Annals of Internal Medicine Spinal Manipulation, Medication, or Home Exercise With Advice for Acute and Subacute Neck Pain A Randomized Trial Gert Bronfort, DC, PhD; Roni Evans, DC, MS; Alfred V. Anderson, DC, MD; Kenneth H. Svendsen, MS; Yiscah Bracha, MS; and Richard H. Grimm, MD, MPH, PhD Background: Mechanical neck pain is a common condition that
adverse events. Blinded evaluation of neck motion was performed
affects an estimated 70% of persons at some point in their lives.
Little research exists to guide the choice of therapy for acute andsubacute neck pain. Results: For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P Յ 0.010), and HEA Objective: To determine the relative efficacy of spinal manipulation
was superior to medication at 26 weeks (P ϭ 0.02). No important
therapy (SMT), medication, and home exercise with advice (HEA)
differences in pain were found between SMT and HEA at any time
for acute and subacute neck pain in both the short and long term.
point. Results for most of the secondary outcomes were similar tothose of the primary outcome. Design: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770) Limitations: Participants and providers could not be blinded. No specific criteria for defining clinically important group differences Setting: 1 university research center and 1 pain management clinic
were prespecified or available from the literature. Conclusion: For participants with acute and subacute neck pain, Participants: 272 persons aged 18 to 65 years who had nonspe-
SMT was more effective than medication in both the short and
long term. However, a few instructional sessions of HEA resulted in
Intervention: 12 weeks of SMT, medication, or HEA.
similar outcomes at most time points. Measurements: The primary outcome was participant-rated pain, Primary Funding Source: National Center for Complementary and
measured at 2, 4, 8, 12, 26, and 52 weeks after randomization.
Alternative Medicine, National Institutes of Health.
Secondary measures were self-reported disability, global improve-ment, medication use, satisfaction, general health status (Short
Ann Intern Med. 2012;156:1-10. www.annals.org
Form-36 Health Survey physical and mental health scales), and
For author affiliations, see end of text. Neck pain is a prevalent condition that nearly three METHODS
quarters of persons experience at some point in
their lives (1, 2). One of the most commonly reported
The trial was conducted from 2001 to 2007 in Min-
symptoms in primary care settings (3, 4), neck pain
neapolis, Minnesota. Eligibility screening, randomization,
results in millions of ambulatory health care visits each
and short-term data collection occurred at a university-
year and increasing health care costs (5– 8). Although it
affiliated research center; long-term data collection took
is not life-threatening, neck pain can have a negative
place by mail. A university-affiliated outpatient clinic pro-
effect on productivity and overall quality of life (1,
vided SMT and instruction for home exercise. Medical
treatment was provided at a pain management clinic. The
Chiropractors, physical therapists, osteopaths, and
institutional review boards of Northwestern Health Sci-
other health care providers commonly apply spinal manip-
ences University and Hennepin County Medical Center
ulation, a manual therapy, for neck pain conditions (12),and home exercise programs and medications are alsowidely used (13). Recent Cochrane reviews (13, 14) report
insufficient evidence to assess the effectiveness of com-monly used medications or home exercise programs for the
treatment of acute neck pain. The evidence for spinal ma-
Editors’ Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
nipulation is similarly limited, with only low-quality evi-
Editorial comment. . . . . . . . . . . . . . . . . . . . . . . . . . . 52
dence supporting its use for neck pain of short duration
Summary for Patients. . . . . . . . . . . . . . . . . . . . . . . I-30
Web-Only
Our goal was to test the hypothesis that spinal manip-
ulation therapy (SMT) is more effective than medication
or home exercise with advice (HEA) for acute and subacute
2012 American College of Physicians 1 Downloaded From: http://annals.org/ on 10/19/2012
Original Research Conservative Interventions for Acute and Subacute Neck Pain
off-site by the study statistician before enrollment and was
concealed from the investigators, treatment providers, and
Persons with acute or subacute neck pain often turn to
research staff by using consecutively numbered, sealed,
chiropractors and other practitioners of spinal manipulation
opaque envelopes. As participants became eligible, enve-
lopes were opened in consecutive order by a research staff
Contribution
member in the presence of the participant.
The intervention protocol was tested in a pilot study
This trial demonstrates that 12 weeks of spinal manipula-
by our research team (19). Maximum treatment duration
tion therapy (SMT) led to greater pain relief than medica-tion up to 1 year after treatment. However, trial partici-
was 12 weeks. Treatment providers were trained in the
pants had as much pain relief with home exercise with
study intervention protocols and were required to docu-
advice (HEA) as with SMT over the same period.
ment treatment activities in standardized clinical records,which were routinely monitored by research staff to ensure
Participants were unblinded to interventions. Implication SMT Group
For relief of acute or subacute neck pain, SMT and HEA
Six chiropractors with a minimum of 5 years’ experi-
seemed to be similarly effective and both were more
ence served as the primary providers of treatment. Visits
lasted 15 to 20 minutes and included a brief history andexamination of the cervical and thoracic spine. The pri-
mary focus of treatment was manipulation of areas of thespine with segmental hypomobility by using diversifiedtechniques, including low-amplitude spinal adjustments (a
approved our study, and all participants gave written in-
high-velocity type of joint thrust manipulation) and mobi-
lization (a low-velocity type of joint oscillation) (20). The
Participants
specific spinal level to be treated and the number of treat-
Participants were recruited by using mailings targeted
ment sessions over the 12 weeks was left to the discretion
to persons with neck pain who were registered with Blue
of the provider, based on manual palpation of the spine
Cross/Blue Shield Minnesota and through newspaper and
and associated musculature and the participant’s response
radio advertisements. Interested persons were screened for
to treatment (21). Adjunct therapy common to clinical
eligibility at 2 baseline appointments by clinicians who
practice included limited light soft-tissue massage, assisted
were blinded to the randomization schedule. Inclusion cri-
stretching, and hot and cold packs to facilitate the manip-
teria were age 18 to 65 years; primary symptom of me-
ulation treatment. Advice to stay active or modify activity
chanical, nonspecific neck pain equivalent to grades I or II
according to the Bone and Joint Decade 2000 –2010 TaskForce on Neck Pain and Its Associated Disorders classifi-
Medication Group
cation (16, 17); current neck pain of 2 to 12 weeks’ dura-
A licensed medical physician provided care to partici-
tion; and a neck pain score of 3 or greater on a scale of 0 to
pants, with the focus of treatment on prescription medica-
10. Participants were asked to refrain from seeking addi-
tion. Visits lasted 15 to 20 minutes and included a brief
tional treatment for neck pain from nonstudy health care
history and examination. The first line of therapy was non-
providers during the 12-week intervention.
steroidal anti-inflammatory drugs, acetaminophen, or both
Exclusion criteria were cervical spine instability, frac-
(22, 23). Participants who did not respond to or could not
ture, neck pain referred from peripheral joints or viscera,
tolerate first-line therapy received narcotic medications.
progressive neurologic deficits, existing cardiac disease re-
Muscle relaxants were also used. Advice to stay active or
quiring medical treatment, blood clotting disorders, diffuse
modify activity was issued as needed. The choice of medi-
idiopathic hyperostosis, inflammatory or destructive tissue
cations and number of visits was made by the physician on
changes of the cervical spine, infectious disease or other
the basis of the participant’s history and response to
severe disabling health problems, substance abuse, preg-
nancy or breastfeeding, previous cervical spine surgery, andpending or current litigation. In addition, participants
HEA Group
were excluded if they had received any of the study treat-
Home exercise with advice was provided in two
1-hour sessions, 1 to 2 weeks apart, at the university-
Randomization and Interventions
affiliated outpatient clinic. Six therapists provided instruc-
Participants were randomly assigned at the second
tion to participants. The primary focus was simple self-
baseline appointment by using permutated blocks of dif-
mobilization exercise (gentle controlled movement) of the
ferent sizes (18). The randomization schedule was prepared
neck and shoulder joints, including neck retraction, exten-
2 3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) www.annals.org Downloaded From: http://annals.org/ on 10/19/2012
Conservative Interventions for Acute and Subacute Neck Pain Original Research
Table 1. Baseline Demographic and Clinical Characteristics Characteristic SMT Group Medication Group HEA Group
Mean duration of neck pain (SD), wk
Pain radiating to upper extremity, %
Awake at night because of neck pain, %
CES-D ϭ Center for Epidemiologic Studies Depression Scale; HEA ϭ home exercise with advice; SMT ϭ spinal manipulation therapy.
* On a scale of 0 (none of the time) to 5 (all of the time). † For example, repetitive motion, stress, or sleep position. ‡ On a scale of 0 to 100. § On a scale of 1 (much better) to 5 (much worse).
the SMT group experienced reductions of pain of at least 50% (Table 3). Differences in participant-rated pain im- Table 2. Details of Interventions
provement between the SMT and HEA groups weresmaller and not statistically significant. Differences be-
Group and Characteristic
tween the HEA and medication groups were also not sta-tistically significant, although a higher absolute proportion
SMT group
of the HEA group experienced reductions in pain of at
least 75% at 12 weeks compared with the medication
Specific aspects of intervention, n (%)
Longer-term analyses showed similar findings. At 26
and 52 weeks, participant-rated pain improvement favored
SMT over medication, but not SMT over HEA or HEA
over medication, compared with baseline. A higher abso-
lute proportion in the SMT group than in the medicationgroup experienced reductions of pain of at least 50% at 26
Medication group
but not 52 weeks. Those proportions did not differ at any
time in comparisons of SMT and HEA, and a higher ab-
Specific aspects of intervention, n (%)
solute proportion in the HEA group than in the medica-
NSAID, opioid analgesic, and muscle relaxant
tion group experienced reductions of pain of at least 75%
Adjustment for baseline imbalances in sex, cause of
pain, and depression did not change the group differences
HEA group Secondary Outcomes
Specific aspects of intervention, n (%)
Group differences in most secondary outcomes were
similar to those of the primary outcomes (Appendix Ta- bles 1 to 4, available at www.annals.org). Spinal manipu-
lation therapy was superior to medication at the end of
treatment and during follow-up in terms of global im-
ADL ϭ activity of daily living; HEA ϭ home exercise with advice; NSAID ϭ
provement, participant satisfaction, and SF-36 –assessed
nonsteroidal anti-inflammatory drug; SMT ϭ spinal manipulation therapy. www.annals.org
3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) 5 Downloaded From: http://annals.org/ on 10/19/2012
Original Research Conservative Interventions for Acute and Subacute Neck Pain
Figure. Study flow diagram. First baseline evaluation to assess eligibility (n = 504) Excluded (n = 165) Did not meet inclusion criteria: 126 Declined to participate: 35 Other: 4 Second baseline evaluation to assess eligibility (n = 339) Excluded (n = 67) Did not meet inclusion criteria: 10 Declined to participate: 32 Other: 25 Random assignment (n = 272) Allocated to SMT group (n = 91) Allocated to medication group (n = 90) Allocated to HEA group (n = 91) Received therapy: 91 Received therapy: 84 Received therapy: 91 Did not receive therapy: 6 Declined to participate: 5 Family issues and side effect concerns: 1 Intervention phase Intervention phase Intervention phase Lost to follow-up (n = 3) Lost to follow-up (n = 21) Lost to follow-up (n = 13) Week 12: 1 Week 12: 6 Week 12: 4 Discontinued therapy (n = 2) Discontinued therapy (n = 3) Discontinued therapy (n = 3) No improvement: 1 Pregnant: 1 Declined to participate: 3 Declined to participate: 1 Declined to participate: 2 Postintervention phase Postintervention phase Postintervention phase Lost to follow-up (n = 22) Lost to follow-up (n = 21) Lost to follow-up (n = 31) Week 26: 10 Week 26: 7 Week 26: 12 Week 52: 12 Week 52: 14 Week 52: 19 Analyzed (n = 91) Analyzed (n = 90) Analyzed (n = 91)
Participants were lost to follow-up if they did not provide data at each time point. Patients who discontinued treatment had the opportunity to providefollow-up data. HEA ϭ home exercise with advice; SMT ϭ spinal manipulation therapy.
expectation of change in neck pain. Table 2 provides de-
We evaluated 504 persons for eligibility, of whom
272 were randomly assigned: 90 to the medication
Primary Outcomes
group, 91 to the SMT group, and 91 to the HEA group.
Improvement in participant-rated pain significantly
The Figure summarizes recruitment, participation, and
differed with SMT compared with medication at 12 weeks
(0.94 greater reduction in pain [95% CI, 0.37 to 1.51];
Table 1 summarizes the demographic and clinical P ϭ 0.001) and in longitudinal analyses that incorporated
characteristics of the randomly assigned participants. Po-
pain ratings every 2 weeks from baseline to 12 weeks (0.55
tentially important between-group differences were noted
greater reduction in pain [CI, 0.10 to 1.00]; P ϭ 0.017).
for sex, duration of neck pain, pain during the night, and
At 12 weeks, a significantly higher absolute proportion of
4 3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) www.annals.org Downloaded From: http://annals.org/ on 10/19/2012
Conservative Interventions for Acute and Subacute Neck Pain Original Research
Table 1. Baseline Demographic and Clinical Characteristics Characteristic SMT Group Medication Group HEA Group
Mean duration of neck pain (SD), wk
Pain radiating to upper extremity, %
Awake at night because of neck pain, %
CES-D ϭ Center for Epidemiologic Studies Depression Scale; HEA ϭ home exercise with advice; SMT ϭ spinal manipulation therapy.
* On a scale of 0 (none of the time) to 5 (all of the time). † For example, repetitive motion, stress, or sleep position. ‡ On a scale of 0 to 100. § On a scale of 1 (much better) to 5 (much worse).
the SMT group experienced reductions of pain of at least 50% (Table 3). Differences in participant-rated pain im- Table 2. Details of Interventions
provement between the SMT and HEA groups weresmaller and not statistically significant. Differences be-
Group and Characteristic
tween the HEA and medication groups were also not sta-tistically significant, although a higher absolute proportion
SMT group
of the HEA group experienced reductions in pain of at
least 75% at 12 weeks compared with the medication
Specific aspects of intervention, n (%)
Longer-term analyses showed similar findings. At 26
and 52 weeks, participant-rated pain improvement favored
SMT over medication, but not SMT over HEA or HEA
over medication, compared with baseline. A higher abso-
lute proportion in the SMT group than in the medicationgroup experienced reductions of pain of at least 50% at 26
Medication group
but not 52 weeks. Those proportions did not differ at any
time in comparisons of SMT and HEA, and a higher ab-
Specific aspects of intervention, n (%)
solute proportion in the HEA group than in the medica-
NSAID, opioid analgesic, and muscle relaxant
tion group experienced reductions of pain of at least 75%
Adjustment for baseline imbalances in sex, cause of
pain, and depression did not change the group differences
HEA group Secondary Outcomes
Specific aspects of intervention, n (%)
Group differences in most secondary outcomes were
similar to those of the primary outcomes (Appendix Ta- bles 1 to 4, available at www.annals.org). Spinal manipu-
lation therapy was superior to medication at the end of
treatment and during follow-up in terms of global im-
ADL ϭ activity of daily living; HEA ϭ home exercise with advice; NSAID ϭ
provement, participant satisfaction, and SF-36 –assessed
nonsteroidal anti-inflammatory drug; SMT ϭ spinal manipulation therapy. www.annals.org
3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) 5 Downloaded From: http://annals.org/ on 10/19/2012
Original Research Conservative Interventions for Acute and Subacute Neck Pain
Table 3. Between-Group Differences for Changes From Baseline in Participant-Rated Pain Variable SMT Group Medication Group HEA Group Pain score*
Mean short-term change from week 0†Week 26
Proportion with absolute reduction in pain
HEA ϭ home exercise with advice; SMT ϭ spinal manipulation therapy.
* On a scale of 0 (no neck pain) to 10 (worst neck pain possible). † Group differences based on data from weeks 2, 4, 8, and 12. ‡ Group differences based on data from weeks 2, 4, 8, 12, 26, and 52.
physical but not mental function; SMT was also superior
questionnaire collected by mail independent of study staff,
to medication in measures of long-term medication use
(1.26 fewer days per week of use at week 52 [CI, 0.53 to1.99 days]; P Ͻ 0.001). Missing Data Analysis
The SMT and HEA groups performed similarly on
Among the 272 participants, 219 (80.5%) provided
most of the secondary outcomes, although SMT per-
data on neck pain at every visit. We considered loss to
formed better than HEA for satisfaction with care in both
follow-up to be nonrandom for 12 participants, 6 of whom
the short and long term. Home exercise with advice was
never commenced treatment (all in the medication group)
superior to medication in both the short and long term for
and 6 of whom stopped participating in the study after
satisfaction with care and for long-term medication use
they received treatment (2 in the medication group, 1 in
(1.00 fewer days per week of use at week 52 [CI, 0.27 to
the SMT group, and 3 in the HEA group). We first im-
puted values to the missing responses of these 12 partici-
Appendix Table 4 shows changes in cervical spine mo-
pants by using the mean percentage reduction from base-
tion after 4 and 12 weeks. Overall, the greatest changes in
line at all time points specific to the group to which they
cervical spine motion were observed in the HEA group.
belonged. Then, we imputed the rest of the missing data
Results of the group differences in 3-dimensional cervical
during treatment and the 2 posttreatment follow-up time
spine motion patterns will be reported elsewhere.
points by using the SAS multiple imputation strategy, on
One of the participants indicated that someone tried
the assumption that the data were missing at random. The
to influence his responses. Because this was a week-52
results of the analyses with imputed values changed the
6 3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) www.annals.org Downloaded From: http://annals.org/ on 10/19/2012
Conservative Interventions for Acute and Subacute Neck Pain Original Research
Table 3—Continued Between-Group Difference (95% CI) SMT Group Minus SMT Group Minus HEA Group Minus Medication Group HEA Group Medication Group
estimates of group differences very little, and all statistically
drowsiness. Dry mouth, cognitive disturbances, rash, con-
significant differences remained the same.
gestion, and disturbed sleep were less commonly reported. Nonstudy Treatments
During the 12-week intervention, 4 participants (3 in
DISCUSSION
the medication group and 1 in the HEA group) reported
In the absence of available criteria for what constitute
visits to other health care providers for their neck pain. By
clinically important group differences, several factors
week 52, about equal numbers of persons in each treat-
should be considered in aggregate. This includes the statis-
ment group sought additional health care after completing
tical significance of the results of our primary efficacy anal-
the treatment phase (18 in the SMT group, 14 in the
ysis, as well as those of the responder and secondary out-
medication group, and 17 in the HEA group).
comes analyses. The durability of the treatment effect, the
Adverse Events
safety and tolerability of the interventions, and the partic-
No serious adverse events were reported in the study.
ipant’s ability and willingness to adhere to treatment
Expected, nonserious adverse events that are typical to
should also be taken into account (56).
these treatments did occur and were all transient in nature,
In this trial of SMT versus medication or HEA for the
requiring little or no change to activity levels. Forty percent
treatment of acute and subacute neck pain, SMT seemed
of the SMT group and 46% of the HEA group reported
more effective than medication according to various mea-
adverse events, primarily musculoskeletal pain. Paresthesia,
sures of neck pain and function. However, SMT demon-
stiffness, headache, and crepitus were less frequent (Appen-
strated no apparent benefits over HEA. Spinal manipula-
dix Table 5, available at www.annals.org). Sixty percent of
tion therapy and HEA led to similar short- and long-term
participants in the medication group reported side effects,
outcomes, but participants who received medication seemed
the most common being gastrointestinal symptoms and
to fare worse, with a consistently higher use of pain med-
www.annals.org
3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) 7 Downloaded From: http://annals.org/ on 10/19/2012
Original Research Conservative Interventions for Acute and Subacute Neck Pain
ication for neck pain throughout the trial’s observation
sessors, and long-term postrandomization follow-up (6 and
period. The performance of the HEA group, which has the
12 months.) It also has limitations. First, participants and
potential for cost savings over both SMT and medication
providers could not be blinded because of the nature of the
treatments received and delivered. Second, no criteria are
Participants and clinicians consider the potential for
available to define clinically important group differences
side effects when making treatment decisions. Although
for the different outcomes. Finally, our study does not
the frequency of reported side effects was similar among
differentiate between the specific effects of treatment and
the 3 groups (41% to 58%), the nature of the side effects
the contextual (nonspecific) effects, including participant–
differed, with participants in the SMT and HEA groups
provider interactions and expectations. This study was in-
reporting predominantly musculoskeletal events and those
tended to be pragmatic in nature and to answer clinical
in the medication group reporting side effects that were
questions regarding commonly used treatment approaches
more systemic in nature. Of note, participants in the med-
by approximating how they are delivered in practice.
ication group reported higher levels of medication use after
For participants with acute and subacute neck pain,
SMT was more effective than management with medica-
Most participants had subacute neck pain that lasted
tion in both the short and long term; however, a few ses-
more than 4 weeks, beyond the time when pain will prob-
sions of supervised instruction in HEA resulted in similar
ably resolve spontaneously, and evidence suggests that one
half of persons with nonspecific neck pain continue to haveneck pain 1 year after the original report (57). Although
From Northwestern Health Sciences University, Pain Management and
our trial did not have a placebo group, the observed results
Rehabilitation Center, and Berman Center for Outcomes and Clinical
are unlikely to be due to natural history alone.
Research at the Minneapolis Medical Research Foundation, Minneapo-lis, Minnesota.
To date, few clinical trials have assessed the effective-
ness of noninvasive interventions for acute and subacute
Acknowledgment: The authors thank the study staff for dedicating sub-
neck pain not associated with whiplash; therefore, no
stantial time and energy to ensure successful completion of the trial, as
evidence-informed first-line therapy for this type of neck
well as Brent Leininger, DC, and Jennifer Hart, MS, for their technical
assistance in preparing this manuscript.
the Cochrane Library, using the terms spinal manipulationGrant Support: By the National Institutes of Health’s National Center for Complementary and Alternative Medicine (grant R01 AT000707).
and neck pain, to identify all randomized trials publishedfrom 1960 to 2011 that evaluated SMT for acute or sub-
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline
acute neck pain. We found 3 trials (58 – 61). Our trial is
.org/authors/icmje/ConflictOfInterestForms.do?msNumϭM11-0299.
most similar to that of Hoving and colleagues (58, 59), inwhich 75% of patients had neck pain of less than 12 weeks’
Reproducible Research Statement: Study protocol and statistical code:
duration. Six weeks of manual therapy (mainly spinal mo-
Available from Dr. Bronfort (e-mail, [email protected]). Data set:
bilization) was compared with usual medical care (advice,
home exercise, and medication). The investigators found
Requests for Single Reprints:
manual therapy to be superior to medical care, with reduc-
Center for Clinical Studies, Northwestern Health Sciences Univer-
tions in pain and disability similar to what we observed at
sity, 2501 West 84th Street, Bloomington, MN 55431; e-mail,
8 weeks but less than what we observed at 12 weeks. Pool
and colleagues (60) compared 6 weeks of manual therapy(up to 6 sessions) with 6 weeks of a behavioral-graded
Current author addresses and author contributions are available at
activity program (maximum of 18 sessions of 30 minutes
each). At 3 months, the behavioral-graded activity programdemonstrated slightly larger reductions in pain and disabil-ity than manual therapy; however, the magnitude of im-
References
provements in the behavioral program was similar to that
1. Coˆte´ P, Cassidy JD, Carroll L. The Saskatchewan health and back pain survey. The prevalence of neck pain and related disability in Saskatchewan adults.
found for SMT in our trial. Finally, Cleland and colleagues
Spine (Phila Pa 1976). 1998;23:1689-98. [PMID: 9704377]
(61) found thrust mobilization and manipulation to be
2. Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world
more effective than nonthrust manual treatment in pa-
population: a systematic critical review of the literature. Eur Spine J. 2006;15:
tients with subacute neck pain. When considered in the
834-48. [PMID: 15999284] 3. Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD,
context of the existing evidence, our results suggest that
Guzman J, et al; Bone and Joint Decade 2000 –2010 Task Force on Neck Pain
SMT and HEA both constitute viable treatment options
and Its Associated Disorders. The burden and determinants of neck pain in the
for managing acute and subacute mechanical neck pain.
general population: results of the Bone and Joint Decade 2000-2010 Task Force
Our study has several strengths, including a rigorous
on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008;33:S39-51. [PMID: 18204398]
concealed randomization procedure, use of recommended
4. Guzman J, Haldeman S, Carroll LJ, Carragee EJ, Hurwitz EL, Peloso P,
reliable outcome measures, masked objective outcomes as-
et al; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its 8 3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) www.annals.org Downloaded From: http://annals.org/ on 10/19/2012
Conservative Interventions for Acute and Subacute Neck Pain Original Research
Associated Disorders. Clinical practice implications of the Bone and Joint De-
24. McKenzie R. Treat Your Own Neck. 3rd ed. Waikanae, New Zealand:
cade 2000-2010 Task Force on Neck Pain and Its Associated Disorders: from
concepts and findings to recommendations. Spine (Phila Pa 1976). 2008;33:
25. Bronfort G, Evans R, Nelson B, Aker PD, Goldsmith CH, Vernon H. A
randomized clinical trial of exercise and spinal manipulation for patients with
5. Riddle DL, Schappert SM. Volume and characteristics of inpatient and am-
chronic neck pain. Spine (Phila Pa 1976). 2001;26:788-97. [PMID: 11295901]
bulatory medical care for neck pain in the United States: data from three national
26. Jaeschke R, Singer J, Guyatt GH. A comparison of seven-point and visual
surveys. Spine (Phila Pa 1976). 2007;32:132-40. [PMID: 17202904]
analogue scales. Data from a randomized trial. Control Clin Trials. 1990;11:43-
6. Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and
alternative medicine use among adults: United States, 2002. Adv Data. 2004:1-
27. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity:
a comparison of six methods. Pain. 1986;27:117-26. [PMID: 3785962]
7. Coulter ID, Hurwitz EL, Adams AH, Genovese BJ, Hays R, Shekelle PG.
28. Huskisson EC. Measurement of pain. Lancet. 1974;2:1127-31. [PMID:
Patients using chiropractors in North America: who are they, and why are they in
chiropractic care? Spine (Phila Pa 1976). 2002;27:291-6. [PMID: 11805694]
29. Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and
8. Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth
validity of the visual analogue scale. Pain. 1983;16:87-101. [PMID: 6602967]
W, et al. Expenditures and health status among adults with back and neck
30. Vernon H, Mior S. The neck disability index: a study of reliability and
problems. JAMA. 2008;299:656-64. [PMID: 18270354]
validity. J Manipulative Physiol Ther. 1991;14:409-15. [PMID: 1834753]
9. Coˆte´ P, van der Velde G, Cassidy JD, Carroll LJ, Hogg-Johnson S, Holm
31. Koes BW, Bouter LM, van Mameren H, Essers AH, Verstegen GM, Hof- LW, et al; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its huizen DM, et al. A blinded randomized clinical trial of manual therapy and Associated Disorders. The burden and determinants of neck pain in workers:
physiotherapy for chronic back and neck complaints: physical outcome measures.
results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and
J Manipulative Physiol Ther. 1992;15:16-23. [PMID: 1531487]
Its Associated Disorders. Spine (Phila Pa 1976). 2008;33:S60-74. [PMID:
32. Deyo RA, Walsh NE, Martin DC, Schoenfeld LS, Ramamurthy S. A
controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise
10. Coˆte´ P, Kristman V, Vidmar M, Van Eerd D, Hogg-Johnson S, Beaton D,
for chronic low back pain. N Engl J Med. 1990;322:1627-34. [PMID: 2140432]
et al. The prevalence and incidence of work absenteeism involving neck pain: a
33. Hansen FR, Bendix T, Skov P, Jensen CV, Kristensen JH, Krohn L,
cohort of Ontario lost-time claimants. Spine (Phila Pa 1976). 2008;33:S192-8. et al. Intensive, dynamic back-muscle exercises, conventional physiotherapy, or
placebo-control treatment of low-back pain. A randomized, observer-blind trial.
11. Linton SJ, Hellsing AL, Hallde´n K. A population-based study of spinal pain
Spine (Phila Pa 1976). 1993;18:98-108. [PMID: 8434332]
among 35-45-year-old individuals. Prevalence, sick leave, and health care use.
34. Bronfort G, Goldsmith CH, Nelson CF, Boline PD, Anderson AV. Trunk
Spine (Phila Pa 1976). 1998;23:1457-63. [PMID: 9670397]
exercise combined with spinal manipulative or NSAID therapy for chronic lowback pain: a randomized, observer-blinded clinical trial. J Manipulative Physiol
12. Gross AR, Hoving JL, Haines TA, Goldsmith CH, Kay T, Aker P, et al; Cervical overview group. Manipulation and mobilisation for mechanical neck
35. Daffner SD, Hilibrand AS, Hanscom BS, Brislin BT, Vaccaro AR, Albert
disorders. Cochrane Database Syst Rev. 2004:CD004249. [PMID: 14974063]
TJ. Impact of neck and arm pain on overall health status. Spine (Phila Pa 1976).
13. Kay TM, Gross A, Goldsmith C, Santaguida PL, Hoving J, Bronfort G; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane
36. Dvorak J, Antinnes JA, Panjabi M, Loustalot D, Bonomo M. Age and
Database Syst Rev. 2005:CD004250. [PMID: 16034925]
gender related normal motion of the cervical spine. Spine (Phila Pa 1976). 1992;
14. Peloso P, Gross A, Haines T, Trinh K, Goldsmith CH, Burnie S; Cervical Overview Group. Medicinal and injection therapies for mechanical neck disor-
37. Petersen CM, Johnson RD, Schuit D. Reliability of cervical range of motion
ders. Cochrane Database Syst Rev. 2007:CD000319. [PMID: 17636629]
using the OSI CA 6000 spine motion analyser on asymptomatic and symptom-
15. Gross A, Miller J, D’Sylva J, Burnie SJ, Goldsmith CH, Graham N, et al.
atic subjects. Man Ther. 2000;5:82-8. [PMID: 10903583]
Manipulation or mobilisation for neck pain. Cochrane Database Syst Rev. 2010:
38. Evans R, Bronfort G, Nelson B, Goldsmith CH. Two-year follow-up of a
randomized clinical trial of spinal manipulation and two types of exercise for
16. Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S,
patients with chronic neck pain. Spine (Phila Pa 1976). 2002;27:2383-9. et al. Scientific monograph of the Quebec Task Force on Whiplash-Associated
Disorders: redefining “whiplash” and its management. Spine (Phila Pa 1976).
39. Littell RC, Milliken GA, Stroup WW, Wolfinger RD. SAS System for
Mixed Models. Cary, NC: SAS Publications; 1996.
17. Guzman J, Hurwitz EL, Carroll LJ, Haldeman S, Coˆte´ P, Carragee EJ,
40. Verbeke G, Molenberghs G, eds. Linear Mixed Models in Practice: A SAS- et al; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its
Oriented Approach. New York: Springer; 1997. Associated Disorders. A new conceptual model of neck pain: linking onset,
41. Brown H, Prescott R. Applied Mixed Models in Medicine. New York: J
course, and care: the Bone and Joint Decade 2000-2010 Task Force on Neck
Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008;33:S14-23.
42. Jennrich RI, Schluchter MD. Unbalanced repeated-measures models with
structured covariance matrices. Biometrics. 1986;42:805-20. [PMID: 3814725]
18. Pocock SJ. Clinical Trials. A Practical Approach. Chichester, United King-
43. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate
adjustment and baseline comparisons in clinical trial reporting: current practice
19. Evans R, Bronfort G, Bittell S, Anderson AV. A pilot study for a randomized
and problems. Stat Med. 2002;21:2917-30. [PMID: 12325108]
clinical trial assessing chiropractic care, medical care, and self-care education for
44. Yu LM, Chan AW, Hopewell S, Deeks JJ, Altman DG. Reporting on
acute and subacute neck pain patients. J Manipulative Physiol Ther. 2003;26:
covariate adjustment in randomised controlled trials before and after revision of
the 2001 CONSORT statement: a literature review. Trials. 2010;11:59. [PMID:
20. Bergmann TF, Peterson DH. Chiropractic Technique: Principles and Pro-
cedures. 3rd ed. St. Louis: Mosby; 2011.
45. Sherman KJ, Cherkin DC, Erro J, Miglioretti DL, Deyo RA. Comparing
21. Seffinger MA, Najm WI, Mishra SI, Adams A, Dickerson VM, Murphy
yoga, exercise, and a self-care book for chronic low back pain: a randomized,
LS, et al. Reliability of spinal palpation for diagnosis of back and neck pain: a
controlled trial. Ann Intern Med. 2005;143:849-56. [PMID: 16365466]
systematic review of the literature. Spine (Phila Pa 1976). 2004;29:E413-25.
46. Levin J, Serlin R, Seaman M. A controlled, powerful multiple-comparison
strategy for several situations. Psychol Bull. 1994;115:153-9.
22. Tierney LM, McPhee SJ, Papadakis MA. Current Medical Diagnosis and
47. Little RJ, Rubin DB. Statistical Analysis with Missing Data. 2nd ed. New
Treatment. 36th ed. Stamford, CT: Appleton & Lange; 1997.
23. Scholten-Peeters GG, Bekkering GE, Verhagen AP, van Der Windt DA,
48. Rubin DB. Inference and missing data. Biometrika 1976;63:581-92. Lanser K, Hendriks EJ, et al. Clinical practice guideline for the physiotherapy of
49. Ostelo RW, de Vet HC. Clinically important outcomes in low back pain.
patients with whiplash-associated disorders. Spine (Phila Pa 1976). 2002;27:412-
Best Pract Res Clin Rheumatol. 2005;19:593-607. [PMID: 15949778]
50. Pool JJ, Ostelo RW, Hoving JL, Bouter LM, de Vet HC. Minimal clinically www.annals.org
3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) 9 Downloaded From: http://annals.org/ on 10/19/2012
Original Research Conservative Interventions for Acute and Subacute Neck Pain
important change of the Neck Disability Index and the Numerical Rating Scale
chronic pain clinical trials: IMMPACT recommendations. Pain. 2009;146:238-
for patients with neck pain. Spine (Phila Pa 1976). 2007;32:3047-51. [PMID:
57. Hill J, Lewis M, Papageorgiou AC, Dziedzic K, Croft P. Predicting persis-
51. Sherman KJ, Cherkin DC, Hawkes RJ, Miglioretti DL, Deyo RA. Ran-
tent neck pain: a 1-year follow-up of a population cohort. Spine (Phila Pa 1976).
domized trial of therapeutic massage for chronic neck pain. Clin J Pain. 2009;
58. Hoving JL, Koes BW, de Vet HC, van der Windt DA, Assendelft WJ, van
52. Fritz JM, Hebert J, Koppenhaver S, Parent E. Beyond minimally important Mameren H, et al. Manual therapy, physical therapy, or continued care by a
change: defining a successful outcome of physical therapy for patients with low
general practitioner for patients with neck pain. A randomized, controlled trial.
back pain. Spine (Phila Pa 1976). 2009;34:2803-9. [PMID: 19910868]
Ann Intern Med. 2002;136:713-22. [PMID: 12020139]
53. Bendtsen L, Bigal ME, Cerbo R, Diener HC, Holroyd K, Lampl C, et al;
59. Hoving JL, de Vet HC, Koes BW, Mameren H, Deville´ WL, van der International Headache Society Clinical Trials Subcommittee. Guidelines for Windt DA, et al. Manual therapy, physical therapy, or continued care by the
controlled trials of drugs in tension-type headache: second edition. Cephalalgia.
general practitioner for patients with neck pain: long-term results from a prag-
2010;30:1-16. [PMID: 19614696] 54. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M,
matic randomized clinical trial. Clin J Pain. 2006;22:370-7. [PMID: 16691091]
et al. Interpreting change scores for pain and functional status in low back pain:
60. Pool JJ, Ostelo RW, Ko¨ke AJ, Bouter LM, de Vet HC. Comparison of the
towards international consensus regarding minimal important change. Spine
effectiveness of a behavioural graded activity program and manual therapy in
(Phila Pa 1976). 2008;33:90-4. [PMID: 18165753]
patients with sub-acute neck pain: design of a randomized clinical trial. Man
55. Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpret-
ing treatment effects in randomised trials. BMJ. 1998;316:690-3. [PMID:
61. Cleland JA, Glynn P, Whitman JM, Eberhart SL, MacDonald C, Childs JD. Short-term effects of thrust versus nonthrust mobilization/manipulation di-
56. Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB,
rected at the thoracic spine in patients with neck pain: a randomized clinical trial. Cowan P, et al. Interpreting the clinical importance of group differences in
Phys Ther. 2007;87:431-40. [PMID: 17341509]
Register to receive the table of contents via e-mail at www.annals.org/site/misc/alerts.xhtml. You may choose to receive any or all of thefollowing:
Notification that a new issue of Annals of Internal Medicine is onlineComplete table of contents for new issuesSpecial announcements from ACP and AnnalsCME coursesEarly-release articles
10 3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) www.annals.org Downloaded From: http://annals.org/ on 10/19/2012 Annals of Internal Medicine Current Author Addresses: Drs. Bronfort and Evans: Wolfe-Harris Author Contributions: Conception and design: G. Bronfort, R. Evans,
Center for Clinical Studies, Northwestern Health Sciences University,
2501 West 84th Street, Bloomington, MN 55431.
Analysis and interpretation of the data: G. Bronfort, R. Evans, K.H.
Dr. Anderson: Medical Pain Management, 5775 Wayzata Boulevard,
Suite 110, St. Louis Park, MN 55416.
Drafting of the article: G. Bronfort, R. Evans, Y. Bracha, R.H. Grimm.
Mr. Svendsen: 900 Forest Avenue, Birmingham, MI 48009.
Critical revision of the article for important intellectual content:
Mr. Bracha: Division of Health Policy and Clinical Effectiveness, Cin-
G. Bronfort, R. Evans, Y. Bracha, R.H. Grimm.
cinnati Children’s Hospital, 3333 Burnet Avenue, MLC 5040, Cincin-
Final approval of the article: G. Bronfort, R. Evans, A.V. Anderson,
Y. Bracha, R.H. Grimm. Provision of study materials or patients: A.V. Anderson.
Dr. Grimm: Berman Center for Outcomes and Clinical Research, 825
Statistical expertise: G. Bronfort, K.H. Svendsen, Y. Bracha,
South 8th Street, Suite 440, Minneapolis, MN 55404.
R.H. Grimm. Obtaining of funding: G. Bronfort, R. Evans, R.H. Grimm. Administrative, technical, or logistic support: G. Bronfort, R. Evans. Collection and assembly of data: R. Evans, A.V. Anderson. www.annals.org
3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) W-1 Downloaded From: http://annals.org/ on 10/19/2012 Medication Difference Medication Between-Group Disability Medication Participant-Rated Baseline Medication Differences Between-Group 1. Table medication disability Appendix Variable Duration W-2 3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) www.annals.org Downloaded From: http://annals.org/ on 10/19/2012 Medication Difference Between-Group Satisfaction Medication Improvement Participant-Rated Medication Differences Between-Group 2. improvement Table satisfaction Appendix Variable www.annals.org
3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) W-3 Downloaded From: http://annals.org/ on 10/19/2012 Medication Difference Between-Group Component Medication Physical Baseline Medication Differences Between-Group 3. Table component component Appendix Physical W-4 3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) www.annals.org Downloaded From: http://annals.org/ on 10/19/2012 Medication Difference Between-Group Medication Cervical Baseline Medication Differences Between-Group 4. Table extension† bending§ Appendix Rotation‡ www.annals.org
3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) W-5 Downloaded From: http://annals.org/ on 10/19/2012 Appendix Table 5. Adverse Events During the 12-Week Treatment Period* SMT Group Medication Group HEA Group Absolute Difference (95% CI), percentage points (n ؍ 84)† SMT Group Minus SMT Group Minus HEA Group Minus Medication Group HEA Group Medication Group
HEA ϭ home exercise with advice; SMT ϭ spinal manipulation therapy.
* Data are the numbers (percentages) of adverse events. Participants who reported an event at least once over the course of treatment; participants could report Ն1 type of
event. † We excluded 6 participants in this group from analysis because they received no treatment. W-6 3 January 2012 Annals of Internal Medicine Volume 156 • Number 1 (Part 1) www.annals.org Downloaded From: http://annals.org/ on 10/19/2012
Congratulations on having registered in The Landmark Forum. The Landmark Forum is an enquiry into one’s relationship to life—to one’s self, family, teachers, school and peers. The Landmark Forum is designed as an opportunity for people to be more powerful, freely expressed and effective in dealing with life. • PARTICIPANTS AND PARENTS: Each one of you will have sections of this form t
Newsletter 2008-12 der AG Medizinrecht im Deutschen AnwaltVerein Liebe Kolleginnen, liebe Kollegen, die Mitglieder Ihrer Arbeitsgemeinschaft wünschen Ihnen eine besinnliche Vorweihnachtszeit und ein ruhiges Fest im Kreise Ihrer Familie und Freunden. Ihre Rita Schulz-Hillenbrand Rechtsanwältin Fachanwältin für Medizinrecht Arzneimittel-, Medizinprodukte- und Apothekenrecht