EFFICACY OF A PATIENT-EDUCATIONAL BOOKLET FOR NECK PAIN
PATIENTS WITH WORKERS’ COMPENSATION: A RANDOMIZED CONTROLLED
TRIAL1
Jane Derebery, M.D., FACOEM*, Geneva M. Giang, MBA**, Robert J. Gatchel, Ph.D.***,
Kent Erickson, M.D. * * * *, and W. Tom Fogarty, M.D. * *
* Concentra Health Services, 10200 Broadway Blvd. - Ste. 201, San Antonio, TX 78217
** Concentra Health Services, 5080 Spectrum Drive - Ste. 1200, West Tower, Addison, TX 75001
*** Department of Psychology, College of Science, The University of Texas at Arlington, Arlington, TX 76019
**** Concentra Health Services, 410 Greens Rd., Houston, TX 77060
Corresponding Author:
Dr. Robert J. Gatchel
Department of Psychology, College of Science The University of Texas at Arlington
Arlington, TX 76019-0528
gatchel@uta.edu
1 The authors would like to thank Dr. Kim Burton for his consulting help in designing this study.
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ABSTRACT
Study Design. A randomized controlled trial of an educational booklet for patients with first-time neck pain.
Objective. To assess the clinical impact of a novel educational book on patients’ functional outcomes and beliefs about neck pain.
Summary of Background Data. Previous research has shown that a novel education booklet (The Back Book) had a positive impact on low back pain patients’ beliefs and clinical outcomes. The current study sought to evaluate the efficacy of a similar education booklet (The Neck Book) for neck pain patients.
Methods. Workers’ compensation patients were given either the experimental booklet, a traditional booklet or no booklet. The primary outcome measures, collected at 2-weeks, 3- months, and 6-months after baseline, were The Fear Avoidance Beliefs Questionnaire (FABQ) and The Neck Pain & Disability Scale (NPDS). Health-related functional measures were also collected at these intervals.
Results. Only 34% (N=1 87) of an original cohort of patients (N=522) had data for all of the follow-up periods. For these 187 patients, repeated-measures analyses of covariance, using the baseline measure as the covariate, revealed no significant differences among the three groups on any of the outcome measures at any of the follow-up periods. For example, at 6-months, the experimental booklet, traditional booklet and no-booklet groups reported NPDS mean scores (SDs) of 31.3 (15.5), 35.3 (17.0) and 31.8 (15.6), respectively. Similarly, there were no significant effects for the FABQ scores—35.9 (21.5), 40.3 (22.1) and 38.0 (23.4), respectively. Conclusions. This study demonstrates that the educational booklets studied were not associated with improved outcomes in patients with neck pain receiving workers’ compensation. Whether
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these results would apply to a non-workers’ compensation population requires further study. The loss of many patients to follow-up also makes any other firm conclusions more difficult to determine.
Key Words. Advice; neck pain; education booklet; randomized controlled trial
Key Points.
1. A new patient-education booklet was no better than a standard booklet or no education booklet at all in reducing workers’ compensation neck-pain patients’ beliefs about neck pain and functional outcomes.
2. These findings are in contrast to earlier results that demonstrated some efficacy of a patient education booklet with low back pain patients. However, whether these results would apply to a non-workers’ compensation population requires further study.
3. Future research is needed to determine if patient education material, when combined with other treatment modalities, may be beneficial.
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MINI ABSTRACT
A randomized controlled study assessed the clinical efficacy of a novel education booklet on workers’ compensation patients’ beliefs about neck pain and functional outcomes. Results revealed that the educational booklet was not associated with improved outcomes. Reasons for the findings are discussed.
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INTRODUCTION
The overall costs associated with the management of neck and back disorders amount to tens of billions of dollars each year in the United States 1 and, according to recent evidence, annual costs due to neck and back problems are continuing to rise substantially. For example, annual expenditures for spine problems and pain have risen 65% during the period 1997 to 2005, without any measurable improvement in outcomes. 2 Moreover, occupational musculoskeletal disorders are also the leading cause of work disability in the U. S. Back and neck pain are the most prevalent forms of these disorders, but neck pain has received less empirical study of
3
interventions, relative to back pain . It is hoped that an effective way of preventing the
4
development of chronic back or neck pain is early intervention at the acute stage . Some clinical researchers have investigated potentially time- and cost-effective methods, namely patient-education booklets administered during the acute phase of low back pain. 5,6 For example, Burton and colleagues 5 developed The Back Book, and found that acute low back pain patients who received it displayed a significantly greater improvement in fear-avoidance beliefs about physical activity, as well as improvement on the Roland Disability Questionnaire, relative to a control group. This control group received a traditional educational booklet which merely focused on the biomedical aspects of back care, such as anatomy, biomechanics, disc disease and injury, versus the psychosocial stress factors and “activity despite pain” promotion of The Back Book.
Unlike the clinical intervention research for low back pain, there has not been comparable research for cervical pain. This is unfortunate because chronic or frequently recurring neck pain occurs in about 14% of the general population 7, and the costs are in the hundreds of millions in each industrialized country. 8 Most patients with acute neck pain recover within 3-6 months.
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However, about 18%-40% develop chronic pain 7 . Thus, it is important to successfully intervene at the acute phase before chronicity develops. As a means of remedying the relative neglect of clinical research on neck pain, a special supplement of Spine has been published that addresses important issues in the study of neck pain 9
In an attempt to duplicate an early education approach for neck pain, similar to that developed for low back pain, McClune, Burton and Waddell 10 developed a patient-educational booklet for this purpose. While traditional educational booklets written for patients with neck pain focused on education about the disorder and ways to reduce pain, the focus of The Neck Book is to allay unrealistic fears of patients, and to promote activity, despite pain. The text of The Neck Book was intended for both patients with cervical strains and for those with whiplash (as was The Neck Owner’s Manual, also used in this study). The Neck Book, though, has not yet been formally tested for its efficacy, especially in a workers’ compensation population. The major purpose of the present study was, therefore, to evaluate the therapeutic efficacy of such an educational booklet on a workers’ compensation neck-pain patient population. This represents the first such RCT of this patient-education booklet 11 in a purely U.S. population of work-related neck-pain patients. The high prevalence of neck pain also makes this an important evaluation. Unlike earlier studies of back pain patients, the present study also used a workers’ compensation population. It was hypothesized that the new Neck Book would be more efficacious than a traditional booklet or no booklet at all.
METHODS
Subjects 
First-time neck pain patients were recruited from 40 occupational medical clinics in the Southwestern part of the United States (Louisiana, New Mexico, Oklahoma and Texas)
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belonging to a large occupational healthcare provider network. All injured workers receiving primary care for neck pain (generally cervical strain) in the specified clinics during the 3-year period from 07/01/2004 to 07/31/2007 were evaluated for eligibility. Only patients between the ages of 20 and 60, who could read and speak English, and who met ICD-9 clinical criteria for a neck-related injury, were eligible to participate. In total, 615 patients were initially recruited, provided consent and completed baseline surveys. Upon review of consent forms and baseline surveys, 63 subjects were disqualified due to incomplete baseline surveys and/or absence of contact information (i.e., did not provide a phone number where they could be reached for follow-up). This exclusion reduced the sample to 552 eligible patients.
Of the 552 patients, only 187 completed the entire study, while 365 were further disqualified during the follow-up periods: 60% at 2 weeks; 26% at 3 months; and 14% at 6 months. The primary reason for attrition consisted of the inability to contact the patients (because they did not answer or return calls) within the specified follow-up time periods (58%). Other reasons included: patient relocation, job change or incorrect phone numbers (28%); patients withdrawing consent (9%); and patients who did not comprehend English or could not continue participation due to illness (5%). The remaining 187 study completers had been randomly assigned to one of the 3 groups: the intervention group (Group 1) received The Neck Book1 1 (n=57); the educational control group (Group 2) received the Neck Owner’s Manual 12 (n=64); the third group (Group 3) did not receive any educational/reading materials (n=66). Figure 1 presents a CONSORT chart of this patient flow. 13 It should be noted that statistical analyses of the major baseline variables (e.g., neck pain, fear avoidance, age, gender, time-since-injury, etc.) revealed no significant differences between the completers (n=1 87) and non-completers (n=365; Table 1).
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INSERT FIGURE 1 AND TABLE 1 ABOUT HERE
It should also be noted that the majority of completers and non-completers had worked for their current employer for more than 12 months (65% and 60% respectively). Most of the patients reported semi-skilled occupations, including truck drivers, production workers, and certified nurses’ assistants. There were also no differences in gender composition between the completers and non-completers (59% and 56% males, respectively). Regarding the patients who completed the 2-week follow-up, there were no differences between completers and non-completers on the initial amount of book material read, whether the patients would recommend the book to others, the helpfulness of the book, or the similarity between the book content and the physicians’ instructions.
The Neck Book. The content of this Book, comparable to that in The Back Book, earlier developed by Burton, Waddell, and colleagues, 5 emphasizes that neck pain is very common, but that it is rarely serious or permanent, and that what patients do about neck pain is usually more important than the exact diagnosis or formal treatment. It also emphasizes that regular activity (including work when recovering from a neck strain) is to be encouraged because it can result in more rapid recovery. Examples of statements include: “Rest ... does not help and may actually prolong pain and disability.” “Neck movement seems to speed recovery...” “Xrays and
MRIs ... don’t usually help in ordinary neck pain ... and may even be misleading.” “The pain usually improves within days or a few weeks, at least to get on with your life.” “The people who cope best with neck pain are those who stay active and get on with their life despite the pain.”
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The Educational Control Booklet. This Booklet focused on biomedical aspects of care, such as anatomy, biomechanics, disc disease and injury, as well as activity restrictions and ergonomic suggestions. It also discussed common types of treatment, as well as self-care. Unlike The Neck Book, but similar to traditional education books, it was more cautionary about activity, and did not focus on addressing patients’ apprehensions and fears about their condition. It was patterned after the educational booklet used as a control in the earlier cited study by
5
Burton et al. on back pain. Examples of statements in this Booklet included: “With stresses such as poor posture ... wear and tear, and accidents, it’s no wonder your neck is at risk for pain and injury. This booklet will help you understand neck problems and their treatments.” “Tests may be done to help your healthcare provider confirm a diagnosis (Xrays, MRI, CT, myelogram, blood tests).” “Treatment usually brings results in 6-8 weeks ... It’s common for problems to return.” “Lying down is one of the easiest things you can do to help relieve pain.”
Procedure 
All patients presenting for treatment of neck pain during the specified period were invited to participate in the study. Patients were informed that their participation was voluntary, involved education and surveys only, and would not affect the type or extent of the treatment that they received for their injury at the clinics. Centers presented consenting patients with a sealed envelope containing baseline questionnaires to be completed at checkout, as well as the sealed envelope with the booklet to read at home (or no booklet). Patients then received follow-up telephone surveys at 2 weeks, 3 months, and 6 months to assess changes from baseline, which also included a self-reported health-related questionnaire. It should be noted that these latter questionnaire items were comparable to those used in a great deal of previous clinical research conducted by Gatchel, Mayer and colleagues, that have been shown to be valid and sensitive to
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treatment changes. 14 Patients were tracked via an ID number present on all packet materials (including the consent form which also included the patients’ name and social security number). At baseline, participants completed a page of demographic questions regarding their work history, length of time with present employer, previous injuries, etc. The primary outcome measures of this study, collected at 2-weeks, 3-months, and 6-months after baseline, were the Fear Avoidance Beliefs Questionnaire (FABQ 15 ) and the Neck Pain & Disability Scale
(NPDS 16) . Furthermore, at each period inclusive of the phone interviews, patients were asked if they read and understood the booklet provided to them.
In terms of the standard treatment administered to patients in all three groups, physicians were instructed to provide their ‘usual care’ to their neck pain patients who were participating in the study (these physicians were blinded as to which group a patient was assigned). Within this large provider practice, “usual care” in the management of patients with cervical strains consisted of multiple visits with a primary care provider, and referrals to physical therapy when appropriate. Also, neck patients were often prescribed medications or given over-the-counter analgesics. Furthermore, patients not responding to treatment within four weeks were generally referred to a specialist, or for diagnostic testing. Analysis showed that there were no significant differences among the three groups on any of these treatment variables (data not shown). Statistical Analyses 
For the initial analyses of potential differences between the study completers versus non-completers, chi square tests were conducted for the categorical variables, and independent t-tests for the continuous variables. For analyses of potential group differences for the baseline measures, chi square tests were again conducted for the categorical variables, and analyses of variance for the continuous variables. Finally, for the evaluation of change in trend across
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follow-up time periods, repeated measures analyses of covariance, with the initial baseline as the covariate, were applied to the data.
RESULTS
Baseline Analyses 
The demographic, FABQ and NPDS variables for the three groups (Group 1 received the Education Booklet, Group 2 received the Control Booklet, while Group 3 received no booklet) are presented in Table 2. A series of analyses of variance (for the continuous variables of age, time-since-injury, FABQ, and NPDS scores) and chi square analysis (for the categorical variables of gender and state-location of the clinic in which the patient was evaluated) yielded no significant differences among the three groups.
INSERT TABLE 2 ABOUT HERE
Outcome Analyses 
Figure 2 displays the NPDS scores for each of the 3 groups, at 2-weeks, 3-months and 6- months post-booklet administration. In order to control for any potential initial baseline effect on the subsequent post-booklet time periods, a 3 (Group) X 3 (Time Period) repeated measures analysis of covariance (ANCOVA), with initial baseline as the covariate, was applied to the data. Results indicated no significant differences among the Groups [F(2, 182) = 0.74, p = .476], no significant linear decrease of pain scores across follow-up Time Periods [F(2, 364) = 0.76, p = .467], and no significant Group X Time Period interaction [F(4, 364) = 0.68, p = .609]. It should be noted that, even though there appears to be a decrease in scores from baseline, this was statistically non-significant when baseline was used as the covariate in the analysis.
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INSERT FIGURE 2 ABOUT HERE
Similarly, a repeated measures ANCOVA was also applied to the FABQ scores (Figure 3). There were again no significant differences observed among Groups [F(2, 179) = 0.23, p = .792], no trends across follow-up Time Periods [F(2, 3 5 8) = 0.06, p = .93 8], or for the Group X Time Period interaction [F(4, 3 5 8) = 1. 67, p = . 15 8]. This was also true for both the Work Component and Activity Component subscales of the FABQ when analyzed separately (data not shown).
INSERT FIGURE 3 ABOUT HERE
The three groups were also assessed on the self-reported health-related questionnaire items at 2-weeks, 3-months, and 6-months post-booklet administration. These items assessed whether patients were: (1) currently seeing a doctor for their neck pain; (2) currently taking medications for their neck pain; and (3) missed any work during the past month. The Chi-Square test statistic was applied to these categorical data. All three groups fared comparably on the health-related assessments, with no significant differences among the groups during all three time periods. Table 3 summarizes the results of the analyses on health-related assessments for the groups at the three time periods.
INSERT TABLE 3 ABOUT HERE
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Subgroup Analyses 
All patients in the two booklet groups (Groups 1 and 2) were also assessed on several items related to their extent of having read the booklet, as well as their perceptions of the usefulness of the booklet. All analyses utilized the Chi-Square test statistic. Table 4 presents these items, as well as the analyses at the 2-week follow-up period. The analyses indicated a significantly smaller proportion of patients reading the booklet in Group 2 (control booklet), relative to Group 1 (education booklet; p = .006). The two groups did not differ on the remainder of the booklet-related questions at 2-weeks. Additionally, both groups were comparable, with no significant differences, on all booklet-related questions at the 3-month and 6-month follow-up periods (data not shown).
INSERT TABLE 4 ABOUT HERE
Finally, both the booklet groups were assessed on the NPDS and the FABQ based on whether they had completed reading the booklet. Independent-sample t-tests were conducted for each of the two booklet groups. Additionally, the association between complete reading of the booklet and the health-related questionnaire items was assessed using the Chi-Square test statistic. Table 5 summarizes the findings of these analyses at the 2-week follow-up period. For the education booklet (Group 1), a significant difference was observed on the NPDS between those patients who completed reading the booklet versus those who did not complete the booklet. Contrary to expectations, the subjects who had completed reading the booklet reported higher NPDS scores compared to the subjects who did not complete the booklet (45.0 vs. 36.4, p = .039). There was also a similarly marginal significance in terms of the percentage of patients
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reporting medication usage at the 2-week follow-up, with patients who completed the booklet reporting approximately 3 times (95%CI: 0.9, 8.7) greater medication usage. There were no significant differences found for the 3- and 6-month follow-ups (data not shown).
INSERT TABLE 5 ABOUT HERE
DISCUSSION
The results of the present RCT demonstrated the lack of efficacy of a patient-education booklet intervention in reducing self-reported pain and fear-avoidance measures in neck pain patients, relative to a non-specific, traditional education-booklet group and the no-booklet control group (of course, it should be noted that these results only apply to a workers’ compensation population such as evaluated in this study). In an earlier evaluation, Harms-Ringdahl and Nachemson 17 had also questioned the efficacy of such an intervention for neck pain patients. This lack of differences is in contrast to the results of Burton et al. 5 and Coudeyre et al. 6 for low back pain. Before discussing the possible reasons for such discrepancies, one important comparable finding should be noted. Similar to the present study, Burton et al. (1999) also did not find significant differences between groups for self-reported pain; there were differences found only for fear-avoidance beliefs.
Again, one important factor that needs to be taken into account when comparing the present study of neck pain patients with the earlier ones of low back pain is that the population used in our investigation consisted only of U.S. patients with workers’ compensation claims. A workers’ compensation claim has itself long been recognized as a risk factor for delayed recovery and disability. There are a number of studies that have reported such neck-pain patients
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to be more difficult to treat than non-workers’ compensation neck-pain patients 18 . Additionally, patients receiving workers’ compensation for musculoskeletal disorders are likely to have less objective evidence of disease than those with comparable diagnoses who are not receiving compensation 19,20 . This would support the fact that patients in the workers’ compensation system are more prone to seek treatment for milder disease than those in the general population. Hence, their reasons for seeking treatment may have less to do with having fear and apprehension about how serious the condition is, and more to do with psychosocioeconomic factors. For the above reasons, typically, workers’ compensation patients are often excluded from randomized clinical trials, unlike the present study, which consisted solely of patients with workers’ compensation claims.
The Neck Book emphasizes that regular activity (including work when recovering from a neck strain) is to be encouraged because it can result in more rapid recovery. Such advice would be viewed as reassuring to workers who are apprehensive about a clinician’s motive in promoting return-to-work, particularly if there are concerns that the clinician is promoting rapid work return because of pressure from the patients’ employers. On the other hand, if a worker’s reluctance to return to work is not because of fear or apprehension, but rather because the medical condition serves as a means of escaping work, then The Neck Book would not be viewed as “helpful” by that patient. Of course, another factor may simply be that neck-pain patients are less responsive to such an educational intervention approach than low back pain patients. Obviously, future studies are needed to evaluate whether non-workers’ compensation neck-pain patients are more responsive to such intervention than are workers’ compensation patients. Finally, one potential limitation of the present study that may have affected the results was the very high loss of patients to follow-up (66%).
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It should also be noted that some earlier studies actually challenged the overall efficacy of such patient-education booklets. 21-23 In fact, in an early critique of such approaches, Cherkin et al. 21 challenged the value of a purely educational approach and functional impact in reducing health-care use related to such back pain. Moreover, in a more recent review of RCTs on the effect of written or audiovisual information on low back pain, Henrotin and colleagues 24 concluded that, even though such information is recommended in order to shift patients’ beliefs about low back pain, it alone is not sufficient to decrease absenteeism and health care costs. Thus, overall, the scientific literature is still equivocal concerning the efficacy of such patient-education booklets in comprehensively reducing all low back pain-related problems (i.e., self-reported pain, fear avoidance beliefs, health-care utilization, etc.). Additional clinical research is still greatly needed.
One important area that requires further investigation is the relative efficacy of a patient-education booklet combined with physician support/reinforcement. A randomized intervention study of 13,000 Madrid workers on temporary work leave for non-traumatic musculoskeletal disorders, including neck pain, demonstrated a substantial reduction in lost time and overall case cost in those patients randomized to an intervention program that emphasized physician
25
involvement in education, providing reassurance, and promoting activity . Other literature
suggests that education alone is not effective in producing improvement in medical patients 26,27. Kovacs and colleagues 27 did find that the administration of a Back Book, supported by a 20- minute talk about it with a physician, did improve low back pain-related disability six months later (relative to two other non-low back pain content booklet groups). One shortcoming of that study, though, was that only elderly persons in nursing homes in Spain were evaluated. Thus, the results may not be generalizable to a working-age population. Additional research is needed
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to further evaluate this potentially promising combined approach. Such an approach would still have significant benefit of saving time for physicians. Finally, one additional advantage of a combined approach should be noted. This relates to a potential reason for the lack of differences among groups in the present study—patients may not have completely read and/or understood all of the material presented in the booklets. Indeed, the subgroup analyses conducted suggested some unreliability of patients’ self-reports on whether they had read the booklet. In any event, this would be another reason why physician involvement would be valuable (i.e., to reiterate the important facts of the education booklet). Finally, neither The Back Book nor The Neck Book focused on occupational/work aspects of the pain experience, and did not specifically address return-to-work issues. This, obviously, would be important information for a workers’ compensation population such as that used in the present study. This, too, will need to be addressed in future studies.
In conclusion, unlike The Back Book for low back pain which produced improvement in fear-avoidance beliefs in patients (but not for self-reported pain), The Neck Book did not produce improvement in either measure for patients with neck pain who were receiving workers’ compensation. Of course, whether the booklet would be similarly unhelpful for a population with neck pain without a disability claim warrants a future investigation. It should also be noted that a number of other factors may explain the equivocal findings of the present study: we evaluated only U.S. workers’ compensation patients; neck-pain patients may be less responsive to such booklet-educational approaches than back-pain patients; occupational and work aspects of the pain experience were not addressed; and patients may not have completely read/understood all of the booklet information. As earlier suggested, a patient-education booklet combined with physician support/reinforcement, may prove more efficacious to ensure full
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comprehension by patients of the booklet information and advice. Such an approach would still have a significant benefit of saving time for physicians. This possibility, however, awaits future investigation.
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