Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713 (TeleOPT)
2021년 10월 20일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
126
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins University
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Utah
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Salt Lake City, Utah, 미국, 84107
- Intermountain Health Care
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Participant Satisfaction with Telehealth Treatment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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 Fatigue from baseline to 26 weeks
기간: 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 Sleep Disturbance from baseline to 10 weeks
기간: 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 Sleep Disturbance from baseline to 26 weeks
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Julie Fritz, PT, PhD, University of Utah
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 8월 18일
기본 완료 (실제)
2020년 12월 18일
연구 완료 (실제)
2021년 8월 13일
연구 등록 날짜
최초 제출
2021년 10월 11일
QC 기준을 충족하는 최초 제출
2021년 10월 20일
처음 게시됨 (실제)
2021년 11월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 11월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 10월 20일
마지막으로 확인됨
2021년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .