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治験 NCT06275074（対象：頸部痛、睡眠障害）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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メイヨー・クリニックDry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06275074 は 介入研究 臨床試験 で、頸部痛、睡眠障害 に関するものです。現在は 実施中／登録終了 で、2024年3月14日 から開始しています。28 名の参加者 の募集が計画されています。この治験は メイヨー・クリニック によって主催され、2026年3月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年4月4日 です。
概要
Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.
詳細説明
The purpose of this pilot study is to determine the feasibility of a large randomized clinical trial (RCT) which aims to investigate the effects of dry needling (DN) in addition to therapeutic exercise (TE) on sleep duration and quality in patients with chronic neck pain (CNP) and sleep disturbance (SD). Specifically, the objective is to explore feasibility of a study protocol and examine the preliminary data of a small sample size for the effectiveness of DN and TE for individuals with CNP and SD to determine effect size of the intervention.
公式タイトル
Effects of Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance - A Pilot Study
疾患／病気
頸部痛睡眠障害その他の研究識別子
- 23-007716
NCT番号
開始日
2024-03-14
最終更新日
2025-04-04
終了予定日
2026-03-01
目標参加者数
28
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
Needling
Sleep Disturbance
Chronic pain
Neck Pain
Actigraphy
Physical Therapy
Feasibility
Sleep Disturbance
Chronic pain
Neck Pain
Actigraphy
Physical Therapy
Feasibility
主目的
その他
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Dry Needling and Therapeutic Exercise | ドライニードリング Insertion of filiform needles into cervicothoracic multifidi, upper trapezius, and suboccipital muscles 治療運動 Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance. |
実薬対照薬Therapeutic Exercise Alone | 治療運動 Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Participant retention rate | One variable to be assessed to determine feasibility is retention rate of participants recruited and enrolled. The retention rate of participants will be calculated as follows: Retention rate = (Number of patients completing the study / Number of patients initially enrolled) x 100. Feasibility will be determined with 4-week attrition rate is less than 20% | 1 year |
Participant intervention adherence | One variable to be assessed to determine feasibility is intervention adherence. Adherence to therapeutic exercise program given to all participants will be assessed with an exercise diary to be completed by the participants to track exercise compliance. A new diary will be provided on a weekly basis to maintenance of records. | 1 year |
Number of adverse responses to treatment | Occurrence of adverse responses to treatment will be accounted for at each subsequent visit after initial treatment administered (visits 3-6). Patients will be asked to complete an intake form that will inquire about their experience post-intervention and provide examples of common adverse responses to determine if such events occurred for each respective participant. | 1 year |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Sleep Duration | Total sleep time and Sleep latency via wrist actigraphy | 5 weeks |
Sleep Quality | Sleep quality will be measured with the use of the Pittsburgh Sleep Quality Index (PSQI). There are seven components that range in scores of 0-3. Total scores range from 0-21 with higher scores indicating worse sleep quality. | 13 weeks |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Neck pain lasting greater than 3 months 28,29
- Age: 18-75 years
- Presence of sleep disturbance - to be defined as a score ≥ 8 on the Insomnia Severity Index
- Ability to understand study procedures and to comply with them for the entire length of the study
Previous surgery to the neck or thoracic spine
Central nervous system disorders
Systemic joint disease (e.g. rheumatoid arthritis)
Infection
Cancer
Raynaud's disease
Pregnancy
Immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
Insufficient English-language skills to complete all questionnaires.
Contraindications to dry needling:
- Presence of needle phobia
- History of abnormal reaction to needling or injection
- History of bleeding disorder (e.g., current anticoagulant therapy or known thrombocytopenia)
メイヨー・クリニック868 件のアクティブな治験を探索責任者
Ray M. Lunasin, 研究責任者, Principal Investigator, Mayo Clinic
連絡先情報がありません。
1 1カ国の場所
Minnesota
Mayo Clinic - Motion Analysis Lab, Rochester, Minnesota, 55905, United States