慢性腰痛患者における感覚識別トレーニングを伴う疼痛神経科学教育の効果
慢性腰痛患者における疼痛神経科学教育と感覚識別訓練の併用が疼痛破局的思考、運動恐怖症、および機能的動作に及ぼす影響:ランダム化比較試験
The current study is a double-blind, parallel-group randomized controlled trial involving 80 participants with chronic low back pain. The trial will compare a program of Pain Neuroscience Education plus Sensory Discrimination Training and core stability exercises with a program of Pain Neuroscience Education and core stability exercises alone. Interventions will be delivered twice weekly for eight weeks. The primary outcome is pain catastrophizing. Secondary outcomes include kinesiophobia and functional movements. Assessments will be conducted at baseline, 4, and 8 weeks. The trial will be carried out at Nutricao Lahore Clinic and Model Town Hospital, Lahore. The hypothesis is that Pain Neuroscience Education with Sensory Discrimination Training will result in greater reductions in pain catastrophizing and kinesiophobia, as well as improvements in functional movements.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Chronic low back pain is a complex condition influenced by biological, psychological, and sensory factors. Pain Neuroscience Education has been shown to reduce maladaptive pain beliefs and improve pain processing, while Sensory Discrimination Training targets altered cortical representation that frequently occurs in chronic pain conditions. Combining these approaches may offer a complementary effect by addressing both cognitive and sensory dimensions of pain.
This study will evaluate the added value of Sensory Discrimination Training when delivered alongside Pain Neuroscience Education and core stability exercises, compared with a control intervention combining Pain Neuroscience Education, and core stability exercises. The trial uses a double-blind, parallel-group randomized controlled design with a total of 80 participants diagnosed with chronic low back pain.
Participants will be randomly assigned to one of two intervention groups. The experimental group will receive structured Pain Neuroscience Education sessions, Sensory Discrimination Training using surface-based tactile discrimination tasks, and a standardized core stability exercise program. The comparison group will receive the same Pain Neuroscience Education protocol, and the same core stability exercise program. Both interventions will be provided twice per week for eight weeks, with each session lasting 45 minutes.
The study aims to investigate whether the addition of Sensory Discrimination Training results in greater improvements in pain-related cognitions, fear-related movement avoidance, and functional movement performance. The primary mechanism of interest is the potential effect of Sensory Discrimination Training on improving cortical sensory mapping, which may contribute to reduced pain catastrophising and improved motor function. Outcome measures will be assessedat baseline, 4, and 8 weeks (end of intervention). The current study will be conducted at Nutricao Lahore Clinic and Model Town Hospital Lahore under standardized procedures to ensure intervention fidelity and consistent delivery across sessions.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:MUHAMMAD TARIQ RAFIQ, PhD
- メール:tariq.rafiq@ubas.edu.pk
研究連絡先のバックアップ
- 名前:MUHAMMAD SAAD JANJUA
- 電話番号:+923167995435
- メール:ubs24lmspt023@ubas.edu.pk
研究場所
-
-
-
Lahore、パキスタン
- 募集
- 1. Boston Physical Therapy Centre Lahore. 2. Nutricao Clinic Lahore. 3. Model Town Hospital Lahore
-
-
参加基準
適格基準
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: 19 to 44 Both Genders Mechanical low back pain (duration more than 6 months and less than 2 years) >4/10 Numerical Pain Rating Scale (NPRS)
Exclusion Criteria:
- Pregnancy or post-partum Trauma Psychological Pain Radicular Pain Cancer, tumor, malignancy Neurological Deficit Recent Surgery <1year
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:トリプル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:Experimental Group
Participants in the experimental group will receive a 45-minute intervention session consisting of three integrated components (Pain Neuroscience Education, Core Stability Exercises and Graded Sensory Discrimination Training ) |
Although both Pain Neuroscience Education and Sensory Discrimination Training have demonstrated potential benefits individually, there is a paucity of research evaluating their combined effects. Integrating cognitive (PNE) and sensorimotor (SDT) approaches may produce synergistic effects, improving pain modulation, functional capacity, and psychological resilience. |
|
アクティブコンパレータ:Control group
Participants in the control group will receive the same 45-minute sessions consisting of two components (Pain Neuroscience Education and Core Stability Exercises). |
Participants in the control group will receive the same 45-minute sessions twice per week, but will not receive sensory discrimination training. |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Catastrophizing
時間枠:From enrollment to the end of treatment at 8 weeks
|
Pain catastrophizing refers to a maladaptive cognitive and emotional response to actual or perceived pain. Pain Catastrophizing is measured by the Pain Catastrophizing Scale. The Pain Catastrophizing Scale is a validated questionnaire used to measure the degree of catastrophic thinking in individuals experiencing pain (Sullivan et al. 1995). The scale consists of 13 items, each representing a different catastrophizing response. For each item, participants rate their experience using a 5-point Likert scale, where 0 = Not at all (the thought or feeling never occurred) and 4 = All the time (the thought or feeling occurred persistently). The total score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. |
From enrollment to the end of treatment at 8 weeks
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Kinesiophobia
時間枠:From enrollment to the end of treatment at 8 weeks
|
Kinesiophobia is a debilitating fear of movement and physical activity due to the belief that movement will cause pain or re-injury. Kinesiophobia is measured by the Tampa Scale for Kinesiophobia. Tampa Scale for Kinesiophobia is the most widely used and validated tool to assess the fear of movement or re-injury. It contains 17 items. Each item is scored using a 4-point Likert scale with 1 = strongly disagree and 4 = strongly agree. Total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia. |
From enrollment to the end of treatment at 8 weeks
|
|
Functional Movements
時間枠:From enrollment to the end of treatment at 8 weeks
|
Functional movement refers to the basic movements that people need in daily life to perform normal activities safely and efficiently. These movements involve multiple joints and muscle groups working together in a coordinated way. Functional movements will be assessed using 2D motion analysis through the Kinovea software. Participants will perform two standardized tasks: forward bending and sit-to-stand. All movements will be recorded using a fixed camera positioned at a consistent height (e.g., 1.2 m) and distance (e.g., 2.5 m) from the participant. Kinovea will be used to extract trunk flexion angle, lumbar deviation from the midline, pelvic tilt angle and task completion time. Higher movement quality, reduced deviation, and faster task completion will be interpreted as improved functional performance. |
From enrollment to the end of treatment at 8 weeks
|
協力者と研究者
捜査官
捜査官
- 主任研究者:MUHAMMAD TARIQ RAFIQ、Lahore University of Biological & Applied Sciences
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- UBAS/ERB/FoRS/25/028
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?
IPD プランの説明
Only IPD used in the results publication will be shared.
IPD 共有時間枠
It will be available after the completion of the study.
IPD 共有アクセス基準
Through the corresponding author.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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
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。