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Is Myofascial Pain Syndrome a Legitimate Primary Diagnosis?
Background:
Myofascial Pain Syndrome (MPS) is hypothesized to be both a primary and/or a secondary chronic pain disorder that can refer symptoms to other parts of the body. MPS is relatively common, affecting millions of people worldwide, particularly those who have experienced muscle overuse, trauma, or stress [1]. MPS can significantly impact daily activities and quality of life, as the persistent pain and discomfort can be both physically and emotionally draining [2]. Despite its notable impact on health and wellness, MPS is a controversial diagnosis that mainly stems from the lack of consensus on its diagnostic criteria and the underlying mechanisms. The objective of this blog is to identify whether MPS meets current criteria as a unique diagnosis, using the four criteria from the World Health Organization (WHO).
Diagnostic Criteria:
Historically, the WHO, through its International Classification of Diseases (ICD) criteria, provides a global standard for diagnostic health data, facilitating international comparisons and collaborations in healthcare. For each unique diagnosis, the WHO requires four criteria [3]: 1) specificity, 2) consistency, 3) significance and 4) diagnostic stability. These criteria have allowed them to differentiate two competing conditions such as influenza and COVID-19, and have allowed them to recognize new diseases/syndromes such as E-Cigs and Vaping-Associated Lung Injury or Post-Traumatic Stress Disorder (PTSD) due to Complex Trauma in Childhood.
Specificity suggests that the condition must have a clear and specific set of symptoms and characteristics that distinguish it from other conditions. Consistency requires that the symptoms and characteristics should be reliably observed across different patients and settings. Significance involves its impact on the individual’s health, functioning, or quality of life. Diagnostic Stability suggests that the diagnosis should remain stable over time, meaning that the condition does not frequently change or evolve into another condition.
Based on the WHO criteria, is MPS a stand-alone, primary diagnosis? The answer is both “yes” and “no”.
According to the WHO, MPS refers to a musculoskeletal disorder characterized by pain originating from tight muscles and the surrounding fascia, often presenting as sensitive “trigger points” that can cause localized pain and referred pain to other areas of the body; this pain can be chronic and is often associated with repetitive motions, poor posture, or stress [4]. Under the ICD-11, MPS is classified under chronic primary pain and chronic secondary musculoskeletal pain. The criteria for chronic primary pain
include persistent or recurrent pain for at least three months, with significant emotional distress or functional disability. For chronic secondary musculoskeletal pain, the pain is associated with a musculoskeletal condition, which persists beyond the usual recovery period. Despite these descriptions from the WHO, neither of the two (for chronic primary and chronic secondary) meets all four of the original WHO criteria.
Truthfully, it is well understood that MPS does not have a clear, routine set of signs and symptoms that distinguishes it from other diagnoses (lacks specificity). This influences consistency as well. These are reasons it is difficult to differentiate MPS from other diagnostic conditions such as fibromyalgia, tension type headaches, and chronic fatigue syndrome. MPS is also traditionally categorized as a nociceptive pain condition, but there’s growing evidence suggesting it can also involve neuropathic or nociplastic pain components. Further, due to the lack of specific laboratory indicators and imaging evidence, there is no unified diagnostic criteria for MPS, adding to the confusion with other diseases [5].
Summary:
Given the prevalence of MPS it is likely that most physical therapists and chiropractors see a high percentage of these individuals in their outpatient practices. As currently defined by ICD coding MPS is highly likely to contribute to patients’ pain experience as a secondary condition [6], which can be very debilitating to the individual [7]. This is likely why other global healthcare groups such as the International Association for the Study of Pain, support the contribution of MPS, which they characterize as local and referred pain perceived as deep, dull, pressure, and aching, along with the presence of myofascial trigger points in any part of the body [8]. As the complex nature of pain and associated pain conditions are further unraveled perhaps MPS will find a better home as a primary pain condition, however, currently, MPS may be difficult to differentiate from other conditions and is likely a secondary contributor to most musculoskeletal conditions seen by rehabilitation providers.
References:
1. Li X, Lin Y, He P, Wang Q. Efficacy and safety of low-intensity ultrasound therapy for myofascial pain syndrome: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2024 Dec 23;25(1):1059.
2. Jaeger B. Myofascial trigger point pain. Alpha Omegan. 2013;106(1–2):14–22.
3. Hebert O, Schlueter K, Hornsby M, Van Gorder S, Snodgrass S, Cook C. The diagnostic credibility of second impact syndrome: A systematic literature review. J Sci Med Sport. 2016 Oct;19(10):789-94.
4. Qureshi N, Hamoud AA, Gazzaffi IMA. Myofascial Pain Syndrome: A Concise Update on Clinical, Diagnostic and Integrative and Alternative Therapeutic
Perspectives. International Neuropsychiatric Disease Journal. 2019 Mar; 13(1): 1-14
5. Cao QW, Peng BG, Wang L, Huang YQ, Jia DL, Jiang H, Lv Y, Liu XG, Liu RG, Li Y, Song T, Shen W, Yu LZ, Zheng YJ, Liu YQ, Huang D. Expert consensus on the diagnosis and treatment of myofascial pain syndrome. World J Clin Cases. 2021 Mar 26;9(9):2077-2089. doi: 10.12998/wjcc.v9.i9.2077.
6. Plaut S. Scoping review and interpretation of myofascial pain/fibromyalgia syndrome: An attempt to assemble a medical puzzle. PLoS One. 2022 Feb 16;17(2):e0263087.
7. Lam C, Francio VT, Gustafson K, Carroll M, York A, Chadwick AL. Myofascial pain – A major player in musculoskeletal pain. Best Pract Res Clin Rheumatol. 2024 Mar;38(1):101944.
8. International Association of the Study of Pain. Myofascial Pain: Fact Sheet 14. Downloaded December 27, 2024 at: https://www.iasp-pain.org/wp-content/uploads/2022/10/14.-Myofascial-Pain-Fact-Sheet-Revised-2017.pdf.
Risk of Bias Measures can be Biased
Navigating the Literature: Navigating the ever-growing, healthcare literature can be challenging [1]. The sheer amount of new research, articles, and guidelines published regularly can be overwhelming. The number of biomedical publications has been steadily increasing over the years. As of 2022, there were approximately 3.3 million scientific and technical articles published worldwide [2]. The volume of information and the time constraints of a busy clinician can lead to information overload. This is particularly important since it can be difficult to determine which information is relevant and credible amidst the vast amount of available content.
In publishing, risk of bias measures are tools and methods used to assess the likelihood that the results of a study are influenced by systematic errors or biases. With the very high number of systematic reviews, which are designed to summarize overall results into a common understanding, the use of risk of bias measures is crucial for evaluating the quality, reliability, and trustworthiness [3-5] of research findings. This, and a focus on transparency in research, has led to the proliferation of risk of bias measures and their adoption into publication practice. However, there are limitations to risk of bias measures that may denude their utility in reconciling the literature. The purpose of this blog is to: 1) outline the limitations of risk of bias measures and 2) discuss the best ways of interpreting the literature when risk of bias measures provides interpretation conflict.
Limitations of Risk of Bias Measures: Risk of bias measures are useful tools that assist in guiding evidence synthesis, particularly in systematic reviews and meta-analyses. Risk of bias measures aid in selecting high-quality studies and weighting their contributions appropriately, leading to more reliable conclusions. Nonetheless, there are limitations to current risk of bias measures, which include: 1) subjectivity of raters, 2) elevating risk when reporting is actually the problem, 3) overemphasis on selected scoring areas and failure to recognize other notable contributors, and 4) interpretation issues (meaningful scaling) within and between instruments.
Subjectivity of raters: Assessments of risk of bias often involve subjective judgments, which can vary between reviewers. Best practice involves two different reviews and a consensus of findings, but assessment requires appropriate training to assure that reviewers truly understand each item of the risk of bias scale. A recent study [6] examined the inter-rater reliability of several risk of bias tools for non-randomized studies and found variability in the assessments that was attributed to differences in the complexity and clarity of the criteria used in the tools. Furthermore, results of the analysis using multiple tools on the same article can yield differing interpretations of the trustworthiness of a causal inference [7]. For this reason, it is
common practice for systematic review guidelines to mandate that two independent reviewers must complete risk of bias assessments and come to consensus on discrepancies [8].
Elevating risk when reporting is actually the problem: Reporting checklists in publishing are essential tools used to improve the transparency, completeness, and quality of research reporting. Common examples of reporting checklists include CONSORT for randomized controlled trials, PRISMA for systematic reviews and meta-analyses, and STROBE for observational studies. Unfortunately, not all studies are written using reporting checklists as a guide, which can lead to the inability to discriminate if the study design excluded the risk of bias component or if it was simply omitted from reporting. Risk of bias can only be evaluated based on what is reported and if what is reported is poor or omitted (despite being performed in the study), the risk of bias may be artificially inflated [9]. A counterfactual argument exists where investigators can use a checklist and report that design elements that meet the checklist occurred, when they did not or were inelegantly applied. This brings investigator intent to the table which we can never accurately assess, but exists nonetheless.
Overemphasis on selected scoring areas: In an effort to reduce administration burden, most risk of bias scales overemphasize areas (e.g., randomization, allocation concealment) and underemphasize others (e.g., interventional fidelity, blinding of outcomes, incomplete outcome data). Certainly, the underemphasized areas are as important or potentially more important than those that are historically supported [9].
Interpretation issues: There are two major considerations when interpreting results of a risk of bias tool. First, most risk of bias scales provide a summary score, but it is questionable whether this score actually reflects a meaningfully elevated risk, especially if the values are not weighted. For example, a high risk of bias score on the PEDro scale, a commonly used measure in physical therapy studies, total PEDro scores of 0-3 are considered ‘poor’, 4-5 ‘fair’, 6-8 ‘good’, and 9-10 ‘excellent’; it is important to note that these classifications have not been validated [10]. Second, the actual impact of bias may be variable depending on the direction of the impact. Two biases may move the outcome in opposite directions offsetting each other and producing minimal, if any, net effect on the inference. Third, best practice suggests that a sensitivity analysis or a subgroup analysis is appropriate when variations in risk of bias measures are identified in a synthesis-based review (e.g., systematic review). Conducting sensitivity analyses helps determine how the inclusion or exclusion of studies with high risk of bias affects the overall results. Performing subgroup analyses helps to explore whether studies with low, moderate, or high risk of bias yield different results [9].
Summary:
Risk of bias measures provide additional data in the determination of study bias or quality, but these tools are not gospel and should not be taken as absolute, unquestionable truth. As with many tools used in interpreting publications, there are limitations to their use. As such, determining a study as “good” or “bad” or “trustworthy” or “not trustworthy”, purely from a risk of bias score should not be recommended.
References 1. https://www.pharmacytimes.com/view/tips-tricks-for-staying-up-to-date-with-medical-literature-guidelines-as-a-busy-pharmacist 2. https://ncses.nsf.gov/pubs/nsb202333/publication-output-by-region-country-or-economy-and-by-scientific-field
3. Riley SP, Flowers DW, Swanson BT, Shaffer SM, Cook CE, Brismée JM. ‘Trustworthy’ systematic reviews can only result in meaningful conclusions if the quality of randomized clinical trials and the certainty of evidence improves: an update on the ‘trustworthy’ living systematic review project. J Man Manip Ther. 2024 Aug;32(4):363-367.
4. Flowers DW, Swanson BT, Shaffer SM, Clewley DJ, Riley SP. Is there ‘trustworthy’ evidence for using manual therapy to treat patients with shoulder dysfunction?: A systematic review. PLoS One. 2024 Jan 18;19(1):e0297234.
5. Riley SP, Swanson BT, Shaffer SM, Flowers DW, Cook CE, Brismée JM. Why do ‘Trustworthy’ Living Systematic Reviews Matter? J Man Manip Ther. 2023 Aug;31(4):215-219.
6. Kalaycioglu I, Rioux B, Briard JN, Nehme A, Touma L, Dansereau B, Veilleux-Carpentier A, Keezer MR. Inter-rater reliability of risk of bias tools for non-randomized studies. Syst Rev. 2023 Dec 7;12(1):227.
7. Jüni P, Witschi A, Bloch R, Egger M. The Hazards of Scoring the Quality of Clinical Trials for Meta-analysis. JAMA. 1999;282(11):1054–1060. doi:10.1001/jama.282.11.1054.
8. Checklists for systematic reviews and research synthesis. https://jbi.global/sites/default/files/2020-08/Checklist_for_Systematic_Reviews_and_Research_Syntheses.pdf
9. Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8: https://training.cochrane.org/handbook/current/chapter-08
10. Assessing risk of bias in included studies. In: Higgins JPT, Churchill R, Chandler J, Cumpston MS (editors), Cochrane Handbook for Systematic Reviews of Interventions version 5.2.0 (updated June 2017), Cochrane, 2017. Available from www.training.cochrane.org/handbook.
Why Isn’t Everyone Using Stepped Care for Musculoskeletal Injuries?
Resource efficiency models
Musculoskeletal (MSK) outcomes have shown some concerning trends over the last decade. Conditions like low back pain, neck pain, and joint pain have become more prevalent, contributing to the overall burden of a MSK disorder [1]. According to a report analyzing medical claims data from 2010 to 2020, MSK healthcare costs have doubled, despite the number of individuals reporting MSK disorders remaining relatively constant. This increase in costs is driven by a rise in per-member costs and the growing number of health plan members [2] and has prompted a number of novel management models that emphasize cost-effectiveness rather than a current fee-for-service dominant strategy (which rewards higher utilization and does not penalize the provider when outcomes are not optimized). These novel “resource efficiency models” focus on the optimal use of resources—such as time, personnel, equipment, and finances—to achieve comparable or superior patient outcomes to a traditional approach.
What is Stepped Care?
Stepped care for MSK conditions is a tailored and structured approach to treatment that starts with the least intensive, most cost-effective interventions first (Figure 1). Care steps up to more intensive treatments as/if needed [3] (only when selected clinical criteria are not met or if the patient is at risk for worsening if they do not receive a dedicated treatment approach). The earliest stepped care options were developed for mental health disorders, diabetes, and other behavioral conditions and thus far there is emerging evidence to support stepped care treatments for individuals with different forms of MSK disorders [4-9].
It works off the premise that there logical are first-line and second-line approaches to MSK conditions, as well as a series of assumptions [10]. These assumptions include: 1) Equivalence of clinical outcomes across the different levels of care. These steps within the model are assumed to be equally effective in achieving clinical outcomes; 2) Efficiency in resource use: The model assumes that using the least intensive, yet effective, intervention first will optimize resource use and reduce costs; 3) Acceptability of minimal interventions: Patients and providers are assumed to accept and adhere to less intensive interventions before moving to more intensive ones (watchful waiting has merit); 4) Self-correcting nature of the model: The model assumes that if an intervention is not effective, the next step in the care pathway will be more intensive and appropriate and may potentially be a better “match” for the patient; and 5) Stepped care reduces overtreatment: Overtreatment in MSK conditions is the provision of medical interventions that are unnecessary or excessive given the patient’s condition.
Why Isn’t Everyone using Stepped Care?
Thus far, there seems to be both clinical efficiency of stepped care and cost-effectiveness as well. If so, especially in light of the rather stagnant results we’ve seen globally in management of MSK conditions, “why isn’t everyone using stepped care?”. The answer for the United States is threefold. First, care within the United States is fragmented, often leading to poor communication across different forms of providers. Second, the parties involved as first-point providers are often those who provide the most invasive and potentially highest costs of care (a proverbial fox guarding the chicken coup scenario). Last, there are no financial incentives in a fee for service system, the payment system that dominates the United States, for adopting stepped car. In fact, it is likely that fee for service providers would lose business to lower cost providers and would also lose market share.
Summary
Stepped care has significant potential for improving the management of MSK conditions in the future. By providing tailored interventions that match the patient’s needs, stepped care can enhance treatment outcomes, reduce healthcare costs, and improve patient satisfaction. This model allows for early intervention with less intensive treatments, reserving more resource-intensive options for those who do not respond to initial therapies. Additionally, stepped care promotes a more efficient use of healthcare resources and encourages a collaborative approach among healthcare providers. As research continues to support its effectiveness, and as payment models are adjusted, stepped care could become a cornerstone of MSK management, leading to better overall health outcomes for patients.
References
- GBD 2021 Other Musculoskeletal Disorders Collaborators. Global, regional, and national burden of other musculoskeletal disorders, 1990-2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Oct 23;5(11):e670-e682.
- Hinge Health. State of MSK Report 2021. Downloaded on December 15, 2024 from: https://healthactioncouncil.org/getmedia/a738c3c5-7c23-4739-bb8d-069dd5f7406b/Hinge-Health-State-of-MSK-Report-2021.pdf
- Kongsted A, Kent P, Quicke JG, Skou ST, Hill JC. Risk-stratified and stepped models of care for back pain and osteoarthritis: are we heading towards a common model? Pain Rep. 2020 Sep 23;5(5):e843
- Garcia AN, Cook CE, Rhon DI. Adherence to Stepped Care for Management of Musculoskeletal Knee Pain Leads to Lower Health Care Utilization, Costs, and Recurrence. Am J Med. 2021 Mar;134(3):351-360.e1.
- Rhon DI, Greenlee TA, Fritz JM. The Influence of a Guideline-Concordant Stepped Care Approach on Downstream Health Care Utilization in Patients with Spine and Shoulder Pain. Pain Med. 2019 Mar 1;20(3):476-485.
- Kroenke K, Bair M, Damush T, Hoke S, Nicholas G, Kempf C, Huffman M, Wu J, Sutherland J. Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study: design and practical implications of an intervention for comorbid pain and depression. Gen Hosp Psychiatry. 2007 Nov-Dec;29(6):506-17.
- Kroenke K, Krebs E, Wu J, Bair MJ, Damush T, Chumbler N, York T, Weitlauf S, McCalley S, Evans E, Barnd J, Yu Z. Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and sample characteristics. Contemp Clin Trials. 2013 Mar;34(2):270-81.
- Mylenbusch H, Schepers M, Kleinjan E, Pol M, Tempelman H, Klopper-Kes H. Efficacy of stepped care treatment for chronic discogenic low back pain patients with Modic I and II changes. Interv Pain Med. 2023 Nov 15;2(4):100292.
- Boyd L, Baker E, Reilly J. Impact of a progressive stepped care approach in an improving access to psychological therapies service: An observational study. PLoS One. 2019 Apr 9;14(4):e0214715.
Figure 1. Example of a Stepped Care Model for Musculoskeletal Conditions.
Three Ways That Recruitment in Randomized Controlled Trials May Not Reflect Real Life
As we wind up a year of recruitment on the SS-MECH trial [1], we are compelled to reflect on our recruitment strategies and study participants. Our study has included four recruitment sites and we’ve enrolled over 110 participants, which is nearly 85% of our targeted sample. We are using well-rehearsed and successful strategies at our work sites, providing access to a wide range of individuals with chronic neck disorders. As an example, the recruitment process at Duke University uses the electronic medical record to identify individuals who have recently been seen for neck related conditions, who are not seeking a physical therapist’s care at the given time. This process and the processes at all recruitment sites have been very effective, leading to high conversion rates (enrollment) and strong study retention. The study investigators provide care for both arms, which increases the fidelity of the interventions, as each of us has a vested interest in doing this right. Further, thanks to generous external funding (https://foundation4pt.org/), we have financial support for our six-month follow-ups, which has also been instrumental in a very high completion rate.
All of this sounds like wonderful news for any clinical trialist. And indeed, by mid 2025, we will complete the last six-month follow-ups for the SS-MECH trial and will be able to report on our findings. In fact, of the >20 randomized clinical trials (RCTs) that we’ve independently been involved in, this one has one of the strongest implementation plans and efforts toward improving the study quality. However, we would be remiss if we did not outline some of the concerns for ALL RCTs, concerns that are not specific to our study but should be considered when reading any published paper. The purpose of this blog is to outline the potential limitations of the samples in RCTs.
Concern Number One: All RCTs have specific inclusion/ exclusion criteria, which may influence the type of participant seen in the trial. This can lead to selection bias, which occurs when the volunteers for the study differ from those who do not volunteer. All RCTs may select a more homogeneous group of patients to reduce variability. The homogeneity of the sample reduces the generalizability of the results, which is whether the results are reflective of a broader patient population seen in everyday clinical practice. All RCTs identify a sample representative of a pre-specified target population [2], which may be dissimilar to the general population with chronic neck pain presenting to clinicians. Individuals who agree to participate in a study are often healthier, live close to the study site, are younger, have higher health literacy, and have higher socioeconomic status [3]. All of these features are also moderators of an outcome and could influence the results of the study. An example of selection bias in our study is our requirement that the research participants not attend physical therapy during the time of their treatment. This is likely to increase non-care seeker enrollment, which is a very different population than a care seeking one [4]; care-seekers tend to have more severe symptoms and may be more motivated to pursue a change in their status.
Concern Number Two: Non-pragmatic RCTs are conducted under idealized and controlled conditions, which may not accurately represent the complexities and variability of real-world clinical settings. This often increases patient compliance and reduces dropouts, influencing a study’s results. Participants in RCTs are often more compliant with treatment protocols and follow-up visits compared to the general patient population, leading to differences in outcomes. Study dropouts can introduce bias, reduce power, and lead to missing data. This can lead to an overestimation or underestimation of the treatment effect. With fewer participants completing the study, the statistical power to detect a difference between treatment groups is reduced. Lastly, missing data from dropouts can complicate the analysis and interpretation of results, requiring the use of statistical methods to handle the missing information.
Concern Number Three: Because of costs, nearly all RCTs have shorter follow-up periods than what might be observed in clinical practice, potentially missing long-term effects and outcomes. The typical follow-up time for physical therapy-led randomized controlled trials (RCTs) can vary, but it often ranges from 6 months to 1 year [5,6]. Short-term outcomes can lead to limited insight into long-term efficacy, failure to capture reoccurrence rates, and a poorer understanding of variability in patient response. Past studies on trajectories demonstrate that outcomes change markedly over a 1-year period [7]. Lastly, short-term outcomes fail to capture the potential behavioral changes that occur because of the treatment and, conversely, the potential for lack of implementation of self-management strategies over the long term. Participants might alter their behavior or adherence to treatment protocols once the trial ends, affecting long-term outcomes.
Summary: This blog highlights three concerns about RCTs germane to all studies. We emphasize the importance of closely examining the inclusion/exclusion criteria to determine if the study population accurately reflects the patients that clinicians encounter in clinical practice. Additionally, consider the demographics, social status, and other relevant factors that describe the sample. How you integrate the findings into your workflow and care plan should be guided by a clear understanding of these limitations.
References
- Cook CE, O’Halloran B, McDevitt A, Keefe FJ. Specific and shared mechanisms associated with treatment for chronic neck pain: study protocol for the SS-MECH trial. J Man Manip Ther. 2024;32(1):85-95.
- Stuart EA, Bradshaw CP, Leaf PJ. Assessing the generalizability of randomized trial results to target populations. Prev Sci. 2015;16(3):475-85.
- Holmberg MJ, Andersen LW. Adjustment for Baseline Characteristics in Randomized Clinical Trials. JAMA. 2022;328(21):2155-2156.
- Clewley D, Rhon D, Flynn T, Koppenhaver S, Cook C. Health seeking behavior as a predictor of healthcare utilization in a population of patients with spinal pain. PLoS One. 2018;13(8):e0201348.
- Herbert RD, Kasza J, Bø K. Analysis of randomised trials with long-term follow-up. BMC Med Res Methodol 2018;18:48.
- Llewellyn-Bennett R, Bowman L, Bulbulia R. Post-trial follow-up methodology in large randomized controlled trials: a systematic review protocol. Syst Rev 2016;5:214.
- Nim C, Downie AS, Kongsted A, Aspinall SL, Harsted S, Nyirö L, Vach W. Prospective Back Pain Trajectories or Retrospective Recall-Which Tells Us Most About the Patient? J Pain. 2024 Nov;25(11):104555.
