Chiropractic + Naturopathic Doctor • September/October 2022 • Chronic low back pain and bracing

VICTORIA MCINTYRE, DEREK KONOPSKI, AND DR. PETER EMARY, DC 2022-09-20 09:41:51

Chronic low back pain (CLBP) is one of the most widespread musculoskeletal disorders experienced by individuals worldwide. The lifetime prevalence of LBP is reported to be as high as 84%, and the prevalence of CLBP is approximately 23%.(1)

Causes of CLBP can be complex with many possible mechanisms. The prevalence of CLBP in adults has increased by more than 100% in the last decade and continues to increase dramatically in the aging population, affecting both men and women in all ethnic groups.(2) Chiropractors serve an important role in assisting patients with regaining motion and functionality, in turn allowing patients’ bodies to heal themselves and improve or prevent pain naturally. The majority of chiropractors use “Diversified Technique,” or High-Velocity Low-Amplitude (HVLA) spinal manipulation, to treat musculoskeletal pain and dysfunction. (3) Other common forms of chiropractic interventions for managing patients with CLBP include soft-tissue manipulation and mobilization, Cox Technic, Graston, Gonstead, and bracing with lumbar orthoses. Back bracing is often used for symptomatic management of CLBP, despite there being limited supportive evidence justifying its use. (4) The objective of this case report is to analyze the effectiveness of bracing as a pain-reducing treatment for CLBP.

A 48-year-old female presented with chronic, intermittent LBP of three years’ duration. The patient had recently aggravated the pain after gardening. She woke up the next day stiff with muscular spasms and pain and this progressed over three more days to a sharp, stabbing pain. Provocative positions included bending at the trunk into flexion and extension as well as walking and standing. Palliative mechanisms were heating pads and non-steroidal anti-inflammatory drugs (NSAIDs) as well as sitting or lying supine with her legs elevated. Her pain at the time of presentation was at 7/10 and she reported that the pain would wake her up at night.

The pain was described as a radiating pain across the low back, but it did not radiate down the patient’s legs. The straight leg raise, Hibb’s and Fabere’s orthopedic tests were negative. Kemp’s test and lumbar range of motion, especially in rotation, provoked her symptoms. Both Yeoman’s and double leg raise tests also provoked her pain. Palpation revealed tenderness and joint restriction in the right and left L4-5 and L5-S1 facet joints. Neurologic testing was normal bilaterally. Grade I spondylolisthesis was visualized on radiographs at L4 on L5. The history and physical exam findings revealed a working diagnosis of an acute exacerbation of chronic, recurrent LBP with bilateral lower lumbar facet joint syndrome and underlying grade I L4-5 spondylolisthesis.

(Note: This case report was written as part of a third-year chiropractic course, Evidence-Informed Chiropractic Practice, at D’Youville University. As such, the report herein was based on a patient scenario rather than an actual patient.)

After being referred by her family physician for chiropractic treatment, the patient in our case had inquired about whether or not to purchase a back brace to help with her CLBP. Her physician had prescribed NSAIDs (Naproxen) and heat pad application, but these only provided mild relief. After analyzing the patient’s case history and clinical presentation, we wanted to provide feedback for her on whether or not a back brace would be a good alternative treatment. To do this, we utilized the following clinical question: In a 48-year-old patient presenting with chronic, recurring LBP from lumbar facet joint syndrome and L4-5 grade I spondylolisthesis, is bracing the low back a more effective form of treatment compared to not bracing at reducing pain?

P (Patient) = 48-year-old female with chronic, recurring LBP from lumbar facet joint syndrome and L4-5 grade I spondylolisthesis

A randomized controlled trial (RCT) is the second highest level of evidence for evaluating therapeutic modalities (5,6)(Figure 1). The database that was used in our search was through the National Library of Medicine (PubMed). Since the topic of interest was about bracing and CLBP, the search terms that were used were ‘chronic low back pain’ and ‘bracing,’ initially using the Boolean term ‘AND.’ As this yielded 74 articles, we decided that additional inclusion and exclusion criteria were needed. We filtered our search to ‘human trials,’ published within the past ‘five years’; thus, articles older than five years were excluded. The age range of patients was filtered to between ‘18 and 85 years.’ All articles with children were excluded. In addition to these criteria, studies had to include patients with uncomplicated CLBP, so any articles that included CLBP with radiculopathy, or had symptomatic scoliosis were not selected. We defined CLBP as LBP that lasted greater than 12 weeks. We also searched for systematic reviews, which would have been a higher level of research evidence than a single RCT, but none were available. Our final search yielded seven articles that were specific to our PICO question.

The article chosen was an RCT from 2021 on lumbar bracing for CLBP by Annaswamy et al.(4) RCTs are the most appropriate study design for research on therapeutic modalities, such as lumbar bracing for CLBP, and is ultimately why we chose this article, in addition to the relevance and similarities between the RCT and our clinical case.

Prior to utilizing lumbar bracing on our patient as a therapeutic modality, the article by Annaswamy et al.(4) was analyzed using the Critical Appraisal Skills Program (CASP) for RCTs.(7) This article was appraised with regard to its validity, importance and applicability to whether or not bracing for CLBP would be a viable treatment plan for our patient.

The article by Annaswamy et al.(4) was an RCT that analyzed the effectiveness of back bracing as a treatment for patients with CLBP. The study’s main objective was to analyze if there was a beneficial effect of bracing uncomplicated CLBP in individuals with stable degenerative spondylolisthesis. The other objective was to see if there were additional symptomatic benefits to bracing CLBP in conjunction with exercise and education of lumbar stabilization training. The study clearly focused on these objectives and incorporated a specific population based on the study’s inclusion and exclusion criteria. The same intervention was given to all participants, with the exception of a semi-rigid back brace, the Horizon 627 one-size adjustable lumbar orthosis back brace,(4) which was also given to participants in the treatment group. All participants were randomized into either a control or treatment group using a computer-generated numbering system, numbered 1-120, to help eliminate systematic (confounding) bias. Although some participants dropped out before the end of the study, the reasons they discontinued the trial were unremarkable (e.g., time constraints, non-compliance) and accounted for. An intention-to-treat analysis was also performed. The treatment intervention was pragmatic because each participant in the trial was managed in a way that was similar to how they would be managed as if being treated in a chiropractic or other clinical office setting. Moreover, the treatment intervention was compared to usual practice (i.e., education and exercises) rather than to a placebo, and patients in the intervention group were also instructed to wear the brace as needed for symptom relief. Participants and clinicians were not blinded in this study due to the nature of the intervention being provided (i.e., a back brace is a visibly obvious intervention). Nevertheless, based on the uniform intervention, control of systematic bias, and a clear concise research question, we deemed the study valid.

The valid results of this study are important, in terms of the negative differences at follow-up in patient-reported outcomes between the control and experimental groups. Descriptive statistics were used to analyze the baseline sociodemographic characteristics of all study participants, and outcome measures were collected at baseline, 6-week, 12-week and six-month time points in both the control and experimental groups. Both groups had similar sociodemographic and clinical characteristics at baseline. The study measured the differences in outcomes at follow- up as the standardized mean difference (SMD) and found a statistically significant difference (p < 0.05) between the treatment group and control group over 6 months. The treatment group reported increased scores on the PDQ (Pain Disability Questionnaire) (SMD, 0.84; p = 0.04), the PROMIS (Patient Reported Outcome Measurement Information System) (SMD, 0.78; p = 0.005), and the EQ-5D (EuroQol 5-Dimension) (SMD, 0.06; p = 0.01), compared to the control group. This indicates statistical significance for increased pain and disability, as well as decreased functionality and quality of life for the treatment group versus the control group. Effect sizes of 0.2 to 0.5 are small/slight, 0.5 to 0.8 are moderate, and >0.8 are large/substantial.(7) This means that, based on the statistical analysis from the study, bracing substantially increased pain and disability, as well as moderately decreased functionality and slightly decreased quality of life. Because of the negative outcomes observed in the intervention group, this trial was halted early before completion.(4)

(iii) Are the valid, important results of the RCT by Annaswamy et al. applicable to this patient?

In the study by Annaswamy et al.,(4) the clinical symptoms and qualifications outlined in the RCT aligned with the patient in our case. For instance, the RCT’s inclusion criteria of age range (18-85), CBLP with stable spondylolisthesis, and greater than 12 weeks of LBP, were all shared by the subjects of the RCT and our patient. The exclusion criteria indicated no instability with the spondylolisthesis, or any spinal surgery. In addition, patients were excluded if they had used a lumbar brace before, had taken part in rehabilitation therapy programs within the last year, or had a mental illness. All individuals that were part of a vulnerable or marginalized population were also excluded.

The application of the tested intervention would likely have yielded similar outcomes in our CLBP patient based on the participant similarities in the clinical inclusion and exclusion criteria from the trial. Therefore, the results from the RCT were deemed applicable to our patient.

In the RCT by Annaswamy et al.,(4) bracing for CLBP substantially increased pain and disability, as well as moderately decreased functionality and slightly decreased quality of life among participants. These results would guide our decision and recommendations to the patient to avoid using bracing as a therapeutic modality. Instead, we would provide education and exercise as treatments in addition to standard chiropractic manipulation for our patient. In addition, we would communicate to the patient that all subjects who participated in the study by Annaswamy et al.(4) benefited from both education about CLBP and adding exercise into their daily routines to manage or decrease pain. The lumbar brace was passive and appeared to work more as a reminder to individuals that they had CLBP rather than provide a helpful form of treatment. We would stress the importance that bracing works to keep the spine stiff and immobile, which may do more harm than good, whereas exercise is active and more effective at managing pain.(8) The patient’s preference for treatment would likely be towards conservative management rather than, for example, cortisone injection or surgery, so exercises and education on proper ergonomics and mechanical lifting in her garden and daily activities would be recommended. Based on our critical appraisal of the study by Annaswamy et al.,(4) bracing for CLBP would not be a treatment recommendation for this patient.

From the evidence presented in the RCT by Annaswamy et al.,(4) bracing as a treatment modality for CLBP would not be expected to provide our patient with any significant pain relief, improvement in functionality, or increased quality of life when compared to not bracing. It can be expected that if this treatment was applied to our patient that she would have scored equal to or worse at follow-up on outcome measures such as the PDQ, PROMIS, or EQ-5D. Had the patient not been informed that bracing CLBP has the potential for negative treatment effects, her quality of life and functionality may have decreased. In addition, the patient’s NSAID intake may have increased in order to compensate for the potential increased pain and discomfort after bracing with a lumbar orthosis. After further analysis of the results of this RCT, it would be an informed decision between us and the patient to not only avoid the recommendation of bracing for CLBP, but it would also be within reason to advise her against pursuing this treatment option on her own, using a “supermarket” approach.(9) As a result, we would recommend that other evidence-based treatment options for CLBP be considered.( 8)

A 48-year-old patient presenting with chronic, recurring LBP had a question of whether or not she should purchase a back brace to help reduce her pain. Through our analysis of the RCT by Annaswamy et al.,(4) it was determined that the utilization of a back brace for CBLP would not be an effective form of treatment. Instead, education and exercise for the low back, in conjunction with chiropractic adjustments, would be recommended as a multi-modal intervention for this patient.

VICTORIA MCINTYRE and DEREK KONOPSKI are 3rd-year chiropractic students at D’Youville University in Buffalo, New York. DR. PETER EMARY is a chiropractor at the Langs Community Health Centre in Cambridge, Ontario. He is a post-doctoral fellow at the Michael G. DeGroote National Pain Centre at McMaster University, and he also teaches in the Chiropractic Department at D’Youville University.

Figure 1. Hierarchy of quantitative research evidence (adapted from Haneline [6]).