Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713 (TeleOPT)
20. oktober 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
126
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University
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Utah
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Salt Lake City, Utah, Forenede Stater, 84107
- Intermountain Health Care
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 64 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Participant Satisfaction with Telehealth Treatment
Tidsramme: 10-weeks
|
Survey of participants evaluating treatment satisfaction
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10-weeks
|
|
Rate of refusal to participate
Tidsramme: Baseline
|
Ratio of persons entering the study among all those eligibility for enrollment
|
Baseline
|
|
Rate of enrolled participants initiating telehealth treatment
Tidsramme: 10-weeks
|
Ratio of persons attending at least 1 treatment session among all those enrolled
|
10-weeks
|
|
Number of sessions
Tidsramme: 10-weeks
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Number of telehealth physical therapy sessions attended
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10-weeks
|
|
Change in Oswestry from baseline to 10-weeks
Tidsramme: baseline, 10 weeks
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10 item measure of back pain-related disability
|
baseline, 10 weeks
|
|
Change in Oswestry from baseline to 26-weeks
Tidsramme: baseline, 26 weeks
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10 item measure of back pain-related disability
|
baseline, 26 weeks
|
|
Change in Pain Interference from baseline to 10 weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline, 26 weeks
|
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
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baseline, 26 weeks
|
|
Change in Fatigue from baseline to 10 weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 Social Role Participation from baseline to 10 weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline, 26 weeks
|
10-item measure of confidence in performing activities even with pain
|
baseline, 26 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Julie Fritz, PT, PhD, University of Utah
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. august 2020
Primær færdiggørelse (Faktiske)
18. december 2020
Studieafslutning (Faktiske)
13. august 2021
Datoer for studieregistrering
Først indsendt
11. oktober 2021
Først indsendt, der opfyldte QC-kriterier
20. oktober 2021
Først opslået (Faktiske)
2. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. oktober 2021
Sidst verificeret
1. oktober 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB_00116150
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