Manipulative Therapy Techniques to Treat Chronic Low Back Pain
2015年10月3日 更新者：Adelaida María Castro-Sánchez、Universidad de Almeria
Short-term Effect of Manipulative Therapy Techniques in People With Chronic Low Back Pain: A Randomized Controlled Trial.
The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.
調査の概要
詳細な説明
Objective: To analyze the effectiveness of a three manipulative therapy techniques in individuals with chronic non-specific low back pain of mechanical etiology.
Design: Randomized clinical trial. Setting: Almeria, South Spain. Participants: Sixty two with chronic non-specific low back pain will be randomly assigned to an experimental or control group.
Intervention: For 3-week, the experimental group will undergo treatment comprising 3 sessions (1/week) of manipulative therapy techniques in the lumbar and sacral areas, and the control group will receive a functional technique in the lumbar area.
Main Outcome Measures: Oswestry disability index, pain visual analogue scale, Tampa scale for kinesiophobia, Roland-Morris disability questionnaire, McQuade test, quality of life scores and the range of trunk anteflexion motion, which were all assessed before the treatment and immediately after the last treatment session.
The primary outcome measure is the change in the RMDQ score at the end of the 3 weeks study period. A difference of 2.5 point is considered to be the minimum clinically important difference in the RMDQ score. A sample size of 62 patients (31 per group) would enable detection of a 2.5 point difference between groups given 80-90% power, a 5% (two-tailed) significance level, and a conservative standard derivation of 5 points. Key baseline demographic variables and clinical measure scores will be compared between groups by using independent Student t tests for continuous data and chi-square tests for categorical data. Separate 2x2 mixed model ANOVA with repeated measurements for the time factor need to be conducted in order to test between-groups differences in visual analogue scale, McQuade test, range of trunk anteflexion motion, Oswestry disability index, Roland Morris disability questionnaire, Tampa scale for kinesiophobia, and quality of life as the dependent variables, with group (functional technique or three manipulative therapy techniques) as the between subjects variable and time (baseline, post-treatment). A paired t-test will perform to test within-group differences in score changes from pre- to post-treatment. Effect size will test using Cohen's d. p = 0.05 will be considered significant in all tests.
研究の種類
介入
入学 (実際)
62
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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Almeria、スペイン、04120
- Adelaida María Castro-Sánchez
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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
25年～55年 (大人)
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:
- Low back pain for ≥ 3 months.
- Score ≥4 on the Roland Morris disability questionnaire.
- No undergoing another physical therapy treatment.
- Inability to achieve lumbar muscle flexion-relaxation in trunk flexion
Exclusion Criteria:
- Clinical signs of radiculopathy.
- Presence of lumbar stenosis.
- Fibromyalgia.
- Spondylolisthesis.
- History of spinal surgery.
- Treatment with corticosteroids in the past two weeks.
- Disease of the central or peripheral nervous system.
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：単一グループの割り当て
- 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 |
|---|---|
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実験的：Manipulative Therapy Techniques
Manipulative Therapy Techniques involve three techniques on lumbar and sacral areas.
This protocol will be administered one a week for 3 weeks.
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アクティブコンパレータ：Functional Technique
Manipulative Therapy Technique involves one technique on lumbar area.
This protocol will be administered one a week for 3 weeks.
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The therapist presses the two anterior superior iliac spines to open the back of the pelvis, this maintained throughout the technique.
Then patient is asked to breathe deeply and exhale, sacrum makes a flexion-extension respectively.
These movements should be symmetrical and of equal duration in time.
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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 |
|---|---|---|
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Roland Morris Disability Questionnaire (RMDQ)
時間枠：At baseline, 3 weeks and 7 weeks
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The Roland Morris disability questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability.
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At baseline, 3 weeks and 7 weeks
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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 |
|---|---|---|
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Oswestry Disability Index (ODI)
時間枠：At baseline, 3 weeks and 7 weeks
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The Oswestry disability index evaluates daily life activity limitations in 10 dimensions, each scored on a 6-point scale (0-5 points); the total points scored are expressed as a percentage, used to classify individuals as minimally disabled (0-10%), moderately disabled (20-40%), severely disabled (40-60%), crippled (60-80%), or bedbound (80-100%).
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At baseline, 3 weeks and 7 weeks
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Visual Analogue Scale (VAS)
時間枠：At baseline, 3 weeks and 7 weeks
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The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.
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At baseline, 3 weeks and 7 weeks
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Tampa Scale for Kinesiophobia (TSK)
時間枠：At baseline, 3 weeks and 7 weeks
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The Tampa Scale for Kinesiophobia comprises 17 items on the fear of movement or recurrent lesion, each scored on a 4-point Likert scale from "completely disagree" to "completely agree".
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At baseline, 3 weeks and 7 weeks
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Quality of Life
時間枠：At baseline, 3 weeks and 7 weeks
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SF-36 Health Questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
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At baseline, 3 weeks and 7 weeks
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Isometric Resistance of Abdominal Muscles
時間枠：At baseline, 3 weeks and 7 weeks
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The McQuade test measures the isometric resistance of abdominal muscles in seconds.
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At baseline, 3 weeks and 7 weeks
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Lumbar Mobility in Flexion
時間枠：At baseline, 3 weeks and 7 weeks
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Lumbar mobility in flexion was determined by measuring the distance from the tip of the third finger to the floor with a tape measure.
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At baseline, 3 weeks and 7 weeks
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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
- スタディディレクター：Adelaida M Castro-Sánchez, PhD、Universidad de Almeria
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。
一般刊行物
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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
2013年3月1日
一次修了 (実際)
2013年10月1日
研究の完了 (実際)
2013年11月1日
試験登録日
最初に提出
2013年2月20日
QC基準を満たした最初の提出物
2013年2月20日
最初の投稿 (見積もり)
2013年2月21日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月6日
QC基準を満たした最後の更新が送信されました
2015年10月3日
最終確認日
2013年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- UAL-1
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