Development of a Pain Rehabilitation Program for Chronic Pain After SCI
Feasibility of a New Digital Pain Rehabilitation Program for People With SCI
Pain rehabilitation programs are essential for optimal treatment of chronic pain and are usually based on the biopsychosocial model. This is, however, not standard care for people with chronic pain after a spinal cord injury (SCI) due to a biomedical focused perspective of SCI and lack of adapted programs.
The aims of this feasibility study:
- Develop a new digital pain rehabilitation program, adapted for the needs of people living with an SCI.
- To investigate the feasibility and acceptability of a new digital pain rehabilitation program.
調査の概要
詳細な説明
This study follows the guidelines of Medical Research Council for complex interventions and the proposed iterative feasibility process to improve and prepare the intervention for future testing in an RCT study. The research group will, toghether with a reference groups, develop a digital intervention porposal. The program will be a team-based, goal-oriented program for patients with spinal cord injury (SCI) and chronic pain.
In this study, eligible participants are included in an 8 week pain rehabilitation program. The program is developed through user-involvement i.e. together with clinicians (experienced in pain rehabilitation and/or SCI rehabilitation), stakeholders, researchers and individuals with SCI. The program will include video material for education, home exercises and group discussions led by clinicians with long experience in pain rehabilitation and SCI.
The participants will fill in self-assessed questionaries at baseline and after the finish of the program about their pain, sleep, mood and quality of life. After the program some of the participants will be asked to participate in semi-structured interviews about how they navigate and engage with different components of the program. The patients will be recruited during a rutine follow up at an SCI clinic.
Seven factors will be studied to assess the feasibility and acceptability of the program, based on set goals according to the Traffic Light method.
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：Gunilla Stenberg, Docent
- 電話番号：+46 90 7869895
- メール：gunilla.stenberg@umu.se
研究連絡先のバックアップ
- 名前：Sofia Björkbacka, MSc
- 電話番号：0046907869349
- メール：sofia.bjorkbacka@umu.se
研究場所
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Umeå、スウェーデン、90736
- Inst. Community Medicine and Rehabilitation
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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:
- two years since injury
- Stable pain medication?
Exclusion Criteria:
- severe cognitive impairment
- Alcohol or drug abuse
- does not understand Swedish
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：なし
- 介入モデル：単一グループの割り当て
- 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：Spinal cord injury (SCI) and chronic pain
People with chronic pain after spinal cord injury
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8- week pain rehabilitation program.
The first meeting of the program is located at a hospital facility and thereafter they will meet at a digital platform.The program include education, home exercises and group meetings.
The program consists of 4 modules.
1. Physical exercise and ergonomics.
2. Structure and recovery.
3. Employment/occupation and social support.
4. ACT and coping.
Each module lasts for two weeks.
The program will include video material for education, home exercises and group discussions led by clinicians with long experience in pain rehabilitation and SCI.
他の名前：
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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 |
|---|---|---|
|
Recruitment rate, number recruited per quarter
時間枠：At enrollment
|
Continue=6 Solve=4 Stop=3
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At enrollment
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Number of participant with treatment-related advere events as assessed by...
時間枠：From enrollment to the end of tretment at 8 weeks
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From enrollment to the end of tretment at 8 weeks
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Participant retention- Completion rates
時間枠：The end of the 8- week program
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>75% continue, 50-75% Solve, <50% stop
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The end of the 8- week program
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Program Adherence
時間枠：The end of the 8-week program
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Continue >75%, solve 50-75%, stop <50%
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The end of the 8-week program
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|
Patients' self-perceived relevance, timing and mode of delivery
時間枠：>70% Continue, Solve 50-70%, Stop <50%
|
Patient evaluation, satisfied patients
|
>70% Continue, Solve 50-70%, Stop <50%
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Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires
時間枠：At the end of the 8-week program
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>80% continue, 50-80% solve, <50% stop
|
At the end of the 8-week program
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Fidelity of delivery - Process evaluations
時間枠：End of the 8-week program
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End of the 8-week program
|
協力者と研究者
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2023-04232-01
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
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
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