[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 34.234.223.162. Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    3 Comments for this article
    EXPAND ALL
    A moratorium on monotherapy on unclassified (undiagnosed) low back pain
    Donald Murphy, DC | Alpert Medical School of Brown University
    This is a well-designed, well-performed, well-written study that is part of a long line of clinical trials for LBP that are of little to no usefulness in the field of spine related disorders. I would recommend a moratorium on clinical trials that study a single modality of treatment in a population of patients with LBP without consideration of 1) the specific features and needs of each patient and 2) the context (1) in which the treatment is applied. Attempts to apply a one-size-fits-all approach to LBP, after decades of study, have provided very little benefits in terms of informing clinicians as to the best way to approach individual patients. This is not a criticism of the professionals who performed this study, but on the unhelpful manner in which clinical trials on the management of patients with LBP have been carried out for a long time.

    I realize that an attempt to classify, using the clinical prediction rule, was done in this study (unlike the majority of other clinical trials in LBP). So my comment regarding patients being "unclassified (undiagnosed)" apply more generally in the field, not to this specific study.

    1. Testa M, Rossettini G: Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes. Man Ther 2016, 24:65-74
    CONFLICT OF INTEREST: None Reported
    READ MORE
    A biopsychosocial approach to managing chronic low back pain is essential now and in future clinical trial designs
    David Byfield, BSc Hons, DC, MPhil | Neurovascular Research Laboratory, School of Health, Sport and Professional Practice, Faculty of Life Sciences and Education, University of South Wales, WalesUK
    We would like to congratulate Thomas et al. for their work. However, in terms of the design, this trial was an efficacy study and not an effectiveness study to evaluate the two interventions for the treatment of chronic low back pain (LBP). These two types of trials are often poorly understood as they serve distinct purposes. Efficacy studies investigate the benefits and harms of an intervention under highly controlled conditions requiring a deviation from routine clinical practice due to restrictions placed on the study sample, ie strict inclusion exclusion criteria. Effectiveness studies evaluate interventions that more closely resemble real-life clinical settings with more varied patient populations, less standardised protocols and interventions delivered in a everyday clinical environment. The authors also haven’t considered the nature and course of chronic LBP by employing only a 4 week follow up from baseline. LBP is a persistant and reoccurring condition and the study timeline was too short to evaluate the effect of the interventions over time. Numerous randomised controlled trials of varying methodological quality and size have examined the benefits and harms of manual therapy for the treatment of LBP. A recent systematic review by Rubenstein et al. (2019) suggested that future clinical trials of manual therapy for chronic LBP are not necessary unless they contain an innovative approach, are well designed, include an economic evaluation and contain qualitative information about patient context, their beliefs and preferences.

    Thomas et al. have also overlooked the seminal work published in the Lancet Low Back Series (Hartvigsen et al., Foster et al., Buchbinder et al., 2018). These publications were the turning point in the understanding and management of chronic LBP and a key message was the assessment and management of LBP should be underpinned by a biopsychosocial model. An awareness of this model has greatly advanced the understanding of the prognostic significance of psychosocial factors in individual patients in a real clinical setting. Continuing to investigate the effectiveness of a single modality in isolation only perpetuates a biomedical approach and underestimating the contextual parameters that accompany this complex clinical presentation.

    Therefore, the conclusion of this study that spinal manipulation or spinal mobilisation are not effective for the treatment of chronic LBP is also out of step with contemporary clinical guidelines for LBP, including, i) the Danish Health Authority Guidelines (2018), ii) the American College of Physicians Guidelines (2017), iii) the National Institute of Clinical Excellence UK (NICE)) Guidelines (2016), which recommend spinal manipulative therapy for both acute and chronic LBP of all ages in conjunction with other interventions such as exercise, advice and education in a non-pharmacological approach. Therefore, we recommend that in future studies reporting interventions for LBP must reflect best practice and focus on the patients’ context and modifiable biopsychosocial factors that influence pain and disability facilitated by education and active self-management protocols.

    References

    Rubenstein SM et al. M. Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. British Medical Journal. 2019; 364:l689

    Singal AG et al. A. A Primer on Effectiveness and Efficacy Trials. Clinical and Translational Gastrooenterology. 2014;5, e45;doi:10.1038/ctg.2013.13
    CONFLICT OF INTEREST: None Reported
    READ MORE
    To Enhance Translation Potential Consider Updating Conclusion and Title
    David Elton, D.C. | UnitedHealth Group
    This research was thoughtfully designed, carefully executed and contains important insights. The title and primary conclusion would benefit from an update to more closely reflect the research performed.

    The study found 6 visits of spinal manipulation or mobilization delivered by Doctors of Osteopathy (DO) and Physical Therapists (PT) as a monotherapy was no better than a placebo monotherapy for 18 to 45-year-old patients with mild to moderate chronic low back pain. Readers may infer from the paper’s title and conclusion extrapolate that this important insight, which could be true, to all spinal manipulation or mobilization.

    In
    addition to the growing body of high-quality research in the public domain, including JAMA Network Open, experience from approximately 1 million complete episodes of non-surgical back pain ending in 2017-2019 in 18 to 45-year-old patients in a commercially insured population provides some additional context for this comment:

    • ~10% of all spinal manipulation or mobilization is performed by DOs or PTs, and is infrequently provided as a monotherapy
    • ~90% of all spinal manipulation or mobilization is performed by Doctors of Chiropractic (DC) using Chiropractic Manipulative Treatment (CMT) codes, and is infrequently provided as a mono-therapy
    • 1-6 visits of CMT provided alone or in combination with other services is associated with several beneficial total episode of care attributes when compared to overall performance for the entire sample of 1 million episodes, a few examples include:
    • 1-6 visits of CMT is associated with lower total episode cost, smaller number of different providers seen during the episode, lower rates of Rx classes like opioids, NSAIDs and skeletal muscle relaxants, and lower rates of spinal imaging and injections.
    • CMT is the only form of spinal manipulation or mobilization that is associated with lower total episode cost when 1-6 visits are provided and is associated with higher total episode cost if never provided.
    • While these are not true clinical outcome measures, they do provide a proxy for potential clinical benefits of CMT.
    • Seemingly consistent with the paper’s findings, 1-6 visits of spinal manipulation performed by a DO or mobilization performed by a PT is not associated with the same beneficial total episode of care attributes observed with 1-6 visits of CMT:
    • 1-6 visits of spinal manipulation performed by a DO or mobilization performed by a PT is associated with higher total episode cost, higher number of different providers seen during the episode, and higher rates of imaging and injection when compared to overall performance for the entire sample of 1 million episodes.
    • Like CMT, 1-6 visits of spinal manipulation performed by a DO or mobilization performed by a PT alone or in combination with other services is associated with lower rates of Rx classes like opioids, NSAIDs and skeletal muscle relaxants.

    The paper's finding that spinal manipulation or mobilization delivered by a DO or PT as monotherapy, while uncommon, is no better than an even less commonly provided placebo monotherapy is an important advance in our understanding of treatment mild to moderate chronic back pain. The paper did not explore either; a. what is by far the most common form of spinal manipulation, Chiropractic Manipulative Treatment, or b. spinal manipulation/mobilization performed by any provider in combination with other services.
    CONFLICT OF INTEREST: None Reported
    READ MORE
    Views 22,474
    Citations 0
    Original Investigation
    Orthopedics
    August 5, 2020

    Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial

    Author Affiliations
    • 1Department of Physical Therapy, Virginia Commonwealth University, Richmond
    • 2Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond
    • 3Division of Physical Therapy, Ohio University School of Rehabilitation and Communication Sciences, Athens
    • 4Ohio Musculoskeletal and Neurological Institute, Ohio University, Athens
    • 5Department of Biomedical Sciences, Ohio University, Athens
    • 6Morsani College of Medicine, University of South Florida School of Physical Therapy and Rehabilitation Sciences, Tampa
    • 7Department of Psychology, Ohio University, Athens
    • 8Applied Biostatistics Laboratory, University of Michigan School of Nursing, Ann Arbor
    • 9Feinberg School of Medicine, Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, Illinois
    JAMA Netw Open. 2020;3(8):e2012589. doi:10.1001/jamanetworkopen.2020.12589
    Key Points español 中文 (chinese)

    Question  What is the comparative effectiveness of spinal manipulation compared with spinal mobilization relative to a placebo control in reducing pain and disability in chronic low back pain?

    Findings  In this randomized clinical trial that included 162 young adults, there was no difference in reduction of pain and disability when comparing spinal manipulation to spinal mobilization relative to the placebo control treatment.

    Meaning  Neither spinal manipulation nor mobilization appeared to be an effective intervention for young adults with mild to moderate chronic low back pain.

    Abstract

    Importance  Low back pain (LBP) is one of the most common reasons for seeking medical care. Manual therapy is a common treatment of LBP, yet few studies have directly compared the effectiveness of thrust (spinal manipulation) vs nonthrust (spinal mobilization) techniques.

    Objective  To evaluate the comparative effectiveness of spinal manipulation and spinal mobilization at reducing pain and disability compared with a placebo control group (sham cold laser) in a cohort of young adults with chronic LBP.

    Design, Setting, and Participants  This single-blinded (investigator-blinded), placebo-controlled randomized clinical trial with 3 treatment groups was conducted at the Ohio Musculoskeletal and Neurological Institute at Ohio University from June 1, 2013, to August 31, 2017. Of 4903 adult patients assessed for eligibility, 4741 did not meet inclusion criteria, and 162 patients with chronic LBP qualified for randomization to 1 of 3 treatment groups. Recruitment began on June 1, 2013, and the primary completion date was August 31, 2017. Data were analyzed from September 1, 2017, to January 20, 2020.

    Interventions  Participants received 6 treatment sessions of (1) spinal manipulation, (2) spinal mobilization, or (3) sham cold laser therapy (placebo) during a 3-week period.

    Main Outcomes and Measures  Coprimary outcome measures were the change from baseline in Numerical Pain Rating Scale (NPRS) score over the last 7 days and the change in disability assessed with the Roland-Morris Disability Questionnaire (scores range from 0 to 24, with higher scores indicating greater disability) 48 to 72 hours after completion of the 6 treatments.

    Results  A total of 162 participants (mean [SD] age, 25.0 [6.2] years; 92 women [57%]) with chronic LBP (mean [SD] NPRS score, 4.3 [2.6] on a 1-10 scale, with higher scores indicating greater pain) were randomized. Fifty-four participants were randomized to the spinal manipulation group, 54 to the spinal mobilization group, and 54 to the placebo group. There were no significant group differences for sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability. At the primary end point, there was no significant difference in change in pain scores between spinal manipulation and spinal mobilization (0.24 [95% CI, −0.38 to 0.86]; P = .45), spinal manipulation and placebo (−0.03 [95% CI, −0.65 to 0.59]; P = .92), or spinal mobilization and placebo (−0.26 [95% CI, −0.38 to 0.85]; P = .39). There was no significant difference in change in self-reported disability scores between spinal manipulation and spinal mobilization (−1.00 [95% CI, −2.27 to 0.36]; P = .14), spinal manipulation and placebo (−0.07 [95% CI, −1.43 to 1.29]; P = .92) or spinal mobilization and placebo (0.93 [95% CI, −0.41 to 2.29]; P = .17).

    Conclusions and Relevance  In this randomized clinical trial, neither spinal manipulation nor spinal mobilization appeared to be effective treatments for mild to moderate chronic LBP.

    Trial Registration  ClinicalTrials.gov Identifier: NCT01854892

    ×