Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial
TL;DR: Whether early physical therapy is more effective than usual care in improving disability for patients with recent-onset LBP fitting a decision rule is evaluated.
Abstract: Importance Low back pain (LBP) is common in primary care. Guidelines recommend delaying referrals for physical therapy. Objective To evaluate whether early physical therapy (manipulation and exercise) is more effective than usual care in improving disability for patients with LBP fitting a decision rule. Design, Setting, and Participants Randomized clinical trial with 220 participants recruited between March 2011 and November 2013. Participants with no LBP treatment in the past 6 months, aged 18 through 60 years (mean age, 37.4 years [SD, 10.3]), an Oswestry Disability Index (ODI) score of 20 or higher, symptom duration less than 16 days, and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit. Interventions All participants received education. Early physical therapy (n = 108) consisted of 4 physical therapy sessions. Usual care (n = 112) involved no additional interventions during the first 4 weeks. Main Outcomes and Measures Primary outcome was change in the ODI score (range: 0-100; higher scores indicate greater disability; minimum clinically important difference, 6 points) at 3 months. Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up, and change in pain intensity, Pain Catastrophizing Scale (PCS) score, fear-avoidance beliefs, quality of life, patient-reported success, and health care utilization at 4-week, 3-month, and 1-year follow-up. Results One-year follow-up was completed by 207 participants (94.1%). Using analysis of covariance, early physical therapy showed improvement relative to usual care in disability after 3 months (mean ODI score: early physical therapy group, 41.3 [95% CI, 38.7 to 44.0] at baseline to 6.6 [95% CI, 4.7 to 8.5] at 3 months; usual care group, 40.9 [95% CI, 38.6 to 43.1] at baseline to 9.8 [95% CI, 7.9 to 11.7] at 3 months; between-group difference, −3.2 [95% CI, −5.9 to −0.47], P = .02). A significant difference was found between groups for the ODI score after 4 weeks (between-group difference, −3.5 [95% CI, −6.8 to −0.08], P = .045]), but not at 1-year follow-up (between-group difference, −2.0 [95% CI, −5.0 to 1.0], P = .19). There was no improvement in pain intensity at 4-week, 3-month, or 1-year follow-up (between-group difference, −0.42 [95% CI, −0.90 to 0.02] at 4-week follow-up; −0.38 [95% CI, −0.84 to 0.09] at 3-month follow-up; and −0.17 [95% CI, −0.62 to 0.27] at 1-year follow-up). The PCS scores improved at 4 weeks and 3 months but not at 1-year follow-up (between-group difference, −2.7 [95% CI, −4.6 to −0.85] at 4-week follow-up; −2.2 [95% CI, −3.9 to −0.49] at 3-month follow-up; and −0.92 [95% CI, −2.7 to 0.61] at 1-year follow-up). There were no differences in health care utilization at any point. Conclusions and Relevance Among adults with recent-onset LBP, early physical therapy resulted in statistically significant improvement in disability, but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care. Trial Registration clinicaltrials.gov Identifier:NCT01726803
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01 Sep 2016
TL;DR: Clinical trial evidence for the efficacy and safety of several specific approaches-acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements, and yoga-as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines are examined.
Abstract: Although most pain is acute and resolves within a few days or weeks, millions of Americans have persistent or recurring pain that may become chronic and debilitating. Medications may provide only partial relief from this chronic pain and can be associated with unwanted effects. As a result, many individuals turn to complementary health approaches as part of their pain management strategy. This article examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S -adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.
187 citations
Cites background from "Early Physical Therapy vs Usual Car..."
...Of these 8 later RCTs, 2 were negative trials(27,32) and 6 were positive trials.(36,41-43,46,54) Inclusion of these trials into the meta-analysis might have lead Rubinstein et al(133) to draw a different conclusion....
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...org or a mixture of types of LBP (total participants, 2621).(33,34,38,39,41-43,47-49,51-55) Six of these studies were of modest to moderate size (ie, >100 participants) and utilized 6 or more sessions of SM....
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TL;DR: A systematic review of studies of the effectiveness and harms of spinal manipulative therapy (SMT) for acute (≤6 weeks) low back pain is presented in this paper. But the authors did not identify any serious adverse events such as increased pain, muscle stiffness and headache.
Abstract: Importance Acute low back pain is common and spinal manipulative therapy (SMT) is a treatment option. Randomized clinical trials (RCTs) and meta-analyses have reported different conclusions about the effectiveness of SMT. Objective To systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. Data Sources Search of MEDLINE, Cochrane Database of Systematic Reviews, EMBASE, and Current Nursing and Allied Health Literature from January 1, 2011, through February 6, 2017, as well as identified systematic reviews and RCTs, for RCTs of adults with low back pain treated in ambulatory settings with SMT compared with sham or alternative treatments, and that measured pain or function outcomes for up to 6 weeks. Observational studies were included to assess harms. Data Extraction and Synthesis Data extraction was done in duplicate. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. This tool has 11 items in the following domains: randomization, concealment, baseline differences, blinding (patient), blinding (care provider [care provider is a specific quality metric used by the CBN Risk of Bias tool]), blinding (outcome), co-interventions, compliance, dropouts, timing, and intention to treat. Prior research has shown the CBN Risk of Bias tool identifies studies at an increased risk of bias using a threshold of 5 or 6 as a summary score. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Main Outcomes and Measures Pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks. Findings Of 26 eligible RCTs identified, 15 RCTs (1699 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, −9.95 [95% CI, −15.6 to −4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, −0.39 [95% CI, −0.71 to −0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT. Conclusions and Relevance Among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.
152 citations
TL;DR: A narrative review of three selected international interdisciplinary guidelines for the management of low back pain considers their development methods, consistent recommendations and inconsistencies between these guidelines.
Abstract: Given the scale and cost of the low back pain problem, it is imperative that healthcare professionals involved in the care of people with low back pain have access to up-to-date, evidence-based information to assist them in treatment decision-making. Clinical guidelines exist to promote the consistent best practice, to reduce unwarranted variation and to reduce the use of low-value interventions in patient care. Recent decades have witnessed the publication of a number of such guidelines. In this narrative review, we consider three selected international interdisciplinary guidelines for the management of low back pain. Guideline development methods, consistent recommendations and inconsistencies between these guidelines are critically discussed.
108 citations
Cites background from "Early Physical Therapy vs Usual Car..."
...However in a recent randomised controlled trial of early physical therapy versus usual care no such beneficial effects were apparent, and no meaningful impact was observed on clinical outcomes [42]....
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01 Jan 2017
TL;DR: Among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms, however, heterogeneity in study results was large.
95 citations
Cites background from "Early Physical Therapy vs Usual Car..."
...Therefore, no statement in this article should be construed as the official position of the Department of Veterans Affairs....
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...These data are included in our EvidenceReport.(14)Outcomeshad tobemeasuredwithin6weeks....
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...This review is part of a larger review commissioned by the Department of Veterans Affairs.(14)...
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...This review is part of a larger review commissioned by the Department of Veterans Affairs.14...
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References
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TL;DR: Results from a limited simulation study indicate that this approach is very reliable even with total sample sizes as small as 100, and the method is illustrated with two data sets.
Abstract: Relative risk is usually the parameter of interest in epidemiologic and medical studies. In this paper, the author proposes a modified Poisson regression approach (i.e., Poisson regression with a robust error variance) to estimate this effect measure directly. A simple 2-by-2 table is used to justify the validity of this approach. Results from a limited simulation study indicate that this approach is very reliable even with total sample sizes as small as 100. The method is illustrated with two data sets.
7,045 citations
TL;DR: In this paper, the Pain Catastrophizing Scale (PCS) was administered to 425 undergraduates and a three component solution comprising (a) rumination, (b) magnification, and (c) helplessness.
Abstract: In Study 1, the Pain Catastrophizing Scale (PCS) was administered to 425 undergraduates. Analyses yielded a three component solution comprising (a) rumination, (b) magnification, and (c) helplessness. In Study 2, 30 undergraduate participants were classified as catastrophizers (n = 15) or noncatastrophizers (n = 15) on the basis of their PCS scores and participated in an cold pressor procedure. Catastrophizers reported significantly more negative pain-related thoughts, greater emotional distress, and greater pain intensity than noncatastrophizers. Study 3 examined the relation between PCS scores, negative pain-related thoughts, and distress in 28 individuals undergoing an aversive electrodiagnostic medical procedure. Catastrophizers reported more negative pain-related thoughts, more emotional distress, and more pain than noncatastrophizers. Study 4 examined the relation between the PCS and measures of depression, trait anxiety, negative affectivity, and fear of pain. Analyses revealed moderate correlations among these measures, but only the PCS contributed significant unique variance t o the prediction of pain intensity.
6,173 citations
TL;DR: The ODI remains a valid and vigorous measure and has been a worthwhile outcome measure, and the process of using the ODI is reviewed and should be the subject of further research.
Abstract: Study design The Oswestry Disability Index (ODI) has become one of the principal condition-specific outcome measures used in the management of spinal disorders. This review is based on publications using the ODI identified from the authors' personal databases, the Science Citation Index, and hand searches of Spine and current textbooks of spinal disorders. Objectives To review the versions of this instrument, document methods by which it has been validated, collate data from scores found in normal and back pain populations, provide curves for power calculations in studies using the ODI, and maintain the ODI as a gold standard outcome measure. Summary of background data It has now been 20 years since its original publication. More than 200 citations exist in the Science Citation Index. The authors have a large correspondence file relating to the ODI, that is cited in most of the large textbooks related to spinal disorders. Methods All the published versions of the questionnaire were identified. A systematic review of this literature was made. The various reports of validation were collated and related to a version. Results Four versions of the ODI are available in English and nine in other languages. Some published versions contain misprints, and many omit the scoring system. At least 114 studies contain usable data. These data provide both validation and standards for other users and indicate the power of the instrument for detecting change in sample populations. Conclusions The ODI remains a valid and vigorous measure and has been a worthwhile outcome measure. The process of using the ODI is reviewed and should be the subject of further research. The receiver operating characteristics should be explored in a population with higher self-report disabilities. The behavior of the instrument is incompletely understood, particularly in sensitivity to real change.
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TL;DR: An approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change is developed, and a plausible range within which the minimal clinically important difference (MCID) falls is established.
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3,387 citations