Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain
2019年10月9日 更新者：Everett Lohman、Loma Linda University
The purpose of this study is to assess the benefit of adding stretching exercises to cervical mobilization and cervical range of motion exercises on cervical range of motion, pain, pain threshold, level of disability and patient satisfaction for patient with non-specific mechanical neck pain
調査の概要
詳細な説明
All recruited participants will sign a statement of informed consent.
Subjects were randomly divided into two groups (combined intervention group and standard intervention group).
The following questionnaires were completed in the following order: Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), and Global Rating of Change Scale (GROC).
Next, Cervical Range of Motion (ROM) and Pain threshold were measured for both groups.
The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
The standard intervention group received cervical mobilization and home program (ROM exercises).
研究の種類
介入
入学 (実際)
43
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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California
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Loma Linda、California、アメリカ、92354
- Loma Linda U
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-
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～60年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- The participant will be eligible to participate in the study if he or she is between 18 and 60 years of age, had non-specific neck pain for at least 2 weeks
Exclusion Criteria:
- Participants will be excluded from the study if they had one or more of the following conditions: had previous surgery in cervical spine area, chronic disease such as diabetes, vertigo, dizziness, fracture of the cervical vertebra or scapula, multiple sclerosis, osteoporosis, rheumatoid arthritis or osteoarthritis as approximately 60% of people who aged between 50-60 years will have osteoarthritis.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：The combined intervention group
The combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
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The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has licensed from the California Board of Physical Therapy.
The cervical passive mobilization were selected by the physical therapist based on the participant's condition.
Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: anterior, middle and posterior scalene, upper fibers of trapezius, pectoralis minor and interspinous muscles .AROM Exercise were performed 10 repetitions 3-4 times daily.
The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers.
The subject was then instructed to rotate to one side as far as possible and return to neutral.
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アクティブコンパレータ：The standard intervention
The standard intervention group will receive cervical mobilization and home program (ROM exercises).
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The standard intervention group will receive cervical mobilization and home program (ROM exercises). Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition. Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral . |
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 |
|---|---|---|
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Cervical Range of Motion
時間枠：Participants ROM measurement at baselines
|
The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.
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Participants ROM measurement at baselines
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Cervical Range of Motion
時間枠：Participants ROM measurement at week 2
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.
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Participants ROM measurement at week 2
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Cervical Range of Motion
時間枠：Participants measurement at week four
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.
|
Participants measurement at week four
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Cervical Range of Motion
時間枠：Participants ROM measurement at week 8
|
The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.
|
Participants ROM measurement at week 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numeric Pain Rating Scale
時間枠：NPRS score at baseline
|
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
The standard error is correct as stated.
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NPRS score at baseline
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Numeric Pain Rating Scale
時間枠：NPRS score at week two
|
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
|
NPRS score at week two
|
|
Numeric Pain Rating Scale
時間枠：NPRS score at week four
|
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
|
NPRS score at week four
|
|
Numeric Pain Rating Scale
時間枠：NPRS score at week eight
|
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
|
NPRS score at week eight
|
|
Neck Disability Index
時間枠：NDI score at baseline
|
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at baseline
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Neck Disability Index
時間枠：NDI score at week two
|
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at week two
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|
Neck Disability Index
時間枠：NDI score at week four
|
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
|
NDI score at week four
|
|
Neck Disability Index
時間枠：NDI score at week eight
|
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at week eight
|
|
Global Rating of Change
時間枠：GROC score at week two
|
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four, and eight.
The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change.
The negative and positive means the patient condition worsens or improves respectively.
The points are scores on a scale (-7-0-+7 = 15 point scale).
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GROC score at week two
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Global Rating of Change
時間枠：GROC score at week four
|
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and eight.
The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change.
The negative and positive means the patient condition worsens or improves respectively.
|
GROC score at week four
|
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Global Rating of Change
時間枠：GROC score at week eight
|
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and right.
The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change.
The negative and positive means the patient condition worsens or improves respectively.
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GROC score at week eight
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Pressure Pain Threshold
時間枠：Pressure Pain Threshold score at baseline
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four, and eight.
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Pressure Pain Threshold score at baseline
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Pressure Pain Threshold
時間枠：Pressure Pain Threshold score at week two
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
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Pressure Pain Threshold score at week two
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Pressure Pain Threshold
時間枠：Pressure Pain Threshold score at week four
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
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Pressure Pain Threshold score at week four
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Pressure Pain Threshold
時間枠：Pressure Pain Threshold score at week eight
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
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Pressure Pain Threshold score at week eight
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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：Everett B Lohman、Loma Linda U
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 (実際)
2016年8月24日
一次修了 (実際)
2018年1月8日
研究の完了 (実際)
2018年1月8日
試験登録日
最初に提出
2017年6月13日
QC基準を満たした最初の提出物
2017年6月20日
最初の投稿 (実際)
2017年6月21日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月31日
QC基準を満たした最後の更新が送信されました
2019年10月9日
最終確認日
2019年10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。
首の痛みの臨床試験
-
Dexa Medica Group完了
combined intervention groupの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)募集
-
University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
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University Hospital, GhentUniversity Ghent募集