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Preliminary Examination of a Proposed Treatment-Based Classification System for Patients Receiving Physical Therapy Interventions for Neck Pain

JM Fritz, PT, PhD, ATC, is Associate Professor, Division of Physical Therapy, University of Utah, and Clinical Outcomes Research Scientist, Intermountain Health Care, 520 Wakara Way, Salt Lake City, UT 84108 (USA)
GP Brennan, PT, PhD, is Director for Clinical Quality and Outcomes, Rehabilitation Agency, Intermountain Health Care

Address all correspondence to Dr Fritz at: julie.fritz{at}hsc.utah.edu

Submitted July 7, 2006; Accepted January 8, 2007

	Abstract

 
Background and Purpose: Neck pain frequently is managed by physical therapists. The development of classification methods for matching interventions to subgroups of patients may improve clinical outcomes. The purpose of this study was to describe a proposed classification system for patients with neck pain by examining data for consecutive patients receiving physical therapy interventions.

Subjects and Methods: Standardized methods for collecting baseline and intervention data were used for all patients receiving physical therapy interventions for neck pain over 1 year. Outcome variables were the Neck Disability Index (NDI), numeric pain rating, and number of visits. Treatment was provided at the discretion of the physical therapist. After the completion of treatment, each patient was classified by use of baseline variables. The interventions received by the patient were categorized as being matched or not matched to the classification. Outcomes for patients who received matched interventions were compared with those for patients who received nonmatched interventions. The interrater reliability of the classification algorithm was examined with a subset of 50 patients.

Results: A total of 274 patients were included in this study (74% women; age [±SD]=44.4±16.0 years). The most common classification was centralization (34.7%); next were exercise and conditioning (32.8%) and mobility (17.5%). The interrater reliability for classification decisions was high (kappa=.95, 95% confidence interval [CI]=0.87–1.0). A total of 113 patients (41.2%) received interventions matched to the classification. Receiving matched interventions was associated with greater improvements in the NDI (mean difference=5.6 points, 95% CI=2.6–8.6) and in pain ratings (mean difference=0.74 point, 95% CI=0.21–1.3) than receiving nonmatched interventions.

Discussion and Conclusion: The development of classification methods for patients with neck pain may improve the outcomes of physical therapy intervention. This study was done to examine a previously proposed classification system for patients receiving physical therapy interventions for neck pain. Receiving interventions matched to the classification system was associated with better outcomes than receiving nonmatched interventions. Although the design of this study prohibited drawing conclusions about the effectiveness of the system, the results suggest that further research on the system may be warranted.

	Introduction

Top Abstract Introduction Method Results Discussion Conclusion References

 
Neck pain is a common condition, with an annual incidence estimated at about 15%.¹ Patients with neck pain frequently are treated without surgery by primary care and physical therapy providers.^2–4 Within physical therapy, there appears to be a great deal of variation in choices of interventions,⁵ indicating a degree of uncertainty about optimal strategies for these patients.⁶ Increased variability in treatments has been suggested to adversely affect the quality of care⁷; this effect may partly explain why research on physical therapy outcomes has revealed smaller effect sizes for patients with neck pain than for patients with other musculoskeletal conditions.³

The literature on the nonsurgical treatment of patients with low back pain suggests that suboptimal clinical outcomes and practice variability may be related to the inability to identify a pathoanatomical cause for the majority of patients, creating uncertainty among practitioners operating within the traditional medical model.^8–10 It appears that the precise pathological etiology underlying many cases of neck pain may be similarly elusive.^11–14 Recognition of the inadequacy of the medical model for the condition of low back pain has led to the development of alternative methods for classifying patients into subgroups based on clinical characteristics to assist in treatment decision making.^15–17 There is evidence that these efforts can improve clinical outcomes for patients receiving physical therapy interventions.^18–21

The development of classification methods based on clinical characteristics for the purpose of specifically directing nonsurgical treatment choices has not advanced for the condition of neck pain as it has for low back pain. Several authors have proposed strategies for the classification of patients with neck pain,^22–24 but little work on validation has been performed. We recently proposed a treatment-based classification approach that seeks to use information from the history and physical examination to place patients into 1 of 5 separate subgroups that provide a direction for the initial physical therapy treatment approach.²²

The classification strategy was developed on the basis of evidence when possible, supplemented with expert opinion and common practice when necessary.²² The rationale for the mobility classification is based on evidence generally supporting the use of manual therapy (either manipulation or mobilization) for patients with neck pain, particularly when these interventions are combined with exercise.²⁵ Further evidence from randomized trials suggests that manipulation or mobilization may be more effective for younger patients with more acute symptoms and without signs of nerve root compression.^26–29

The rationale for the centralization classification is based on research demonstrating the prognostic significance of the centralization phenomenon.³⁰ For patients with distal symptoms and signs of nerve root compression, the promotion of centralization of symptoms is recommended as a treatment goal, and interventions such as retraction exercises and traction often are used.³¹ The rationale for the exercise and conditioning classification is based on evidence of the effectiveness of exercise—in particular, strengthening exercises for the deep neck flexor, cervical spine, and upper-quarter muscles—for patients who have chronic neck pain but who do not have signs of nerve root compression.^32–36 The pain control classification encompasses patients with acute, traumatic onset of neck pain with a whiplash mechanism and with very high levels of pain and disability. Evidence for patients fitting this subgroup recommends mobilization,³⁷ neck active range-of-motion (ROM) exercises, and avoidance of immobilization (eg, cervical collar).^38,39 Finally, the headache classification includes patients with a chief complaint of headache presumed to originate from structures in the cervical spine.⁴⁰ The evidence for physical therapy interventions for patients with cervicogenic headaches supports strengthening of the deep neck flexor and upper-quarter muscles along with mobilization or manipulation of the cervical spine.⁴¹

Classification systems are designed to direct treatment and improve outcomes. Proposed systems should be examined to determine whether treatment decision making that matches the recommendation of a system results in better outcomes. Little work has been done to examine proposed classification systems for patients with neck pain. We sought to begin the process of examining the proposed system by prospectively collecting standardized information from the examination, interventions, and clinical outcomes of patients receiving physical therapy interventions for neck pain. We purposefully did not attempt to standardize the treatment decision making of the therapists. The purposes of this study were to examine the proposed treatment-based classification system by describing the prevalence of the subgroups in a sample of patients receiving physical therapy interventions for neck pain and to compare the other characteristics of patients placed in these subgroups. We also sought to examine the interrater reliabilities of the classification algorithm and the treatment-matching criteria and to compare the clinical outcomes of care when treatment decision making matched the system with the outcomes of care when decision making was not matched to the system.

	Method

Top Abstract Introduction Method Results Discussion Conclusion References

 
Procedures

Data for this study were collected from 4 outpatient physical therapy clinics of Intermountain Health Care, a private, nonprofit health care system. In each participating clinic, clinical outcomes are routinely tracked for all patients receiving physical therapy interventions. Each new patient is entered into an electronic database, and at each physical therapy session, a condition-specific disability outcome score and a numeric pain rating (from 0 to 10)⁴² are collected and entered into the database. For patients with neck pain, the Neck Disability Index (NDI)⁴³ is the condition-specific disability measure used at each session. The NDI comprises 10 items related to neck pain and the patient's tolerance for daily activities, each scored from 0 to 5; the scores are summed and expressed as a percentage. The NDI is the most commonly used region-specific scale for patients with neck pain⁴⁴ and has been demonstrated to be a reliable and valid outcome measure for patients with neck pain.^45–48

This study was a prospective longitudinal project involving the collection of standardized data from the examination, interventions, and outcomes of patients receiving physical therapy interventions for neck pain. Prior to data collection, a standardized baseline examination form was developed to gather consistent information on all patients. Key examination variables that were standardized for collection on all patients are shown in Table 1. A standardized form for recording interventions used during each physical therapy session was developed to record consistent intervention information. The categories of interventions recorded and the operational definitions used are shown in Table 2. Physical therapists working in participating clinics attended at least 2 training sessions conducted to familiarize the therapists with the standardized forms. The procedures used for examination items and the operational definitions of the interventions were reviewed. Interventions were discussed, but no explicit instruction in the classification process or clinical decision making was provided. The purpose of the training was to standardize data collection procedures, not to standardize treatment decision making.

Patient Classification

Using the proposed classification system, we developed an algorithm to prioritize the findings and place each patient into a classification category on the basis of variables from the baseline examination (Figure). A classification category was assigned for each patient by a reviewer who was unaware of the interventions used and the patient's clinical outcomes. A second reviewer, also unaware of the interventions and outcomes and unaware of the judgments of the first reviewer, classified a randomly selected subset of 50 patients to examine the interrater reliability of the classification algorithm.

View larger version (23K): [in this window] [in a new window]   Figure. Classification decision-making algorithm. MVA=motor vehicle accident, NDI=Neck Disability Index.

On the basis of evidence regarding interventions for patients with chronic neck pain, strengthening exercises for both the upper-extremity muscles and the cervical or deep neck flexor muscles were considered matched components for the exercise and conditioning classification.^32,36,55,56 Each component had to be received in at least 50% of the sessions. For the pain control classification, cervical mobilization and ROM exercises for the cervical spine were supported by evidence^37–39 and were considered matched components. Because of the acute nature of the condition, each component had to be received within the first 3 sessions. For the headache classification, evidence supported cervical mobilization or manipulation and strengthening exercises for the upper-quarter and deep neck flexor muscles as matched components.^41,57 All 3 components had to be received to be considered matched.

To examine the interrater reliability of determining treatment matching, another reviewer, unaware of the judgments of the first reviewer, was provided with the interventions used for the randomly selected subset of 50 patients mentioned above. This additional reviewer rated the treatment procedures as being matched or not matched to the classification categories.

Data Analysis

To permit the evaluation of clinical outcomes, the analysis included only patients with at least 2 physical therapy visits. The interrater reliabilities of the classification algorithm and the treatment-matching criteria were examined by calculating percentage agreement and kappa coefficients with 95% confidence intervals (CIs) between the judgments of the first and second reviewers. Equal category weights were used in the calculation of the kappa coefficients.

Descriptive statistics were calculated for the baseline characteristics of each classification category, including, for continuous variables, means with standard deviations or medians with ranges of scores and, for categorical variables, frequencies and percentages. Differences among classification categories were examined by analysis of variance, Kruskal-Wallis, or Pearson chi-square tests as appropriate. Clinical outcomes were calculated for each patient by computing the amounts of change in pain rating and NDI scores. To examine the outcomes of the classification categories, we compared clinical outcomes, including the number of sessions, by using Kruskal-Wallis tests, and we compared changes in pain rating and NDI scores across classification categories by using analysis of covariance with the age, sex, and baseline scores of the dependent variables serving as covariates.

The interventions received by each patient were examined by an investigator unaware of the outcome of treatment. On the basis of the necessary components for each classification category (Tab. 3), each patient's treatment was categorized as being matched or not matched to the patient's classification. Treatment was categorized as being matched if each of the necessary components for the patient's classification was received over the course of treatment. We compared the numbers of sessions for patients receiving matched treatments and those receiving nonmatched treatments by using independent t tests. We compared clinical outcomes (changes in NDI and pain rating scores) by using separate analysis of covariance procedures with covariates of age, sex, duration of symptoms, classification category, and baseline score for the outcome measure. We also compared the proportions of patients in the matched and nonmatched groups achieving the minimum detectable change (MDC) for the NDI by using chi-square tests. The MDC represents the smallest amount of change in an outcome measure that likely reflects true change rather than measurement error alone.⁵⁸ The MDC for the NDI has been defined as 8 points.⁴⁷ We categorized any patient with a change score of 8 or greater as achieving the MDC, whereas patients with a change score of 8 or less were categorized as not achieving the MDC. For the examination of the MDC, we excluded patients with a baseline NDI score of less than 10%. We also calculated the clinical outcomes for patients receiving matched treatments and those receiving nonmatched treatments within each category, and we report these values descriptively. Statistical comparisons were not performed because of inadequate power.

	Results

Top Abstract Introduction Method Results Discussion Conclusion References

The centralization category had the largest number of patients (n=95, 34.7%); next were the exercise and conditioning (n=90, 32.8%), mobility (n=48, 17.5%), headache (n=25, 9.1%), and pain control (n=16, 5.8%) categories. The baseline characteristics for these categories are shown in Tables 3 and 4. Patients in the exercise and conditioning category tended to be older and, along with those in the centralization category, had longer symptom durations. Patients in the pain control category had less ROM and were more likely to experience symptom aggravation with ROM. Patients in the centralization category were most likely to experience peripheralization with ROM. Patients in the pain control category had higher baseline NDI and pain rating scores (Tab. 4). Patients in the centralization category experienced fewer changes in NDI and pain rating scores than those in the mobility and pain control categories.

	Discussion

Top Abstract Introduction Method Results Discussion Conclusion References

Developing a classification structure requires the consideration of numerous attributes. Classification categories that are both mutually exclusive and comprehensive must be described. Although aspects of a patient's clinical presentation typically can fit several categories, a useful classification system must be able to prioritize these findings to permit physical therapists to make clinical decisions and researchers to define homogeneous subgroups for future studies. In this article, we have described specific criteria for membership within each classification category and a decision-making algorithm to prioritize these criteria (Figure). Using our mostly clinical experience, we prioritized findings associated with the pain control classification first and findings associated with the centralization classification next. The results of the present study showed that the decision-making algorithm could be applied consistently by different examiners considering the same patient data (kappa value for interrater agreement=.95), but only additional research can evaluate and refine the algorithm so that it results in the best outcomes for patients. Additional research is also necessary to further examine the overall reliability of the classification system, not just the proposed algorithm.

In order to maximize clinical utility, classification systems need to be as comprehensive as possible. The system examined in the present study primarily addresses patients with neck pain and associated symptoms (eg, headache and upper-extremity symptoms) believed to be attributable to dysfunctions of the cervical spine. The decision-making process for screening patients for nonmechanical etiologies is not addressed in this system. Patients with neck pain referred from other structures (eg, temporomandibular joint) are not considered in this system. For patients with neck pain and associated symptoms, the system is designed to assign a specific category to each patient. The literature supports the notions that distinctions between patients with acute symptoms and patients with chronic symptoms^63,64 and between patients with and patients without signs and symptoms associated with nerve root compression⁶⁵ are important for treatment decision making. Patients with acute, traumatic onset (eg, whiplash injury)⁶⁶ and those with headache as a predominant symptom⁴¹ also may represent distinct categories of patients. Further research is needed to determine whether additional subgroups should be added to the system.

Ultimately, the most important attribute of a classification system is its ability to improve patient outcomes when it is used for treatment decision making in clinical practice. Research must demonstrate that outcomes are better when patients receive interventions matched to their classifications than when they receive nonmatched interventions. The design of the present study does not permit any conclusions about the effectiveness of this system for improving clinical outcomes to be drawn. The necessary research design to eventually document the superiority of any decision-making system is a randomized trial.⁶⁷ In the present study, we used a prospective, observational design as a preliminary step toward this end. The results of the present study showed an association between receiving matched treatments and experiencing greater reductions in pain and disability. These findings encourage further research examining the effect of classification methods on clinical outcomes for patients with neck pain.

We examined the overall clinical outcomes of patients receiving treatments that were judged to be matched or not matched to their classifications. Because of the small numbers of patients in some classifications, we did not separately examine the association between clinical outcomes and receiving matched treatments within each classification category. The intent of a classification system is to define combinations of treatments that uniquely benefit patients with certain characteristics. If all patients with neck pain are equally likely to receive benefit from the same combinations of treatments, then classification becomes unnecessary. Further research is needed to examine the relationship between clinical outcomes and receiving matched treatments within each classification category.

The most common classification among the patients in the present study was centralization. This classification was identified by the presence of signs of nerve root compression or symptoms distal to the elbow. Patients in this classification also were more likely to show peripheralization with active ROM at the baseline examination, a finding that may be useful to consider as a classification criterion for this subgroup of patients. Overall, this classification was associated with fewer changes in NDI and pain rating scores than other classifications, a finding that is consistent with the poorer prognosis reported for people with radicular findings in other reports.^14,68 The exercise and conditioning classification was the second most common classification and had the second lowest rate of matched interventions. The exercise and conditioning classification includes older patients with more chronic symptoms than the other classifications. Matched interventions, as indicated by evidence in the literature, focus on strengthening the upper-quarter and cervical muscles. The low rate of matched interventions in this classification may indicate a tendency for therapists not to emphasize strengthening in this subgroup of patients. Patients in the mobility classification tended to experience the most change in pain and disability, consistent with literature supporting a better prognosis for patients with acute neck pain but without radicular symptoms.^11,14

Fewer patients were classified into the headache or pain control classifications. In the headache classification, very few patients received matched interventions (deep neck flexor strengthening, cervical spine manipulation or mobilization, and upper-extremity strengthening). As indicated above, this finding may represent a tendency among the therapists participating in this project not to emphasize strengthening interventions. As expected, patients in the pain control classification reported more pain and disability and greater ROM restrictions, were more likely to report aggravation of symptoms with various movements than patients in other classifications at baseline, and reported the most change in pain and disability with treatment.

The design of the present study has several limitations and potential for bias in the results. Patients were not randomly assigned to receive matched or nonmatched treatments. Despite statistical control for baseline variables such as age, sex, duration of symptoms, and baseline pain or disability scores, important disparities between patients receiving matched treatments and patients receiving nonmatched treatments within each classification may have contributed to the observed differences. Therefore, the present study cannot provide evidence for the predictive validity of the proposed system. Only a study randomizing patients to receive matched or nonmatched treatments could provide such evidence.

Another limitation is the lack of standardization of the intervention procedures. It was left to the physical therapists in the present study to categorize the interventions that were provided. There were likely a wide variety of specific procedures included within many of the categories, such as upper-extremity strengthening exercises. We attempted to record only the basic category of each treatment, not specific techniques or parameters. We did not record the dosage or intensity of exercise or the specific manual techniques used. On the basis of research on patients with low back pain suggesting better outcomes with more standardized interventions than with therapist-selected interventions,⁶⁹ we believe that the presence of associations between categories of treatment and outcomes for subgroups of patients in the present study suggests the potential for the identification of even greater treatment effects in future research with more specific and standardized interventions. Further research is required to determine the critical parameters needed within a treatment category to standardize interventions for the purpose of achieving optimal outcomes.

	Conclusion

Top Abstract Introduction Method Results Discussion Conclusion References

 
Developing classification strategies for patients receiving physical therapy interventions for neck pain is an important priority considering the frequency with which such patients are treated by physical therapists. In the present study, we examined a previously proposed treatment-based classification system for patients receiving physical therapy interventions for neck pain. We found associations between receiving interventions matched to the system and better clinical outcomes. These preliminary results suggest opportunities for further research.

	Footnotes

 
Both authors provided concept/idea/research design, data collection, and project management. Dr Fritz provided, writing, data analysis, and fund procurement. Dr Brennan provided facilities/equipment.

This study qualified for exempt review by the Institutional Review Board of Intermountain Health Care.

This study was supported by a grant from the Deseret Foundation.

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