Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713 (TeleOPT)
2021年10月20日 更新者：Julie Fritz、University of Utah
Observational Study of Telehealth Physical Therapy Provided for Persons With Chronic Low Back Pain
This study evaluated the feasibility of an 8-week physical therapy program for persons with chronic low back pain provided entirely using telehealth with real-time, interactive video sessions with a physical therapist.
調査の概要
詳細な説明
At the time of the onset of the COVID pandemic, the research team was conducting a clinical trial (the OPTIMIZE trial) investigating different nonpharmacologic treatments for persons with chronic low back pain (NCT03859713). One intervention arm in this trial is in-person physical therapy. COVID-related restrictions on in-person care prompted suspension of the OPTIMIZE trial. In order to accommodate persons in the midst of receiving treatment at the time of suspension, the study team adapted the in-person protocol for physical therapy for telehealth delivery using two-way, real-time video sessions. Because of the lack of research examining the feasibility of telehealth physical therapy provided in this manner, the study team decided to conduct a pilot study to examine the feasibility of the telehealth protocol.
This study was a prospective, longitudinal cohort of persons with chronic LBP seeking care in one of three healthcare systems; University of Utah Health and Intermountain Healthcare in Salt Lake City, Utah, and Johns Hopkins Medicine in Baltimore, Maryland. All participants were offered up to 8 weekly sessions of telehealth physical therapy. Outcomes included measures of acceptability, appropriateness, feasibility and fidelity as well as effectiveness measures including the Oswestry Disability Index and the PROMIS-29 health domains. Assessments occurred at baseline and after 10- and 26-weeks.
研究の種類
介入
入学 (実際)
126
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins University
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Utah
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Salt Lake City、Utah、アメリカ、84107
- Intermountain Health Care
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～64年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age 18 - 64 years at the time of enrollment.
- Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem for you? and 2) How often has LBP been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP.
- Healthcare visit for LBP in the past 90 days.
- At least moderate levels of pain and disability requiring ODI score >24 and pain intensity rating > 4.
Exclusion Criteria:
- Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
- Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc.
- Knowingly pregnant
- Unable to participate in telehealth due to lack of technology or internet access
- Has received physical therapy for LBP in prior 90 days
- Currently receiving substance use disorder treatment
- Any lumbar spine surgery in the past year.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：Telehealth Physical Therapy
Weekly sessions of education, advice and exercise instruction provided by a licensed physical therapist using real-time, interactive video conferencing platform.
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Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.
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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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Participant Satisfaction with Telehealth Treatment
時間枠：10-weeks
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Survey of participants evaluating treatment satisfaction
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10-weeks
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Rate of refusal to participate
時間枠：Baseline
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Ratio of persons entering the study among all those eligibility for enrollment
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Baseline
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Rate of enrolled participants initiating telehealth treatment
時間枠：10-weeks
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Ratio of persons attending at least 1 treatment session among all those enrolled
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10-weeks
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Number of sessions
時間枠：10-weeks
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Number of telehealth physical therapy sessions attended
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10-weeks
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Change in Oswestry from baseline to 10-weeks
時間枠：baseline, 10 weeks
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10 item measure of back pain-related disability
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baseline, 10 weeks
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Change in Oswestry from baseline to 26-weeks
時間枠：baseline, 26 weeks
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10 item measure of back pain-related disability
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baseline, 26 weeks
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Change in Pain Interference from baseline to 10 weeks
時間枠：baseline, 10 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 10 weeks
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Change in Pain Interference from baseline to 26 weeks
時間枠：baseline, 26 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 26 weeks
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Change in Pain Intensity from baseline to 10 weeks
時間枠：baseline, 10 weeks
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PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
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baseline, 10 weeks
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Change in Pain Intensity from baseline to 26 weeks
時間枠：baseline, 26 weeks
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PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
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baseline, 26 weeks
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Change in Fatigue from baseline to 10 weeks
時間枠：baseline, 10 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 10 weeks
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Change in Fatigue from baseline to 26 weeks
時間枠：baseline, 26 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 26 weeks
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Change in Sleep Disturbance from baseline to 10 weeks
時間枠：baseline, 10 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 10 weeks
|
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Change in Sleep Disturbance from baseline to 26 weeks
時間枠：baseline, 26 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 26 weeks
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Change in Anxiety from baseline to 10 weeks
時間枠：baseline, 10 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 10 weeks
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Change in Anxiety from baseline to 26 weeks
時間枠：baseline, 26 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 26 weeks
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Change in Depression from baseline to 10 weeks
時間枠：baseline, 10 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 10 weeks
|
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Change in Depression from baseline to 26 weeks
時間枠：baseline, 26 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 26 weeks
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Change in Social Role Participation from baseline to 10 weeks
時間枠：baseline, 10 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 10 weeks
|
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Change in Social Role Participation from baseline to 26 weeks
時間枠：baseline, 26 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 26 weeks
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Change in Physical Function from baseline to 10 weeks
時間枠：baseline, 10 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 10 weeks
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Change in Physical Function from baseline to 26 weeks
時間枠：baseline, 26 weeks
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PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
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baseline, 26 weeks
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Change in Pain Self-Efficacy Scale from baseline to 10 weeks
時間枠：baseline, 10 weeks
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10-item measure of confidence in performing activities even with pain
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baseline, 10 weeks
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Change in Pain Self-Efficacy Scale from baseline to 26 weeks
時間枠：baseline, 26 weeks
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10-item measure of confidence in performing activities even with pain
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baseline, 26 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Julie Fritz, PT, PhD、University of Utah
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Skolasky RL, Wegener ST, Aaron RV, Ephraim P, Brennan G, Greene T, Lane E, Minick K, Hanley AW, Garland EL, Fritz JM. The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain. BMC Musculoskelet Disord. 2020 May 11;21(1):293. doi: 10.1186/s12891-020-03324-z.
- Fritz JM, Minick KI, Brennan GP, McGee T, Lane E, Skolasky RL, Thackeray A, Bardsley T, Wegener ST, Hunter SJ. Outcomes of Telehealth Physical Therapy Provided Using Real-Time, Videoconferencing for Patients With Chronic Low Back Pain: A Longitudinal Observational Study. Arch Phys Med Rehabil. 2022 Oct;103(10):1924-1934. doi: 10.1016/j.apmr.2022.04.016. Epub 2022 Jun 3.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年8月18日
一次修了 (実際)
2020年12月18日
研究の完了 (実際)
2021年8月13日
試験登録日
最初に提出
2021年10月11日
QC基準を満たした最初の提出物
2021年10月20日
最初の投稿 (実際)
2021年11月2日
学習記録の更新
投稿された最後の更新 (実際)
2021年11月2日
QC基準を満たした最後の更新が送信されました
2021年10月20日
最終確認日
2021年10月1日
詳しくは
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。
腰痛の臨床試験
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityまだ募集していません
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Dexa Medica Group完了
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Daiichi Sankyo募集
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Daiichi Sankyo完了
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完了
Telehealth Physical Therapyの臨床試験
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University of OttawaThe Ottawa Hospital; Queen's University; Consortium of Multiple Sclerosis Centers完了
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Centre Hospitalier Universitaire de Besancon募集
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Saglik Bilimleri UniversitesiMedical Park Hospital Istanbul完了
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Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
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Universitätsklinikum Hamburg-Eppendorf完了