Education With Therapeutic Alliance Did Not Improve Symptoms in Patients With Chronic Low Back Pain and Low Risk of Poor Prognosis Compared to Education Without Therapeutic Alliance: A Randomized Controlled Trial

Abstract

Objectives To compare the effectiveness of an education intervention with or without the addition of the therapeutic alliance to no education intervention in patients with nonspecific chronic low back pain (LBP) and low risk of poor prognosis. Design Randomized controlled trial. Randomization was performed using randomly generated numbers. Methods Two hundred twenty-two patients with nonspecific chronic LBP and low risk of poor prognosis from 2 university physical therapy services in Taubaté, Brazil were randomized into 3 groups: education plus therapeutic alliance, education only, and no education. Primary outcomes were pain (measured with the numeric pain-rating scale) and patient-specific disability (measured with the Patient-Specific Functional Scale), assessed 1 month after randomization. The patients, therapists, and assessors were not blinded due to the nature of the intervention and self-reported outcomes. Results Patients were recruited between November 2015 and February 2017. There was a loss of 17 (7.6%) follow-up assessments at 1 month, 28 (12.6%) at 6 months, and 31 (13.9%) at 12 months after randomization, and intention-to-treat analyses were conducted. There were no significant differences in pain between groups. However, there was a significant improvement in patient-specific disability for the education-plus–therapeutic alliance and education-only groups compared to no education after 1 month (mean difference, −1.41; 95% confidence interval: −2.31, −0.51 and −0.95; 95% confidence interval: −1.85, −0.04, respectively). Conclusion An education intervention did not provide clinically relevant improvements in patient-specific disability and did not influence pain in patients with nonspecific chronic LBP and low risk of poor prognosis. Additionally, there was no difference between interventions with or without emphasis on the therapeutic alliance. J Orthop Sports Phys Ther 2021;51(8):392–400. Epub 7 May 2021. doi:10.2519/jospt.2021.9636

Impact of contextual factors on patient outcomes following conservative low back pain treatment: systematic review

“…LBP is typically more common in females, but these differences appear to diminish once chronicity is accounted for [56] whilst age-related LBP prevalence is generally negatively skewed and reported to be highest between 40 to 69 years [4] whilst global LBP prevalence reportedly peaks around 80 years old [57]. Accordingly, nine studies [36,38,41,44,46,47,50,52,54] scored '1' for satisfying both conditions: (i) the proportion of females is higher but less than 60% overall; and (ii) the mean/ median age falls within the range of 40.00 to 63.5 years (but 10 and 17 studies satisfied one condition respectively -see Additional file 1: Item 11 scoring grid Results S1). Since comorbid and/or confounding conditions (e.g., age restrictions, pregnancy, neurological, rheumatological, cancer, fractures, recent surgery) were generally excluded, these samples are fairly homogenous since their inclusion-exclusion criteria were comparable, but older patients were typically excluded.…”

“…Although not universally applicable, the NICE guideline [23] for non-invasive LBP treatments guided the assessment. Studies receiving a zero rating involved the following: three employed experimental techniques (namely classical conditioning, and sham versus verum interferential current therapy (IFC)) [37,45,46]; two offered a single educational pain biology session (not specifically encouraging self-management behaviours) [42,51]; and four used cognitive behavioural approaches but were not combined with exercise and/or manual therapies [38,44,48,54].…”

“…Twenty-one studies (N = 3075 participants) with a wide range of research designs were included in the review; specifically, 12 randomised clinical trials (RCTs; n = 1064 [35][36][37][38][39][40][42][43][44][45][46]; n = 255 cluster-randomised [41]), three non-randomised, controlled clinical trials (CCTs; n = 460) [47][48][49], four observational cohort studies (n = 1220) [52][53][54][55], one case series (n = 50) [51], and one interrupted time series (n = 26) [50]. RCT sample sizes ranged from 38 (pilot [42]) to 222 (3-armed trial [44]) patients. Across the remaining studies, sample sizes ranged from 26 (interrupted time series [50]) to 688 participants (prospective cohort; [52]).…”

“…Patient Specific Functional Scale (PSFS) [39,44,54], the Hannover Activities of Daily Living Questionnaire (ADL) accompanied by the specified activities [45,46], a lumbar flexion test operationalised as the change in distance between the fingertips to the floor [51], and a Timed-Upand-Go (TUG, measured in seconds) [43]. Three studies used more than one measure of physical functioning, namely, the ODI and PSFS [39,44] and the RMDQ and TUG [43]. Refer to Additional file 1: Table S1 for a summary of the key characteristics of the included studies.…”

“…Across the 21 studies, patient's beliefs were the most commonly manipulated (16 studies) [35, 36, 38-48, 50, 51, 54] or measured CF (1 study) [55] followed by the patient-practitioner relationship (nine studies) [35,37,41,42,44,47,49,52,53], and the treatment characteristics (seven studies) [35,37,39,40,43,45,46] whilst only one modified the treatment context [49]. Nine modified (or measured) one CF only [36,38,48,[50][51][52][53][54][55] while 12 modified two or more CFs [35,37,[39][40][41][42][43][44][45][46][47]49]. None of the included studies examined the influence of practitioner beliefs and characteristics.…”