Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS) (NAP SAPS CSI)
Association Between Pain Phenotype and Change in Pain Following Routine Corticosteroid Injection in Patients With Subacromial Pain Syndrome - A Prospective Cohort Study.
The goal of this prospective cohort study is to investigate whether pain phenotype is associated with subsequent change in pain intensity after corticosteroid injection given as part of routine care in patients diagnosed with SAPS.
The main question it aims to answer is:
Does change in shoulder pain from baseline to 4 weeks after corticosteroid injection differ between patients classified as having a nociplastic pain phenotype and those classified as having a non-nociplastic pain phenotype?
調査の概要
詳細な説明
This study is part of a larger study investigating the prevalence of nociplastic pain phenotype according to the International Association for the Study of Pain (IASP) clinical criteria (The NAP SAPS Study). This prospective cohort component includes participants with SAPS who receive a corticosteroid shoulder injection as part of routine clinical care.
Musculoskeletal pain poses a significant burden on individuals and society. The IASP describes different pain mechanisms, including nociceptive, neuropathic and nociplastic pain. Identification of different pain mechanisms may be relevant for understanding pain presentation and variation in treatment response among patients with musculoskeletal pain.
Shoulder pain ranks among the most prevalent musculoskeletal complaints, with subacromial pain syndrome (SAPS) ranking highest, and serves as a common diagnosis for non-traumatic shoulder pain.
Exercise and other conservative treatments, including corticosteroid injection, are commonly used in the management of SAPS. However, a substantial proportion of patients experience limited or transient treatment effects and may develop persistent shoulder pain. Differences in underlying pain mechanisms may contribute to variation in treatment response among patients with SAPS. Corticosteroid injection is primarily used to target local inflammatory and nociceptive processes, and differences in pain phenotype may therefore be associated with variation in response to treatment. Emerging evidence suggests that altered pain processing may also be present in patients with shoulder pain, supporting the investigation of whether pain phenotype is associated with treatment response.
Clinical criteria have been proposed to identify different pain mechanisms in musculoskeletal pain conditions. The IASP clinical criteria for nociplastic pain provide a structured approach to classifying patients based on clinical features.
However, the possible association between pain response following corticosteroid injection and classification according to the IASP clinical criteria for nociplastic pain has, to our knowledge, not been sufficiently investigated among patients with SAPS.
The overall objective is to investigate the association between pain phenotype, classified according to the IASP clinical criteria for nociplastic pain, and subsequent change in pain intensity four weeks after corticosteroid injection.
Primary hypothesis: Patients classified as having a nociplastic pain phenotype will demonstrate a significantly smaller mean reduction in pain intensity (VAS) from baseline to four weeks after corticosteroid injection compared with patients classified as having a non-nociplastic pain phenotype.
Secondary hypothesis: A significantly lower proportion of patients classified as having a nociplastic pain phenotype will achieve a reduction of at least 2 points on the VAS four weeks after corticosteroid injection compared with patients classified as having a non-nociplastic pain phenotype.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Thomas Sørensen, PT, Cand.san
- 電話番号:+45 79409871
- メール:thomas.soerensen1@rsyd.dk
研究場所
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Vejle、デンマーク
- Vejle Hospital
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コンタクト:
- Thomas Sørensen, PT, Cand.san
- 電話番号:+4579409871
- メール:thomas.soerensen1@rsyd.dk
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Diagnosed with SAPS (dm751, dm753, dm754, dm755
- Shoulder pain ≥ 3 months
- ≥ 3 out of 5 specific shoulder test
- Age 18-70 years
- Increased pain during active arm elevation
- Pain during active elevation ≥ 3 (VAS)
- Receving a corticosteroid injection based on routine clinical proctice
Exclusion Criteria:
- Severe visual impairment
- Epilepsy
- Severe cognitive or physical impairment
- Language barrier (Danish)
- Receving a corticosteroid injection at a site other than the subacromial bursa (e.g. acromioclavicular joint or intra-articular injection)
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Patients diagnosed with SubAcromial Pain Syndrome (SAPS)
Patients with SAPS will be classified according to the IASP criteria for nociplastic pain as having either nociplastic or non-nociplastic pain phenotype
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Participants undergo a standardised clinical assessment including medical history, specific orthopedic shoulder test, diagnostic ultrasound and x-ray of the shoulder. Participants are included in this cohort only if they receive a corticosteroid injection as part of usual clinical care. The decision to administer the corticosteroid injection, is made part of usual clinical care and is independent of participation in the study. All corticosteroid injections are administered by experienced clinicians under ultrasound-guidance into the subacromial bursa. |
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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Change in pain between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
時間枠:4 weeks
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Pain intensity will be assessed with Visual Analog Scale.
Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
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4 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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Change in pain between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS)
時間枠:10 minutes
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Pain intensity will be assessed with Visual Analog Scale.
Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
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10 minutes
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Change in pain between baseline and twelve weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
時間枠:12 weeks
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Pain intensity will be assessed with Visual Analog Scale (VAS).
Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
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12 weeks
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Change in Shoulder Function between baseline and four weeks after corticosteroid injection as measured by the QuickDASH
時間枠:4 weeks
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QuickDASH is a self-reported questionnaire and it will be used to assess shoulder function.
Scoring range from 0 (no disability) to 100 (most severe disability)
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4 weeks
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Change in Shoulder Function between baseline and twelve weeks after corticosteroid injection as measured by the QuickDASH
時間枠:12 weeks
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QuickDASH is a self-reported questionnaire and it will be used to assess shoulder function.
Scoring range from 0 (no disability) to 100 (most severe disability)
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12 weeks
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Proportion of patients with nociplastic and non-nociplastic pain phenotype achieving a Patient Acceptable Symptom State (PASS) four weeks after corticosteroid injection as measured by the PASS questionnaire.
時間枠:4 weeks
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PASS will be assessed with the following question: "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory"
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4 weeks
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Proportion of patients with nociplastic and non-nociplastic pain phenotype achieving a Patient Acceptable Symptom State (PASS) twelve weeks after corticosteroid injection as measured by the PASS questionnaire.
時間枠:12 weeks
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PASS will be assessed with the following question: "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory"
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12 weeks
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Proportion af patients with nociplastic and non-nociplastic pain phenotype reporting a clinically relevant improvement in Global Perceived Effect (GPE) four weeks after corticosteroid injection as measured by the GPE scale.
時間枠:4 weeks
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The GPE will be assessed for shoulder function and shoulder pain on a 15 point Likert scanle ranging from "a very great deal worse"(worst) to "a very great deal better"(best)
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4 weeks
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Proportion af patients with nociplastic and non-nociplastic pain phenotype reporting a clinically relevant improvement in Global Perceived Effect (GPE) twelve weeks after corticosteroid injection as measured by the GPE scale.
時間枠:12 weeks
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The GPE will be assessed for shoulder function and shoulder pain on a 15 point Likert scanle ranging from "a very great deal worse"(worst) to "a very great deal better"(best)
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12 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Thomas Sørensen, PT, Cand.san、University of Southern Denmark
- スタディディレクター:kim G Ingwersen, PT, PhD、University of Southern Denmark
- スタディチェア:Claus Varnum, Prof., PhD, MD、University of Southern Denmark
- スタディチェア:Henrik B Vægter, Prof., PT, PhD、Odense University Hospital and University of Southern Denmark
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
追加の関連 MeSH 用語
その他の研究ID番号
- The Nap SAPS CSI study
- 2024-0039 (その他の助成金/資金番号:Research Council of Lillebaelt Hospital)
- 2024-0242 (その他の助成金/資金番号:The Region of Southern Denmark)
- 2025-0023 (その他の助成金/資金番号:Research Council of Lillebaelt Hospital)
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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