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Research Reports |
JA Cleland, PT, PhD, OCS, FAAOMPT, is Associate Professor, Department of Physical Therapy, Franklin Pierce College, 5 Chenell Dr, Concord, NH 03301 (USA); Research Coordinator, Rehabilitation Services, Concord Hospital, Concord, NH; and Faculty, Manual Physical Therapy Fellowship Program, Regis University, Denver, Colo
JM Fritz, PT, PhD, ATC, is Associate Professor, Division of Physical Therapy, University of Utah, Salt Lake City, Utah, and Clinical Outcomes Research Scientist, Intermountain Health Care, Salt Lake City, Utah
JM Whitman, PT, DSc, OCS, FAAOMPT, is Assistant Faculty, Department of Physical Therapy, Regis University, and Faculty, Manual Physical Therapy Fellowship Program, Regis University
R Heath, PT, is Physical Therapist, Rehabilitation Services, Concord Hospital
Address all correspondence to Dr Cleland at: clelandj{at}fpc.edu
Submitted September 23, 2006;
Accepted July 26, 2007
 | Abstract |
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Subjects and Methods: A total of 96 consecutive patients referred for physical therapy for cervical radiculopathy were the sources of data for this study. All subjects underwent a standardized examination and completed the Neck Disability Index (NDI), the Patient-Specific Functional Scale (PSFS), and the Numeric Pain Rating Scale (NPRS) at baseline and at discharge. The subjects were treated according to the discretion of the individual therapists. At the time of discharge, the subjects completed the Global Rating of Change as well. Subjects surpassing the minimal clinically important change for all 4 outcome tools were categorized as achieving short-term success. Individual variables from the examination and interventions provided were tested for univariate relationships with outcomes. Variables with a significance level of less than .10 were retained as potential predictor variables and were entered into a stepwise logistic regression model to determine the most accurate set of variables for predicting outcomes.
Results: The pretest probability for the likelihood of short-term (28-day follow-up) success was 53%. A 4-variable model optimally identified subjects who were most likely to achieve success with physical therapy interventions (age of <54 years; dominant arm is not affected; looking down does not worsen symptoms; and multimodal treatment including manual therapy, cervical traction, and deep neck flexor muscle strengthening for at least 50% of visits). When 3 of these 4 variables were present, the positive likelihood ratio (+LR) was 5.2 (95% confidence interval [CI]=2.4, 11.3), and the posttest probability of success was 85%. When all 4 variables were present, the +LR was 8.3 (95% CI=1.9, 63.9), and the posttest probability of success was 90%.
Discussion and Conclusion: These results suggest that a subset of predictor variables can accurately identify which people with cervical radiculopathy are likely to experience short-term successful outcomes. The study design did not allow for the identification of a cause-and-effect relationship, but it appears that intermittent cervical traction, manual therapy, and deep neck flexor muscle strengthening may be beneficial in the management of cervical radiculopathy. Future research is needed to substantiate these findings.
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 TopAbstract Introduction MethodResultsDiscussionConclusionAppendix 1.Appendix 2.References |
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Several intervention strategies are commonly used in the management of cervical radiculopathy and range from conservative approaches, including physical therapy, to surgical intervention. The long-term benefits of surgical intervention in the management of cervical radiculopathy are questionable, as more than 25% of people who undergo surgery continue to experience debilitating pain at a 12-month follow-up.1 Additionally, other studies9,11 have shown that people treated with conservative management approaches may experience outcomes superior to those achieved with surgical intervention.
Several physical therapy interventions are commonly used in the management of cervical radiculopathy, yet it is unclear whether any physical therapy approach is effective. Although intermittent cervical traction is commonly used in the management of cervical radiculopathy,12–16 only one clinical trial to date has attempted to isolate the effects of cervical traction. Joghataei et al12 randomly assigned 30 people to take part in a treatment program consisting of ultrasound and exercise either with or without intermittent cervical traction for 10 sessions. The group receiving intermittent cervical traction exhibited greater improvements in grip strength (force-generating capacity), the primary outcome measure after 5 sessions; however, no statistically significant difference between groups existed at the time of discharge from physical therapy (10 treatment sessions at 3 sessions per week).12 Unfortunately, the authors did not measure any outcomes associated with pain, function, or disability; therefore, the true benefits of cervical traction could not be ascertained.
The majority of the studies reporting outcomes in people referred for physical therapy have not used well-defined outcome measures or an eligibility criterion that ensures a homogeneous group of people with cervical radiculopathy. However, in 2 recently published case series,14,15 a test item cluster17 was used to identify the presence of cervical radiculopathy. In both case series, study participants were treated with a multimodal treatment approach including manual therapy, strengthening exercises, and cervical traction; the vast majority of participants exhibited improved outcomes. A more recent prospective cohort design16 described the clinical outcomes of study participants receiving a combination of cervical thrust manipulation or muscle energy techniques, neural mobilization, end-range exercises to promote the centralization of symptoms, cervical stabilization, and "over-the-door" traction. The results demonstrated that, at the time of discharge (mean=11 visits), 24 of 31 participants (77.4%) surpassed the minimal clinically important difference for changes in the Bournemouth Disability Questionnaire. This value increased to 93% (25 of 27 participants) at the time of a long-term follow-up (mean=8.2 months).16
There appears to be relative consistency regarding the clinical prognosis for people with cervical radiculopathy.7,9 For example, Radhakrishnan and colleagues7 reported that nearly 90% of people with cervical radiculopathy had only mild symptoms at a median follow-up of 4.9 years. However, Honet and Puri9 found that only 70% of people with cervical radiculopathy exhibited good or excellent outcomes after a 2-year follow-up. Although the outcomes for the people in the aforementioned studies7,9 appeared to be favorable and suggested that 70% to 90% of this population can experience dramatic improvement without surgical intervention, clinical variables for determining which people are most likely to experience successful outcomes have not been identified. The purpose of this prospective cohort study was to identify whether variables from the baseline examination or particular physical therapy interventions received could predict the clinical course in a group of people who had a clinical diagnosis of cervical radiculopathy and who were treated with physical therapy management programs.
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1.Appendix 2.References |
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Between February 2004 and September 2006, 141 consecutive patients were screened for possible eligibility criteria. A total of 101 patients met the eligibility criteria; 5 of them did not return for a reexamination visit. As a result, there were no follow-up measurements for these patients; therefore, they were excluded from the analysis. Ninety-six patients, with a mean age of 50.8 years (SD=9.5, range=27–76) (64% women), satisfied the eligibility criteria and were included in the analysis. The mean number of visits for all patients was 6.4 (SD=1.7, range=4–13), with a mean duration of 28 days (SD=9, range=10–56) between the initial examination and the final follow-up treatment session.
To be included in the present study, the patients were required to complete self-report measures at the initial examination and follow-up self-report measures at either a re-examination visit or discharge. In addition, the patients had to read and understand English well enough to complete the self-report measures.
This study qualified for exempt status from the institutional review boards at Concord Hospital, SOAR Physical Therapy, and Franklin Pierce College. All subjects signed informed consent forms approved by the appropriate aforementioned institutional review boards.
Therapists
A total of 10 physical therapists (mean age=38.3 years, SD=7.5, range=27–50) participated in recruiting subjects. All therapists were provided a comprehensive manual of standard procedures with the operational definitions of each examination procedure used in this study. The purpose of the manual of standard procedures was to standardize the examination procedure only; thus, no details regarding the selection of treatment interventions were included. All therapists underwent a 30-minute training session provided by the principal investigator for the examination techniques used in this study. Interventions were selected solely at the discretion of the treating physical therapists.
Participating therapists had a mean of 11.6 years (SD=8.7, range=1–25) of clinical experience. Nine of the 10 participating therapists treated patients on a full-time basis, and 2 therapists were board certified in orthopedics by the American Board of Physical Therapy Specialties. When asked about their experience with manual therapy techniques, 1 therapist reported less than 1 year of experience, 2 reported 1 to 3 years of experience, 3 reported 3 to 5 years of experience, 1 reported between 3 and 10 years of experience, and 3 reported more than 10 years of experience. None of the therapists had undergone formal residency or fellowship training in manual therapy techniques prior to data collection. However, all therapists reported that they had participated in at least 20 hours of continuing education training in manual therapy techniques directed at the spine.
Examination
All subjects completed several self-report measures before a detailed history taking and physical examination were performed by a physical therapist. The self-report measures included the Neck Disability Index (NDI), the Patient-Specific Functional Scale (PSFS), and the Numeric Pain Rating Scale (NPRS). The NDI contains 10 items, 7 related to activities of daily living, 2 related to pain, and 1 related to concentration.20 Each item is scored from 0 to 5, and the total score is expressed as a percentage, with higher scores corresponding to greater disability. The NDI has demonstrated moderate test-retest reliability (intraclass correlation coefficient [ICC]=.68; 95% CI=.03, .90) and has been shown to be a valid health outcome measure for a population of people with cervical radiculopathy.21
The PSFS requires people to list 3 activities that are difficult to perform as a result of their symptoms, injury, or disorder.22 The people rate each activity on a scale of 0 to 10, with 0 representing the inability to perform the activity and 10 representing the ability to perform the activity as well as they could prior to the onset of symptoms.23 The final PSFS score is determined by averaging the 3 activity scores. The PSFS was developed by Stratford et al23 in an attempt to devise a standardized measure for recording a patient's perceived level of disability across a variety of conditions. The PSFS has been shown to exhibit validity as well as test-retest reliability (ICC=.82; 95% CI=.54, .93) for a population of people with cervical radiculopathy.21
The NPRS is used to measure a person's level of pain. People are asked to indicate the intensities of current, best, and worst levels of pain over the preceding 24 hours by using an 11-point scale ranging from 0 ("no pain") to 10 ("worst pain imaginable").24 The average of the 3 ratings is used to represent the person's level of pain over the preceding 24 hours. This method of measuring a person's pain levels was recently used by Cleland et al21 for a group of people with cervical radiculopathy and exhibited test-retest reliability (ICC=.63; 95% CI=.28, .96). The subjects in the present cohort study were not asked to separately identify the magnitude of pain in the neck and upper extremity; thus, only one value was calculated for the NPRS for each subject, as in the proceedings described by Cleland et al.21 The NPRS has been shown to be significantly correlated (P<.001) with the PSFS for a population of people with cervical radiculopathy.21
The standardized history consisted of age, sex, past medical history, location of symptoms (with the use of a body diagram), duration and nature of symptoms, relieving or aggravating activities, medication usage, and prior episodes of neck and arm pain. All data were collected with standardized data collection forms to determine whether the findings differed between subjects who experienced short-term successful outcomes and those who did not.
The physical examination consisted of the previously described tests and measures, which are part of the test item cluster for identifying the presence of cervical radiculopathy (Appendix 1).17 In addition, all physical therapists performed a postural assessment,25 a neurological assessment (myotomes, dermatomes, and reflexes)26 (Appendix 2), an assessment of cervical and thoracic active range of motion and symptom responses,17 segmental mobility testing of the cervical spine (mobility of the segment in a transverse plane), spring testing of the cervical and thoracic (T1–T9) spine in a posteroanterior direction,27 and examination of deep neck flexor28 and scapulothoracic25 muscle strength.
The operational definitions for the postural assessment used in this study were as follows: the subject was identified as having a forward head if the subject's external auditory meatus was anteriorly deviated (anterior to the lumbar spine),25 and the shoulders were identified as protracted if the acromion was noted to be anteriorly deviated (anterior to the lumbar spine).25 The examiners were instructed to identify the contour of the spine for the following groups of segments: C7 to T2 (cervicothoracic junction), T3 to T5, and T6 to T10. Each group of segments was recorded as being normal (no deviation) or having excessive kyphosis or diminished kyphosis.29 Excessive kyphosis was defined as an increase in the convexity of the thoracic spine, and diminished kyphosis was defined as a flattening of the convexity of the thoracic spine (for each group of segments).29
A reliability analysis for the aforementioned tests and measures was not performed in this study. However, clinicians were instructed to perform the physical examination in a manner identical to that in a previous study in which the reliability data for these tests and measures were reported to range from poor to substantial.30
Interventions
Because no evidence exists to suggest the best practice for this population, no specific guidance was provided to clinicians with regard to what interventions were most appropriate for the subjects. Therapists were instructed to select interventions on the basis of their own clinical decision making, and their intervention choices were recorded on a standardized treatment data collection form at each visit (Supplemental Appendix).
Reexamination and Follow-up
At reexamination visits (every 5 or 6 visits) and at discharge, subjects again completed the self-report measures. The last set of self-report measures collected from each subject was used for data analysis. For example, when a subject completed the measures at a reexamination visit and then again at discharge, only the measures completed at discharge were used for data analysis. Conversely, when a subject completed the measures at a reexamination visit, attended 3 more physical therapy sessions, and then did not return for the final treatment session, the measures completed at that reexamination visit were used for data analysis. Additionally, interventions performed for that subject after the re-examination visit were not entered into the database. This system was used in an attempt to include all subjects attending physical therapy sessions for the management of cervical radiculopathy rather than omitting those who did not return for the final treatment session.
Categorizing Interventions
Because the most effective interventions and dose responses for these interventions in a population of people with cervical radiculopathy are unknown, subjects were categorized as having received a particular intervention if they received that intervention in at least 50% of the sessions that they attended. The 50% criterion was used in a recent study investigating the validity of a classification system for the management of neck pain.31 Additionally, on the basis of interventions used in a few recent case studies,14,15 we elected to determine whether subjects receiving a multimodal treatment approach including cervical traction (manual or mechanical), manual therapy, and deep neck flexor muscle strengthening exhibited a better prognosis for a successful outcome than those who did not receive this treatment strategy. Manual therapy for the analysis carried out in this cohort study could have included muscle energy techniques or thrust/nonthrust mobilization/manipulation techniques directed at the cervical or thoracic spine.
Classifying Subjects as Experiencing Short-Term Successful Outcomes
Subjects were classified as having experienced successful outcomes if, at the time of discharge from physical therapy or at their last re-examination, they surpassed the minimal clinically important change (MCIC) for all outcome measures, including the NDI, PSFS, NPRS, and the Global Rating of Change (GROC). It has been reported that the MCIC for the NDI in a population of people with cervical radiculopathy is 7 points, whereas that for the PSFS in the same population has been shown to be 2 points.21 The MCIC has not been specifically identified for people with cervical radiculopathy; hence, we decided to use the reported MCIC of 2 points derived from a population of people with spinal pain.32
The GROC is a 15-point global rating scale ranging from –7 ("a very great deal worse") to 0 ("about the same") to +7 ("a very great deal better").33 Intermittent descriptors of worsening and improving are assigned values from –1 to –6 and from +1 to +6, respectively.34,35 It has been reported that scores of +4 and +5 are indicative of moderate changes in a person's status and that scores of +6 and +7 indicate large changes in a person's status.33 It was determined that subjects who rated their perceived recovery on the GROC as "a very great deal better," "a great deal better," or "quite a bit better" (ie, a score of +5 or greater) at a reexamination visit would be considered to have experienced short-term successful outcomes.
Data Analysis
Subjects were dichotomized as "successful" and "unsuccessful" on the basis of achieving the MCIC for the NDI, NPRS, PSFS, and GROC at the time of a reexamination visit. Individual variables from self-report measures, the history, and the physical examination as well as the number of physical therapy visits, duration of physical therapy, and interventions received were tested for univariate relationships with the reference criteria by use of independent sample t tests for continuous variables and chi-square tests for categorical variables. Additionally, the multimodal treatment approach including cervical traction (manual or mechanical), manual therapy, and deep neck flexor muscle strengthening was tested for univariate relationships on the basis of previous case studies14,15 that offered preliminary evidence for the effectiveness of this type of approach. Variables with a significance level of less than .10 were retained as potential predictor variables.36 For continuous variables with significant univariate relationships, sensitivity and specificity values for identifying subjects who experienced successful outcomes were calculated for all possible cutoff points and then plotted as a receiver operating characteristic curve.37 The point on the curve nearest the upper left-hand corner represented the value with the best diagnostic accuracy, and this point was selected as the cutoff value defining a positive test, indicating that a subject was likely to experience a short-term successful outcome.37 Sensitivity, specificity, +LR, and negative likelihood ratio values were calculated for potential predictor variables.
Additionally, all potential predictor variables were entered into a stepwise logistic regression model to determine the most accurate set of variables for predicting success. A significance level of greater than .10 was required for removal from the equation to minimize the likelihood of excluding potentially helpful variables.36 For prognostic purposes, variables retained in the regression model were used as the most optimal cluster of variables for predicting optimal outcomes for subjects in physical therapy management programs for cervical radiculopathy. Odds ratios (ORs) and corresponding 95% CIs were calculated for all variables that were retained in the model. Additionally, change scores between groups (successful versus unsuccessful) for the NDI, PSFS, NPRS, and GROC were calculated and analyzed with independent t tests. Data analysis was performed with the SPSS version 14.0 statistical software package.*
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1.Appendix 2.References |
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| Discussion |
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TopAbstractIntroductionMethodResultsDiscussionConclusionAppendix 1.Appendix 2.References |
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The study revealed 8 predictor variables that identified people who were referred for physical therapy for cervical radiculopathy and who were likely to exhibit short-term success. Three of these variables were obtained from the subject history (age of <54 years, dominant arm is not affected, and looking down does not worsen symptoms), 1 was obtained from the clinical examination (>30° of cervical flexion), and 4 were associated with the interventions received (receiving mechanical traction, receiving thoracic spine thrust manipulation, not receiving soft-tissue mobilization, and a multimodal approach). As in the present study, age (women over 50 years of age) was previously shown to be a predictor of poor outcomes in people with cervical radiculopathy.40 It is also possible that people who exhibited greater cervical flexion that did not exacerbate their symptoms had a less severe case of cervical radiculopathy, as it is believed that forward flexion might cause a cervical disk to bulge posteriorly and compress a nerve root.6,41
The aforementioned variables individually exhibited likelihood ratios between 1.3 and 2.2, which resulted in a relatively small shift in probability that a subject would be likely to experience a successful outcome.42 However, the logistic regression analysis identified a parsimonious set of predictor variables that maximized the ability to identify a subject likely to experience a successful outcome: age of less than 54 years; dominant arm is not affected; looking down does not worsen symptoms; and multimodal treatment including manual therapy, cervical traction, and deep neck flexor muscle strengthening for at least 50% of visits. When all 4 variables were present, the +LR was 8.3 and the posttest probability of success was 90%. However, the 95% CI for this +LR was wide (1.9, 63.9). With a smaller 95% CI, a clinician might achieve better accuracy in predicting whether a subject would be likely to have a short-term successful outcome if only 3 of the 4 variables were present (posttest probability=85%). That is, if 3 of the 4 previously mentioned variables were present, a clinician could predict successful outcomes in 85% of subjects referred for physical therapy for cervical radiculopathy.
Interestingly, none of the interventions in isolation was maintained in the model as a predictor of outcome, yet a multimodal approach including cervical traction, manual therapy, and deep neck flexor muscle exercises was included in the final subset of predictors. These findings coincide with those of 2 recent case series14,15 and a prospective cohort design,16 which reported dramatic reductions in disability following a management strategy that included both cervical traction and manual therapy interventions. Although it appears that a multimodal treatment approach including cervical traction, manual therapy, and deep neck flexor muscle exercises may be associated with positive outcomes, an optimal dose response cannot be determined from the present study because no control was exerted over the interventions used by the treating therapists. For example, clinicians selected different forces and durations of mechanical traction for the subjects, and the numbers of manual therapy techniques used for the subjects varied. Additionally, we did not measure the length of time for which some interventions were used. Therefore, inferences regarding the effectiveness of individual versus multimodal treatment approaches cannot be made from the present study. Future randomized clinical trials should be performed to further investigate the effectiveness of such approaches.
Persson and colleagues43 reported that outcomes associated with physical therapy were as good as those associated with surgical intervention in the management of cervical radiculopathy. It seems sensible that people would select the most conservative approach to treatment prior to agreeing to surgical intervention, which often has mixed and disappointing results.9,11
In the present prospective cohort study, 53% of subjects referred for physical therapy for cervical radiculopathy exhibited successful outcomes. This value is lower than the values reported by Radhakrishnan et al7 and Honet and Puri,9 although the percentages of patients achieving positive outcomes with conservative care were recorded at a long-term follow-up in each of those studies (4.9 and 2 years, respectively). The short-term follow-up in our study is a limitation because the subjects might have improved simply over the passage of time rather than because of the influence of any other variable, and we cannot be certain that the same outcomes would have existed at a long-term follow-up. Honet and Puri9 reported that the percentages of patients experiencing positive outcomes diminished between the completion of conservative care and the 2-year follow-up, suggesting that spontaneous recovery might not be the reason why they found higher percentages of positive outcomes than we did.
Another reason for the differences in outcomes reported in the present study and those of Radhakrishnan et al7 and Honet and Puri9 may be directly related to the operational definitions used to identify positive outcomes. Radhakrishnan et al7 arbitrarily categorized patients as having positive outcomes if they were normal or mildly incapacitated (symptoms producing slight incapacity but not preventing ordinary everyday activities), as determined through medical record reviews. Honet and Puri9 also identified positive outcomes through medical record reviews and classified patients as having good outcomes when the quantitative findings decreased, yet the patients did not need to show a full obliteration of qualitative symptoms.
We prospectively collected data on subjects, identified positive outcomes by using reliable and valid methods, and set the cutoff rather high by requiring subjects to have surpassed the MCIC for 4 outcome tools: NDI, NPRS, PSFS, and GROC. Additionally, the successful group experienced change scores that were significantly higher than those experienced by the unsuccessful group. All subjects in the present study exceeded a change in outcome measures that surpassed the MCIC for the NDI, PSFS, and NPRS. If we had reduced the criteria for success, then the results of the present study might have been similar to those reported by Radhakrishnan et al7 and Honet and Puri.9
Besides the short-term follow-up, there are other limitations of the present study. The use of the test item cluster described by Wainner et al17 for the inclusion of cervical radiculopathy may in itself be a limitation. The study by Wainner et al17 was the first step in the development of a decision rule, and follow-up studies are required to validate the findings.44 Wainner et al17 also recruited a cohort of patients who were referred for electrodiagnostic testing, perhaps suggesting that this cluster captured patients with more serious cases of cervical radiculopathy. It also is possible that using the test item cluster established by Wainner et al17 as an inclusion criterion resulted in the exclusion of subjects with radiculopathy associated with the eighth cervical nerve root. The consecutive prospective design used by Wainner et al17 included a measurement for only one patient with expected C8 radiculopathy; hence, we cannot be confident about the diagnostic utility of the test item cluster for people with C8 nerve root involvement. Although we might have missed some subjects with C8 radiculopathy, the most common level of nerve root involvement is C7, followed by C67; this level of involvement appears to be representative of our sample on the basis of the neurological examination. Additionally, findings from the neurological examination also indicated that we did obtain measurements for at least some subjects referred for physical therapy for expected C8 radiculopathy (Tab. 2).
It is possible that some unmeasured factors also might have predicted improved outcomes achieved by subjects; these include psychosocial variables that were not measured at baseline, subjects' motivation, and subjects' adherence to home exercise programs. Numerous interventions are used by physical therapists in the management of cervical radiculopathy; however, we are not able to ascertain treatment effectiveness from the present study. We recommend that further scientific investigations in the form of clinical trials be performed to determine whether a cause and effect relationship exists between individual and multimodal treatment approaches and outcomes in people with cervical radiculopathy.
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* SPSS Inc, 233 S Wacker Dr, Chicago, IL 60606. 
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