Man Ther. 2015 (Apr); 20 (2): 335–341 ~ FULL TEXT
Michele Maiers, Roni Evans, Jan Hartvigsen, Craig Schulz, Gert Bronfort
Wolfe-Harris Center for Clinical Studies,
Northwestern Health Sciences University,
2501 W 84th Street, Bloomington, MN 55431, USA.
Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making. This paper provides a detailed report of AE experienced by elderly participants in a randomized comparative effectiveness trial of SMT and exercise for chronic NP. AE data, consistent with CONSORT recommendations, were collected on elderly participants who received 12 weeks of SMT with home exercise, supervised plus home exercise, or home exercise alone. Standardized questions were asked at each treatment; participants were additionally encouraged to report AE as they occurred. Qualitative interviews documented participants' experiences with AE. Descriptive statistics and content analysis were used to categorize and report these data. Compliance was high among the 241 randomized participants. Non-serious AE were reported by 130/194 participants. AE were reported by three times as many participants in supervised plus home exercise, and nearly twice as many as in SMT with home exercise, as in home exercise alone. The majority of AE were musculoskeletal in nature; several participants associated AE with specific exercises. One incapacitating AE occurred when a participant fell during supervised exercise session and fractured their arm. One serious adverse event of unknown relationship occurred to an individual who died from an aneurysm while at home. Eight serious, non-related AE also occurred. Musculoskeletal AE were common among elderly participants receiving SMT and exercise interventions for NP. As such, they should be expected and discussed when developing care plans.
KEYWORDS: Adverse events; Elderly; Exercise; Spinal manipulation
From the Full-Text Article:
Neck pain is common and a growing public health concern
among seniors (Vaupel et al., 1998; Hartvigsen et al., 2003, 2004).
Spinal manipulative therapy (SMT) and exercise are two nonpharmacological
therapies with demonstrated effectiveness for
neck pain in the general population (Hurwitz et al., 2008; Miller
et al., 2010; Kay et al., 2012) including the elderly (Maiers et al.,
2013). When considering the clinical utility of any intervention, it
is essential to weigh the balance of benefit versus harm (Ioannidis
et al., 2004). This may be of greater consequence for an elderly
population, where risk of harm is heightened due to general decline
in health, competing co-morbid conditions, poorer balance, and
slower recovery times. Further, there has been a call for increased
research of non-pharmacological treatments in the elderly to
minimize the risks associated with pain medication, including
complications associated with drug interactions (Fitzcharles et al.,
2010; Abdulla et al., 2013).
There are few clinical trials reporting AE associated with SMT
and exercise (Gross et al., 2010; Kay et al., 2012) and fewer still that
include the elderly (Dougherty et al., 2012). While generally
underreported in the literature, studies report AE in 31e56% of
adults receiving SMT. These are typically described as non-serious,
transient, and musculoskeletal in nature (Cagnie et al., 2004;
Hurwitz et al., 2004; Thiel et al., 2007; Rubinstein et al., 2008;
Eriksen et al., 2011; Bronfort et al., 2012; Walker et al., 2013). A
recent randomized clinical trial (RCT) investigated the occurrence
of AE associated with usual chiropractic care (primarily manipulation,
soft tissue therapy, range of motion exercises, and mobilization)
compared to sham treatment. Among adults aged 20e85
with spine pain, the authors found no difference in relative risk.
Further, the authors concluded that AE after chiropractic treatment may likely be the result of natural history variation and nonspecific
effects (Walker et al., 2013). While the exercise literature has more
studies of AE among older adults, it too suffers from underreporting.
One systematic review examined trials investigating
progressive strength training in adults over 60 years of age (Liu and
Latham, 2010). Among 121 studies identified, 68 assessed AE, 43 of
which reported that AE occurred. The majority of AE were
musculoskeletal in nature, including muscle strain and joint pain.
Serious AE were more rare, and were most commonly falls and
AE were systematically collected on a sub-sample of individuals
participating in an RCT performed by our group, comparing the
effectiveness of spinal manipulative therapy and exercise interventions
among seniors with chronic neck pain (Maiers et al.,
2013). The purpose of this paper is to report on the AE that were
recorded, including occurrence, categorization by seriousness, and
type of adverse event by intervention group. Additionally,
An RCT was conducted to determine the relative short- and
long-term effectiveness of spinal manipulative therapy with home
exercise (SMT with home exercise), supervised rehabilitative exercise
and home exercise (supervised plus home exercise), and
home exercise alone for seniors with neck pain (Maiers et al., 2007).
Participants needed to have a primary complaint of weekly, mechanical
neck pain with an average rating of ≥3 (0–10) over the
previous two weeks. Additional inclusion criteria consisted of age
65 years or older, independent ambulation and community
dwelling, stable pain medication, and a score of ≥20 on the Folstein
Mini-Mental State Examination (Folstein et al., 1975).
Approval for the trial was granted by the institutional review
boards of all participating institutions. Informed consent was obtained
from all participants. Risks described in the consent form
included pain and muscle soreness with any of the treatments. In
addition, it was noted that, while rare, cervical spinal manipulation
had been associated with vertebrobasilar stroke (Cassidy et al.,
Home exercise consisted of four, 45–60 min sessions provided
by 9 practitioners (exercise therapists or chiropractors) certified by
study investigators to give instruction on standardized exercises
and patient education (Maiers et al., 2007). Sessions included basic
pain management and postural information and practical demonstrations
of body mechanics for common activities of daily living.
Simple neck and back exercises to improve flexibility, balance, and
coordination were demonstrated and prescribed to do daily at
home (American Geriatrics Society Panel on Exercise and
Osteoarthritis, 2001). These exercises were individualized based
on patient ability and included graded progressions once 20 repetitions
of an exercise could be done with proper form.
Spinal manipulative therapy
Spinal manipulative therapy (SMT) was delivered by 11 chiropractors
with a minimum 5 years of clinical practice (Maiers et al.,
2007). Areas of the cervical spine treated were identified by pain
provocation (Seffinger et al., 2004) and static/motion palpation
(Haldeman, 1983) findings. Treatment consisted primarily of
manual SMT to induce joint motion, using a diversified, thrust
technique. Mobilization, a low velocity type of joint oscillation, was
less frequently employed (Peterson & Bergmann, 2011). The patient
position, provider contact, and level of force applied were modified
to accommodate the age and physical condition of the study participants.
Adjunct therapies included limited use of light soft tissue
massage, assisted stretching, and hot and cold packs applied to the
cervical and upper thoracic area. The number and frequency of
treatments was determined by the individual chiropractor, with a
maximum of 20 visits.
Supervised rehabilitative exercise
Supervised rehabilitative exercise consisted of 20, 1-h exercise
sessions supervised by one of 9 exercise therapists certified to
deliver the intervention by study investigators (Maiers et al., 2007).
Exercises were individualized according to patients' abilities in
terms of load and repetitions. Supervised exercise sessions
expanded on the home exercise program with additional
strengthening exercises for the neck and upper torso and progressions
to participant tolerance. Exercise therapists supervised
each session to monitor form, modify exercises, and provide
encouragement to complete repetitions.
Adverse events data collection
Consistent with CONSORT recommendations (Ioannidis et al.,
2004), AE are defined in this paper as “side effects that are
Several methods were used to collect AE data on study participants,
including standardized solicitation by providers, unsolicited
reporting by patients as AE occurred, and qualitative interviews.
Standardized questions were employed with the entire sample of
individuals in the SMT with home exercise group. Due to a delay in
protocol implementation, AE questions were collected in a consecutive
convenience sub-sample of those in the supervised plus home
exercise (n = 59) and home exercise alone (n = 57) groups. Questions
were asked by providers prior to each treatment visit. Inquiry began
with, “Did you experience any side effects or problems after the last
treatment?” A simple “yes” or “no” response from the patient was
elicited. If “yes,” the patient was asked to describe their experience,
which was recorded in a narrative format in the treatment notes. Interventionsweremodified
if necessary, as per the study providerwith
consultation fromthe investigative team. Study participantswere also
encouraged to report AE as they occurred outside their treatment
appointments by contacting study staff. In these instances, study cliniciansmade
contactwiththeparticipant todocument clinical details.
An AE was classified as “severe” if it resulted in incapacitation
for more than 24 h, resulting in loss of work, bed rest, or decreased
social activities. An adverse event was defined as “serious” if it
resulted in permanent or severe disability, hospitalization, or death
Severe and serious AE triggered extensive evaluation to determine
possible causal relationship, adjudicated by the principal investigator
and co-investigative team, who were not blinded to treatment
allocation. All serious AE were reported to the IRB.
Qualitative interviews, conducted with all participants at the
end of the 12-week intervention phase, created an additional,
incidental opportunity to collect information about AE (Maiers
et al., 2007). Assured confidentiality, those who consented to be
recorded were asked semi-structured questions about satisfaction
with care, perceived change, whether study care was worthwhile,
and what was liked most and least about study treatment.
Descriptive statistics were used to analyze baseline and clinical
characteristics of study participants, as well as AE data collected during treatment encounters and compliance with study intervention.
Categories of AE were defined a priori, reflecting those
most commonly reported in the literature (Rubinstein et al., 2008;
Liu and Latham, 2010; Eriksen et al., 2011) and added to or revised
using an iterative process based on those reported by this sample.
Content analysis was used to analyze transcripts of qualitative
interview data. Themes that emerged from analysis were organized
in NVivo® v9.2 (QSR International Pty Ltd, Victoria, Australia) to
quantify their occurrence and explore relationships among them
(Miles and Huberman, 1994). Interviews in which AE were indicated
in response to any question were identified and used to
inform this paper. Other themes that emerged from the qualitative
analysis will be reported in a subsequent publication.
A total of 241 individuals were enrolled in the study, with
comparable baseline demographic and clinical characteristics
across groups (Table 1). Results showed statistically significant
between-group differences in favor of SMT with home exercise
after 12 weeks of treatment, compared to both supervised plus
home exercise, and home exercise alone. Compliance, defined as
attending 80% of the recommended sessions, was generally high in
all three intervention groups. The average number of SMT visitswas
15.1 (range 5–19); the average number of supervised exercise
sessions was 16.6 (range 0–19). Compliance with exercises done at
home was not measured in any of the groups. AE data collection
rates are reported in Figure 1.
Non-serious adverse events
AE were reported by 130/194 participants on whom complete
AE data was collected, with 73% of those reporting 1–2 different
types of AE (see Figure 2). Table 2 describes the different types of AE
and their definitions, in addition to their incidence in each
randomly assigned group. Compared to the home exercise alone
group (n = 40), participants randomized to the supervised plus
home exercise group reported three times as many AE (n = 140),
and participants randomized to the SMT with home exercise group
reported almost twice as many AE (n = 74). The overwhelming
majority of AE were musculoskeletal in nature, with over one-third
reported as an aggravation of neck pain symptoms. Importantly, no
participants withdrew from study participation due to non-serious
One severe, related adverse event occurred during a supervised
exercise session when a participant lost his balance and fell to the
floor. Imaging confirmed a fracture of the radial head; the participant
used a soft sling to immobilize his arm for one week.
Serious adverse events
One serious adverse event of unknown relationship occurred to
an individual during the intervention phase. This individual died at
home of an abdominal aortic aneurysm approximately one week
following his fourth treatment session in the supervised plus home
exercise group. It is unknown when he had last performed home
Additionally, eight serious AE occurred during the study and
were judged likely to be non-related by study investigators due to
their nature and lack of temporal relationship. They include
bradycardia and arrhythmia (n = 2) and myocardial infarction
(n = 1) in the chiropractic with home exercise group; pneumonia
(n = 1), stroke (n = 1), and tachycardia (n = 1) in the supervised
plus home exercise group; and bladder cancer (n = 1) and stroke
(n = 1) in the home exercise group.
Two participants withdrew from the intervention phase due to
serious, non-related AE experienced during the intervention phase:
one post-stroke; a second due to pneumonia.
Qualitative interview results
During the post-treatment phase interviews, AE were noted by
38/222 participants, ten of whom raised the issue of their experiences
with AE across multiple questions. Aggravation of NP was
most commonly cited (n = 15), followed by an increase in pain: in
general (n = 9), in the lower extremity (n = 6), and in the upper
extremity (n = 3). Thirty-four participants inferred an association
between their AE and a specific exercise. Descriptions commonly
included language that minimized concern over the AE, even
accepting AE as a part of treatment: “I did get a sore neck from the
head [retraction against resistance], but they said could happen…I
could feel I had really worked the muscles and they felt kind of sore.”
(home exercise patient #8200) Three individuals qualified their
negative experience by noting that their provider made modifications
to treatment to address AE.
Notably, two participants shared their experience with AE that
had a more dramatic impact on activities and quality of life:
“[Home exercise] made my legs and back and arms and everything
else more sore.
When I have a lot of pain…you get so tired. It takes your energy away.”
SMT with home exercise patient #9654.
“I did exactly what I was supposed to, increased [exercises] gradually,
and then all
of a sudden my neck got so bad…it took me a couple of weeks with a lot of ibuprofen.
I felt like I was a zombie with all that I was taking.”
Home exercise patient #8107.
Four mentioned co-morbidities that they felt impacted their
treatment and were the cause of AE.
“I have no cartilage in my knee joint and the knee would get uncomfortable about
two-thirds of the way through the exercises.”
Supervised plus home exercise patient #11418.
. Two participants who suffered a stroke
while enrolled in this trial received exercise interventions designed
to be mild to moderate in intensity. Both stroke events were
determined to be temporally independent from physical exertion
or exercise activity, and subsequently deemed non-related.
The AE identified in this study were primarily musculoskeletal
or pain related and non-serious. This is consistent with other
literature on SMT and exercise (Thiel et al., 2007; Rubinstein et al.,
2008; Liu and Latham, 2010; Eriksen et al., 2011; Evans et al., 2012; Walker et al., 2013). Moreover, musculoskeletal AE were so common
among study participants that these may be considered
normal reactions to SMT and exercise therapies in this population
and should be expected. The multimodal intervention groups in
this study (supervised plus home exercise and SMT with home
exercise) reported more AE; whether that is attributable to an increase
in the incidence of AE or increased reporting is uncertain.
Aggravated neck pain and muscle soreness were frequently cited,
most notably among those in the supervised plus home exercise
group. It appears that supervision did not mitigate the provocation
of AE among the participants who were randomized to the more
intensive exercise program. While further research would be
needed to determine thresholds of AE risk relative to exercise intensity
in seniors, patients should be made aware of this potential
and informed of self care strategies to cope with transient AE. Of
note, extremity joint aggravation was a commonly reported AE in
this study. Although recommended exercises may focus on the
spine, the possibility of extremity joint pain and soreness should be
discussed with patients, particularly those who have known
arthritic co-morbidities (Neogi and Zhang, 2013).
A patient fall during an exercise session constituted the only
severe, related adverse event. While study providers and staff were mindful of taking measures to minimize the risk of falls in our facility,
this event underscores the need for close supervision and
modification of supervised exercise programs to accommodate
functional limitations of some seniors. This is an important clinical
consideration for providers implementing exercise interventions
with this population.
Patients' perceptions are critical to understanding the experience
of AE and the extent to which individuals perceive their
impact. People tend to underestimate what they consider to be
“common” risk (Moore et al., 2008). There may be a misconception
among some that non-invasive therapies, like SMT and exercise,
are without risk of harm (Carlesso et al., 2011). One qualitative
study of expectations for managing pain induced by exercise and
mobilization found a range of views, from ambivalence and
acceptance of AE as part of the “healing process,” to having a
negative impact on health-related quality of life (Alami et al.,
2011). This study echoed the range of rationales offered by participants
to explain or minimize AE. Participants often normalized
their AE as part of the therapeutic process or identified comorbidities
like arthritis as underlying culprits. While many participants
associated AE with specific exercises, providers were
noted for supporting care with modifications to treatment as
necessary, to patients' satisfaction.
Another qualitative study of manual therapy patients found
greater tolerance for harm when the likelihood of benefit was
perceived to be favorable (Carlesso et al., 2011). Prior to study
treatment, patients in this RCT reported greater expectations for
improvement with the multi-modal groups compared to home
exercise alone. Primary results found a clinically important
decrease in pain in favor of SMT with home exercise compared with
supervised plus home exercise, or home exercise alone, in the
short-term (Maiers et al., 2013). Those receiving SMT with home
exercise reported fewer AE than those in the supervised plus home
exercise group, although less than the home exercise alone group.
Providers should discuss possible risk of harm alongside potential
benefit from SMT and exercise therapies to better inform shared
decision-making by patients (Herxheimer, 2005; Naik et al., 2012).
This conversation can provide patients with important alternatives
to commonly used pharmacological interventions for neck pain,
which may have relatively greater risk of harm (Abdulla et al.,
Stroke is a significant public health concern (US Department of
Health and Human Services, 2003); the risk of stroke occurring as
an adverse event with exercise and SMT has also been raised as an
area of concern (Ernst, 2001, 2002; Mostofsky et al., 2011; Wand et al., 2012; Boyne et al., 2013; Biller et al., 2014). Seniors have a
2e6-fold increase in the risk of stroke during the hours immediately
following moderate or vigorous physical activity (Anderson
et al., 2003; Koton et al., 2004; Krarup et al., 2007; Mostofsky
et al., 2011). Regular exercise appears to be protective for stroke
overall (Mostofsky et al., 2011), and current recommendations
encourage seniors to engage in regular exercise at a level sufficient
to challenge their cardiovascular capacity and functional ability
(American College of Sports Medicine; Centers for Disease Control
and Prevention, 2014)
The incidence of a stroke event associated with SMT is very rare
(Haldeman et al., 2001; Cassidy et al., 2008). Further, caseecontrol
studies demonstrate this association primarily in adults under the
age of 45 (Haynes et al., 2012), suggesting it is a less relevant risk
concern for the elderly. A recent analysis of Medicare data in 1.1
million beneficiaries 65–99 years of age compared the incidence of
stroke with visits for chiropractic cervical spine manipulation
compared to medical primary care. There was no difference in the
incidence of any type of stroke between the two groups, and the
incidence of vertebrobasilar stroke was negligible (Whedon et al.,
Serious AE occurred in similar numbers across the treatment
groups in this study. Although serious AE are infrequent, providers
of SMT and exercise therapy should use clinical indicators with
caution to identify seniors at increased risk. While the most
commonly used screening tests used to identify poor candidates for
SMT lack validity (Hutting et al., 2013; Scholten-Peeters et al.,
2014), a clinical reasoning framework has been proposed in attempt
to guide clinicians through a clinical reasoning process to minimize
risk. Recommendations include taking a thorough patient history
and considering any physical examination findings that may suggest
possible contraindications to care in the context of the full
patient presentation and the individual's preferences (Rushton
et al., 2014). The lack of clear evidence in this area underscores
the need for open communication between providers and patients
about what is and is not known about risk, in addition to clinical
experience and the patients' expectations for care.
This study is important in that it reports on AE occurring during
an RCT. We utilized a detailed protocol to systematically collect AE
information, with clear pathways in place to engage study clinicians,
participants, investigators, project managers, and the IRB.
The design of an RCT may lend itself to better evidence of harms
than from epidemiological research (Ioannidis and Lau, 2002). A
comparison of harms reported in randomized versus nonrandomized
studies across several topics demonstrated that nonrandomized
studies tended to generate more conservative estimates
of harm (Papanikolaou et al., 2006). This may be a disadvantage
to clinicians when advising their patients of risk.
Unfortunately, harm associated with interventions in clinical trials
is commonly underreported (Pitrou et al., 2009; Turner et al., 2011)
and is further complicated by the use of inconsistent terminology
and the absence of reporting standards. Recommendations have
been made by the CONSORT group to improve the reporting of
harms in clinical trials. These include differentiation between side
effects, which do not necessarily imply harm, and AE, defined as
side effects that are harmful (Ioannidis et al., 2004). This paper
complies with CONSORT recommendations for reporting AE.
This study is limited in the strength of generalizations that can
be drawn about AE associated with the therapies used in this study.
While the trial was adequately powered to investigate the
comparative effectiveness of these treatments on pain, the sample
size was too small to detect uncommon AE. A large trial or metaanalysis
of several RCTs would be needed provide adequate power
to address absolute and relative risks of AE among the elderly
with these interventions (Papanikolaou et al., 2006). Further, while
a three-month course of treatment may be typical for these therapies,
this time frame may be too short to detect all possible AE.
Underreporting could be expected in light of our data collection
methods. AE questions were asked by the provider and at the time
of treatment; it is possible that the therapeutic relationship between
provider and participant may have influenced AE reporting.
A standardized process for collecting AE data was late in being
implemented with the supervised and home exercise interventions,
omitting approximately one quarter of those visits. AE
were not asked about specifically during qualitative interviews, nor
were interview comments about AE member-checked after analysis
or triangulated with clinical records. An attempt to attribute AE to
individual trial therapies was not made, primarily because several
therapies were combined in the context of study intervention (e.g.,
SMT with home exercise and supervised plus home exercise).
Non-serious musculoskeletal AE were common among elderly
study participants receiving SMT and exercise interventions for
chronic neck pain. In light of their high occurrence, these AE may be
regarded as normal reactions to SMT and exercise and should be
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