare the short-term effects of superficial hot or cold applications on pain, range of motion and functional status in patients with NBA.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Turkey
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Istanbul、Turkey、トルコ（Türkiye）、+90
- Nuray ALACA
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Istanbul、Turkey、トルコ（Türkiye）、34752
- Acibadem University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Being diagnosed with nonspecific neck pain by a doctor,
- To be between the ages of 18-65,
- Neck pain lasting for less than 3 month
- No previous neck or shoulder surgery,
- No shoulder pain due to any cause,
- A tumour or inflammatory disease underlying the neck pain not to be found,
- A clinically underlying stenosis or discogenic problem not to be present.
- Negative results from the following clinical examination tests;
Spurling test, Lhermitte test, Cervical distraction test, Adson test,
Exclusion Criteria:
- Not meeting the inclusion criteria,
- Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
- Systemic rheumatological or metabolic diseases or cancer
- Refusal to participate in the study,
- Failure to complete treatment,
- Having any neurological problem
- Severe psychological illnesses
研究計画
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：シャムグループ
|
An unrefrigerated room temperature Cold Pack will be wrapped in a towel and applied to the patient's posterior neck and back for 15 minutes while the patient is lying face down. |
|
アクティブコンパレータ：ホットパックグループ
|
Hot pack (55-60 degrees) application will be wrapped in a towel and applied to the back side neck and back of the patient for 15 minutes while the patient is lying face down. |
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アクティブコンパレータ：コールドパックグループ
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Cold pack application (2-4 degrees) will be wrapped in a towel and applied to the patient's back side neck and back for 15 minutes while the patient is lying prone. |
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 |
|---|---|---|
|
The Numerical Rating Scale (NPRS-11)
時間枠：Change from baseline pain score at 3th day
|
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain. |
Change from baseline pain score at 3th day
|
|
Range of Motion
時間枠：Change from baseline range of motion at 3th day
|
CROM device will be used. The active range of motion of each individual will be measured and measured in accordance with the manufacturer's procedures |
Change from baseline range of motion at 3th day
|
|
Global Rating of Change scale (Patient Satisfaction)
時間枠：Change from baseline Global Rating of Change scale at 3th day
|
Patient satisfaction regarding improvement in cervical situtaion will be evaluated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly between -2 to +2, with a higher value indicating better condition in this study. |
Change from baseline Global Rating of Change scale at 3th day
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neck disability index
時間枠：Change from baseline disability scale at 3th day
|
Since some parts of the 10-item questionnaire could not be answered by the patients (driving, working life), the average neck disability index score will be calculated by dividing the total score by the number of questions answered. The scoring is between 0 and 50. 0 points means the best result, 50 points means the worst result. 0 - 4 points; no disability, 5 - 14 points; mild disability, 15 - 24 points; moderate disability, 25 - 34 points; severe disability, > 35 points; complete disability |
Change from baseline disability scale at 3th day
|
|
Pressure Pain Threshold
時間枠：Change from baseline Pressure Pain Threshold at 3th day
|
A digital pressure algometer will be applied to the web space of the cervical opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold). |
Change from baseline Pressure Pain Threshold at 3th day
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2024/9/340
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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