Effectiveness Comparison of Thoracic Thrust Manipulation in People With Neck or Low Back Pain
Comparison of the Effectiveness of the Thoracic Thrust Manipulation in People With Neck or Low Back Pain
Objective:
To compare the effectiveness of thoracic thrust manipulation, together with massages techniques and stretching, between people with neck pain versus people with low back pain.
Methods:
The research will be performed from August 2021 to October 2021 at the University of Alcala de Henares. (Madrid)
A minimum of forty-six (46) volunteers will participate in this research, and they will be divided in two groups of twenty-three (23). One group will be formed by candidates suffering from neck pain (group A) and the other one by candidate with low back pain (group B).
Both groups will receive the same treatment and specific stretching exercises as applicable in accordance to the pain area, e.g.: group A will get the massage and the stretching exercises more suitable for the neck pain and group B the same but for the low back pain. Nevertheless both groups will receive the same technical thrust manipulation in thoracic area.
All these treatments will be applied of the volunteers at the University of Alcalá.
The treatment includes the following activities:
- Twenty (20) minutes massage in the pain area, as applicable.
- Technical thrust manipulation in thoracic area.
- Ten (10) minutes stretching in accordance to the pain area treated. The stretching shall be repeated twice a week by each volunteer.
A total of six (6) sessions will be carried out during six (6) weeks, one session per week.
Pain, disability, kinesiophobia, HRQoL will be assessed as follow:
- Before first session. (In this evaluation will be also analyzed demographic variables i.e.: height, weight, age, gender, academic level, smoker/no smoker)
- Between third and fourth session.
- After sixth session.
- Four weeks after sixth session.
調査の概要
状態
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
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Madrid
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Alcalá De Henares、Madrid、スペイン、28801
- Alicia Masip
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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:
- Age between 18 and 65 years
- Non-specific neck/low back pain for the last three (3) months before the first session.
Exclusion Criteria:
- Previous surgery in the areas covered by this research (neck and/or low back)
- Red flags: Cancer or tumor, fracture...
- Scoliosis or osteoporosis
- Neck or low back pain with radiculopathy symptoms
- Central nervous system involvement
- Fear to manipulation
- Neck pain associated with whiplash injuries on the last six (6) months
- Pregnant women
- Not understand, write and speak Spanish fluently
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
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：A group: neck pain
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実験的：B group: low back pain
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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 |
|---|---|---|
|
Change in Neck and Low Back Pain
時間枠：Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
|
using a Visual Analogue Scale (VAS) from 0 to 10
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Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Neck Pain related disability
時間枠：Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
|
Using the Neck Disability Index (NID) Questionnaire
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Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
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Change in Health related quality of life (HRQoL)
時間枠：Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
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Using the SF-12 Quality of Life Questionnaire
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Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
|
|
Change in kinesiophobia
時間枠：Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
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Using the fear avoidance beliefs (FAB) questionnaire
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Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
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Change in Low Back Pain related disability
時間枠：Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
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Using the Oswestry Disability Index (ODI) Questionnaire
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Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
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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
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。
腰痛の臨床試験
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