Spinal Mobilization and Manipulation for Nonspecific Low Back Pain (SMM-LBP)
Effects of Spinal Mobilization and Manipulation Added to Conventional Physiotherapy on Pain Intensity, Functional Disability, Fear-Avoidance Beliefs, and Lumbar Range of Motion in Individuals With Non-Specific Low Back Pain: A Randomized Controlled Trial
Low back pain is one of the most common musculoskeletal disorders worldwide and is a major cause of pain and disability. Manual therapy techniques such as spinal mobilization and spinal manipulation are frequently used together with conventional physiotherapy; however, their additional benefits remain unclear.
This randomized controlled trial aims to investigate whether adding spinal mobilization and spinal manipulation to conventional physiotherapy improves pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion in individuals with non-specific low back pain. Participants will be randomly assigned to receive either conventional physiotherapy alone or conventional physiotherapy combined with spinal mobilization and manipulation. Outcome measures will be assessed before and after the six-week intervention. The findings of this study may provide evidence regarding the effectiveness of combining manual therapy with conventional physiotherapy for the management of non-specific low back pain.
調査の概要
状態
詳細な説明
Background
Non-specific low back pain is one of the leading causes of disability worldwide and is associated with substantial physical, psychological, and socioeconomic burden. Conservative physiotherapy is recommended as the first-line treatment, and manual therapy techniques such as spinal mobilization and spinal manipulation are frequently used as adjunctive interventions. However, evidence regarding their additional effectiveness when combined with conventional physiotherapy remains limited.
Objective
The aim of this randomized controlled trial is to investigate the effects of spinal mobilization and manipulation in addition to conventional physiotherapy on pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion in individuals with non-specific low back pain.
Methods
Thirty participants with non-specific low back pain will be randomly allocated to either a conventional physiotherapy group or a conventional physiotherapy plus spinal mobilization and manipulation group. Both groups will receive conventional physiotherapy three times per week for six consecutive weeks. The intervention group will additionally receive spinal mobilization and spinal manipulation performed by an experienced physiotherapist.
Pain intensity will be assessed using the Visual Analog Scale (VAS), functional disability using the Roland-Morris Disability Questionnaire (RMDQ), fear-avoidance beliefs using the Fear-Avoidance Beliefs Questionnaire (FABQ), and lumbar range of motion using a universal goniometer. Outcome assessments will be performed at baseline and after completion of the six-week intervention.
Expected Outcomes
It is hypothesized that adding spinal mobilization and spinal manipulation to conventional physiotherapy will result in greater improvements in pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion compared with conventional physiotherapy alone.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ali Yıldırım, PhD
- 電話番号：+905399306460
- メール：devri-alem-61@hotmail.com
研究場所
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Istanbul、トルコ（Türkiye）、34744
- Ozel Mediworld
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 to 60 years.
- Diagnosis of non-specific low back pain.
- Symptoms persisting for more than 12 weeks.
- Able to understand the study procedures and provide written informed consent.
- Willing to participate in the study and comply with the intervention protocol
Exclusion Criteria:
- Structural spinal abnormalities.
- Spinal infection or tumor.
- Inflammatory spinal diseases.
- Neurological disorders or neurological deficits.
- Psychiatric disorders.
- Pregnancy.
- History of recent spinal surgery.
- Chronic or systemic diseases that could affect participation.
- Conditions that could interfere with adherence to the treatment protocol
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：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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アクティブコンパレータ：Conventional Physiotherapy Group
Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes), administered three times per week for six consecutive weeks.
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Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes).
The intervention was administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.
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実験的：Conventional Physiotherapy + Spinal Mobilization and Manipulation Group
Participants received the same conventional physiotherapy program as the active comparator group.
In addition, spinal mobilization according to the Maitland concept and high-velocity, low-amplitude (HVLA) spinal manipulation were applied by an experienced physiotherapist three times per week for six consecutive weeks.
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Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes).
The intervention was administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.
Spinal mobilization and spinal manipulation were administered sequentially during the same treatment session.
Grade III central posterior-anterior oscillatory mobilization according to the Maitland concept was applied to the identified hypomobile lumbar segment, followed immediately by a high-velocity, low-amplitude (HVLA) rotational thrust manipulation performed in the side-lying position.
The intervention was individualized according to each participant's clinical presentation, symptom response, and joint mobility assessment.
All procedures were performed by the same physiotherapist with more than 10 years of clinical experience in orthopedic manual therapy, three times per week for six consecutive weeks.
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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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Pain intensity measured using the Visual Analog Scale (VAS)
時間枠：Baseline and after 6 weeks of intervention
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Pain intensity will be assessed under three conditions (at rest, during activity, and at night) using a 10-cm Visual Analog Scale (VAS).
Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
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Baseline and after 6 weeks of intervention
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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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Functional disability measured using the Roland-Morris Disability Questionnaire (RMDQ)
時間枠：Baseline and after 6 weeks of intervention
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Functional disability will be assessed using the 24-item Roland-Morris Disability Questionnaire (RMDQ).
Scores range from 0 to 24, with higher scores indicating greater disability.
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Baseline and after 6 weeks of intervention
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Fear-avoidance beliefs measured using the Fear-Avoidance Beliefs Questionnaire (FABQ)
時間枠：Baseline and after 6 weeks of intervention
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Fear-avoidance beliefs will be evaluated using the Fear-Avoidance Beliefs Questionnaire (FABQ), including physical activity and work subscales.
Higher scores indicate greater fear-avoidance beliefs.
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Baseline and after 6 weeks of intervention
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Lumbar range of motion
時間枠：Baseline and after 6 weeks of intervention
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Lumbar flexion, extension, lateral flexion, and rotation will be measured using a universal goniometer.
Three measurements will be obtained for each movement, and the mean value will be used for analysis.
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Baseline and after 6 weeks of intervention
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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 (推定)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
その他の研究ID番号
- 1915
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