Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713 (TeleOPT)
20. Oktober 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
126
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21287
- Johns Hopkins University
-
-
Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84107
- Intermountain Health Care
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 64 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Telehealth Physical Therapy
Weekly sessions of education, advice and exercise instruction provided by a licensed physical therapist using real-time, interactive video conferencing platform.
|
Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Participant Satisfaction with Telehealth Treatment
Zeitfenster: 10-weeks
|
Survey of participants evaluating treatment satisfaction
|
10-weeks
|
|
Rate of refusal to participate
Zeitfenster: Baseline
|
Ratio of persons entering the study among all those eligibility for enrollment
|
Baseline
|
|
Rate of enrolled participants initiating telehealth treatment
Zeitfenster: 10-weeks
|
Ratio of persons attending at least 1 treatment session among all those enrolled
|
10-weeks
|
|
Number of sessions
Zeitfenster: 10-weeks
|
Number of telehealth physical therapy sessions attended
|
10-weeks
|
|
Change in Oswestry from baseline to 10-weeks
Zeitfenster: baseline, 10 weeks
|
10 item measure of back pain-related disability
|
baseline, 10 weeks
|
|
Change in Oswestry from baseline to 26-weeks
Zeitfenster: baseline, 26 weeks
|
10 item measure of back pain-related disability
|
baseline, 26 weeks
|
|
Change in Pain Interference from baseline to 10 weeks
Zeitfenster: baseline, 10 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 10 weeks
|
|
Change in Pain Interference from baseline to 26 weeks
Zeitfenster: baseline, 26 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 26 weeks
|
|
Change in Pain Intensity from baseline to 10 weeks
Zeitfenster: baseline, 10 weeks
|
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
|
baseline, 10 weeks
|
|
Change in Pain Intensity from baseline to 26 weeks
Zeitfenster: baseline, 26 weeks
|
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
|
baseline, 26 weeks
|
|
Change in Fatigue from baseline to 10 weeks
Zeitfenster: baseline, 10 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 10 weeks
|
|
Change in Fatigue from baseline to 26 weeks
Zeitfenster: baseline, 26 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 26 weeks
|
|
Change in Sleep Disturbance from baseline to 10 weeks
Zeitfenster: baseline, 10 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 10 weeks
|
|
Change in Sleep Disturbance from baseline to 26 weeks
Zeitfenster: baseline, 26 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 26 weeks
|
|
Change in Anxiety from baseline to 10 weeks
Zeitfenster: baseline, 10 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 10 weeks
|
|
Change in Anxiety from baseline to 26 weeks
Zeitfenster: baseline, 26 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 26 weeks
|
|
Change in Depression from baseline to 10 weeks
Zeitfenster: baseline, 10 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 10 weeks
|
|
Change in Depression from baseline to 26 weeks
Zeitfenster: baseline, 26 weeks
|
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 Social Role Participation from baseline to 10 weeks
Zeitfenster: baseline, 10 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 10 weeks
|
|
Change in Social Role Participation from baseline to 26 weeks
Zeitfenster: baseline, 26 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 26 weeks
|
|
Change in Physical Function from baseline to 10 weeks
Zeitfenster: baseline, 10 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 10 weeks
|
|
Change in Physical Function from baseline to 26 weeks
Zeitfenster: baseline, 26 weeks
|
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
|
baseline, 26 weeks
|
|
Change in Pain Self-Efficacy Scale from baseline to 10 weeks
Zeitfenster: baseline, 10 weeks
|
10-item measure of confidence in performing activities even with pain
|
baseline, 10 weeks
|
|
Change in Pain Self-Efficacy Scale from baseline to 26 weeks
Zeitfenster: baseline, 26 weeks
|
10-item measure of confidence in performing activities even with pain
|
baseline, 26 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Julie Fritz, PT, PhD, University of Utah
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
18. August 2020
Primärer Abschluss (Tatsächlich)
18. Dezember 2020
Studienabschluss (Tatsächlich)
13. August 2021
Studienanmeldedaten
Zuerst eingereicht
11. Oktober 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Oktober 2021
Zuerst gepostet (Tatsächlich)
2. November 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. November 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Oktober 2021
Zuletzt verifiziert
1. Oktober 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB_00116150
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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