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A randomized trial of behavioral physical therapy interventions for acute and sub-acute low back pain (NCT00373867).

ABSTRACT: Psychological factors consistent with fear-avoidance models are associated with the development of chronic low back pain (LBP). As a result, graded activity (GA) and graded exposure (GX) have been suggested as behavioral treatment options. This clinical trial compared the effectiveness of treatment-based classification (TBC) physical therapy alone to TBC augmented with GA or GX for patients with acute and sub-acute LBP. Our primary hypothesis was that GX would be most effective for those with elevated pain-related fear. In total, 108 patients enrolled in this clinical trial and were randomly assigned to receive TBC, GA, or GX. Outcomes were assessed by a blinded evaluator at 4 weeks and by mail at 6 months. The primary outcomes for this trial were disability and pain intensity, and the secondary outcomes were fear-avoidance beliefs, pain catastrophizing, and physical impairment. There were no differences in 4-week and 6-month outcomes for reduction of disability, pain intensity, pain catastrophizing, and physical impairment. GX and TBC were associated with larger reductions in fear-avoidance beliefs at 6 months only. Six-month reduction in disability was associated with reduction in pain intensity, while 6-month reduction in pain intensity was associated with reductions in fear-avoidance beliefs and pain catastrophizing. This trial suggests that supplementing TBC with GA or GX was not effective for improving important outcomes related to the development of chronic LBP.

SUBMITTER: George SZ

PROVIDER: S-EPMC2596955 | biostudies-literature | 2008 Nov

REPOSITORIES: biostudies-literature

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A randomized trial of behavioral physical therapy interventions for acute and sub-acute low back pain (NCT00373867).

George Steven Z SZ Zeppieri Giorgio G Cere Anthony L AL Cere Melissa R MR Borut Michael S MS Hodges Michael J MJ Reed Dalton M DM Valencia Carolina C Robinson Michael E ME

Pain 20080910 1

Psychological factors consistent with fear-avoidance models are associated with the development of chronic low back pain (LBP). As a result, graded activity (GA) and graded exposure (GX) have been suggested as behavioral treatment options. This clinical trial compared the effectiveness of treatment-based classification (TBC) physical therapy alone to TBC augmented with GA or GX for patients with acute and sub-acute LBP. Our primary hypothesis was that GX would be most effective for those with el ...[more]

PMID: 18786762

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Project description:BackgroundYoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain.ObjectiveTo determine whether yoga is noninferior to PT for cLBP.Design12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927).SettingAcademic safety-net hospital and 7 affiliated community health centers.Participants320 predominantly low-income, racially diverse adults with nonspecific cLBP.InterventionParticipants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice.MeasurementsPrimary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life.ResultsOne-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups.LimitationsParticipants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up.ConclusionA manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain.Primary funding sourceNational Center for Complementary and Integrative Health of the National Institutes of Health.

Project description:Low back pain accounts for nearly 4 million emergency department (ED) visits annually and is a significant source of disability. Physical therapy has been suggested as a potentially effective nonopioid treatment for low back pain; however, no studies to our knowledge have yet evaluated the emerging resource of ED-initiated physical therapy. The study objective was to compare patient-reported outcomes in patients receiving ED-initiated physical therapy and patients receiving usual care for acute low back pain. This was a prospective observational study of ED patients receiving either physical therapy or usual care for acute low back pain from May 1, 2018, to May 24, 2019, at a single academic ED (>91,000 annual visits). The primary outcome was pain-related functioning, assessed with Oswestry Disability Index (ODI) and Patient-Reported Outcomes Measurement Information System pain interference (PROMIS-PI) scores. The secondary outcome was use of high-risk medications (opioids, benzodiazepines, and skeletal muscle relaxants). Outcomes were compared over 3 months using adjusted linear mixed and generalized estimating equation models. For 101 participants (43 receiving ED-initiated physical therapy and 58 receiving usual care), the median age was 40.5 years and 59% were women. Baseline outcome scores in the ED-initiated physical therapy group were higher than those in the usual care group (ODI = 51.1 vs 36.0; PROMIS-PI = 67.6 vs 62.7). Patients receiving ED-initiated physical therapy had greater improvements in both ODI and PROMIS-PI scores at the 3-month follow-up (ODI = -14.4 [95% CI = -23.0 to -5.7]; PROMIS-PI = -5.1 [95% CI = -9.9 to -0.4]) and lower use of high-risk medications (odds ratio = 0.05 [95% CI = 0.01 to 0.58]). In this single-center observational study, ED-initiated physical therapy for acute low back pain was associated with improvements in functioning and lower use of high-risk medications compared with usual care; the causality of these relationships remains to be explored. ED-initiated physical therapy is a promising therapy for acute low back pain that may reduce reliance on high-risk medications while improving patient-reported outcomes. Emergency department-initiated physical therapy for low back pain was associated with greater improvement in functioning and lower use of high-risk medications over 3 months.

Project description:BackgroundFew studies have examined primary care management for acute sciatica, including referral to physical therapy.ObjectiveTo evaluate whether early referral to physical therapy reduced disability more than usual care (UC) alone for patients with acute sciatica.DesignRandomized controlled clinical trial. (ClinicalTrials.gov: NCT02391350).Setting2 health care systems in Salt Lake City, Utah.Patients220 adults aged 18 to 60 years with sciatica of less than 90 days' duration who were making an initial primary care consultation.InterventionAll participants received imaging and medication at the discretion of the primary care provider before enrollment. A total of 110 participants randomly assigned to UC were provided 1 session of education, and 110 participants randomly assigned to early physical therapy (EPT) were provided 1 education session and then referred for 4 weeks of physical therapy, including exercise and manual therapy.MeasurementsThe primary outcome was the Oswestry Disability Index (OSW) score after 6 months. Secondary outcomes were pain intensity, patient-reported treatment success, health care use, and missed workdays.ResultsParticipants in the EPT group had greater improvement from baseline to 6 months for the primary outcome (relative difference, -5.4 points [95% CI, -9.4 to -1.3 points]; P = 0.009). The OSW and several secondary outcomes favored EPT after 4 weeks. After 1 year, between-group differences favored EPT for the OSW (relative difference, -4.8 points [CI, -8.9 to -0.7 points]) and back pain intensity (relative difference, -1.0 points [CI, -1.6 to -0.4 points]). The EPT group was more likely to self-report treatment success after 1 year (45.2%) than the UC group (27.6%) (relative risk, 1.6 [CI, 1.1 to 2.4]). There were no significant differences in health care use or missed workdays.LimitationThe patients and providers were unblinded, and specific physical therapy interventions responsible for effects could not be determined.ConclusionReferral from primary care to physical therapy for recent-onset sciatica improved disability and other outcomes compared with UC.Primary funding sourceAgency for Healthcare Research and Quality.

Project description:BackgroundPoor sleep is common among adults with chronic low back pain (cLBP), but the influence of cLBP treatments, such as yoga and physical therapy (PT), on sleep quality is under studied.ObjectiveEvaluate the effectiveness of yoga and PT for improving sleep quality in adults with cLBP.DesignSecondary analysis of a randomized controlled trial.SettingAcademic safety-net hospital and 7 affiliated community health centers.ParticipantsA total of 320 adults with cLBP.InterventionTwelve weekly yoga classes, 1-on-1 PT sessions, or an educational book.Main measuresSleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) global score (0-21) at baseline, 12 weeks, and 52 weeks. Additionally, we also evaluated how the proportion of participants who achieved a clinically meaningful improvement in sleep quality (>?3-point reduction in PSQI) at 12 weeks varied by changes in pain and physical function at 6 weeks.Key resultsAmong participants (mean age?=?46.0, 64% female, 82% non-white), nearly all (92%) reported poor sleep quality (PSQI >?5) at baseline. At 12 weeks, modest improvements in sleep quality were observed among the yoga (PSQI mean difference [MD]?=?-?1.19, 95% confidence interval [CI] -?1.82, -?0.55) and PT (PSQI MD?=?-?0.91, 95% CI -?1.61, -?0.20) groups. Participants who reported a ??30% improvement in pain or physical function at 6 weeks, compared with those who improved <?10%, were more likely to be a sleep quality responder at 12 weeks (odds ratio [OR]?=?3.51, 95% CI 1.73, 7.11 and OR?=?2.16, 95% CI 1.18, 3.95, respectively). Results were similar at 52 weeks.ConclusionIn a sample of adults with cLBP, virtually all with poor sleep quality prior to intervention, modest but statistically significant improvements in sleep quality were observed with both yoga and PT. Irrespective of treatment, clinically important sleep improvements at the end of the intervention were associated with mid-intervention pain and physical function improvements.Trial registrationClinicalTrials.gov Identifier: NCT01343927.

Dataset Information

A randomized trial of behavioral physical therapy interventions for acute and sub-acute low back pain (NCT00373867).

Publications

A randomized trial of behavioral physical therapy interventions for acute and sub-acute low back pain (NCT00373867).

Similar Datasets

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