The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 94, Issue 23

Scientific Articles | December 05, 2012

Smoking Cessation Related to Improved Patient-Reported Pain Scores Following Spinal Care

Caleb Behrend, MD¹; Mark Prasarn, MD²; Ellen Coyne, MS¹; MaryBeth Horodyski, EdD, ATC³; John Wright, MS¹; Glenn R. Rechtine, MD¹

¹ Department of Orthopaedics, University of Rochester Medical Center, 601 Elmwood Avenue, Box 665, Rochester, NY 14625. E-mail address for C. Behrend: behrend@ucla.edu
² Department of Orthopaedic Surgery, University of Texas Medical School at Houston, 6400 Fannin, Suite 1700, Houston, TX 77030
³ UF Orthopaedics and Sports Medicine Institute, University of Florida, P.O. Box 112727, Gainesville, FL 32611

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Investigation performed at the University of Rochester, Rochester, New YorkDisclaimer: The contents of this paper do not represent the views of the Department of Veterans Affairs or the United States Government.This article was chosen to appear electronically on October 24, 2012, in advance of publication in a regularly scheduled issue.

J Bone Joint Surg Am, 2012 Dec 05;94(23):2161-2166. doi: 10.2106/JBJS.K.01598

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Abstract

Background:

Smoking is associated with low back pain, intervertebral disc disease, inferior patient outcomes following surgical interventions, and increased rates of postoperative complications. The purpose of the present study was to examine the effect of smoking and smoking cessation on pain and disability in patients with painful spinal disorders.

Methods:

We examined a prospectively maintained database of records for 5333 patients with axial or radicular pain from a spinal disorder with regard to smoking history and the patient assessment of pain on four visual analog scales during the course of care. Confounding factors, including secondary gain, sex, age, and body mass index, were also examined. The mean duration of follow-up was eight months. Multivariate statistical analysis was performed with variables including smoking status, secondary gain status, sex, depression, and age as predictors of pain and disability.

Results:

Compared with patients who had never smoked, patients who were current smokers reported significantly greater pain in all visual analog scale pain ratings (p < 0.001). The mean improvement in reported pain over the course of care was significantly different between nonsmokers and current smokers (p <0.001). Compared with patients who had continued to smoke, those who had quit smoking during the course of care reported significantly greater improvement in pain in visual analog scale pain ratings for worst (p = 0.013), current (p < 0.05), and average weekly pain (p = 0.024). The mean improvement in the visual analog scale pain ratings was clinically important in patients in all three groups of nonsmokers. As a group, those who had continued smoking during treatment had no clinically important improvement in reported pain.

Conclusions:

Given a strong association between improved patient-reported pain and smoking cessation, this study supports the need for smoking cessation programs for patients with a painful spinal disorder.

Level of Evidence:

Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Figures in this Article

Introduction

Introduction | Materials and Methods | Results | Discussion | Acknowledgements

Nearly all individuals will be seen by a physician for back pain or other painful spinal disorders at some point in their lives. The socioeconomic impact of such common disorders in terms of cost of care and lost productivity is daunting. Smoking has been identified as a modifiable risk factor for chronic pain disorders^1-4. The underlying relationship between pain and smoking is complex. Patients may be newly exposed, may be habituated, or may have smoked previously. In addition, acute and chronic pain may have a different association with smoking⁵. Nicotine, the most recognized component of tobacco smoke, has analgesic properties in animal models. Analgesic properties have been shown in some studies in humans, but these effects are modulated by the duration of exposure^5-9. This finding is in apparent contrast to the many clinical studies that show smokers to be at increased risk of chronic pain disorders^2-4. The association is particularly noted with regard to back pain^3,10-17. Furthermore, with regard to chronic pain disorders, smokers have reported an increased magnitude of pain when compared with nonsmokers^1,18. Glassman et al. found that smoking cessation in patients undergoing spinal arthrodesis was associated with increased patient satisfaction, fusion rates, and return to work¹⁹. Large epidemiologic studies have found compelling associations between smoking and degenerative disc disease with increased rates of disc degeneration and discectomy for smokers^20,21. Animal models of degenerative disc disease have shown increased pro-inflammatory markers and structural changes in the disc anulus with tobacco smoke exposure^22,23. Further studies found evidence for vasoconstriction and altered nutrient distribution to the disc^24,25. Direct cellular toxicity from the components of tobacco smoke on bovine and human disc cells has also recently been reported^22,26.

The present study examined the relationship among patient smoking status, smoking cessation, and a patient self-assessment of pain and disability during treatment for axial or radicular pain associated with spinal disorders. The purpose of the present study was to determine if there is an association with improved reported pain from this cost-effective intervention in addition to the dramatic benefits of smoking cessation on long-term health.

Materials and Methods

Introduction | Materials and Methods | Results | Discussion | Acknowledgements

Approval was obtained from our institutional review board to conduct a study of patients undergoing spinal care. A prospectively maintained database for patients managed at two academic hospital centers was examined with regard to smoking history, secondary gain factors, the Oswestry Disability Index, and the patient assessment of pain on visual analog scales (VAS) pain rating (worst, least, weekly, and current pain). The change in these assessments was also followed between the time of the initial visit and the time of the latest follow-up with the treating physician. The differences in body mass index (BMI), sex, age, and the Oswestry Disability Index among groups were also examined. Smoking status was defined by four groups: (1) those who had never smoked, (2) smokers who had quit prior to entry into care, (3) current active smokers, and (4) those who had quit smoking during the course of care. Confounding secondary gain factors known to affect outcomes were also examined^27-34. Secondary gain was defined as individuals who reported ongoing Workers’ Compensation, litigation, disability, or malpractice claims related to the painful spinal disorder. The data set included the fully completed questionnaire records for 5333 patients at the time of entry into care and at the time of the latest follow-up with the treating physician. The treating physicians included operative and nonoperative spine specialists, and the overall rate of operative treatment was low in all groups, representing 3.2% (n = 168) of the patient population. Nonoperative treatment for pain included physical therapy, over-the-counter pain medications, a home exercise program, injections, and smoking cessation counseling. The smoking cessation program for patients included counseling by the treating physician, referral to a smoking cessation hotline, and recommendations to discuss smoking cessation with their primary care physicians.

The patient baseline characteristics are summarized in Figure 1. On the basis of the diagnosis at the initial evaluation, 86.5% (n = 4613) of the patients in the study group were managed for the degenerative disease of the cervical or lumbar spine. In addition, 6.9% (n = 368) of the patients had a diagnosis of painful spinal deformity, 3.8% (n = 200) had musculoskeletal low back pain, and 4.3% (n = 231) were followed for fractures of the spine. Cumulatively, <0.6% (n = 32) of patients were followed for other diagnoses, including rheumatologic, oncologic, or infectious disease processes. More than one primary diagnosis code for spinal pathology was present in some cases. The mean duration of follow-up was eight months (range, one to forty-two months). Multivariate statistical analysis was performed with use of SPSS Statistics 19 software (IBM, Armonk, New York). A general linear model was used with independent variables, including smoking status, secondary gain status, sex, depression, and age. Dependent variables included self-reported VAS pain ratings, the Oswestry Disability Index, changes in the VAS pain ratings, and the change in the Oswestry Disability Index from the first visit to the latest follow-up. The level of significance was set at p < 0.05. When appropriate, post hoc analysis was performed with use of the Bonferroni correction.

Fig. 1

Flowchart showing patient demographic and clinical characteristics of 5333 patients. (Of the original 6779 patients, 643 were excluded for having follow-up [f/u] of less than one month and 803 were excluded for having an incomplete smoking history.) At the time of entry into treatment, the data are given as the mean number of patients, categorized by smoking status, sex, and the mean (and standard deviation) values of age, body mass index (BMI), and the Oswestry Disability Index (ODI).

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Source of Funding

This study was conducted with support from a grant by the Southwestern Medical Foundation. Grant funding was used to create and maintain the patient database.

Results

Introduction | Materials and Methods | Results | Discussion | Acknowledgements

The mean reported pain scores at the time of the first visit and at the time of the latest follow-up are shown in Table I with four VAS: (1) the worst pain, (2) the average weekly pain, (3) the current pain that the patient was experiencing, and (4) the least pain. At the time of entry into care, patients who had never smoked and prior smokers reported significantly less pain than did those who were currently smoking and those who had quit smoking during the study period (p < 0.001). On the basis of the number of patients in the present study, no difference was observed in reported pain on any pain scale between patients who were currently smoking and the subset of patients who quit smoking at the beginning of the study period.

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TABLE I VAS Pain Scales for Each Smoking Group at the Time of Entry into Care, at the Time of the Latest Follow-up, and the Difference*

VAS Pain Scale	Smoking Status	At the Time of Entry into Care	At the Time of the Latest Follow-up	Difference
Worst	Never	7.53 (7.43 to 7.63)	6.04 (5.92 to 6.15)	−1.50 (−1.63 to −1.36)
	Prior	7.53 (7.40 to 7.66)	6.27 (6.12 to 6.42)	−1.27 (−1.43 to −1.10)
	Current	8.21 (8.05 to 8.36)	7.50 (7.30 to 7.70)	−0.70 (−0.90 to −0.51)
	Quit†	8.22 (7.93 to 8.51)	6.66 (6.28 to 7.04)	−1.56 (−1.94 to −1.17)
Least	Never	2.84 (2.74 to 2.94)	2.29 (2.20 to 2.38)	−0.55 (−0.65 to −0.45)
	Prior	2.79 (2.67 to 2.91)	2.40 (2.28 to 2.53)	−0.38 (−0.51 to −0.26)
	Current	3.76 (3.59 to 3.93)	3.40 (3.24 to 3.56)	−0.36 (−0.53 to −0.19)
	Quit†	3.83 (3.51 to 4.16)	3.22 (2.92 to 3.52)	−0.61 (−0.92 to −0.31)
Weekly	Never	5.56 (5.45 to 5.66)	4.29 (4.18 to 4.40)	−1.26 (−1.38 to −1.14)
	Prior	5.55 (5.41 to 5.67)	4.57 (4.42 to 4.71)	−0.98 (−1.13 to −0.82)
	Current	6.24 (6.07 to 6.41)	5.78 (5.59 to 5.97)	−0.46 (−0.66 to −0.27)
	Quit†	6.49 (6.16 to 6.82)	5.26 (4.91 to 5.62)	−1.23 (−1.56 to −0.86)
Current	Never	4.58 (4.47 to 4.68)	3.59 (3.49 to 3.70)	−0.98 (−1.10 to −0.87)
	Prior	4.45 (4.31 to 4.59)	3.76 (3.62 to 3.90)	−0.70 (−0.85 to −0.55)
	Current	5.32 (5.14 to 5.50)	4.86 (4.68 to 5.04)	−0.46 (−0.66 to −0.28)
	Quit†	5.56 (5.22 to 5.89)	4.49 (4.15 to 4.84)	−1.07 (−1.44 to −0.70)

*The values are given as the mean in points, with the 95% CI in parentheses.
†Current smokers who later quit during the treatment.

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TABLE I VAS Pain Scales for Each Smoking Group at the Time of Entry into Care, at the Time of the Latest Follow-up, and the Difference*

VAS Pain Scale	Smoking Status	At the Time of Entry into Care	At the Time of the Latest Follow-up	Difference
Worst	Never	7.53 (7.43 to 7.63)	6.04 (5.92 to 6.15)	−1.50 (−1.63 to −1.36)
	Prior	7.53 (7.40 to 7.66)	6.27 (6.12 to 6.42)	−1.27 (−1.43 to −1.10)
	Current	8.21 (8.05 to 8.36)	7.50 (7.30 to 7.70)	−0.70 (−0.90 to −0.51)
	Quit†	8.22 (7.93 to 8.51)	6.66 (6.28 to 7.04)	−1.56 (−1.94 to −1.17)
Least	Never	2.84 (2.74 to 2.94)	2.29 (2.20 to 2.38)	−0.55 (−0.65 to −0.45)
	Prior	2.79 (2.67 to 2.91)	2.40 (2.28 to 2.53)	−0.38 (−0.51 to −0.26)
	Current	3.76 (3.59 to 3.93)	3.40 (3.24 to 3.56)	−0.36 (−0.53 to −0.19)
	Quit†	3.83 (3.51 to 4.16)	3.22 (2.92 to 3.52)	−0.61 (−0.92 to −0.31)
Weekly	Never	5.56 (5.45 to 5.66)	4.29 (4.18 to 4.40)	−1.26 (−1.38 to −1.14)
	Prior	5.55 (5.41 to 5.67)	4.57 (4.42 to 4.71)	−0.98 (−1.13 to −0.82)
	Current	6.24 (6.07 to 6.41)	5.78 (5.59 to 5.97)	−0.46 (−0.66 to −0.27)
	Quit†	6.49 (6.16 to 6.82)	5.26 (4.91 to 5.62)	−1.23 (−1.56 to −0.86)
Current	Never	4.58 (4.47 to 4.68)	3.59 (3.49 to 3.70)	−0.98 (−1.10 to −0.87)
	Prior	4.45 (4.31 to 4.59)	3.76 (3.62 to 3.90)	−0.70 (−0.85 to −0.55)
	Current	5.32 (5.14 to 5.50)	4.86 (4.68 to 5.04)	−0.46 (−0.66 to −0.28)
	Quit†	5.56 (5.22 to 5.89)	4.49 (4.15 to 4.84)	−1.07 (−1.44 to −0.70)

*The values are given as the mean in points, with the 95% CI in parentheses.
†Current smokers who later quit during the treatment.

At the latest follow-up visit, in all VAS pain rating scales, current smokers had significantly higher mean pain (p < 0.001) when compared with patients who had never smoked and those who had previously quit smoking. Compared with patients who had never smoked, patients who had quit smoking prior to the study period reported significantly higher rates of mean worst pain (p = 0.028) and average weekly pain (p = 0.049).

The mean improvement in worst pain, weekly pain, and current pain during the course of care was significantly different between nonsmokers and current smokers (p < 0.001). These mean differences were also greater than the minimal clinically important difference for changes in self-reported pain on a VAS of >15%²⁷. When compared with patients who were smokers, those who had quit smoking reported significantly greater improvement in VAS pain ratings for worst pain (p = 0.013), current pain (p < 0.05), and average weekly pain (p = 0.024). No significant differences were observed with pairwise comparisons between groups for the change in the least pain variable.

Moderate clinically important differences in pain for the VAS pain rating when patients report that symptoms are much improved or have some improvement are defined as a decrease of >30%³⁵. In the present study, the percentage of patients reporting a >30% decrease in worst pain was calculated for each of the four groups: (1) patients who had never smoked (31.2%), (2) prior smokers (29.1%), (3) current smokers (16.6%), and (4) those who had quit smoking (32.0%). To have one additional patient report >30% decrease in initial pain on the average weekly VAS pain rating scale, the number of smokers who needed to quit during treatment was 6.2.

The Oswestry Disability Index differed significantly for those who had never smoked, prior smokers, and current smokers. All four groups reported some decrease in disability as assessed by means of the Oswestry Disability Index. Greater mean improvement was observed in patients who had never smoked (−7.3 points [95% confidence interval (95% CI), −8.1 to −6.5 points]) compared with current smokers (−4.6 points [95% CI, −5.6 to −3.6 points]). Other changes for the Oswestry Disability Index between smoking groups were not significant. None of the changes were clinically important.

The effects of secondary gain and other factor interactions, including sex and age, were also evaluated in the multivariate statistical analysis. A significant interaction of reported secondary gain was observed with all reported assessments of pain as shown in Table II. Patients with reported secondary gain reported significantly more pain on all scales (p < 0.001) and significantly less pain on the VAS weekly and worst pain scales (p ≤ 0.001). Changes in the least-reported pain variable were not significant.

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TABLE II VAS Pain Scales for Each Secondary Gain Group at the Time of Entry into Care, at the Time of Discharge from Care, and the Difference*

VAS Pain Scale	At the Time of Entry into Care	At the Time of Discharge from Care	Difference
Worst
With secondary gain	8.29 (8.16 to 8.42)	7.38 (7.22 to 7.53)	−0.92 (−1.08 to −0.76)
Without secondary gain	7.50 (7.42 to 7.58)	6.09 (6.00 to 6.19)	−1.41 (−1.52 to −1.30)
Least
With secondary gain	3.87 (3.72 to 4.01)	3.49 (3.35 to 3.65)	−0.38 (−0.53 to −0.23)
Without secondary gain	2.78 (2.71 to 2.86)	2.28 (2.06 to 2.36)	−0.50 (−0.58 to −0.42)
Weekly
With secondary gain	6.45 (6.31 to 6.59)	5.74 (5.65 to 5.89)	−0.71 (−0.86 to −0.55)
Without secondary gain	5.50 (5.42 to 5.59)	4.36 (4.28 to 4.46)	−1.14 (−1.24 to −1.04)
Current
With secondary gain	5.53 (5.38 to 5.68)	4.90 (4.75 to 5.06)	−0.63 (−0.79 to −0.48)
Without secondary gain	4.48 (4.39 to 5.36)	3.61 (3.53 to 3.70)	−0.87 (−0.97 to −0.78)

*The values are given as the mean in points, with the 95% CI in parentheses.

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TABLE II VAS Pain Scales for Each Secondary Gain Group at the Time of Entry into Care, at the Time of Discharge from Care, and the Difference*

VAS Pain Scale	At the Time of Entry into Care	At the Time of Discharge from Care	Difference
Worst
With secondary gain	8.29 (8.16 to 8.42)	7.38 (7.22 to 7.53)	−0.92 (−1.08 to −0.76)
Without secondary gain	7.50 (7.42 to 7.58)	6.09 (6.00 to 6.19)	−1.41 (−1.52 to −1.30)
Least
With secondary gain	3.87 (3.72 to 4.01)	3.49 (3.35 to 3.65)	−0.38 (−0.53 to −0.23)
Without secondary gain	2.78 (2.71 to 2.86)	2.28 (2.06 to 2.36)	−0.50 (−0.58 to −0.42)
Weekly
With secondary gain	6.45 (6.31 to 6.59)	5.74 (5.65 to 5.89)	−0.71 (−0.86 to −0.55)
Without secondary gain	5.50 (5.42 to 5.59)	4.36 (4.28 to 4.46)	−1.14 (−1.24 to −1.04)
Current
With secondary gain	5.53 (5.38 to 5.68)	4.90 (4.75 to 5.06)	−0.63 (−0.79 to −0.48)
Without secondary gain	4.48 (4.39 to 5.36)	3.61 (3.53 to 3.70)	−0.87 (−0.97 to −0.78)

*The values are given as the mean in points, with the 95% CI in parentheses.

Discussion

Introduction | Materials and Methods | Results | Discussion | Acknowledgements

The present study consists of results from the analysis of a large, prospectively maintained database of patients evaluated at two university centers. The patients were managed for painful spinal disorders with an average follow-up duration of eight months. At the time of entry to care and at the time of discharge from care, smokers reported more pain than nonsmokers did. Smoking cessation prior to treatment or even acutely during the course of care was related to a greater improvement in reported pain. These differences were clinically important within groups for nonsmokers and between groups for smokers and nonsmokers. Patients who continued smoking during treatment had no clinically important improvement in reported pain on any scale. Although not all relationships achieved significance, there were consistent relationships among the acuity of smoking exposure, reported pain, and reported improvement in pain during treatment.

When current smokers were compared with those who had never smoked, smoking was associated with greater reported disability, as defined by the Oswestry Disability Index, and less improvement in disability, as defined by a change in the Oswestry Disability Index. No significant difference was observed in BMI on the basis of the number of patients in the present study. Current smokers and patients in the smoking cessation group were younger, and those who had never smoked or those who had quit smoking were older (Fig. 1). This result is consistent with prior studies that have found smoking to be a predictor of back pain and to be associated with degenerative disease of the spine at a younger age^13,14.

The strengths of the present study were the size of the study combined with the quality of documentation of smoking status, secondary gain, and other patient factors. Because of the large number of patients, the study population could be inferred to be a diverse group; hence, generalizability was enhanced.

One of the weaknesses of the present study was the inability to capture the effects of all possible factors that may influence reported pain in the various groups and the types of interventions provided by other physicians caring for these patients to assist with smoking cessation or treatment of pain. Another weakness is that the design of the current study did not allow the evaluation of when smoking cessation or improvement in reported pain occurred.

Clinical studies have shown that very few patients who undergo treatment for chronic pain quit smoking, despite a variety of supportive measures for treatment³⁶. This finding is not thought to be attributable to the patient desire to quit³⁷. For the patient population in the present study, the rate of smoking cessation was 22% (n = 253). In the context of care by a surgeon for painful spinal disorders, up to 36% of patients are able to quit smoking with an appropriately structured program and education³⁸. The present study supports the need for smoking cessation programs for patients with axial or radicular pain of spinal etiology, given a strong association between improved patient-reported pain and smoking cessation.

Acknowledgements

Introduction | Materials and Methods | Results | Discussion | Acknowledgements

Note: VA Title, VA Service, Department of Veterans Affairs, Bay Pines VA Healthcare System, Bay Pines, Florida. This material is based on work supported (or supported in part) by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development or “This material is the result of work supported with resources and the use of facilities at the Bay Pines VA Healthcare System.”

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Soegaard R; Bünger CE; Christiansen T; Christensen FB. Determinants of cost-effectiveness in lumbar spinal fusion using the net benefit framework: a 2-year follow-up study among 695 patients. Eur Spine J. 2007 Nov;16( 11):1822-31. Epub 2007 May 23.[CrossRef]

Vaccaro AR; Ring D; Scuderi G; Cohen DS; Garfin SR. Predictors of outcome in patients with chronic back pain and low-grade spondylolisthesis. Spine (Phila Pa 1976). 1997 Sep 1;22( 17):2030-4; discussion 2035.[CrossRef]

Dworkin RH; Turk DC; Wyrwich KW; Beaton D; Cleeland CS; Farrar JT; Haythornthwaite JA; Jensen MP; Kerns RD; Ader DN; Brandenburg N; Burke LB; Cella D; Chandler J; Cowan P; Dimitrova R; Dionne R; Hertz S; Jadad AR; Katz NP; Kehlet H; Kramer LD; Manning DC; McCormick C; McDermott MP; McQuay HJ; Patel S; Porter L; Quessy S; Rappaport BA; Rauschkolb C; Revicki DA; Rothman M; Schmader KE; Stacey BR; Stauffer JW; von Stein T; White RE; Witter J; Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9( 2):105-21. Epub 2007 Dec 11.[CrossRef]

Hooten WM; Townsend CO; Bruce BK; Schmidt JE; Kerkvliet JL; Patten CA; Warner DO. Effects of smoking status on immediate treatment outcomes of multidisciplinary pain rehabilitation. Pain Med. 2009 Mar;10( 2):347-55. Epub 2008 Aug 18.[CrossRef]

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Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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TABLE I VAS Pain Scales for Each Smoking Group at the Time of Entry into Care, at the Time of the Latest Follow-up, and the Difference*

VAS Pain Scale	Smoking Status	At the Time of Entry into Care	At the Time of the Latest Follow-up	Difference
Worst	Never	7.53 (7.43 to 7.63)	6.04 (5.92 to 6.15)	−1.50 (−1.63 to −1.36)
	Prior	7.53 (7.40 to 7.66)	6.27 (6.12 to 6.42)	−1.27 (−1.43 to −1.10)
	Current	8.21 (8.05 to 8.36)	7.50 (7.30 to 7.70)	−0.70 (−0.90 to −0.51)
	Quit†	8.22 (7.93 to 8.51)	6.66 (6.28 to 7.04)	−1.56 (−1.94 to −1.17)
Least	Never	2.84 (2.74 to 2.94)	2.29 (2.20 to 2.38)	−0.55 (−0.65 to −0.45)
	Prior	2.79 (2.67 to 2.91)	2.40 (2.28 to 2.53)	−0.38 (−0.51 to −0.26)
	Current	3.76 (3.59 to 3.93)	3.40 (3.24 to 3.56)	−0.36 (−0.53 to −0.19)
	Quit†	3.83 (3.51 to 4.16)	3.22 (2.92 to 3.52)	−0.61 (−0.92 to −0.31)
Weekly	Never	5.56 (5.45 to 5.66)	4.29 (4.18 to 4.40)	−1.26 (−1.38 to −1.14)
	Prior	5.55 (5.41 to 5.67)	4.57 (4.42 to 4.71)	−0.98 (−1.13 to −0.82)
	Current	6.24 (6.07 to 6.41)	5.78 (5.59 to 5.97)	−0.46 (−0.66 to −0.27)
	Quit†	6.49 (6.16 to 6.82)	5.26 (4.91 to 5.62)	−1.23 (−1.56 to −0.86)
Current	Never	4.58 (4.47 to 4.68)	3.59 (3.49 to 3.70)	−0.98 (−1.10 to −0.87)
	Prior	4.45 (4.31 to 4.59)	3.76 (3.62 to 3.90)	−0.70 (−0.85 to −0.55)
	Current	5.32 (5.14 to 5.50)	4.86 (4.68 to 5.04)	−0.46 (−0.66 to −0.28)
	Quit†	5.56 (5.22 to 5.89)	4.49 (4.15 to 4.84)	−1.07 (−1.44 to −0.70)

*The values are given as the mean in points, with the 95% CI in parentheses.
†Current smokers who later quit during the treatment.

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TABLE I VAS Pain Scales for Each Smoking Group at the Time of Entry into Care, at the Time of the Latest Follow-up, and the Difference*

VAS Pain Scale	Smoking Status	At the Time of Entry into Care	At the Time of the Latest Follow-up	Difference
Worst	Never	7.53 (7.43 to 7.63)	6.04 (5.92 to 6.15)	−1.50 (−1.63 to −1.36)
	Prior	7.53 (7.40 to 7.66)	6.27 (6.12 to 6.42)	−1.27 (−1.43 to −1.10)
	Current	8.21 (8.05 to 8.36)	7.50 (7.30 to 7.70)	−0.70 (−0.90 to −0.51)
	Quit†	8.22 (7.93 to 8.51)	6.66 (6.28 to 7.04)	−1.56 (−1.94 to −1.17)
Least	Never	2.84 (2.74 to 2.94)	2.29 (2.20 to 2.38)	−0.55 (−0.65 to −0.45)
	Prior	2.79 (2.67 to 2.91)	2.40 (2.28 to 2.53)	−0.38 (−0.51 to −0.26)
	Current	3.76 (3.59 to 3.93)	3.40 (3.24 to 3.56)	−0.36 (−0.53 to −0.19)
	Quit†	3.83 (3.51 to 4.16)	3.22 (2.92 to 3.52)	−0.61 (−0.92 to −0.31)
Weekly	Never	5.56 (5.45 to 5.66)	4.29 (4.18 to 4.40)	−1.26 (−1.38 to −1.14)
	Prior	5.55 (5.41 to 5.67)	4.57 (4.42 to 4.71)	−0.98 (−1.13 to −0.82)
	Current	6.24 (6.07 to 6.41)	5.78 (5.59 to 5.97)	−0.46 (−0.66 to −0.27)
	Quit†	6.49 (6.16 to 6.82)	5.26 (4.91 to 5.62)	−1.23 (−1.56 to −0.86)
Current	Never	4.58 (4.47 to 4.68)	3.59 (3.49 to 3.70)	−0.98 (−1.10 to −0.87)
	Prior	4.45 (4.31 to 4.59)	3.76 (3.62 to 3.90)	−0.70 (−0.85 to −0.55)
	Current	5.32 (5.14 to 5.50)	4.86 (4.68 to 5.04)	−0.46 (−0.66 to −0.28)
	Quit†	5.56 (5.22 to 5.89)	4.49 (4.15 to 4.84)	−1.07 (−1.44 to −0.70)

*The values are given as the mean in points, with the 95% CI in parentheses.
†Current smokers who later quit during the treatment.

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TABLE II VAS Pain Scales for Each Secondary Gain Group at the Time of Entry into Care, at the Time of Discharge from Care, and the Difference*

VAS Pain Scale	At the Time of Entry into Care	At the Time of Discharge from Care	Difference
Worst
With secondary gain	8.29 (8.16 to 8.42)	7.38 (7.22 to 7.53)	−0.92 (−1.08 to −0.76)
Without secondary gain	7.50 (7.42 to 7.58)	6.09 (6.00 to 6.19)	−1.41 (−1.52 to −1.30)
Least
With secondary gain	3.87 (3.72 to 4.01)	3.49 (3.35 to 3.65)	−0.38 (−0.53 to −0.23)
Without secondary gain	2.78 (2.71 to 2.86)	2.28 (2.06 to 2.36)	−0.50 (−0.58 to −0.42)
Weekly
With secondary gain	6.45 (6.31 to 6.59)	5.74 (5.65 to 5.89)	−0.71 (−0.86 to −0.55)
Without secondary gain	5.50 (5.42 to 5.59)	4.36 (4.28 to 4.46)	−1.14 (−1.24 to −1.04)
Current
With secondary gain	5.53 (5.38 to 5.68)	4.90 (4.75 to 5.06)	−0.63 (−0.79 to −0.48)
Without secondary gain	4.48 (4.39 to 5.36)	3.61 (3.53 to 3.70)	−0.87 (−0.97 to −0.78)

*The values are given as the mean in points, with the 95% CI in parentheses.

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TABLE II VAS Pain Scales for Each Secondary Gain Group at the Time of Entry into Care, at the Time of Discharge from Care, and the Difference*

VAS Pain Scale	At the Time of Entry into Care	At the Time of Discharge from Care	Difference
Worst
With secondary gain	8.29 (8.16 to 8.42)	7.38 (7.22 to 7.53)	−0.92 (−1.08 to −0.76)
Without secondary gain	7.50 (7.42 to 7.58)	6.09 (6.00 to 6.19)	−1.41 (−1.52 to −1.30)
Least
With secondary gain	3.87 (3.72 to 4.01)	3.49 (3.35 to 3.65)	−0.38 (−0.53 to −0.23)
Without secondary gain	2.78 (2.71 to 2.86)	2.28 (2.06 to 2.36)	−0.50 (−0.58 to −0.42)
Weekly
With secondary gain	6.45 (6.31 to 6.59)	5.74 (5.65 to 5.89)	−0.71 (−0.86 to −0.55)
Without secondary gain	5.50 (5.42 to 5.59)	4.36 (4.28 to 4.46)	−1.14 (−1.24 to −1.04)
Current
With secondary gain	5.53 (5.38 to 5.68)	4.90 (4.75 to 5.06)	−0.63 (−0.79 to −0.48)
Without secondary gain	4.48 (4.39 to 5.36)	3.61 (3.53 to 3.70)	−0.87 (−0.97 to −0.78)